L. Ed. 2
Some reporters only include cases from a specific court. For example, the United States Reports only publishes opinions from the Supreme Court of the United States. On the other hand, some reporters includes cases from courts within a specific geographical region, also known as regional reporters. For example, the South Eastern Reporter publishes reported cases from the southeastern United States, such as Georgia and North Carolina. Moreover, some reporters only publish cases on a specific topic, such as bankruptcy or tax.
In addition to these designations, reporters are also classified as official or unofficial reporters. An official reporter simply means that it is the publication designated by statute or court order as official. Generally it will contain only the text of the opinion. A case published in an unofficial reporter will include the same text of the same case from the official reporter, but it will also include headnotes, topics, key numbers, and other aids to assist researchers.
Parallel Citations
As mentioned above, a case can be published in an official reporter and an unofficial reporter. For that reason, a single case may have 2 or more citations. When a case has more than one citation, the subsequent citations are known as parallell citations. A classic example of this is Bush v. Gore , 531 U.S. 98, 121 S. Ct. 525, 148 L. Ed. 2d 388 (2000).
As one can see, not only is Bush v. Gore cited in the official reporter ( United States Reports ), but also in two unofficial reporters ( Supreme Court Reporter and Lawyer's Edition .
Case citations allow a researcher to find a case quickly and easily. Similiar to statutory citations, all case citations follow the same structured format. This enables researchers to clearly identify the parts of a citation and where to locate the case.
Here is a breakdown of the citation for Roe v. Wade, 410 U.S. 113 (1973).
Roe v. Wade | 410 | U.S. | 113 | 1973 |
Case Name/Party Names | Reporter Volume | Reporter Abbreviation | First Page of Case | Date of Decision |
From this, a researcher can determine that the case Roe v. Wade is located in United States Reports , Volume 410, Page 113.
The process is the same with parallel citations. So if we use the previous example of Bush v. Gore , 531 U.S. 98, 121 S. Ct. 525, 148 L. Ed. 2d 388 (2000), the breakdown would look something like this:
Bush v. Gore | 531 U.S. 98 | 121 S. Ct. 525 | 148 L. Ed. 2d 388 | 2000 |
Case Name/Party Names | , Volume 531, Page 98 | , Volume 121, Page 525 | , Volume 148, Page 388 | Date of Decision |
Thus, a researcher would be able to either of these 3 reporters and find the same case using that reporter's volume and page numbers.
Pinpoint Cite
A researcher may also come across a citation that includes an additional number after the page number. This additional number, numbers or range of numbers are called pinpoint cites. Cases and articles will often use these to refer researchers to exactly where the thought arose from. Here is an example using Bush v. Gore , 531 U.S. 98 (2000).
, 531 U.S. 98, 100 (2000). | Citing specifically to page 100 of Volume 531 of the . |
, 531 U.S. 98, 100, 104 (2000). | Citing specifically to pages 100 and 104 of Volume 531 of the . |
, 531 U.S. 98, 100-102 (2000). | Citing specifically to pages 100 through 102 of Volume 531 of the . |
Federal Reporter Citation
Cases cited to Federal Reporter will have an extra element in the citation to identify the court. Unlike the United States Reports, Supreme Court Reporter, and Lawyer's Edition, which only publishes cases from the Supreme Court of the United States, the Federal Reporter publishes cases from several different courts. Therefore, cases published in these reporters include an element in the parentheses to identify the court that rendered the decision.
Here is an example using United States v. MacDonald , 531 F.2d 196 (4th Cir. 1976).
531 | F.2d | 196 | 4th Cir. | 1976 | |
Name of Case/Party Names | Volume Number | Reporter Abbreviation | First page of case | Deciding Court | Date of decision |
In this case, the deciding court is 4th Cir. which means United States Court of Appeals, 4th Circuit.
Each circuit court will have its own abbreviation which will help the researcher identify the court that rendered the decision. This is important for researchers because they might only want to find cases from their jurisdiction.
Here is a table circuits and their abbreviations used in case citations for the United States Court of Appeals:
First Circuit | 1st Cir. |
Second Circuit | 2d Cir. |
Third Circuit | 3d Cir. |
Fourth Circuit | 4th Cir. |
Fifth Circuit | 5th Cir. |
Sixth Circuit | 6th Cir. |
Seventh Circuit | 7th Cir. |
Eight Circuit | 8th Cir. |
Ninth Circuit | 9th Cir. |
Tenth Circuit | 10th Cir. |
Eleventh Circuit | 11th Cir. |
D.C. Circuit | D.C. Cir. |
Federal Circuit | Fed. Cir. |
Federal Supplement Citation
Similar to the Federal Reporter , cases cited to the Federal Supplemen t will also include an extra element in the citation. Cases cited to the Federal Supplement are United States District Court decisions. Therefore, an extra element will be included in these citations so that a researcher can determine which court rendered the decision.
Here is an example using Jenkins v. Byrd , 103 F. Supp. 2d 1350 (S.D. Ga. 2000).
Jenkins v. Byrd | 103 | F. Supp. 2d | 1350 | S.D. Ga. | 2000 |
Name of Case/Party Names | Volume Number | Reporter Abbreviation | First page of case | Deciding Court | Date of decision |
In this case, the deciding court was the S.D. Ga, which means the United States District Court,Southern District of Georgia.
Because there could be several United States District Courts inside one state, a researcher unfamiliar with a state may need to look up the court abbreviation to determine which court is referenced in the citation.
Here is a brief list of some abbreviations for United States District Courts that might be most useful for researchers in Georgia:
Northern District of Georgia | N.D. Ga. |
Middle District of Georgia | M.D. Ga. |
Southern District of Georgia | S.D. Ga. |
For additional district court abbreviations, please refer to George Butterfield's libguide titled Legal Abbreviations.
Here are some research guides created by other law schools that might be helpful in explaining how to conduct case law legal research.
The term case study refers to both a method of analysis and a specific research design for examining a problem, both of which are used in most circumstances to generalize across populations. This tab focuses on the latter--how to design and organize a research paper in the social sciences that analyzes a specific case.
A case study research paper examines a person, place, event, phenomenon, or other type of subject of analysis in order to extrapolate key themes and results that help predict future trends, illuminate previously hidden issues that can be applied to practice, and/or provide a means for understanding an important research problem with greater clarity. A case study paper usually examines a single subject of analysis, but case study papers can also be designed as a comparative investigation that shows relationships between two or among more than two subjects. The methods used to study a case can rest within a quantitative, qualitative, or mixed-method investigative paradigm.
Case Studies . Writing@CSU. Colorado State University; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010 ; “What is a Case Study?” In Swanborn, Peter G. Case Study Research: What, Why and How? London: SAGE, 2010.
General information about how to choose a topic to investigate can be found under the " Choosing a Research Problem " tab in this writing guide. Review this page because it may help you identify a subject of analysis that can be investigated using a single case study design.
However, identifying a case to investigate involves more than choosing the research problem . A case study encompasses a problem contextualized around the application of in-depth analysis, interpretation, and discussion, often resulting in specific recommendations for action or for improving existing conditions. As Seawright and Gerring note, practical considerations such as time and access to information can influence case selection, but these issues should not be the sole factors used in describing the methodological justification for identifying a particular case to study. Given this, selecting a case includes considering the following:
Eisenhardt, Kathleen M. “Building Theories from Case Study Research.” Academy of Management Review 14 (October 1989): 532-550; Emmel, Nick. Sampling and Choosing Cases in Qualitative Research: A Realist Approach . Thousand Oaks, CA: SAGE Publications, 2013; Gerring, John. “What Is a Case Study and What Is It Good for?” American Political Science Review 98 (May 2004): 341-354; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Seawright, Jason and John Gerring. "Case Selection Techniques in Case Study Research." Political Research Quarterly 61 (June 2008): 294-308.
The purpose of a paper in the social sciences designed around a case study is to thoroughly investigate a subject of analysis in order to reveal a new understanding about the research problem and, in so doing, contributing new knowledge to what is already known from previous studies. In applied social sciences disciplines [e.g., education, social work, public administration, etc.], case studies may also be used to reveal best practices, highlight key programs, or investigate interesting aspects of professional work. In general, the structure of a case study research paper is not all that different from a standard college-level research paper. However, there are subtle differences you should be aware of. Here are the key elements to organizing and writing a case study research paper.
I. Introduction
As with any research paper, your introduction should serve as a roadmap for your readers to ascertain the scope and purpose of your study . The introduction to a case study research paper, however, should not only describe the research problem and its significance, but you should also succinctly describe why the case is being used and how it relates to addressing the problem. The two elements should be linked. With this in mind, a good introduction answers these four questions:
Each of these questions should be addressed in no more than a few paragraphs. Exceptions to this can be when you are addressing a complex research problem or subject of analysis that requires more in-depth background information.
II. Literature Review
The literature review for a case study research paper is generally structured the same as it is for any college-level research paper. The difference, however, is that the literature review is focused on providing background information and enabling historical interpretation of the subject of analysis in relation to the research problem the case is intended to address . This includes synthesizing studies that help to:
III. Method
In this section, you explain why you selected a particular subject of analysis to study and the strategy you used to identify and ultimately decide that your case was appropriate in addressing the research problem. The way you describe the methods used varies depending on the type of subject of analysis that frames your case study.
If your subject of analysis is an incident or event . In the social and behavioral sciences, the event or incident that represents the case to be studied is usually bounded by time and place, with a clear beginning and end and with an identifiable location or position relative to its surroundings. The subject of analysis can be a rare or critical event or it can focus on a typical or regular event. The purpose of studying a rare event is to illuminate new ways of thinking about the broader research problem or to test a hypothesis. Critical incident case studies must describe the method by which you identified the event and explain the process by which you determined the validity of this case to inform broader perspectives about the research problem or to reveal new findings. However, the event does not have to be a rare or uniquely significant to support new thinking about the research problem or to challenge an existing hypothesis. For example, Walo, Bull, and Breen conducted a case study to identify and evaluate the direct and indirect economic benefits and costs of a local sports event in the City of Lismore, New South Wales, Australia. The purpose of their study was to provide new insights from measuring the impact of a typical local sports event that prior studies could not measure well because they focused on large "mega-events." Whether the event is rare or not, the methods section should include an explanation of the following characteristics of the event: a) when did it take place; b) what were the underlying circumstances leading to the event; c) what were the consequences of the event.
If your subject of analysis is a person. Explain why you selected this particular individual to be studied and describe what experience he or she has had that provides an opportunity to advance new understandings about the research problem. Mention any background about this person which might help the reader understand the significance of his/her experiences that make them worthy of study. This includes describing the relationships this person has had with other people, institutions, and/or events that support using him or her as the subject for a case study research paper. It is particularly important to differentiate the person as the subject of analysis from others and to succinctly explain how the person relates to examining the research problem.
If your subject of analysis is a place. In general, a case study that investigates a place suggests a subject of analysis that is unique or special in some way and that this uniqueness can be used to build new understanding or knowledge about the research problem. A case study of a place must not only describe its various attributes relevant to the research problem [e.g., physical, social, cultural, economic, political, etc.], but you must state the method by which you determined that this place will illuminate new understandings about the research problem. It is also important to articulate why a particular place as the case for study is being used if similar places also exist [i.e., if you are studying patterns of homeless encampments of veterans in open spaces, why study Echo Park in Los Angeles rather than Griffith Park?]. If applicable, describe what type of human activity involving this place makes it a good choice to study [e.g., prior research reveals Echo Park has more homeless veterans].
If your subject of analysis is a phenomenon. A phenomenon refers to a fact, occurrence, or circumstance that can be studied or observed but with the cause or explanation to be in question. In this sense, a phenomenon that forms your subject of analysis can encompass anything that can be observed or presumed to exist but is not fully understood. In the social and behavioral sciences, the case usually focuses on human interaction within a complex physical, social, economic, cultural, or political system. For example, the phenomenon could be the observation that many vehicles used by ISIS fighters are small trucks with English language advertisements on them. The research problem could be that ISIS fighters are difficult to combat because they are highly mobile. The research questions could be how and by what means are these vehicles used by ISIS being supplied to the militants and how might supply lines to these vehicles be cut? How might knowing the suppliers of these trucks from overseas reveal larger networks of collaborators and financial support? A case study of a phenomenon most often encompasses an in-depth analysis of a cause and effect that is grounded in an interactive relationship between people and their environment in some way.
NOTE: The choice of the case or set of cases to study cannot appear random. Evidence that supports the method by which you identified and chose your subject of analysis should be linked to the findings from the literature review. Be sure to cite any prior studies that helped you determine that the case you chose was appropriate for investigating the research problem.
IV. Discussion
The main elements of your discussion section are generally the same as any research paper, but centered around interpreting and drawing conclusions about the key findings from your case study. Note that a general social sciences research paper may contain a separate section to report findings. However, in a paper designed around a case study, it is more common to combine a description of the findings with the discussion about their implications. The objectives of your discussion section should include the following:
Reiterate the Research Problem/State the Major Findings Briefly reiterate the research problem you are investigating and explain why the subject of analysis around which you designed the case study were used. You should then describe the findings revealed from your study of the case using direct, declarative, and succinct proclamation of the study results. Highlight any findings that were unexpected or especially profound.
Explain the Meaning of the Findings and Why They are Important Systematically explain the meaning of your case study findings and why you believe they are important. Begin this part of the section by repeating what you consider to be your most important or surprising finding first, then systematically review each finding. Be sure to thoroughly extrapolate what your analysis of the case can tell the reader about situations or conditions beyond the actual case that was studied while, at the same time, being careful not to misconstrue or conflate a finding that undermines the external validity of your conclusions.
Relate the Findings to Similar Studies No study in the social sciences is so novel or possesses such a restricted focus that it has absolutely no relation to previously published research. The discussion section should relate your case study results to those found in other studies, particularly if questions raised from prior studies served as the motivation for choosing your subject of analysis. This is important because comparing and contrasting the findings of other studies helps to support the overall importance of your results and it highlights how and in what ways your case study design and the subject of analysis differs from prior research about the topic.
Consider Alternative Explanations of the Findings It is important to remember that the purpose of social science research is to discover and not to prove. When writing the discussion section, you should carefully consider all possible explanations for the case study results, rather than just those that fit your hypothesis or prior assumptions and biases. Be alert to what the in-depth analysis of the case may reveal about the research problem, including offering a contrarian perspective to what scholars have stated in prior research.
Acknowledge the Study's Limitations You can state the study's limitations in the conclusion section of your paper but describing the limitations of your subject of analysis in the discussion section provides an opportunity to identify the limitations and explain why they are not significant. This part of the discussion section should also note any unanswered questions or issues your case study could not address. More detailed information about how to document any limitations to your research can be found here .
Suggest Areas for Further Research Although your case study may offer important insights about the research problem, there are likely additional questions related to the problem that remain unanswered or findings that unexpectedly revealed themselves as a result of your in-depth analysis of the case. Be sure that the recommendations for further research are linked to the research problem and that you explain why your recommendations are valid in other contexts and based on the original assumptions of your study.
V. Conclusion
As with any research paper, you should summarize your conclusion in clear, simple language; emphasize how the findings from your case study differs from or supports prior research and why. Do not simply reiterate the discussion section. Provide a synthesis of key findings presented in the paper to show how these converge to address the research problem. If you haven't already done so in the discussion section, be sure to document the limitations of your case study and needs for further research.
The function of your paper's conclusion is to: 1) restate the main argument supported by the findings from the analysis of your case; 2) clearly state the context, background, and necessity of pursuing the research problem using a case study design in relation to an issue, controversy, or a gap found from reviewing the literature; and, 3) provide a place for you to persuasively and succinctly restate the significance of your research problem, given that the reader has now been presented with in-depth information about the topic.
Consider the following points to help ensure your conclusion is appropriate:
Note that, depending on the discipline you are writing in and your professor's preferences, the concluding paragraph may contain your final reflections on the evidence presented applied to practice or on the essay's central research problem. However, the nature of being introspective about the subject of analysis you have investigated will depend on whether you are explicitly asked to express your observations in this way.
Problems to Avoid
Overgeneralization One of the goals of a case study is to lay a foundation for understanding broader trends and issues applied to similar circumstances. However, be careful when drawing conclusions from your case study. They must be evidence-based and grounded in the results of the study; otherwise, it is merely speculation. Looking at a prior example, it would be incorrect to state that a factor in improving girls access to education in Azerbaijan and the policy implications this may have for improving access in other Muslim nations is due to girls access to social media if there is no documentary evidence from your case study to indicate this. There may be anecdotal evidence that retention rates were better for girls who were on social media, but this observation would only point to the need for further research and would not be a definitive finding if this was not a part of your original research agenda.
