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Ethical Considerations – Types, Examples and Writing Guide

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Ethical Considerations

Ethical considerations in research refer to the principles and guidelines that researchers must follow to ensure that their studies are conducted in an ethical and responsible manner. These considerations are designed to protect the rights, safety, and well