Failure to Document Limitations No case is going to reveal all that needs to be understood about a research problem. Therefore, just as you have to clearly state the limitations of a general research study , you must describe the specific limitations inherent in the subject of analysis. For example, the case of studying how women conceptualize the need for water conservation in a village in Uganda could have limited application in other cultural contexts or in areas where fresh water from rivers or lakes is plentiful and, therefore, conservation is understood differently than preserving access to a scarce resource.
Failure to Extrapolate All Possible Implications Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings. If you do not, your reader may question the validity of your analysis, particularly if you failed to document an obvious outcome from your case study research. For example, in the case of studying the accident at the railroad crossing to evaluate where and what types of warning signals should be located, you failed to take into consideration speed limit signage as well as warning signals. When designing your case study, be sure you have thoroughly addressed all aspects of the problem and do not leave gaps in your analysis.
Case Studies . Writing@CSU. Colorado State University; Gerring, John. Case Study Research: Principles and Practices . New York: Cambridge University Press, 2007; Merriam, Sharan B. Qualitative Research and Case Study Applications in Education . Rev. ed. San Francisco, CA: Jossey-Bass, 1998; Miller, Lisa L. “The Use of Case Studies in Law and Social Science Research.” Annual Review of Law and Social Science 14 (2018): TBD; Mills, Albert J., Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Putney, LeAnn Grogan. "Case Study." In Encyclopedia of Research Design , Neil J. Salkind, editor. (Thousand Oaks, CA: SAGE Publications, 2010), pp. 116-120; Simons, Helen. Case Study Research in Practice . London: SAGE Publications, 2009; Kratochwill, Thomas R. and Joel R. Levin, editors. Single-Case Research Design and Analysis: New Development for Psychology and Education . Hilldsale, NJ: Lawrence Erlbaum Associates, 1992; Swanborn, Peter G. Case Study Research: What, Why and How? London : SAGE, 2010; Yin, Robert K. Case Study Research: Design and Methods . 6th edition. Los Angeles, CA, SAGE Publications, 2014; Walo, Maree, Adrian Bull, and Helen Breen. “Achieving Economic Benefits at Local Events: A Case Study of a Local Sports Event.” Festival Management and Event Tourism 4 (1996): 95-106.
At Least Five Misconceptions about Case Study Research
Social science case studies are often perceived as limited in their ability to create new knowledge because they are not randomly selected and findings cannot be generalized to larger populations. Flyvbjerg examines five misunderstandings about case study research and systematically "corrects" each one. To quote, these are:
Misunderstanding 1 : General, theoretical [context-independent knowledge is more valuable than concrete, practical (context-dependent) knowledge. Misunderstanding 2 : One cannot generalize on the basis of an individual case; therefore, the case study cannot contribute to scientific development. Misunderstanding 3 : The case study is most useful for generating hypotheses; that is, in the first stage of a total research process, whereas other methods are more suitable for hypotheses testing and theory building. Misunderstanding 4 : The case study contains a bias toward verification, that is, a tendency to confirm the researcher’s preconceived notions. Misunderstanding 5 : It is often difficult to summarize and develop general propositions and theories on the basis of specific case studies [p. 221].
While writing your paper, think introspectively about how you addressed these misconceptions because to do so can help you strengthen the validity and reliability of your research by clarifying issues of case selection, the testing and challenging of existing assumptions, the interpretation of key findings, and the summation of case outcomes. Think of a case study research paper as a complete, in-depth narrative about the specific properties and key characteristics of your subject of analysis applied to the research problem.
Flyvbjerg, Bent. “Five Misunderstandings About Case-Study Research.” Qualitative Inquiry 12 (April 2006): 219-245.
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Methodology
Published on May 8, 2019 by Shona McCombes . Revised on November 20, 2023.
A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.
A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating and understanding different aspects of a research problem .
When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyze the case, other interesting articles.
A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.
Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.
You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.
Research question | Case study |
---|---|
What are the ecological effects of wolf reintroduction? | Case study of wolf reintroduction in Yellowstone National Park |
How do populist politicians use narratives about history to gain support? | Case studies of Hungarian prime minister Viktor Orbán and US president Donald Trump |
How can teachers implement active learning strategies in mixed-level classrooms? | Case study of a local school that promotes active learning |
What are the main advantages and disadvantages of wind farms for rural communities? | Case studies of three rural wind farm development projects in different parts of the country |
How are viral marketing strategies changing the relationship between companies and consumers? | Case study of the iPhone X marketing campaign |
How do experiences of work in the gig economy differ by gender, race and age? | Case studies of Deliveroo and Uber drivers in London |
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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:
TipIf your research is more practical in nature and aims to simultaneously investigate an issue as you solve it, consider conducting action research instead.
Unlike quantitative or experimental research , a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.
Example of an outlying case studyIn the 1960s the town of Roseto, Pennsylvania was discovered to have extremely low rates of heart disease compared to the US average. It became an important case study for understanding previously neglected causes of heart disease.
However, you can also choose a more common or representative case to exemplify a particular category, experience or phenomenon.
Example of a representative case studyIn the 1920s, two sociologists used Muncie, Indiana as a case study of a typical American city that supposedly exemplified the changing culture of the US at the time.
While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:
To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.
There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews , observations , and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data.
Example of a mixed methods case studyFor a case study of a wind farm development in a rural area, you could collect quantitative data on employment rates and business revenue, collect qualitative data on local people’s perceptions and experiences, and analyze local and national media coverage of the development.
The aim is to gain as thorough an understanding as possible of the case and its context.
Professional editors proofread and edit your paper by focusing on:
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In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.
How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis , with separate sections or chapters for the methods , results and discussion .
Others are written in a more narrative style, aiming to explore the case from various angles and analyze its meanings and implications (for example, by using textual analysis or discourse analysis ).
In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.
If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.
Research bias
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A case note is something that every law student is asked to write at some point in their studies and, without some direction, can be a daunting task. This article aims to briefly explain what a case note is, what the benefits of writing a case note are, and how to actually write a case note. Further information is also included at the end of the piece about the Gernot Biehler Case Note competition.
What is a Case Note?
A case note is a summary and analysis of a single case, as opposed to an article, which examines an area of law. A case note should outline the facts of the case, as well as its ratio decedendi , and also provide a critical analysis of the decision. The analysis should concern the correctness of the decision, with reference to case law, accepted logic and academic opinion. A good case note usually contains analysis of the effect that the decision may have on future cases, especially if the decision is a departure from a previously settled point of law.
What to Keep in Mind when Selecting a Case
If you have the option of selecting the case you would like to write on, below are some factors you should keep in mind:
How to Write a Case Note
(A) Research
As with any piece of legal writing, the first step in writing a case note is conducting the necessary research. Read the case multiple times and note down the facts and the ratio decedendi . The case should be read in the context of the area of law as a whole; understanding how the case relates to existing principles and case law is key in forming a critique and analysis. Further consideration should be given to whether the law is still relevant, and whether it is still considered to be a strong precedent. While a case note tends not to rely on academic sources as much as a legal essay, it is still worth exploring academic commentary around the case, from which a greater perspective can be gleaned.
(B) Writing
There is no rigid structure for how a case note should be written, but this article will attempt to lay out a basic structure and guide for writing the case note itself. It is worth noting that many brilliant case notes do not follow this structure, and can often depart from it dramatically, so there is no pressure to follow this structure.
As is the case in most legal writing, it is generally recommended that the piece is broken down into separate headings. This can make the case note easier to follow, and direct the reader to the important elements of the piece. When writing a case note for a legal journal or a university assignment, regard should be had for the word-count when deciding on how specific the headings are; if there is a lower word-count, it might make sense to merge some of the headings together.
(i) The Introduction
The introduction of a case note should introduce the case and indicate the court in which it was decided. It should lay out the structure of the case note, explain the significance of the case (i.e. the change in the law brought about by the case), and briefly outline your opinion of the case.
(ii) The Facts of the Case
The second section of the case note should briefly outline the facts of the case. It is important to keep in mind that a case note is not simply a summary of a case; the facts simply set out the background for your analysis. Due to this, this section of the case note should not be too long, and the aim should be to illustrate the facts that were relevant in the court’s reasoning, rather than the entirety of the factual circumstances. This is generally a good place to mention the decisions of the lower courts in relation to the case at hand.
(iii) The Decision and the Ratio Decidendi
This section of the case note should deal with the reasoning that lead to the court’s decision, and specific emphasis should be placed on the key decisions and the ratio decedendi . Here, detail should be provided on the case law that the court either relied on or moved away from, and a short explanation of the reasoning behind such moves should be given. The way that the decision was handled should also be mentioned (e.g. was the judgment suspended to allow the government to amend the issue?), as this is often indicative of the attitude of the courts in relation to the issue at hand.
(iv) Critical Analysis/Further Discussion
The primary aim of a case note is to critically analyse a particular decision and the effect it has on the law. “Critically analyse” can be a confusing phrase, so considering some of the following questions may be a useful starting point:
It is worth noting that “critically analyse” does not mean you have to disagree with a judgment; the best critical analysis praises some aspects of a judgment, and attacks others. Commentary on previous related decisions may help to inform your opinion on a case, and help with the critical analysis. It is recommended that some thought is given to how the case may have a lasting impact, and it should be acknowledged whether or not the case might be open to appeal. However, as in any legal piece, it is advisable that a certain degree of critical analysis is woven throughout the piece, rather than isolated to one section.
(v) Conclusion
The conclusion should very briefly summarise the decision, the flaws and achievements that have been discussed throughout the case note, and your overall opinion. A general rule for any piece of writing is that new substantive arguments that have not been discussed in the body of the piece should not be introduced in the conclusion. Finally, some concluding remarks could be offered about the effect of the case on that area of law, and how future cases may be influenced by it.
Some Final Tips
As is the case with any piece of legal writing, there should be a cohesive thread of argument that runs through the case note, but this may be difficult to pick up on after several hours of writing by yourself. As a result, the argument you have crafted might make sense to you, but not to a new reader. One of the best ways to deal with this is to ask someone else to read over the piece and offer some of their own comments.
While it is always advised to read through previous academic pieces written on your chosen area, make sure when citing academics that you are also evaluating their arguments to the reader. Do you agree with what the academic has said? How does their argument bolster yours? Or, how would you refute what the academic has argued? Analysing the academic commentary you have utilised is key to presenting critical analysis in your piece.
In the same vein, when presenting your arguments, it is recommended that you recognise ‘the other side.’ This is particularly important in controversial areas of law, like socio-economic rights, where presenting a one-sided argument will reflect poorly on the author’s critical analysis.
As a final note, the TCLR Online has published many case notes, and reading over these can help you to form a picture of what a case note looks like, and what a case note should contain. Many longer case notes have also been published in the print version of the TCLR, which can be found on the legal article database Heinonline.
The Gernot Biehler Case Note Competition
The Trinity College Law Review runs an annual case note competition in honour of Dr. Gernot Biehler. Dr. Biehler was a distinguished fellow of Trinity College and a lecturer in international law and conflicts of law, who died aged 48. Dr. Biehler was a keen supporter of the work of the Law Review.
The competition is open to first and second year undergraduate students from all universities. Case notes are subject to a word limit of 3,000 words excluding footnotes, and the deadline for submitting your entry is the 17th January 2020. The winning entry is published in the print journal of the Trinity College Law Review, and the winner receives a cash prize of €250. More information on the competition can be found at www.trinitycollegelawreview.org/submissions/ .
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O'Mathúna D, Iphofen R, editors. Ethics, Integrity and Policymaking: The Value of the Case Study [Internet]. Cham (CH): Springer; 2022. doi: 10.1007/978-3-031-15746-2_1
Chapter 1 making a case for the case: an introduction.
Dónal O’Mathúna and Ron Iphofen .
Published online: November 3, 2022.
This chapter agues for the importance of case studies in generating evidence to guide and/or support policymaking across a variety of fields. Case studies can offer the kind of depth and detail vital to the nuances of context, which may be important in securing effective policies that take account of influences not easily identified in more generalised studies. Case studies can be written in a variety of ways which are overviewed in this chapter, and can also be written with different purposes in mind. At the same time, case studies have limitations, particularly when evidence of causation is sought. Understanding these can help to ensure that case studies are appropriately used to assist in policymaking. This chapter also provides an overview of the types of case studies found in the rest of this volume, and briefly summarises the themes and topics addressed in each of the other chapters.
When asked to judge the ethical issues involved in research or any evidence-gathering activity, any research ethicist worth their salt will (or should) reply, at least initially: ‘It depends’. This is neither sophistry nor evasive legalism. Instead, it is a specific form of casuistry used in ethics in which general ethical principles are applied to the specifics of actual cases and inferences made through analogy. It is valued as a structured yet flexible approach to real-world ethical challenges. Case study methods recognise the complexities of depth and detail involved in assessing research activities. Another way of putting this is to say: ‘Don’t ask me to make a judgement about a piece of research until I have the details of the project and the context in which it will or did take place.’ Understanding and fully explicating a context is vital as far as ethical research (and evidence-gathering) is concerned, along with taking account of the complex interrelationship between context and method (Miller and Dingwall 1997 ).
This rationale lies behind this collection of case studies which is one outcome from the EU-funded PRO-RES Project. 1 One aim of this project was to establish the virtues, values, principles and standards most commonly held as supportive of ethical practice by researchers, scientists and evidence-generators and users. The project team conducted desk research, workshops and consulted throughout the project with a wide range of stakeholders (PRO-RES 2021a ). The resulting Scientific, Trustworthy, and Ethical evidence for Policy (STEP) ACCORD was devised, which all stakeholders could sign up to and endorse in the interests of ensuring any policies which are the outcome of research findings are based upon ethical evidence (PRO-RES 2021b ).
By ‘ethical evidence’ we mean results and findings that have been generated by research and other activities during which the standards of research ethics and integrity have been upheld (Iphofen and O’Mathúna 2022 ). The first statement of the STEP ACCORD is that policy should be evidence-based, meaning that it is underpinned by high-quality research, analysis and evidence (PRO-RES 2021b ). While our topic could be said to be research ethics, we have chosen to refer more broadly to evidence-generating activities. Much debate has occurred over the precise definition of research under the apparent assumption that ‘non-research projects’ fall outside the purview of requirements to obtain ethics approval from an ethics review body. This debate is more about the regulation of research than the ethics of research and has contributed to an unbalanced approach to the ethics of research (O’Mathúna 2018 ). Research and evidence-generating activities raise many ethical concerns, some similar and some distinct. When the focus is primarily on which projects need to obtain what sort of ethics approval from which type of committee, the ethical issues raised by those activities themselves can receive insufficient attention. This can leave everyone involved with these activities either struggling to figure out how to manage complex and challenging ethical dilemmas or pushing ahead with those activities confident that their approval letter means they have fulfilled all their ethical responsibilities. Unfortunately, this can lead to a view that research ethics is an impediment and burden that must be overcome so that the important work in the research itself can get going.
The alternative perspective advocated by PRO-RES, and the authors of the chapters in this volume, is that ethics underpins all phases of research, from when the idea for a project is conceived, all the way through its design and implementation, and on to how its findings are disseminated and put into practice in individual decisions or in policy. Given the range of activities involved in all these phases, multiple types of ethical issues can arise. Each occurs in its own context of time and place, and this must be taken into account. While ethical principles and theories have important contributions to make at each of these points, case studies are also very important. These allow for the normative effects of various assumptions and declarations to be judged in context. We therefore asked the authors of this volume’s chapters to identify various case studies which would demonstrate the ethical challenges entailed in various types of research and evidence-generating activities. These illustrative case studies explore various innovative topics and fields that raise challenges requiring ethical reflection and careful policymaking responses. The cases highlight diverse ethical issues and provide lessons for the various options available for policymaking (see Sect. 1.6 . below). Cases are drawn from many fields, including artificial intelligence, space science, energy, data protection, professional research practice and pandemic planning. The issues are examined in different locations, including Europe, India, Africa and in global contexts. Each case is examined in detail and also helps to anticipate lessons that could be learned and applied in other situations where ethical evidence is needed to inform evidence-based policymaking.
Case studies have increasingly been used, particularly in social science (Exworthy and Powell 2012 ). Many reasons underlie this trend, one being the movement towards evidence-based practice. Case studies provide a methodology by which a detailed study can be conducted of a social unit, whether that unit is a person, an organization, a policy or a larger group or system (Exworthy and Powell 2012 ). The case study is amenable to various methodologies, mostly qualitative, which allow investigations via documentary analyses, interviews, focus groups, observations, and more.
At the same time, consensus is lacking over the precise nature of a case study. Various definitions have been offered, but Yin ( 2017 ) provides a widely cited definition with two parts. One is that a case study is an in-depth inquiry into a real-life phenomenon where the context is highly pertinent. The second part of Yin’s definition addresses the many variables involved in the case, the multiple sources of evidence explored, and the inclusion of theoretical propositions to guide the analysis. While Yin’s emphasis is on the case study as a research method, he identifies important elements of broader relevance that point to the particular value of the case study for examining ethical issues.
Other definitions of case studies emphasize their story or narrative aspects (Gwee 2018 ). These stories frequently highlight a dilemma in contextually rich ways, with an emphasis on how decisions can be or need to be made. Case studies are particularly helpful with ethical issues to provide crucial context and explore (and evaluate) how ethical decisions have been made or need to be made. Classic cases include the Tuskegee public health syphilis study, the Henrietta Lacks human cell line case, the Milgram and Zimbardo psychology cases, the Tea Room Trade case, and the Belfast Project in oral history research (examined here in Chap. 10 ). Cases exemplify core ethical principles, and how they were applied or misapplied; in addition, they examine how policies have worked well or not (Chaps. 2 , 3 and 5 ). Cases can examine ethics in long-standing issues (like research misconduct (Chap. 7 ), energy production (Chap. 8 ), or Chap. 11 ’s consideration of researchers breaking the law), or with innovations in need of further ethical reflection because of their novelty (like extended space flight (Chap. 9 ) and AI (Chaps. 13 and 14 ), with the latter looking at automation in legal systems). These case studies help to situate the innovations within the context of widely regarded ethical principles and theories, and allow comparisons to be made with other technologies or practices where ethical positions have been developed. In doing so, these case studies offer pointers and suggestions for policymakers given that they are the ones who will develop applicable policies.
Not everyone is convinced of the value of the case study. It must be admitted that they have limitations, which we will reflect on shortly. Yet we believe that others go too far in their criticisms, revealing instead some prejudices against the value of the case (Yin 2017 ). In what has become a classic text for research design, Campbell and Stanley ( 1963 ) have few good words for what they call the ‘One Shot Case Study.’ They rank it below two other ‘pre-experimental’ designs—the One-Group Pretest–Posttest and the Static-Group Comparison—and conclude that case studies “have such a total absence of control to be of almost no scientific value” (Campbell and Stanley 1963 , 6). The other designs have, in turn, a baseline and outcome measure and some degree of comparative analysis which provides them some validity. Such a criticism is legitimate if one prioritises the experimental method as the most superior in terms of effectiveness evidence and, as for Campbell and Stanley, one is striving to assess the effectiveness of educational interventions.
What is missing from that assessment is that different methodologies are more appropriate for different kinds of questions. Questions of causation and whether a particular treatment, policy or educational strategy is more effective than another are best answered by experimental methods. While experimental designs are better suited to explore causal relationships, case studies are more suited to explore “how” and “why” questions (Yin 2017 ). It can be more productive to view different methodologies as complementing one another, rather than examining them in hierarchical terms.
The case study approach draws on a long tradition in ethnography and anthropology: “It stresses the importance of holistic perspectives and so has more of a ‘humanistic’ emphasis. It recognises that there are multiple influences on any single individual or group and that most other methods neglect the thorough understanding of this range of influences. They usually focus on a chosen variable or variables which are tested in terms of their influence. A case study tends to make no initial assumptions about which are the key variables—preferring to allow the case to ‘speak for itself’” (Iphofen et al. 2009 , 275). This tradition has sometimes discouraged people from conducting or using case studies on the assumption that they take massive amounts of time and lead to huge reports. This is the case with ethnography, but the case study method can be applied in more limited settings and can lead to high-quality, concise reports.
Another criticism of case studies is that they cannot be used to make generalizations. Certainly, there are limits to their generalisability, but the same is true of experimental studies. One randomized controlled trial cannot be generalised to the whole population without ensuring that its details are evaluated in the context of how it was conducted.
Similarly, it should not be assumed that generalisability can adequately guide practice or policy when it comes to the specifics of an individual case. A case study should not be used to support statistical generalizations (that the same percentage found in the case will be found in the general public). But a case study can be used to expand and generalize theories and thus have much usefulness. It affords a method of examining the specific (complex) interactions occurring in a case which can only be known from the details. Such an analysis can be carried out for individuals, policies or interventions.
The current COVID-19 pandemic demonstrates the dangers of generalising in the wrong context. Some people have very mild cases of COVID-19 or are asymptomatic. Others get seriously ill and even die. Sometimes people generalise from cases they know and assume they will have mild symptoms. Then they refuse to take the COVID-19 vaccine, basically generalising from similar cases. Mass vaccination is recommended for the sake of the health of the public (generalised health) and to limit the spread of a deadly virus. Cases are reported of people having adverse reactions to COVID-19 vaccines, and some people generalise from these that they will not take whatever risks might be involved in receiving the vaccine themselves. It might be theoretically possible to discover which individuals WILL react adversely to immunisation on a population level. But it is highly complex and expensive to do so, and takes an extensive period of time. Given the urgency of benefitting the health of ‘the public’, policymakers have decided that the risks to a sub-group are warranted. Only after the emergence of epidemiological data disclosing negative effects of some vaccines on some individuals will it become more clear which characteristics typify those cases which are likely to experience the adverse effects, and more accurately quantify the risks of experiencing those effects.
Much literature now points to the advantages and disadvantages of case studies (Gomm et al. 2000 ), and how to use them and conduct them with adequate rigour to ensure the validity of the evidence generated (Schell 1992 ; Yin 2011 , 2017 ). At the same time, legitimate critiques have been made of some case studies because they have been conducted without adequate rigor, in unsystematic ways, or in ways that allowed bias to have more influence than evidence (Hammersley 2001 ). Part of the problem here is similar to interviewing, where some will assume that since interviews are a form of conversation, anyone can do it. Case studies have some similarities to stories, but that doesn’t mean they are quick and easy ways to report on events. That view can lead to the situation where “most people feel that they can prepare a case study, and nearly all of us believe we can understand one. Since neither view is well founded, the case study receives a lot of approbation it does not deserve” (Hoaglin et al., cited in Yin 2017 , 16).
Case studies can be conducted and used in a wide range of ways (Gwee 2018 ). Case studies can be used as a research method, as a teaching tool, as a way of recording events so that learning can be applied to practice, and to facilitate practical problem-solving skills (Luck et al. 2006 ). Significant differences exist between a case study that was developed and used in research compared to one used for teaching (Yin 2017 ). A valid rationale for studying a ‘case’ should be provided so that it is clear that the proposed method is suitable to the topic and subject being studied. The unit of study for a case could be an individual person, social group, community, or society. Sometimes that specific case alone will constitute the actual research project. Thus, the study could be of one individual’s experience, with insights and understanding gained of the individual’s situation which could be of use to understand others’ experiences. Often there will be attempts made at a comparison between cases—one organisation being compared to another, with both being studied in some detail, and in terms of the same or similar criteria. Given this variety, it is important to use cases in ways appropriate to how they were generated.
The case study continues to be an important piece of evidence in clinical decision-making in medicine and healthcare. Here, case studies do not demonstrate causation or effectiveness, but are used as an important step in understanding the experiences of patients, particularly with a new or confusing set of symptoms. This was clearly seen as clinicians published case studies describing a new respiratory infection which the world now knows to be COVID-19. Only as case studies were generated, and the patterns brought together in larger collections of cases, did the characteristics of the illness come to inform those seeking to diagnose at the bedside (Borges do Nascimento et al. 2020 ). Indeed case studies are frequently favoured in nursing, healthcare and social work research where professional missions require a focus on the care of the individual and where cases facilitate making use of the range of research paradigms (Galatzer-Levy et al. 2000 ; Mattaini 1996 ; Gray 1998 ; Luck et al. 2006 ).
Our main concern in this collection is not with case study aetiology but rather to draw on the advantages of the method to highlight key ethical issues related to the use of evidence in influencing policy. Thus, we make no claim to causal ‘generalisation’ on the basis of these reports—but instead we seek to help elucidate ethics issues, if even theoretical, and anticipate responses and obstacles in similar situations and contexts that might help decision-making in novel circumstances. A key strength of case studies is their capacity to connect abstract theoretical concepts to the complex realities of practice and the real world (Luck et al. 2006 ). Ethics cases clearly fit this description and allow the contextual details of issues and dilemmas to be included in discussions of how ethical principles apply as policy is being developed.
Since cases are highly focussed on the specifics of the situation, more time can be given over to data gathering which may be of both qualitative and quantitative natures. Given the many variables involved in the ‘real life’ setting, increased methodological flexibility is required (Yin 2017 ). This means seeking to maximise the data sources—such as archives (personal and public), records (such as personal diaries), observations (participant and covert) and interviews (face-to-face and online)—and revisiting all sources when necessary and as case participants and time allows.
Case studies allow researchers and practitioners to learn from the specifics of a situation and apply that learning in similar situations. Ethics case studies allow such reflection to facilitate the development of ethical decision-making skills. This volume has major interests in ethics and evidence-generation (research), but also in a third area: policymaking. Cases can influence policymaking, such as how one case can receive widespread attention and become the impetus to create policy that aims to prevent similar cases. For example, the US federal Brady Law was enacted in 1993 to require background checks on people before they purchase a gun (ATF 2021 ). The law was named for White House Press Secretary James Brady, and his case became widely known in the US. He was shot and paralyzed during John Hinckley, Jr.’s 1981 assassination attempt on President Ronald Reagan. Another example, this time in a research context, was how the Tuskegee Syphilis Study led, after its public exposure in 1971, to the US Department of Health, Education and Welfare appointing an expert panel to examine the ethics of that case. This resulted in federal policymakers enacting the National Research Act in 1974, which included setting up a national commission that published the Belmont Report in 1976. This report continues to strongly influence research ethics practice around the world. These examples highlight the power of a case study to influence policymaking.
One of the challenges for policymakers, though, is that compelling cases can often be provided for opposite sides of an issue. Also, while the Belmont Report has been praised for articulating a small number of key ethical principles, how those principles should be applied in specific instances of research remains an ongoing challenge and a point of much discussion. This is particularly relevant for innovative techniques and technologies. Hence the importance of cases interacting with general principles and leading to ongoing reflection and debate over the applicable cases. At the same time, new areas of research and evidence generation activities will lead to questions about how existing ethical principles and values apply. New case studies can help to facilitate that reflection, which can then allow policymakers to consider whether existing policy should be adapted or whether whole new areas of policy are needed.
Case studies also can play an important role in learning from and evaluating policy. Policymakers tend to focus on practical, day-to-day concerns and with the introduction of new programmes (Exworthy and Peckam 2012 ). Time and resources may be scant when it comes to evaluating how well existing policies are performing or reflecting on how policies can be adapted to overcome shortcomings (Hunter 2003 ). Effective policies may exist elsewhere (historically or geographically) and be more easily adapted to a new context instead of starting policymaking from scratch. Case studies can permit learning from past policies (or situations where policies did not exist), and they can illuminate various factors that should be explored in more detail in the context of the current issue or situation. Chaps. 2 , 3 and 5 in this volume are examples of this type of case study.
This volume reflects the ambiguity of ethical dilemmas in contemporary policymaking. Analyses will reflect current debates where consensus has not been achieved yet. These cases illustrate key points made throughout the PRO-RES project: that ethical decision-making is a fluid enterprise, where values, principles and standards must constantly be applied to new situations, new events and new research developments. The cases illustrate how no ‘one point’ exists in the research process where judgements about ethics can be regarded as ‘final.’ Case studies provide excellent ways for readers to develop important decision-making skills.
Research produces novel products and processes which can have broad implications for society, the environment and relationships. Research methods themselves are modified or applied in new ways and places, requiring further ethical reflection. New topics and whole fields of research develop and require careful evaluation and thoughtful responses. New case studies are needed because research constantly generates new issues and new ethics questions for policymaking.
The cases found in this volume address a wide range of topics and involve several disciplines. The cases were selected by the parameters of the PRO-RES project and the Horizon 2020 funding call to which it responded. First, the call was concerned with both research ethics and scientific integrity and each of the cases addresses one or both of these areas. The call sought projects that addressed non-medical research, and the cases here address disciplines such as social sciences, engineering, artificial intelligence and One Health. The call also sought particular attention be given to (a) covert research, (b) working in dangerous areas/conflict zones and (c) behavioral research collecting data from social media/internet sources. Hence, we included cases that addressed each of these areas. Finally, while an EU-funded project can be expected to have a European focus, the issues addressed have global implications. Therefore, we wanted to include cases studies from outside Europe and did so by involving authors from India and Africa to reflect on the volume’s areas of interest.
The first case study offered in this volume (Chap. 2 ) examines a significant policy approach taken by the European Union to address ethics and integrity in research and innovation: Responsible Research and Innovation (RRI). This chapter examines the lessons that can be learned from RRI in a European context. Chapter 3 elaborates on this topic with another policy learning case study, but this time examining RRI in India. One of the critiques made of RRI is that it can be Euro-centric. This case study examines this claim, and also describes how a distinctively Indian concept, Scientific Temper, can add to and contextualise RRI. Chapter 4 takes a different approach in being a case study of the development of research ethics guidance in the United Kingdom (UK). It explores the history underlying the research ethics framework commissioned by the UK Research Integrity Office (UKRIO) and the Association of Research Managers and Administrators (ARMA), and points to lessons that can be learned about the policy-development process itself.
While staying focused on policy related to research ethics, the chapters that follow include case studies that address more targeted concerns. Chapter 5 examines the impact of the European Union’s (EU) General Data Protection Regulation (GDPR) in the Republic of Croatia. Research data collected in Croatia is used to explore the handling of personal data before and after the introduction of GDPR. This case study aims to provide lessons learned that could contribute to research ethics policies and procedures in other European Member States.
Chapter 6 moves from policy itself to the role of policy advisors in policymaking. This case study explores the distinct responsibilities of those elevated to the role of “policy advisor,” especially given the current lack of policy to regulate this field or how its advice is used by policymakers. Next, Chap. 7 straddles the previous chapters’ focus on policy and its evaluation while introducing the focus of the next section on historical case studies. This chapter uses the so-called “race for the superconductor” as a case study by which the PRO-RES ethics framework is used to explore specific ethical dilemmas (PRO-RES 2021b ). This case study is especially useful for policymakers because of how it reveals the multiple difficulties in balancing economic, political, institutional and professional requirements and values.
The next case study continues the use of historical cases, but here to explore the challenges facing innovative research into unorthodox energy technology that has the potential to displace traditional energy suppliers. The wave power case in Chap. 8 highlights how conducting research with integrity can have serious consequences and come with considerable cost. The case also points to the importance of transparency in how evidence is used in policymaking so that trust in science and scientists is promoted at the same time as science is used in the public interest. Another area of cutting-edge scientific innovation is explored in Chap. 9 , but this time looking to the future. This case study examines space exploration, and specifically the ethical issues around establishing safe exposure standards for astronauts embarking on extended duration spaceflights. This case highlights the ethical challenges in policymaking focused on an elite group of people (astronauts) who embark on extremely risky activities in the name of science and humanity.
Chapter 10 moves from the physical sciences to the social sciences. The Belfast Project provides a case study to explore the ethical challenges of conducting research after violent conflict. In this case, researchers promised anonymity and confidentiality to research participants, yet that was overturned through legal proceedings which highlighted the limits of confidentiality in research. This case points to the difficulty of balancing the value of research archives in understanding conflict against the value of providing juridical evidence to promote justice. Another social science case is examined in Chap. 11 , this time in ethnography. This so-called ‘urban explorer’ case study explores the justifications that might exist for undertaking covert research where researchers break the law (in this case by trespassing) in order to investigate a topic that would remain otherwise poorly understood. This case raises a number of important questions for policymakers around: the freedoms that researchers should be given to act in the public interest; when researchers are justified in breaking the law; and what responsibilities and consequences researchers should accept if they believe they are justified in doing so.
Further complexity in research and evidence generation is introduced in Chap. 12 . A case study in One Health is used to explore ethical issues at the intersection of animal, human and environmental ethics. The pertinence of such studies has been highlighted by COVID-19, yet policies lag behind in recognising the urgency and complexity of initiating investigations into novel outbreaks, such as the one discussed here that occurred among animals in Ethiopia. Chapter 13 retains the COVID-19 setting, but returns the attention to technological innovation. Artificial intelligence (AI) is the focus of these two chapters in the volume, here examining the ethical challenges arising from the emergency authorisation of using AI to respond to the public health needs created by the COVID-19 pandemic. Chapter 14 addresses a longer term use of AI in addressing problems and challenges in the legal system. Using the so-called Robodebt case, the chapter explores the reasons why legal systems are turning to AI and other automated procedures. The Robodebt case highlights problems when AI algorithms are built on inaccurate assumptions and implemented with little human oversight. This case shows the massive problems for hundreds of thousands of Australians who became victims of poorly conceived AI and makes recommendations to assist policymakers to avoid similar debacles. The last chapter (Chap. 15 ) draws some general conclusions from all the cases that are relevant when using case studies.
This volume focuses on ethics in research and professional integrity and how we can be clear about the lessons that can be drawn to assist policymakers. The cases provided cover a wide range of situations, settings, and disciplines. They cover international, national, organisational, group and individual levels of concern. Each case raises distinct issues, yet also points to some general features of research, evidence-generation, ethics and policymaking. All the studies illustrate the difficulties of drawing clear ‘boundaries’ between the research and the context. All these case studies show how in real situations dynamic judgements have to be made about many different issues. Guidelines and policies do help and are needed. But at the same time, researchers, policymakers and everyone else involved in evidence generation and evidence implementation need to embody the virtues that are central to good research. Judgments will need to be made in many areas, for example, about how much transparency can be allowed, or is ethically justified; how much risk can be taken, both with participants’ safety and also with the researchers’ safety; how much information can be disclosed to or withheld from participants in their own interests and for the benefit of the ‘science’; and many others. All of these point to just how difficult it can be to apply common standards across disciplines, professions, cultures and countries. That difficulty must be acknowledged and lead to open discussions with the aim of improving practice. The cases presented here point to efforts that have been made towards this. None of them is perfect. Lessons must be learned from all of them, towards which Chap. 15 aims to be a starting point. Only by openly discussing and reflecting on past practice can lessons be learned that can inform policymaking that aims to improve future practice. In this way, ethical progress can become an essential aspect of innovation in research and evidence-generation.
PRO-RES is a European Commission-funded project aiming to PROmote ethics and integrity in non-medical RESearch by building a supported guidance framework for all non-medical sciences and humanities disciplines adopting social science methodologies. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 788352. Open access fees for this volume were paid for through the PRO-RES funding.
Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
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Post by: Jackie Kim and Lisa Brem
Why should legal educators use case studies and other experiential teaching methods, such as role plays and simulations, in their classes? Hasn’t the Langdell method served legal education well these last 140 years? Certainly creating and using experiential materials requires a different set of skills from faculty, elicits a different response and level of engagement from students, and poses barriers to implementation. The ABA’s LEAPS Project [i] has a comprehensive list of objections to practical problem solving in the classroom: materials are time consuming and expensive to create and deploy; addition of a case study or simulation to a syllabus inherently displaces other material; and there are few incentives from law school leaders to introduce this type of teaching.
Yet, the argument promoting experiential materials and techniques is strong. The 2007 Carnegie Report [ii] recommended integrating lawyering skills practice into the curriculum alongside doctrinal courses, and the ABA added simulation courses to the list of practical experiences that can and should be offered by law schools in its 2015 Guidance Memo [iii] .
In a 2007 Vanderbilt Law Review article [iv] , HLS Dean Martha Minow and Professor Todd D. Rakoff argued that Langdell’s approach to teaching students using appellate cases does not do enough to prepare law students for real-world problems: “The fact is, Langdell’s case method is good for some things, but not good for others. We are not talking about fancy goals here; we are talking about teaching students ‘how to think like a lawyer.’”
But does the case study method result in a higher degree of student learning? While we have not yet seen a study on the efficacy of the case study method vs. the Langdell method in law schools, research [v] from political science professor Matthew Krain suggests that case studies and problem-based activities do enhance certain types of learning over other types of pedagogy. In his investigation, Krain compared the results of pre-and post-course surveys of students who participated in active learning with those who received a traditional lecture course. The case studies and problems that Krain used in his non-traditional classes included: case studies in the form of popular press articles, formal case studies, films, or problem-based case exercises that required students to produce a work product.
Krain found that:
Student-centered reflection, in which students have the opportunity to discuss their understanding of the case, allows both students and instructors to connect active learning experiences back to a larger theoretical context. Case learning is particularly useful for dramatizing abstract theoretical concepts, making seemingly distant events or issues seem more “authentic” or “real,” demonstrating the connection between theory and practice, and building critical-thinking and problem-solving skills (Inoue & Krain, 2014; Krain, 2010; Kuzma & Haney, 2001; Lamy, 2007; Swimelar, 2013).
This study suggests that case-based approaches have great utility in the classroom, and they should be used more often in instances where students’ understanding of conceptual complexity or knowledge of case details is critical. Moreover, case-based exercises can be derived from a variety of different types of materials and still have great utility. If deployed selectively in the context of a more traditional classroom setting as ways to achieve particular educational objectives, case-based approaches can be useful tools in our pedagogical toolbox.
For those who might be ready to try a case study, role play, or simulation, there are resources that can help. Harvard Law School produces case studies for use throughout the legal curriculum. The HLS Case Studies program publishes these teaching materials, and makes them available to educators, academic staff, students, and trainers. Outside of Harvard Law School, links to resources for educators implementing the case study method can be found on the Case Studies Program Resources page. Listed are case study affiliates at Harvard, legal teaching and learning tools, tips for case teaching, and free case materials. Examples include the Legal Education, ADR, and Practical Problem Solving (LEAPS) Project [vi] from the American Bar Association , which provides resources for various topics on legal education, and the Teaching Post , an educators’ forum offered by the Harvard Business School where professors can seek or provide advice on case study teaching.
“… [O]ur society is full of new problems demanding new solutions, and less so than in the past are lawyers inventing those solutions. We think we can, and ought to, do better.” – Dean Martha Minow & Professor Todd Rakoff. [vii]
[i] “Overcoming Barriers to Teaching ‘Practical Problem-Solving’.” Legal Education, ADR & Practical Problem-Solving (LEAPS) Project, American Bar Association, Section of Dispute Resolution. Accessed March 16, 2017, http://leaps.uoregon.edu/content/overcoming-barriers-teaching-%E2%80%9Cpractical-problem-solving%E2%80%9D. [ii] William M. Sullivan, Anne Colby, Judith Welch Wegner, Lloyd Bond, and Lee S. Shulman, “Educating Lawyers,” The Carnegie Foundation for the Advancement of Teaching (2007). [iii] American Bar Association, “Managing Director’s Guidance Memo,” Section of Legal Education and Admissions to the Bar (2015). [iv] Martha Minow and Todd D. Rakoff, “A Case for Another Case Method,” Vanderbilt Law Review 60(2) (2007): 597-607. [v] Matthew Krain, “Putting the learning in case learning? The effects of case-based approaches on student knowledge, attitudes, and engagement,” Journal on Excellence in College Teaching 27(2) (2016): 131-153. [vi] “Overcoming Barriers to Teaching ‘Practical Problem-Solving’.” [vii] Minow and Rakoff.
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Teaching & Learning
First year module introduces students to law by exploring the interaction of legal norms with climate change and homelessness, as Professor Maria Lee, UCL Laws, explains
21 March 2019
In 2018, UCL Laws introduced an ambitious, innovative, compulsory induction module for first year law students, Laws’ Connections: Legal Doctrine and Contemporary Challenges .
The case study is the central teaching methodology for Laws’ Connections . In 2018, four case studies were available, of which each student took two:
In Laws’ Connections , students begin their time with us by engaging with the way that the legal system and legal norms interact with a social issue, rather than from the perspective of a legal category (such as contract, property or crime). This means that we can begin to think critically and deeply about law and ideas right from the start, even as the students are just beginning to develop their knowledge of legal doctrine. We are also able to explore some necessary introductory material on basic legal structures and legal concepts, which can seem quite abstract and dry at this stage, in a more urgent and compelling way.
The case studies also introduce students to some important legal skills, and we require them to:
Careful support is provided in small groups for each of these activities, and detailed feedback provided.
Each case study is made up of 5x3 hour classes, and involves no compulsory out of class preparation (save preparing for the final assessment). Time for reading and thinking is provided within the schedule, in a small group of peers, with a teacher. This reduces anxiety and allows students the space to settle into the broader social side of university life, as well as guiding expectations.
In addition to the case studies, each student on Laws’ Connections takes Introduction to Law . A moodle site is available for new students to access before they arrive at UCL. It includes bespoke material that I produced in four chapters:
Each chapter contains links to reading from various sources, including chapters from introductory English Legal System texts, as well as websites and more ‘popular’ books such as The Secret Barrister .
A number of colleagues made short (under 5 minute) videos on various foundational or important legal issues – UCL made us all look rather wonderful, and this personalized and livened up potentially dry material.
The Introduction to Law element of Laws’ Connections also includes a series of skills lectures, including topics like essay writing, problem solving, getting the most out of lectures and tutorials [see Case Study: It's a trap! How I got students to engage with assessment: the power of guided marking ]
Each student is assessed (pass/fail) in one of their two case studies. The assessments this year were comprised of group presentations (two case studies), a blog and an essay. Students can take the assessment as many times as necessary to pass.
Introduction to Law is assessed by multiple choice questions, with a pass being 20 out of 25. Students can take the test as many times as they need.
I took the lead on developing, designing and running Laws’ Connections , initially in my capacity as Vice-Dean (Programme Development and Delivery), although now simply as module convenor.
But this sort of innovation takes the commitment of many colleagues. Most obviously, the four case studies were each put together by different people (I led the climate change case study). About a dozen colleagues and students reviewed the case studies and Introduction to Law .
Equally importantly, convenors of our four compulsory first year subjects ‘donated’ a lecture and a tutorial each. And nearly fifty individuals taught on Laws’ Connections . Teachers on the case studies included final year law students and some of our recent graduates, as well as all levels of faculty, from post-graduate research students to very experienced professors. The final year students and recent graduates enriched the teaching, and they confirmed in feedback that they gained a great deal from the experience. One thing we had not anticipated was that Laws’ Connections provides a different sort of ‘clinical’ legal experience for our students.
Such an ambitious and intensive programme also requires practical, moral and financial support from senior colleagues, and we had that from the Faculty of Laws Dean’s Team and the Dean.
And of course, without the enthusiasm of our professional services colleagues for improving the student experience, and their extraordinary support, we could not have done this.
It had never been my ambition to develop such an ambitious initiative. Laws’ Connections emerged from many discussions with a large number of colleagues and students about our experiences and our hopes.
We reflected on the enormous privilege of engaging with all of these young people, on their first steps in the transformative experience of higher education, within our walls and within our discipline. What did we really want their first experience to be?
We asked for anonymous feedback about Laws Connections from students and staff:
“ Laws Connections introduced me to the integration of the law into society and the importance of it in the issues that we face today.
“ It gave me a better understanding of how law works in the UK, in terms of how legislation is passed and how power is distributed. It also introduced the ethical issues that lawyers could potentially face.
“ The best thing about Laws’ Connections was being able to speak to different academics, students or experts about each topic, since every single person has a different aspect to introduce to your analysis.
“ The opportunity to introduce students to the connection between law and social issues, and to law in action, so early in their degree studies was fantastic. The teaching teams worked incredibly well - there was a team camaraderie and enthusiasm that made the teaching experience especially rewarding and also engaged students in the subject matter.
“ The programme is very exciting...I'm not sure the students will have realised just how much they have learned about how to be a law student.
These things don’t and shouldn’t last forever. But Laws’ Connections does feel sustainable, and should be able to flourish and evolve for a number of years. A few colleagues are working on additional case studies for 2019 and 2020, and many colleagues are keen to stay involved, or to get involved for the first time next year. We want to work harder on integrating Laws’ Connections into the rest of our programme.
We’re all applying the experience of teaching Laws’ Connections to other areas of our teaching and professional lives. Through some of our conversations around Laws’ Connections , we’ve empowered ourselves to teach across the curriculum in the way we think best.
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Blog about Writing Case Study and Coursework
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If you’re looking for examples of how to write an introduction for a case-study report, you’ve come to the right place. Here you’ll find a sample, guidelines for writing a case-study introduction, and tips on how to make it clear. In five minutes or less, recruiters will read your case study and decide whether you’re a good fit for the job.
An example of a case study introduction should be written to provide a roadmap for the reader. It should briefly summarize the topic, identify the problem, and discuss its significance. It should include previous case studies and summarize the literature review. In addition, it should include the purpose of the study, and the issues that it addresses. Using this example as a guideline, writers can make their case study introductions. Here are some tips:
The first paragraph of the introduction should summarize the entire article, and should include the following sections: the case presentation, the examinations performed, and the working diagnosis, the management of the case, and the outcome. The final section, the discussion, should summarize the previous subsections, explain any apparent inconsistencies, and describe the lessons learned. The body of the paper should also summarize the introduction and include any notes for the instructor.
The last section of a case study introduction should summarize the findings and limitations of the study, as well as suggestions for further research. The conclusion section should restate the thesis and main findings of the case study. The conclusion should summarize previous case studies, summarize the findings, and highlight the possibilities for future study. It is important to note that not all educational institutions require the case study analysis format, so it is important to check ahead of time.
The introductory paragraph should outline the overall strategy for the study. It should also describe the short-term and long-term goals of the case study. Using this method will ensure clarity and reduce misunderstandings. However, it is important to consider the end goal. After all, the objective is to communicate the benefits of the product. And, the solution should be measurable. This can be done by highlighting the benefits and minimizing the negatives.
The structure of a case study introduction is different from the general introduction of a research paper. The main purpose of the introduction is to set the stage for the rest of the case study. The problem statement must be short and precise to convey the main point of the study. Then, the introduction should summarize the literature review and present the previous case studies that have dealt with the topic. The introduction should end with a thesis statement.
The thesis statement should contain facts and evidence related to the topic. Include the method used, the findings, and discussion. The solution section should describe specific strategies for solving the problem. It should conclude with a call to action for the reader. When using quotations, be sure to cite them properly. The thesis statement must include the problem statement, the methods used, and the expected outcome of the study. The conclusion section should state the case study’s importance.
In the discussion section, state the limitations of the study and explain why they are not significant. In addition, mention any questions unanswered and issues that the study was unable to address. For more information, check out the APA, Harvard, Chicago, and MLA citation styles. Once you know how to structure a case study introduction, you’ll be ready to write it! And remember, there’s always a right and wrong way to write a case study introduction.
During the writing process, you’ll need to make notes on the problems and issues of the case. Write down any ideas and directions that come to mind. Avoid writing neatly. It may impede your creative process, so write down a rough draft first, and then draw it up for your educational instructor. The introduction is an overview of the case study. Include the thesis statement. If you’re writing a case study for an assignment, you’ll also need to provide an overview of the assignment.
A case study is not a formal scientific research report, but it is written for a lay audience. It should be readable and follow the general narrative that was determined in the first step. The introduction should provide background information about the case and its main topic. It should be short, but should introduce the topic and explain its context in just one or two paragraphs. An ideal case study introduction is between three and five sentences.
The case study must be well-designed and logical. It cannot contain opinions or assumptions. The research question must be a logical conclusion based on the findings. This can be done through a spreadsheet program or by consulting a linguistics expert. Once you have identified the major issues, you need to revise the paper. Once you have revised it twice, it should be well-written, concise, and logical.
The conclusion should state the findings, explain their significance, and summarize the main points. The conclusion should move from the detailed to the general level of consideration. The conclusion should also briefly state the limitations of the case study and point out the need for further research in order to fully address the problem. This should be done in a manner that will keep the reader interested in reading the paper. It should be clear about what the case study found and what it means for the research community.
The case study begins with a cover page and an executive summary, depending on your professor’s instructions. It’s important to remember that this is not a mandatory element of the case study. Instead, the executive summary should be brief and include the key points of the study’s analysis. It should be written as if an executive would read it on the run. Ultimately, the executive summary should include all the key points of the case study.
Clarity in a case study introduction should be at the heart of the paper. This section should explain why the case was chosen and how you decided to use it. The case study introduction varies according to the type of subject you are studying and the goals of the study. Here are some examples of clear and effective case study introductions. Read on to find out how to write a successful one. Clarity in a case study introduction begins with a strong thesis statement and ends with a compelling conclusion.
The conclusion of the case study should restate the research question and emphasize its importance. Identify and restate the key findings and describe how they address the research question. If the case study has limitations, discuss the potential for further research. In addition, document the limitations of the case study. Include any limitations of the case study in the conclusion. This will allow readers to make informed decisions about whether or not the findings are relevant to their own practices.
A case study introduction should include a brief discussion of the topic and selected case. It should explain how the study fits into current knowledge. A reader may question the validity of the analysis if it fails to consider all possible outcomes. For example, a case study on railroad crossings may fail to document the obvious outcome of improving the signage at these intersections. Another example would be a study that failed to document the impact of warning signs and speed limits on railroad crossings.
As a conclusion, the case study should also contain a discussion of how the research was conducted. While it may be a case study, the results are not necessarily applicable to other situations. In addition to describing how a solution has solved the problem, a case study should also discuss the causes of the problem. A case study should be based on real data and information. If the case study is not valid, it will not be a good fit for the audience.
A good case study introduction serves as a map for the reader to follow. It should identify the research problem and discuss its significance. It should be based on extensive research and should incorporate relevant issues and facts. For example, it may include a short but precise problem statement. The next section of the introduction should include a description of the solution. The final part of the introduction should conclude with the recommended action. Once the reader has a sense of the direction the study will take, they will feel confident in pursuing the study further.
In the case of social sciences, case studies cannot be purely empirical. The results of a case study can be compared with those of other studies, so that the case study’s findings can be assessed against previous research. A case study’s results can help support general conclusions and build theories, while their practical value lies in generating hypotheses. Despite their utility, case studies often contain a bias toward verification and tend to confirm the researcher’s preconceived notions.
In the case of case studies, the conclusions section should state the significance of the findings, stating how the findings of the study differ from other previous studies. Likewise, the conclusion section should summarize the key findings, and make the reader understand how they address the research problem. In the case of a case study, it is crucial to document any limitations that have been identified. After all, a case study is not complete without further research.
After the introduction, the main body of the paper is the case presentation. It should provide information about the case, such as the history, examination results, working diagnosis, management, and outcome. It should conclude with a discussion, explaining the correlations, apparent inconsistencies, and lessons learned. Finally, the conclusion should state whether the case study presented the results in the desired way. The findings should not be overgeneralized, and the conclusions must be derived from this information.
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Under President Biden’s Inflation Reduction Act, some people with Medicare will pay less for some Part B drugs if the drug’s price increased faster than the rate of inflation.
The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today announced that some Medicare enrollees will pay less for 64 drugs available through Medicare Part B. The drugs will have a lowered Part B coinsurance rate from July 1, 2024 – September 30, 2024, since each drug company raised prices faster than the rate of inflation. Over 750,000 people with Medicare use these drugs annually, which treat conditions such as osteoporosis, cancer, and infections. White House Domestic Policy Advisor Neera Tanden will announce the cost savings on these life-saving drugs in a keynote address on the Biden-Harris Administration’s focus on lowering costs today at the Center for American Progress.
“Without the Inflation Reduction Act, seniors were completely exposed to Big Pharma’s price hikes. Not anymore. Thanks to President Biden and the new Medicare inflation rebate program, seniors are protected and benefitting from lower Part B drug costs,” said White House Domestic Policy Advisor Neera Tanden. “The Biden-Harris Administration will continue fighting to bring down the cost of health care and prescription drugs for all Americans.”
“President Biden’s Medicare prescription drug rebate program is putting money back in the pockets of seniors and people with disabilities, said HHS Secretary Xavier Becerra. “President Biden made lowering prescription drug costs for Americans a top priority, and he is delivering on that promise. Our work is not complete, and we will continue to fight for lower health care costs for all Americans.”
Please find soundbites from HHS’ Chief Competition Officer, Stacy Sanders, here .
Because of President Biden’s lower cost prescription drug law, the Inflation Reduction Act, which established the Medicare Prescription Drug Inflation Rebate Program, some people with Medicare who use these drugs during this time period may save between $1 and $4,593 per day.
“Everyone should be able to afford their medication, and the Inflation Reduction Act continues to deliver on this goal to improve affordability,” said CMS Administrator Chiquita Brooks-LaSure. “Discouraging drug companies from price increases above the rate of inflation is a key part of this effort, and CMS continues to implement the law to bring savings to people with Medicare.”
Padcev, a medication used to treat advanced bladder cancer, is an example of a prescription drug with a price that has increased faster than the rate of inflation every quarter since the Medicare Part B inflation rebate program went into effect, resulting in lowered Part B coinsurances for seniors and others with Medicare. A beneficiary taking Padcev as part of their cancer treatment may have saved as much as $1,181 from April 1, 2023 through March 31, 2024, depending on their coverage and course of treatment. Another example, Crysvita, treats a rare genetic disorder that causes impaired growth, muscle weakness, and bone pain. A beneficiary taking Crysvita may have saved as much as $765 from July 1, 2023 through March 31, 2024 depending on their coverage and course of treatment.
The Medicare Prescription Drug Inflation Rebate Program is just one of the Inflation Reduction Act’s prescription drug provisions aimed at lowering drug costs. In addition to this program, the law expanded eligibility for full benefits under the Low-Income Subsidy program (LIS or “Extra Help”) under Medicare Part D at the beginning of this year. Nearly 300,000 people with low and modest incomes are now benefiting from the program’s expansion. A comprehensive public education campaign is underway to reach the more than three million people who are likely eligible for the program but not yet enrolled.
In addition, as of January 1, 2024, some people enrolled in Medicare Part D who have high drug costs have their annual out-of-pocket costs capped at about $3,500. In 2025, all people with Medicare Part D will benefit from a $2,000 cap on annual out-of-pocket prescription drug costs.
The Inflation Reduction Act requires drug companies to pay rebates to Medicare when prices increase faster than the rate of inflation for certain drugs. CMS intends to begin invoicing prescription drug companies for rebates owed to Medicare no later than fall 2025. The rebate amounts paid by drug companies will be deposited in the Federal Supplementary Medical Insurance Trust Fund, which will help ensure the long-term sustainability of the Medicare program for future generations.
For more information on the Medicare Prescription Drug Inflation Rebate Program visit, https://www.cms.gov/inflation-reduction-act-and-medicare/inflation-rebates-medicare
To view the fact sheet on the 64 Part B drugs with a coinsurance reduction for the quarter July 1, 2024 – September 30, 2024, visit, https://www.cms.gov/files/document/reduced-coinsurance-certain-part-b-rebatable-drugs-july-1-september-30-2024.pdf
More information and helpful resources about the Inflation Reduction Act and how it is helping to lower costs for people with Medicare can be found at LowerDrugCosts.gov .
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FILE - A flag supporting LGBTQ+ rights decorates a desk on the Democratic side of the Kansas House of Representatives during a debate, March 28, 2023, at the Statehouse in Topeka, Kan. The U.S. Supreme Court agreed Monday to consider whether a Tennessee ban on gender-affirming care for minors is constitutional. (AP Photo/John Hanna, File)
The U.S. Supreme Court said Monday that it will hear arguments on the constitutionality of state bans on gender-affirming care for transgender minors.
The issue has emerged as a big one in the past few years. While transgender people have gained more visibility and acceptance in many respects, half the states have pushed back with laws banning certain health care services for transgender kids.
Things to know about the issue:
Gender-affirming care includes a range of medical and mental health services to support a person’s gender identity, including when it’s different from the sex they were assigned at birth.
The services are offered to treat gender dysphoria, the unease a person may have because their assigned gender and gender identity don’t match. The condition has been linked to depression and suicidal thoughts.
Gender-affirming care encompasses counseling and treatment with medications that block puberty, and hormone therapy to produce physical changes. Those for transgender men cause periods to stop, increase facial and body hair, and deepen voices, among others. The hormones used by transgender women can have effects such as slowing growth of body and facial hair and increasing breast growth.
Gender-affirming care can also include surgery, including operations to transform genitals and chests. These surgeries are rarely offered to minors .
Over the past three years, 26 Republican-controlled states have passed laws restricting gender-affirming care for minors. Most of the laws ban puberty blockers, hormone treatment and surgery for those under 18. Some include provisions that allow those already receiving treatment to continue.
The laws also make exceptions for gender-affirming treatments that are not part of a gender transition, such as medications to stop breast growth in boys and excessive facial hair in girls.
One of the laws — in Arkansas — was nixed by a federal court and is not being enforced.
Meanwhile, at least 14 Democratic-controlled states have adopted laws intended to protect access to gender-affirming care.
The gender-affirming care legislation is a major part of a broader set of laws and policies that has emerged in Republican-controlled states that rein in rights of transgender people. Other policies, adopted in the name of protecting women and girls, bar transgender people from school bathrooms and sports competitions that align with their gender.
Most of the bans have faced court challenges, and most are not very far along in the legal pipeline yet.
The law in Arkansas is the only one to have been struck down entirely, but the state has asked a federal appeals court to reverse that ruling.
The 6th U.S. Circuit Court of Appeals, one step below the Supreme Court, last year ruled that Kentucky and Tennessee can continue to enforce their bans amid legal challenges. The high court has agreed to hear the Tennessee case in the term that starts later this year.
The U.S. Supreme Court in April ruled that Idaho can enforce its ban while litigation over it proceeds. A lower court had put it on hold.
Every major U.S. medical group, including the American Academy of Pediatrics and the American Medical Association, has opposed the bans and said that gender-affirming treatments can be medically necessary and are supported by evidence.
But around the world, medical experts and government health officials are not in lockstep. Some European countries in recent years have warned about overdiagnosis of gender dysphoria.
In England, the state-funded National Health Service commissioned a review of gender identity services for children and adolescents, appointing retired pediatrician Dr. Hilary Cass to lead the effort. The final version of the Cass Review , published in April, found “no good evidence on the long-term outcomes of interventions to manage gender-related distress.”
England’s health service stopped prescribing puberty blockers to children with gender dysphoria outside of a research setting, following recommendations from Cass’ interim report.
The World Professional Association for Transgender Health and its U.S. affiliate issued a statement in May saying they’re deeply concerned about the process, content and consequences of the review, saying it “deprives young trans and gender diverse people of the high-quality care they deserve and causes immense distress and harm to both young patients and their families.”
Introduction, background and methods, limitations, acknowledgements, data availability.
Md Mamunur Rashid, Kumar Selvarajoo, Advancing drug-response prediction using multi-modal and -omics machine learning integration (MOMLIN): a case study on breast cancer clinical data, Briefings in Bioinformatics , Volume 25, Issue 4, July 2024, bbae300, https://doi.org/10.1093/bib/bbae300
The inherent heterogeneity of cancer contributes to highly variable responses to any anticancer treatments. This underscores the need to first identify precise biomarkers through complex multi-omics datasets that are now available. Although much research has focused on this aspect, identifying biomarkers associated with distinct drug responders still remains a major challenge. Here, we develop MOMLIN, a multi-modal and -omics machine learning integration framework, to enhance drug-response prediction. MOMLIN jointly utilizes sparse correlation algorithms and class–specific feature selection algorithms, which identifies multi-modal and -omics–associated interpretable components. MOMLIN was applied to 147 patients’ breast cancer datasets (clinical, mutation, gene expression, tumor microenvironment cells and molecular pathways) to analyze drug-response class predictions for non-responders and variable responders. Notably, MOMLIN achieves an average AUC of 0.989, which is at least 10% greater when compared with current state-of-the-art (data integration analysis for biomarker discovery using latent components, multi-omics factor analysis, sparse canonical correlation analysis). Moreover, MOMLIN not only detects known individual biomarkers such as genes at mutation/expression level, most importantly, it correlates multi-modal and -omics network biomarkers for each response class. For example, an interaction between ER-negative-HMCN1-COL5A1 mutations-FBXO2-CSF3R expression-CD8 emerge as a multimodal biomarker for responders, potentially affecting antimicrobial peptides and FLT3 signaling pathways. In contrast, for resistance cases, a distinct combination of lymph node-TP53 mutation-PON3-ENSG00000261116 lncRNA expression-HLA-E-T-cell exclusions emerged as multimodal biomarkers, possibly impacting neurotransmitter release cycle pathway. MOMLIN, therefore, is expected advance precision medicine, such as to detect context–specific multi-omics network biomarkers and better predict drug-response classifications.
The advent of high-throughput sequencing technologies has revolutionized our ability to collect various ‘omics’ data types, such as deoxyribonucleic acid (DNA) methylations, ribonucleic acid (RNA) expressions, proteomics, metabolomics and bioimaging datasets, from the same samples or patients with unprecedented details [ 1 ]. By far, most studies have performed single omics analytics, which capture only a fraction of biological complexity. The integration of these multiple omics datasets offers a more comprehensive understanding of the underlying complex biological processes than single-omic analyses, particularly in human diseases like cancer and cardiovascular disease, where it significantly enhances prediction of clinical outcomes [ 2 , 3 ].
Cancer is a highly complex and deadly disease if left unchecked, and its heterogeneity poses significant challenges for treatment [ 4 ]. Standard treatments, including chemotherapy with or without targeted therapies, aim to reduce tumor burden and improve patient outcomes such as survival rate and quality of life [ 5–7 ]. However, even for the most advanced therapies, such as immunotherapies, treatment effectiveness varies widely across cancer types and even between patients with same diagnosis [ 8 ]. This heterogeneity is believed to be due to tumor microenvironment heterogeneity and their effects on the resultant complex and myriad molecular interactions within cells and tissues [ 9 , 10 ]. This variability underscores the urgent need to identify precise biomarkers to predict individual patient responses and potential adverse reactions to a particular therapy [ 11 ]. This can be made possible through multi-omics data integration analyses at the individual patient scale [ 12 ].
To assess treatment response, such as pathologic complete response (pCR) and residual cancer burden (RCB), current clinical practice relies on clinical parameters (e.g. tumor size/volume and hormone receptor status), along with genetic biomarkers (e.g. TP53 mutations) [ 13–15 ]. However, these approaches do not fully capture the complex intracellular regulatory dynamics [ 16 , 17 ] or the tumor-immune microenvironment (TiME) interactions that influence outcomes [ 18 , 19 ]. Thus, to enhance personalized cancer treatments, we need novel methodologies that can handle large, complex molecular (omics) and clinical datasets. Machine learning (ML) methods integrating multi-omics data offer a promising avenue to improve prediction accuracy and uncover robust biomarkers across drug-response classes [ 20 ], which may be overlooked by single-omics analytics. This approach can predict patients benefiting from standard treatments and those requiring alternative plans like combination therapies or clinical trials.
The current drug-response prediction methods can be broadly categorized into ML-based and network-based approaches. ML methods often analyze each data type (e.g. mutations and gene expression) independently using univariable selection [ 21 , 22 ] or dimension reduction methods [ 23 ]. These results are then integrated using various classifiers or regressors [e.g. support vector machine, elastic-net regressor, logistic regression (LR) and random forest (RF)] [ 24–26 ] and ensemble classifier to make predictions [ 9 ]. However, these methods often overlooked the crucial interactions among different data modalities. Deep learning methods, while gaining popularity, are limited by the need for large clinical sample sizes to achieve sufficient accuracy [ 27 ]. Recent ML advancements have focused on integrating multimodal omics features with patient phenotypes to improve predictive performance [ 28 , 29 ]. To discover multimodal biomarker, techniques such as multi-omics factor analysis (MOFA) and sparse canonical correlation analysis (SCCA), including its variant multiset SCCA (SMCCA) offer realistic strategies for integrating diverse data modalities [ 30–32 ]. However, although these methods are suitable for classification tasks, they are unsupervised and do not directly incorporate phenotypic information (e.g. disease status) to integrate diverse data types. As a result, they are limited to identify phenotype-specific biomarkers.
Recently, advanced supervised approaches like data integration analysis for biomarker discovery using latent components (DIABLO) by Sing et al. (2019) have emerged to overcome these limitations [ 28 ]. DIABLO is an extension of generalized SCCA (GSCCA), considers cross-modality relationships and extracts a set of common factors associated with different response categories. Network-based methods, like unsupervised network fusion or random walk with restart approaches construct drug–target interaction and sample similarity networks that are effective for patient stratification [ 20 , 33 ]. However, these methods lack a specific feature selection design, limiting their utility for identifying biomarkers for patient classification. Nevertheless, none of these ML methods are rigorous in terms of task/class-specific biomarker discovery and interpretability, and both SMCCA and GSCCA struggle with gradient dominance problem due to naive data fusion strategies [ 34 ]. Therefore, it is essential to develop novel interpretable methods for identifying robust multimodal network biomarkers across diverse data types to advance our understanding of the complex factors that influence drug responses.
In this study, we introduce MOMLIN, a multi-modal and -omics ML integration framework to enhance the prediction of anticancer drug responses. MOMLIN integrates weighted multi-class SCCA (WMSCCA) that identifies interpretable components and enables effective feature selection across multi-modal and -omics datasets. Our method contributes in three keyways: (i) innovates a class-specific feature selection strategy with SCCA methods for associating multimodal biomarkers, (ii) includes an adaptive weighting scheme into multiple pairwise SCCA models to balance the influence of different data modalities, preventing dominance during training process and (iii) ensures robust feature selection by employing a combined constraint mechanism that integrate lasso and GraphNet constraints to select both the individual features and subset of co-expressed features, thereby preventing overfitting to high-dimensional data.
We applied MOMLIN to a multimodal breast cancer (BC) dataset of 147 patients comprising clinical features, DNA mutation, RNA expression, tumor microenvironment and molecular pathway data [ 9 ], to predict drug-response classes, specifically distinguishing responders and non-responders. Our results demonstrate MOMLIN’s superiority in terms of outperforming state-of-the-art methods and interpretability of the underlying biological mechanisms driving these distinct response classes.
The workflow of our proposed method MOMLIN for identifying class- or task-specific biomarkers from multimodal data is shown in Fig. 1 . The core of this pipeline involves three stages: (i) identification of response-specific sparse components, in terms of input features and patients, (ii) development of drug-response predictor using latent components of patients and (iii) interpretation of sparse components and multi-modal and -omics biomarker discovery.
Schematic representation of the proposed framework. In stage 1, multimodal datasets from cancer patients (e.g. BC) were sourced from a published study [ 9 ]. This dataset comprises clinical features, DNA mutations, and gene expression from pre-treatment tumors, alongside post-treatment response classes (pCR, RCB-I to III). TiME and pathway activity were derived from transcriptomic data using statistical algorithms. For identifying class-specific correlated biomarkers, class binarization and oversampling were used to balance between classes. WMSCCA models the multimodal associations across different biomarkers and identifies response-specific sparse components on diverse input features and patients. In stage 2, a binary LR classifier then utilizes these patient latent components for predicting response to therapies, evaluated by AUROC. Next in stage 3, class–specific sparse components are shown in a heatmap, highlighting key signatures (non-zero loading) in colors. Finally, the identified multi-modal and -omics signatures then formed a correlation network, revealing pathways associations with multi-modal and -omics biomarkers for each response class. Nodes with colors in the network indicate multimodal features.
The rationales underpinned of this approach is that effective biomarkers are: (i) response–related multimodal features including genes, cell types and pathways, and (ii) features that demonstrate prediction capabilities on unseen patients. The first stage, a ‘feature selection step’ that selects multimodal features on the generated sparse components based on their relevance to drug-response categories (pCR and RCB-I to III). Features with high loading identified are considered as potential biomarker candidates. The second stage, a ‘classification step’, validates these biomarkers by assessing their predictive power in distinguishing responders from non-responders to anticancer therapy; any predictions indicating chemo-resistant tumors should be considered for enrolment in clinical trials for novel therapies. The third stage, an ‘interpretation step,’ analyzes the candidate biomarkers in a multi-modal and-omics network associated with relevant biological pathways. This step aims to elucidate the underlying biological processes differentiating between drug–response phenotypes.
Multi-modal and -omics data overview and preparation.
This study utilized clinical attributes, DNA mutation and gene expression (transcriptome) data from147 matched samples of early and locally advanced BC patients (categorized as pCR, n = 38, RCB-I, n = 23, or RCB-II, n = 61, or RCB-III, n = 25), obtained from the TransNEO cohort at Cambridge University Hospitals NHS Foundation [ 9 ]. The dataset includes clinical attributes (8 features, summary attributes are available in Supplementary Table S1 available online at http://bib.oxfordjournals.org/ ), genomic features (31 DNA mutation genes, applying a strict criterion of genes mutated in at least 10 patients) and RNA-sequencing (RNA-Seq) features (18 393 genes), covering major BC subtypes-normal-like, basal-like, Her2, luminalA and luminalB. Although DNA mutation genes typically represent binary data, we used mutation frequencies to construct a mutation count matrix. Initial data pre-processing involved a log2 transformation on the RNA-Seq features after filtering out less informative features at 25th percentile (in terms of mean and standard deviation) using interquartile range. For integrative modeling, we used the top 40% of variable genes (3748 genes, based on median absolute deviation ranking) from the RNA-Seq datasets. Finally, each feature was normalized dividing by its Frobenius norm, adjusting the offset between high and low intensities across different data modalities.
To characterize TiME and pathway markers, we applied various statistical algorithms on the RNA-Seq data. The GSVA algorithm [ 35 ] calculated (i) the GGI gene sets [ 36 ] and (ii) STAT1 immune signature scores [ 37 ]. For immune cell enrichment, three methods were used: (i) MCPcounter [ 37 ] with voom-normalized RNA-Seq counts; (ii) enrichment over 14 cell types using 60 gene markers, employing log2-transformed geometric mean of transcript per million (TPM) expression [ 38 ]; and (iii) z -score scaling of cancer immunity parameters [ 39 ] to classify four immune processes (major histocompatibility complex molecules, immunomodulators, effector cells and suppressor cells). Additionally, the TIDE algorithm [ 40 ] computed T-cell dysfunction and exclusion metrics for each tumor sample using log2-transformed TPM matrix of counts, which can serve as a surrogate biomarker to predict the response to immune checkpoint blockade. Pathway activity scores for each tumor sample were computed using the GSVA algorithm with input gene sets from Reactome [ 41 ], PIP [ 42 ] and BioCarta databases within the MSigDB C2 pathway database [ 43 ].
In this study, lowercase letters denote a vector, and uppercase ones denote matrices, respectively. The term |${\left\Vert .\right\Vert}_{1,1}$| denotes the matrix |${l}_1$| -norm, and |${\left\Vert .\right\Vert}_{gn}$| denotes the GraphNet regularization. The sparse multiset canonical correlation analysis (SMCCA) is an extension of dual-view SCCA, proposed to model associations among multiple types of datasets [ 31 ]. Given the multiple types of datasets, let |$X\in{\mathcal{R}}^{n\times p}$| represent gene expression data with |$p$| features, and |${Y}_k\in{\mathcal{R}}^{n\times{q}_k}$| represent the |$k$| -th data modality (e.g. clinical, DNA mutation and tumors microenvironment) with |${q}_k$| features. Both |$X$| and |${Y}_k$| have |$n$| samples, and |$k=\left(1,\dots, K\right)$| , where |$K$| denotes the number of different data modalities. The objective function of SMCCA is defined as follows:
where |$u$| and |${v}_k$| are the canonical weight vectors corresponding to |$X$| and |${Y}_k$| , indicating the importance of each respective biomarkers. The term |${\left\Vert .\right\Vert}_1$| represents the |${l}_1$| regularization to detect small subset of discriminative biomarkers and prevent model overfitting. |${\lambda}_u,{\lambda}_{vk}$| are non-negative tuning parameters balancing between the loss function and regularization terms. The term |${\left\Vert .\right\Vert}_2^2$| denotes the squared Euclidean norm to constraint weight vectors |$u$| and as unit length |${v}_k$| , respectively.
However, SMCCA has limitations: (i) it is naturally unsupervised, meaning SMCCA cannot leverage phenotypic information (e.g. disease status and drug-response classes); (ii) pairwise association among multiple data types can vary significantly and can lead to gradient dominance issues during optimization; and (iii) SMCCA mines a common subset of biomarkers for classifying different tasks, which diminishes its relevance, as each task might require distinct features sets.
To address the above limitations, here we propose weighted multi-class SCCA (WMSCCA), a formal model for class/tasks-specific feature selection, different from the conventional SMCCA. Throughout this study, we used the terms tasks/classes/drug-response classes interchangeably. WMSCCA includes phenotypic information as an additional data type, employs a weighting scheme to resolve the gradient dominance issue and innovates traditional class–specific feature selection strategies through the one-versus-all strategies into its core objective function. In this study, the underlying motivation is WMSCCA can jointly identify drug-response class–specific multimodal biomarkers to improve drug-response prediction. For ease of presentation, we consider |$n$| patients with data matrices |${X}_c\in{\mathcal{R}}^{n\times p},{Y}_{ck}\in{\mathcal{R}}^{n\times{q}_k}$| , and |$Z\in{\mathcal{R}}^{n\times C}$| from C different drug-response classes. Here, |${X}_c$| denotes |$p$| features from gene expression datasets, |${Y}_{ck}$| denotes |${q}_k$| features from |$k$| -th data modality (e.g. mutation, clinical features, TiME and pathway activity), |${Z}_c$| denotes |$c$| response class, and |$k=\left(1,\dots, K\right)$| , |$K$| denotes the number of data modalities. The WMSCCA optimization problem can be formulated as follows:
where |$U\in{\mathcal{R}}^{p\times C},{V}_k\in{\mathcal{R}}^{q_k\times C}$| are canonical loading matrices correspond to |$X$| and |${Y}_k$| , representing the importance of candidate biomarkers for each class |$C$| , respectively. In this equation, the first term models associations among |$X$| , and |${Y}_k$| datasets; the second- and third terms correlate class labels |${Z}_c$| with |$X$| and |${Y}_k$| data modalities for each |${C}^{th}$| class, aiming to identify class-specific features and their relationships; |$\psi (U)$| and |$\psi \left({V}_k\right)$| represent sparsity constraints on |$U$| and |${V}_k$| , to select a subset of discriminative feature. As mentioned in Equation ( 1 ), to address gradient dominance, the adjusting weight parameter |${\sigma}_{xy}$| , |${\sigma}_{xz}$| and |${\sigma}_{yz}$| can be defined as:
where |$k=\left(1,\dots, K\right)$| , |$K$| denotes the number of data modalities. |${\sigma}_{..}$| adjusts a larger weight if the non-squared loss (denominator term) between datasets is small and vice versa.
Given high-dimensional datasets, the model in Equation ( 2 ) encounters an overfitting problem. Therefore, the use of a sparsity constraint is appropriate to address this issue. We hypothesized that gene expression biomarkers can be either single genes or co-expressed sets; thus, a combined penalty is designed for the |$X$| dataset. Therefore, |$\psi (U)$| for |$X$| takes the following form:
where, |${\mathrm{\alpha}}_u,\beta$| are nonnegative tuning parameters. |$\beta$| balances between the effect of co-expressed and individual feature selection. The first sparsity constraint is matrix |${l}_{1,1}$| -norm, which is defined as follows:
This penalty promotes class-specific features on |$U$| . The second sparsity constraint GraphNet regularization, defined as follows:
where |${L}_c$| represents the Laplacian matrices of the connectivity in |$\boldsymbol{X}$| matrices. The Laplacian matrix is defined as |$L=D-A$| , where |$D$| is the degree matrix of connectivity matrix |$A$| (e.g. gene co-expression or correlation network). This penalty term promotes a subset of connected features to discriminate each response on |$U$| .
Besides, neither every mutation marker nor every clinical/TiME/pathways involves in predicting response classes, therefore, the |${l}_{1,1}$| -norm is used on the |${Y}_k$| datasets to select individual markers, i.e. |$\psi \left({V}_k\right)$| for the |${\boldsymbol{Y}}_k$| data modalities take the following form:
where |${\mathrm{\alpha}}_{vk}$| is non-negative tuning parameter.
Finally, we obtained C pairs of canonical weight matrices |$\big({U}_c{V}_{ck}\big)\left(c=1,\dots, C;k=1,\dots, K\right)$| using an iterative alternative algorithm by solving Equation ( 2 ) [ 44 , 45 ]. Detected features with non-zero weights in each class in the weight vectors were extracted as correlated sets.
The WMSCCA method involves parameters |${\mathrm{\alpha}}_u,\mathrm{\beta}, and\ {\mathrm{\alpha}}_{vk}$| |$\left(k=1, \dots, K\right)$| . Given the limited number of samples, we applied a nested cross-validation (CV) strategy on training sets and evaluated the maximum correlation on the test datasets. Optimal values for the regularization parameters were determined within each training set via internal five-fold CV.
To predict drug-response categories, we trained LR classifier using the latent components of patients (or raw multimodal features) generated by MOMLIN in Fig. 1 : stages 1 and 2. We used a binary classification scheme, distinguishing pCR versus non-pCR, RCB-I versus non-RCB-I, RCB-II versus non-RCB-II and RCB-III versus non-RCB-III, to evaluate model performance. In addition, we performed analyses with existing multi-omics methods, including SMCCA+LR, MOFA+LR, DIABLO and latent principal component analysis (PCA) features, with LR classifiers. To assess prediction performance for the response to treatment in an unbiased manner, we used five-fold cross-validated performance and repeated the process over 100 runs. The partitioning of data was kept consistent across all models for fair comparisons. The accuracy of response prediction was evaluated using area under the receiver operating characteristic curve (AUROC).
After learning sparse latent components of features across different data modalities using MOMLIN, we identify the most relevant feature based on the loading weight of genes, TiME and pathways, which reveal underlying interactions for discriminating response classes. The larger the loading weight, the more important the pair of features in discriminating response categories. We then use these selected features to construct a sample correlation network, or a relationship matrix based on their canonical weights [ 46 ]. In this network, nodes represent selected features, and the edge weights between two interconnected features indicate correlation or relatedness. The generated network is visualized using the ggraph package in R ( https://cran.r-project.org ). Finally, we prioritize multi-omics biomarkers based on their degree centrality within the interconnected correlation network.
We applied MOMLIN to analyze a breast cancer (BC) dataset to predict treatment response and gain molecular insights. The dataset comprised 147 BC patients with early and locally advanced pretherapy tumors [ 9 ], categorized as follows: pCR with 38 patients, RCB-I (good response) with 23 patients, RCB-II (moderate response) with 61 patients and RCB-III (resistance) with 25 patients. After preprocessing and filtering least informative features, the final dataset comprised 3748 RNA genes (top 40% out of 9371 genes), 31 mutation genes, 8 clinical attributes, 64 TiME and 178 pathways activities ( Fig. 1 : stage 1). Supplementary Table S1 available online at http://bib.oxfordjournals.org/ summarizes overall clinical characteristics by patients’ response classes.
While our proposed framework offers general applicability for identifying context-specific multi-omics biomarkers, this study specifically focused on discovering drug-response–specific biomarkers to enhance the prediction of pCR and RCB resistance. MOMLIN decomposed the input multimodal data into response-associated sparse latent components of input-features and patients. These sparse components reveal patterns of how various features (e.g. genes and mutations) and clinical attributes related to treatment outcomes ( Fig. 1 : stage 1–3), and their effectiveness was evaluated by measuring prediction performance. We assessed the predictive ability of MOMLIN through five-fold CV repeated 100 times. In each iteration, the dataset is divided into five-folds, with one random fold assigned as the held-out test set, and the remaining folds used as the training set. MOMLIN was trained using the training dataset, including detection of predictive marker candidates, and its performance was evaluated on the ‘unseen’ test set. This process was repeated for all five-folds to ensure robust evaluation of MOMLIN’s generalizability. Performance was measured by the AUROC matrices ( Fig. 1 : stage 2).
To evaluate the prediction capability of MOMLIN, we modeled each response category as a binary classification problem and compared its prediction accuracy to existing multi-omics integration algorithms. For comparison, we randomly split the dataset into a training set (70%) and a test set (30% unseen data), with balanced inclusion of response classes. We employed LR as the classifier to assess predictive performance of multimodal biomarkers. We compared MOMLIN with four other classification algorithms for omics data: (i) SMCCA, which integrates multi-omics data by projecting it onto latent components for discriminant analysis; (ii) MOFA, which decomposes multi-omics data into common factors for discriminant analysis; (iii) sparse PCA; and (iv) DIABLO, a supervised integrative analysis method, represent the state-of-the-art in classification. All methods were trained on the same preprocessed data.
The classification results showed that MOMLIN outperformed the compared multi-omics integration methods in most classification tasks on unseen test samples ( Fig. 2A ). Notably, DIABLO, the next best performer, was 10 to 15% less effective than our MOMLIN. Additionally, we compared the performance of component-based LR models against raw feature-based LR models to predict RCB response classes. Although raw feature-based models showed improved prediction, their performance was notably dropped compared to component-based models ( Fig. 2B ). This indicates the superior adaptability and effectiveness of component-based models in leveraging multi-omics data for predictive purposes.
Performance comparison with existing methods and detection of informative data combination. All results in the plots depict test AUROC over five-fold CV obtained from 100 runs. (A) Box plots comparing response prediction performance of MOMLIN against existing state-of-the-art multi-omics methods. (B) Performance comparison between predictors based on latent components and those utilizing a selected subset of multimodal features. (C) Comparing AUROCs for the models with different data subset combinations (clinical, clinical + DNA, clinical + RNA and clinical + DNA + RNA) using MOMLIN.
Moreover, to test and demonstrate generalizability of this framework, we applied MOMLIN to a preprocessed multi-omics dataset of colorectal adenocarcinoma (COAD) with 256 patients [ 47 ]. This dataset included gene expression, copy number variations and micro-RNA expression data, which we used to classify COAD subtypes such as chromosomal instability (CIN, n = 174), genomically stable (GS, n = 34) and microsatellite instability (MSI, n = 48). The performance results shown in Supplementary Table S2 available online at http://bib.oxfordjournals.org/ and Supplementary Figure S1 available online at http://bib.oxfordjournals.org/ , indicate that MOMLIN outperformed all state-of-the-art methods tested in classifying COAD subtypes. Moreover, when comparing the raw feature-based accuracies with sparse components-based (features derived from MOMLIN) accuracies, we found that raw feature-based classifier was superior against existing methods ( Figure S1A and B ), but lower than the components-based classifier. This consistent observation supports our findings with BC drug-response performances.
To assess the added value of integrating multimodal data for predicting treatment response, we trained four prediction models with different feature combinations: (i) clinical features only, plus adding (ii) DNA, (iii) RNA and (iv) both DNA and RNA. We found that adding different data modalities improved prediction performance across all response classes ( Fig. 2C ). Notably, the models that combined clinical data with either RNA or both DNA and RNA demonstrated superior and comparable performance with an average AUROC of 0.978. In contrast, the model based on clinical features alone had much lower AUROC, ranging from 0.51 to 0.82. These results suggest that RNA transcriptome is the most informative data modality in this dataset. Thus, integrating gene expression with clinical features could significantly improve our ability to predict treatment outcomes in BC.
To understand the molecular landscape of treatment response in BC, we used MOMLIN to model response–specific bi-multivariate associations across multiple data modalities. We observed stronger correlations between RNA gene expression and both TiME ( r = 0.701) and pathway activity ( r = 0.868), indicating greater overlap or explained information between them. Conversely, moderate correlations were found between RNA gene expression and DNA mutations ( r = 0.526), or clinical features ( r = 0.488), indicating partially overlapping or independent information. These results suggest that multimodal biological features provide complementary information in a combinatorial manner.
When investigating the importance of each feature to predict response classes, MOMLIN identified four distinct loading vectors corresponding to pCR and RCB response classes, highlighting distinct weight patterns for pCR versus non-pCR and RCB versus non-RCB classes ( Fig. 3 ). For example, in the pCR (complete response) components—taking the top five molecular features across different modalities revealed distinct molecular patterns. Specifically, gene expression analysis showed that downregulation of FBXO2 and RPS28P7 inhibits tumor cell proliferation, and potentially may enhance treatment efficacy, and the upregulation of C2CD4D-AS1, CSF3R, and SMPDL3B genes may promote immune response, increasing tumor cell vulnerability and therapeutic effect ( Fig. 3A ). Mutational analysis revealed negative associations of marker genes HMCN1 and GATA3, but a positive association for COL5A1 ( Fig. 3C ). Additionally, tumor mutation burden (TMB), and homologous recombination deficiency (HRD)-Telomeric AI signatures were higher in pCR patients, suggesting high genomic instability compared to RCB patients [ 9 ]. TiME analysis showed reduced immunosuppressive mast cells and extracellular matrix (ECM), along with increased infiltration of neutrophils, TIM-3 and CD8+ T-cells ( Fig. 3D ). Subsequently, the pathway analysis further revealed potential downregulation of the PDGFRB pathway, involved in stromal cell activity and associated with improved patient response [ 49 ], while upregulation of pathways for antimicrobial peptides, FLT3 signaling, ephrin B reverse signaling and potential therapeutics for SARS ( Fig. 3E ), suggesting enhanced immune surveillance and interaction with tumor cells. In summary, MOMLIN reveals distinct genomic landscape with higher immune activity and genomic instability in pCR that characterizes its favorable treatment response.
Heatmaps illustrate the features importance on response-associated components identified by MOMLIN. Each row in the heatmap represents a drug-response class, pCR, RCB-I , RCB-II and RCB-III, with columns representing features across different data modalities. The color gradient indicates feature loading or importance, representing the strength of association with response classes. The sign (negative or positive) of gradient denotes the association directions to response classes. All results in the heatmaps depict an average over 100 runs of five-fold CV. (A–E) represents the response-associated candidate biomarkers detected in latent components in (A) gene expression data (highlighting DE genes), (B) clinical features, (C) DNA mutations (highlighting mutated genes), (D) TiME cells and (E) functional pathway profiles (highlighting altered pathways).
Similarly, in the RCB-I (good response) components—RNA expression analysis revealed that lower expression of genes GPX1P1 and HBB are linked to less aggressive tumors [ 48 ], while those of thiosulfate sulfurtransferase (TST), NPIPA5 and GSDMB were overexpressed, linked to enhanced immune response and therapeutic effectiveness [ 49 , 50 ]. Mutational analysis showed positive association for therapeutic targets signatures TP53, MUC16 and RYR2 [ 51 , 52 ], but a negative in NEB, and CIN scores. TiME analysis demonstrated increased infiltration of Tregs, cancer-associated fibroblast (CAF), monocytic lineage and natural killer (NK) cells, indicating more active of immune environment [ 9 ], with reduced TEM CD4 cells. Pathway analysis further identified downregulation of NOD1/2 signaling, EPHA-mediated growth cone collapse and toll-like receptor (TLR1, TLR2) pathways, involved in inflammation and immune response, with the upregulation of allograft rejection, and G0 and early G1 pathways. In summary, tumors that achieve RCB-I is marked by distinct genomics marker, active immune response, and lower CIN.
In RCB-II (moderate response) components: RNA expression analysis revealed overexpression of RPLP0P9, FTH1P20, RNF5P1 pseudogenes, following accumulation of overexpressed ERVMER34-1, and PON3 genes play an oncogenic role in BC [ 53 ]. Mutation analysis revealed positive association of HRD-LOH, RYR1 and MT-ND4, but negative association of MACF1 and neoantigen loads, in line with previous reports [ 54 , 55 ]. Analysis of TiME features demonstrated increased infiltration of IDO1 and TAP2, with reduced CTLA 4, NK cells and PD-L2 cells, indicating a less suppressive immune environment. Pathways analysis further revealed downregulation pathways of G1/S DNA damage checkpoints and TP53 regulation, highlighting DNA repair issues, with the upregulation of PDGFRB pathway, E2F targets and signaling by Hedgehog associated with cell proliferation. In summary, RCB-II patients display distinct genomics markers including pseudogenes, lack of suppressive immune environment and active proliferation.
In RCB-III (resistant) components: RNA gene expression analysis revealed lower expression of therapeutic target PON3, and FGFR4 [ 56 ], and flowed accumulation of lower expressed lncRNAc ENSG00000225489, ENSG00000261116 and RNF5P1. Mutation signature analysis identified a positive association of MT-ND1, but a negative association in therapeutic targets TP53, and MT-ND4 [ 7 , 52 ]. Neoantigen loads were higher following lower TMB indicate reduced tumor suppressor activity. TiME analysis revealed reduced activity of T-cell exclusion, and HLA-E, with increased ECM, HLA DPA1 and LAG3, suggesting an immune suppressive tumor environment. Pathway analysis revealed upregulation of pathways involved in neurotransmitter release, cell-cycle progression (RB-1) and immune system diseases, suggesting active cell signaling and proliferation, with downregulation of EPHB FWD pathway and nucleotide catabolism. In summary, patients that attained RCB-III, characterized by low mutational burden and an immune suppressive environment, leading to treatment resistance.
To further extract multimodal network biomarkers and understand the complex biological interactions in patients with pCR and RCB, we performed cross-interaction network analysis using candidate signatures identified by MOMLIN across different modalities. This analysis included clinical features, DNA mutations, gene expression, TiME cells and enriched pathways, aiming to elucidate the underlying biology associated with specific treatment responses. Figure 4 shows the interaction networks of selected multimodal features for each RCB class. To identify potential biomarkers associated with pCR and RCB response, we specifically focused on the top ten multimodal features based on network edge connections. For example, tumors that attained in pCR, the network analysis revealed co-enrichment of mutations in HMCN1 and COL5A1 genes, particularly in estrogen receptor (ER)-negative patients. HMCN1 and COL5A1 therapeutic targets like molecules encode proteins for ECM structure, and mutations of these genes regulate tumor architecture and cell adhesion, potentially facilitating immune cell infiltration [ 52 ]. We also observed elevated expressions of FBXO2, CSF3R, C2CD4D-AS1 and RPS28P7 genes, alongside increased infiltration of CD8+ T-cells [ 9 , 57 ]. FBXO2 is a component of the ubiquitin-proteasome system, which regulates protein degradation and influences cell cycle and apoptosis [ 58 ], while CSF3R plays a vital role in granulocyte production and immune response [ 59 ]. These gene expression patterns, coupled with increased CD8+ T-cell infiltration, suggest a robust anti-tumor immune response. Furthermore, these molecular perturbations may be linked to antimicrobial peptide pathways and FLT3 signaling, potentially contributing to the favorable outcome in achieving pCR [ 60 , 61 ]. Future work could specifically search for these complex interactions across different molecules to gain more clinically relevant insights into pCR tumors. Supplementary Table S3 available online at http://bib.oxfordjournals.org/ presents the more detailed list (top 30) of the multi-modal and -omics biomarkers identified using the MOMLIN pipeline.
Multimodal network biomarkers explain drug-response classes. The multimodal networks detail the candidate biomarkers and their interactions for each response class, (A) the pCR patients (B) the RCB-I patients (good response), (C) the RCB-II patients (moderate response) and (D) the RCB-III resistance patients. Nodes in the network represent candidate biomarkers derived from clinical features, DNA mutations, gene expression, enriched cell-types and pathways, each indicated in different colors in the figure legend. Negative edges are light green; positive edges are in light magenta. Edge width reflects the strength of the interaction between features. Node size corresponds to the number of connections (degree), and the font size of node labels scales with degree centrality, highlighting the most interconnected biomarkers.
Similarly, RCB-I tumors exhibited co-enriched mutations in MUC16 and TP53, particularly in HER2+ cases [ 14 ]. MUC16 (CA125) is therapeutic molecule associated with immune evasion and tumor growth [ 51 ], while TP53 mutations can lead to loss of cell cycle control and genomic instability [ 62 ]. We also observed elevated expression of TST involved in the detoxification processes and GPX1P1 [long non-coding RNA (lncRNA)] involved in oxidative stress response. The immune landscape of these tumors showed increased infiltration of TEM CD4 cells (adaptive immunity), monocytic lineage cells (phagocytosis and antigen presentation) and NK cells (innate immunity), as well as CAFs. This immune landscape, coupled with potential perturbations in the allograft rejection pathway, suggests an active but potentially incomplete immune response against the tumor, resulting in minimal residual disease.
RCB-II tumors had lower neoantigen loads compared to pCR, both in ER-negative and HER2+ patients. This reduced neoantigen load might contribute to a weaker immune response. Gene expression analysis showed elevated levels of specific lncRNAs, including FTH1P20 (associated with iron metabolism), RNF5P1 (potentially affecting protein degradation) and RPLP0P9 (involved in protein synthesis), along with ERVMER34-1, which can influence gene expression and immune response in BC patients. Numerous studies have underscored the key regulatory roles of lncRNAs in tumors and the immune system. Notably, increased expression of the immune checkpoint protein IDO1 negatively regulates the expression of CTLA-4, both known to modulate antitumor immune responses [ 63 ]. The combined effect of these molecular alterations suggests potential tumor survival mechanisms, including immune evasion and dysregulation of G1/S DNA damage [ 64 ] contributing to moderate residual disease.
In RCB-III tumors, we observed the reduced prevalence of TP53 and MT-ND4 mutations, typically associated with genomic instability and aggressive tumor behavior [ 51 ], coupled with a higher neoantigen load, suggesting an alternative mechanism (pathways) that drives tumor progression. Despite the higher neoantigen loads, increased expression of HLA-E immune checkpoints and T-cell exclusion in the tumor microenvironment hindered effective anti-tumor immune responses. Additionally, the low-expressed genes PON3, ENSG00000261116 (lncRNA) and RNF5P1 are involved in detoxification, gene regulation and protein degradation, respectively, represents an adaptive response to cellular stress in these tumors. Clinical markers indicating lymph node involvement suggest a more advanced disease state [ 9 ]. These findings, along with potential perturbations in the neurotransmitter release cycle pathway, collectively portray RCB-III tumors as genetically unstable, yet effectively evading immune surveillance, contributing to their significant treatment resistance. Overall, further investigation of these interactive molecular networks, comprising both positive and negative interactions offers a more depth understudying of these potential candidate biomarkers for distinguishing treatment-sensitive pCR and resistant RCB tumors.
The advent of multi-omics technologies has revolutionized our understanding of cancer biology, offering unprecedented insights into the complex molecular interactions that shape tumor behavior and treatment response. In this study, we presented MOMLIN (multi-modal and -omics ML integration), a novel method to enhance cancer drug-response prediction by integrating multi-omics data. MOMLIN specifically utilizes class-specific feature learning and sparse correlation algorithms to model multi-omics associations, enables the detection of class-specific multimodal biomarkers from different omics datasets. Applied to a BC multimodal dataset of 147 patients (comprising RNA expression, DNA mutation, tumor microenvironment, clinical features and pathway functional profiles), MOMLIN was highly predictive of responses to anticancer therapies and identified cohesive multi-modal and -omics network biomarkers associated with responder (pCR) and various levels of RCB (RCB-I: good response, RCB-II: moderate response and RCB-III: resistance).
Using MOMLIN, we identified that pCR is determined by an interactive set of multimodal network biomarkers driven by distinct genetic alterations, such as HMCN1 and COL5A1, particularly in ER-negative tumors [ 9 , 65 ]. Gene expression signatures, including FBXO2 and CSF3R were associated with the immune cell infiltration (CD8+ T-cells), which has been previously reported as a key determinant of response [ 57 ]. The association of these biomarkers with antimicrobial peptide and FLT3 signaling pathways suggests a robust immune response [ 61 ] as a critical driver of complete response. Additionally, C2CD4D-AS1, an lncRNA was identified, and its exact role with these complex molecular interactions in BC remains to be elucidated. Future work could specifically search for these complex interactions across different molecules to gain more clinically relevant insights into pCR tumors.
RCB-I tumors, despite responding well to response, were associated with a distinct multimodal molecular signature. These tumors were enriched for mutations in the therapeutic target MUC16 (CA125), known for its role in immune evasion [ 51 ], and the tumor suppressor gene TP53, particularly in HER2+ cases [ 14 ]. Elevated expression of TST and GPX1P1 (lncRNA involved in oxidative stress response) were associated with increased infiltration of diverse immune cells, including Tem CD4+ cells, monocytes and NK cells [ 10 ]. This active immune landscape and the intricate interactions of these signature with the potential perturbations in the allograft rejection pathway, suggests a robust yet potentially incomplete anti-tumor immune response, contributing to the minimal residual disease observed in this subtype.
RCB-II tumors showed lower neoantigen loads compared to pCR, which could contribute to a weaker immune response, particularly in ER-negative and HER2+ subtypes. Increased expression of lncRNAs, such as FTH1P20, RNF5P1, RPLP0P9 and ERVMER34–1, were associated with the immune checkpoint protein IDO1, and negatively regulate the CTLA-4 protein expression, suggests immune evasion and alterations in tumor cell metabolism and proliferation. These molecules altered intricate interactions implicate dysregulation of G1/S DNA damage as a possible mechanism for moderate treatment response [ 64 ].
RCB-III tumors, classified as resistant, were associated with a distinct multimodal molecular landscape driven by reduced TP53 and MT-ND4 mutations [ 52 ], accompanied with higher neoantigen loads compared to other response groups. This suggests an alternative mechanism driving tumor progression and immune evasion. Despite the high neoantigen load which could potentially trigger immune response, these tumors exhibited immune evasion through increased HLA-E immune checkpoints and T-cell exclusion [ 40 , 55 ]. Also, the downregulation of genes like PON3 and the lncRNA ENSG00000261116, along with lymph node involvement, pointed to advanced disease and cellular stress adaptation [ 9 ]. The presence of these complex interactions, including potential perturbations in the neurotransmitter release cycle pathway, could contribute to treatment resistance in RCB-III tumors. Future studies targeting these immunosuppressive mechanisms and exploring novel pathways could offer promising avenues to overcome resistance in this aggressive subtype.
These findings above emphasize the potential of MOMLIN to enable deeper understanding of complex biological mechanism correspondence to each response class, ultimately paving the way for personalized treatment strategies in cancer. MOMLIN also demonstrated the best prediction performance for unseen patients by utilizing these identified sets of network biomarkers. By identifying response-associated biomarkers, researchers can stratify patients based on their likelihood of achieving pCR or experiencing RCB to anticancer treatments, facilitating more informed treatment decisions and potentially improving patient outcomes. Moreover, the identified biomarkers could serve as valuable targets for the development of novel therapeutic interventions and new biological hypothesis generation. However, the clinical translation of multimodal biomarkers necessitates addressing the potential economic burden associated with multi-omics testing. Developing targeted biomarker panels and prioritizing key hub molecules from the large-scale candidate multimodal network biomarkers identified by MOMLIN could be a viable strategy for reducing costs while maintaining predictive accuracy. Furthermore, ongoing advancements in sequencing and diagnostic technologies are expected to make multi-omics testing more accessible and affordable over time.
In conclusion, our study demonstrates MOMLIN’s capacity to uncover nuanced molecular signatures associated with different drug-response classes in BC. By integrating multi-modal and -omics datasets, we have highlighted the complex interplay between genetic alterations, gene expression, immune infiltration and cellular pathways that contribute to treatment response and resistance. Future research in this direction holds promise for refining risk stratification, optimizing treatment selection and ultimately improving patient outcomes.
While MOMLIN demonstrates promising results as shown, a key limitation lies in its reliance on correlation-based algorithms for multi-omics data integration. These algorithms are great at identifying associations, but they can fall short when it comes to inferring causality between different omics layers. This is a challenge faced by most current state-of-the-art methods [ 28 , 30 ]. In the future iterations of MOMLIN, we aim to incorporate causal inference methodologies alongside sparse correlation algorithms to better understand the complex causal relationships within multi-omics datasets.
We proposed MOMLIN, a novel framework designed to integrate multimodal data and identify response-associated network biomarkers, to understand biological mechanisms and regulatory roles.
MOMLIN employed an adaptive weighting for different data modalities and employs innovative regularization constraint to ensure robust feature selection to analyze high-dimensional omics data.
MOMLIN demonstrates significantly improved performance compared to current state-of-the-art methods.
MOMLIN identifies interpretable and phenotype-specific components, providing insights into the molecular mechanisms driving treatment response and resistance.
We thank Dr Yoshihiro Yamnishi and Mr Chen Yuzhou for their technical help.
This work was supported by the core research budget of Bioinformatics Institute, ASTAR.
Supplemental information and software are available at the Bib website. Our algorithm’s software is available for free download at https://github.com/mamun41/MOMLIN_softwar/tree/main
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A new study analyzed 50 years of friend-of-the-court briefs and found that abortion opponents were more relentless than their adversaries, with some reflected in the justices’ opinions.
By Adam Liptak
Reporting from Washington
When the Supreme Court decided Roe v. Wade in 1973, establishing a constitutional right to abortion, it noted that it had received 14 friend-of-the-court briefs and listed them in a snug footnote at the beginning of the decision.
By 1992, when the court reaffirmed Roe’s core holding in Planned Parenthood v. Casey, the number of such filings, which lawyers call amicus briefs, had swelled to more than 30, and the footnote reciting them had grown unwieldy, taking up more than a page .
In the decision that overturned Roe in 2022, Dobbs v. Jackson Women’s Health Organization, the court was flooded with more than 140 amicus briefs . The footnote had metastasized, spanning seven pages.
Those 50 years of amicus briefs tell a cumulative story, one explored in a new study published in The Missouri Law Review , “The Rhetoric of Abortion in Amicus Briefs.” Using corpus linguistics, a social-science tool that analyzes patterns of words in large databases, the study found that the briefs “serve as a barometer revealing how various constituencies talk about abortion, women, fetuses, physicians, rights and harms over time.”
The study, conducted by Jamie R. Abrams , a law professor at American University, and Amanda Potts , who teaches at Cardiff University, concluded that opponents of abortion had in some ways been more effective, remaining “resolutely intent on advancing fetal personhood.” The anti-abortion briefs were nimble, they wrote, and were “able to adapt and evolve in response to doctrinal shifts of the court.”
Overall, the authors wrote, abortion opponents had pressed “a more relentlessly human, emotional, personal attack to pursue its political agenda.”
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Texas lawmakers touted their heartbeat law as an effort to save lives , but the state's near-total ban on abortion appears to have triggered an increase in infant deaths, according to a new study published Monday .
The findings in JAMA Pediatrics show that infant deaths rose after Texas’ Senate Bill 8, which banned all abortion after about six weeks from conception. S.B. 8 became Texas law in September 2021 and U.S. Supreme Court overturned the constitutional right to abortion just over nine months later, on June 24, 2022. The high court ruling in the Dobbs case prompted more than a dozen states to issue near-total bans on abortion. Observers speculate that evidence will also show increases in infant deaths in those states, akin to what Texas has seen, the study said.
“It just points to some of the devastating consequences of abortion bans that maybe people weren't thinking about when they passed these laws,” Alison Gemmill, an assistant professor at Johns Hopkins University’s Bloomberg School of Public Health who authored the study, told USA TODAY. She called the deaths following the Texas heartbeat law its “spillover effects on moms and babies.”
Abortion bans: More than 171K patients traveled out-of-state for abortions in 2023, new data shows
In the wake of the law's passage in Texas, more babies died before their first birthday, likely due to birth defects or genetic problems that wouldn't have allowed them to live, the study found. These pregnancies would typically have been terminated by abortion, according to researchers. The Texas heartbeat law does not provide exceptions for pregnancies involving such conditions. Mothers are legally obligated to carry these babies to birth under state law.
In the peer-reviewed Journal of the American Medical Association, Gemmill and researchers from Johns Hopkins and Michigan State University wrote that the Texas law was linked to "unexpected increases in infant and neonatal deaths" between 2021 and 2022. Prior research drew a correlation between the uptick in infant deaths and anti-abortion laws taking effect, however, no studies until now have attributed the fatalities directly to the laws prohibiting the termination of these pregnancies.
"Abortion care is an essential component of comprehensive healthcare, and when it is restricted, the human impacts are devastating," Wendy Davis, a senior adviser for Planned Parenthood Texas Votes, said in a statement. Davis, who filibustered for abortion rights when she was a Democratic state senator, noted that the study only covered 2022, not the results in 2023 and 2024 in the wake of a more restrictive abortion ban that came with the Dobbs decision. This "likely means the situation on the ground today is even more dire," Davis said.
Texas Gov. Greg Abbott's office did not dispute the study's findings but defended the Republican-controlled state's anti-abortion record. This effort included the 2021 heartbeat law "to save the innocent unborn, and now thousands of children have been given a chance at life," Andrew Mahaleris, a spokesperson for Abbott, said in a statement to USA TODAY. He said the governor has taken "significant action to protect the sanctity of life" and offered resources to expectant mothers "so they can choose life for their child."
Anti-abortion advocates also didn't contest the uptick in infant deaths cited in the study. Advocates for the heartbeat law and other legislation to restrict abortions say such bans protect life. They say terminating a fetus with a terminal illness is “choosing to kill that child intentionally.”
The overwhelming majority of such abortions happen before the fetus is viable. In Texas, legislation has dramatically reduced the number of abortions performed in the state.
Amy O’Donnell, a spokesperson for Texas Alliance for Life, said the study’s findings didn’t come as a surprise. She said babies born with disabilities and even fatal anomalies deserve a chance at life, even if that means a newborn dies after birth from a condition doctors anticipated would be lethal. The death of a child is not easy, she acknowledged. She noted that her nonprofit offers resources for families grieving from such losses.
“In Texas, we celebrate every unborn child's life saved. We treasure the fact that our laws are protecting women's lives,” she said. “We don't apologize for the fact that we don't support discrimination against children facing disabilities or fatal diagnoses in or out of the womb. And that's the line that we just believe should not be crossed.”
Gemmill, of Johns Hopkins, said babies that died shortly after being born with birth defects "probably caused a lot of unnecessary trauma to families."
Maternal health: Chronic hypertension has soared among pregnant women. Treatment is not keeping pace
The researchers examined death records beginning after the heartbeat law went into effect. The study created a “synthetic Texas” that simulated outcomes that would have happened had the law not been in effect and compared the numbers to national trends during that period. In 2021, 1,985 Texas infants died before their first birthday. The next year, with S.B. 8 in effect, the fatalities jumped to 2,240, a 12.9% increase that came as the U.S. experienced an overall increase of less than 2%. Deaths attributable to congenital anomalies or birth defects spiked nearly 23% in Texas compared to a 3% decrease nationally.
“It suggests that, really, this policy was responsible for this increase in infant deaths in Texas,” Gemmill said.
The study is significant because of Texas’ role as a conservative state with urban and rural areas that may reflect what happens in the rest of the U.S., according to Dr. Tracey Wilkinson, an associate professor of pediatrics and obstetrics and gynecology at the Indiana University School of Medicine. Texas has been living under restrictions longer than other states that enacted abortion bans after the Dobbs ruling.
“When people ask me why this is happening, it’s really simple,” said Wilkinson, who was not involved with the new study. “When you take away people’s ability to make decisions (about) if and when they have pregnancies, you’re going to see outcomes like increasing infant and maternal mortality.”
The study did not examine the effects of infant deaths on the health of mothers who were legally required to deliver dead babies to term, nor did it look at the mental health effects of carrying infants and delivering them, only to see them die. The study also raises but does not tackle questions about the financial cost to families of carrying and delivering terminally ill newborns.
Gemmill is now working to understand the impact of abortion restrictions on parents of different races and ethnicities. Prior research has shown that Black mothers and babies face higher death rates than other groups.
The study reflects what Molly Duane, a senior staff attorney at the abortion rights advocacy nonprofit Center for Reproductive Rights, has seen in the courtroom arguing against Texas' laws. She recently represented women who sued the state after they were denied medical abortions. One of her clients, Samatha Casiano, was required by law to carry a child that developed without a brain. In late May, the Texas Supreme Court ruled pregnant patients must have a “life-threatening condition” in order to terminate a pregnancy.
Duane questioned the claim by anti-abortion activists that Texas is a “pro-life” state, given the study's findings. “Women are hurting, families are hurting, babies are dying, and no one in the state is taking responsibility for any of that real human suffering,” she said.
In late 2023, a U.S. Centers for Disease Control and Prevention report found increases in infant deaths for the first time in more than 20 years. The states identified in the report with increased fatalities were states that restricted abortion access, however, experts cautioned at the time that they could not say what had caused the spike in fatalities.
The Texas study went one step further, finding one state where abortion restrictions resulted in more deaths.
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Learn how to write a case brief for law school with a simple explanation from LexisNexis. This is a great resource to help rising first year law students or prelaw students prepare for classes. How to write a case brief for law school: Excerpt reproduced from Introduction to the Study of Law: Cases and Materials,
Introduction. Every law student and practicing attorney must be able to find, read, analyze, and interpret case law. Under the common law principles of stare decisis, a court must follow the decisions in previous cases on the same legal topic. Therefore, finding cases is essential to finding out what the law is on a particular issue.
Case title and date. It is also wise to list the page in the casebook for easy reference. Due both to the case method of studying the law and the common law emphasis on judicial opinions, the title of an opinion (Jones v. Smith) becomes a symbol of the rule for which it stands. So, for instance, a court wanting to talk about the rule
Introduction. Each branch of government produces a different type of law. Case law is the body of law developed from judicial opinions or decisions over time (whereas statutory law comes from legislative bodies and administrative law comes from executive bodies). This guide introduces beginner legal researchers to resources for finding judicial ...
The issue, as presented by the court; the issue as interpreted by the reader. The holding, which includes the answer to the issue and the reasons. The statement of the prevailing rule in that doctrine. The analytical approach or pattern used by the court. The commentary provided by the court, usually called.
Here are five tips for writing an effective introduction…. 1. State the issue: Begin by stating the issue that the brief will address. This should be a clear and concise statement that lets the reader know what your brief is about. 2. Provide contex t: Once you've stated the issue, provide some context for it. Explain why the issue is ...
As a new law student, one of the essential skills you need to develop is the ability to write effective legal case briefs. A case brief is a concise summary of a legal case that highlights the key issues, legal principles, and holdings of the court. Writing a good case brief can help you better understand the law, prepare for class discussions ...
Features an excerpt from Guide to the Study of Law: An Introduction, 2nd ed. (LexisNexis 2001) by L.H. LaRue. ... An introduction to cases, an explanation of how past case opinions can help with legal analysis, and an explanation of a published case opinion. How To Write A Case Brief or Case Outline for Law School (With An Example) ...
A case starts at the trial court level, which could either be a trial by judge or trial by jury. Generally, evidence and witnesses are presented at the trial court level. An appellate court will hear appeals from parties seeking to change the result of the case heard at the trial court. An appellate court will not answer questions of fact, meaning they will not review the evidence in a case.
The introduction to a case study research paper, however, should not only describe the research problem and its significance, but you should also succinctly describe why the case is being used and how it relates to addressing the problem. ... Rev. ed. San Francisco, CA: Jossey-Bass, 1998; Miller, Lisa L. "The Use of Case Studies in Law and ...
Identify the key problems and issues in the case study. Formulate and include a thesis statement, summarizing the outcome of your analysis in 1-2 sentences. Background. Set the scene: background information, relevant facts, and the most important issues. Demonstrate that you have researched the problems in this case study. Evaluation of the Case
Case studies are good for describing, comparing, evaluating and understanding different aspects of a research problem. Table of contents. When to do a case study. Step 1: Select a case. Step 2: Build a theoretical framework. Step 3: Collect your data. Step 4: Describe and analyze the case.
Online Courses. These online courses are for lawyers looking to do a deep dive into a particular area, and for anyone looking to learn about how law works in practice. Offered by Harvard Law School in collaboration with Harvard's Vice Provost for Advances in Learning and edX, these courses are part of our ongoing commitment to lifelong learning.
c. Arguments: Both parties present their arguments and legal reasoning to support their positions. d. Precedents: Case studies often reference previous court decisions (precedents) that may have bearing on the current case. e. Court Decision: The case study provides an analysis of the court's final decision and its reasoning. 5. Benefits of Studying Legal Case Studies: Studying legal case ...
A case note is something that every law student is asked to write at some point in their studies and, without some direction, can be a daunting task. This article aims to briefly explain what a case note is, what the benefits of writing a case note are, and how to actually write a caseContinue reading →
Case studies provide a methodology by which a detailed study can be conducted of a social unit, whether that unit is a person, an organization, a policy or a larger group or system (Exworthy and Powell 2012). The case study is amenable to various methodologies, mostly qualitative, which allow investigations via documentary analyses, interviews ...
Although case studies have been discussed extensively in the literature, little has been written about the specific steps one may use to conduct case study research effectively (Gagnon, 2010; Hancock & Algozzine, 2016).Baskarada (2014) also emphasized the need to have a succinct guideline that can be practically followed as it is actually tough to execute a case study well in practice.
Examples include the Legal Education, ADR, and Practical Problem Solving (LEAPS) Project from the American Bar Association, which provides resources for various topics on legal education, and the Teaching Post, an educators' forum offered by the Harvard Business School where professors can seek or provide advice on case study teaching.
Step 3: Identify the relevant facts. At the basis of every legal case, there has to be a story of a dispute between two parties. However, not all of the facts and circumstances associated with ...
Each student is assessed (pass/fail) in one of their two case studies. The assessments this year were comprised of group presentations (two case studies), a blog and an essay. Students can take the assessment as many times as necessary to pass. Introduction to Law is assessed by multiple choice questions, with a pass being 20 out of 25 ...
Case study examples. Case studies are proven marketing strategies in a wide variety of B2B industries. Here are just a few examples of a case study: Amazon Web Services, Inc. provides companies with cloud computing platforms and APIs on a metered, pay-as-you-go basis. This case study example illustrates the benefits Thomson Reuters experienced ...
The introduction should provide background information about the case and its main topic. It should be short, but should introduce the topic and explain its context in just one or two paragraphs. An ideal case study introduction is between three and five sentences. The case study must be well-designed and logical.
Law and legal knowledge is relevant to a huge range of careers, not just training to be a lawyer, barrister or solicitor. Journalism, policy roles, teaching, politics, finance, management and many more jobs are available to people who study law and legal subjects. Tutorials. Finding Australian case law 25 minutes; Finding Australian legislation ...
Law document from University of Phoenix, 4 pages, Criminal Courts and Sentencing Goals Case Study Courtney Scott University of Phoenix CJS/201: Introduction to Criminal Justice Dr. C June 19, 2023 Criminal Courts and Sentencing Goals Case Study Gabby Petito and Brian Laundrie left New York in July 2021
In addition to this program, the law expanded eligibility for full benefits under the Low-Income Subsidy program (LIS or "Extra Help") under Medicare Part D at the beginning of this year. Nearly 300,000 people with low and modest incomes are now benefiting from the program's expansion.
The law in Arkansas is the only one to have been struck down entirely, but the state has asked a federal appeals court to reverse that ruling. The 6th U.S. Circuit Court of Appeals, one step below the Supreme Court, last year ruled that Kentucky and Tennessee can continue to enforce their bans amid legal challenges. The high court has agreed to ...
In August 2023, Slovenia suffered some of the worst flooding in its history. Approximately 85% of its municipalities 1 endured severe floods and landslides, exacerbated by the country's mountainous topography. According to the government's estimates, the direct cost of the damages was as high as €9.9 billion, 2 or 16% of the country's 2023 gross domestic product (GDP). 3 That's the ...
Introduction. The advent of high-throughput sequencing technologies has revolutionized our ability to collect various 'omics' data types, such as deoxyribonucleic acid (DNA) methylations, ribonucleic acid (RNA) expressions, proteomics, metabolomics and bioimaging datasets, from the same samples or patients with unprecedented details [].By far, most studies have performed single omics ...
The study, conducted by Jamie R. Abrams, a law professor at American University, and Amanda Potts, who teaches at Cardiff University, concluded that opponents of abortion had in some ways been ...
Texas lawmakers touted their heartbeat law as an effort to save lives, but the state's near-total ban on abortion appears to have triggered an increase in infant deaths, according to a new study ...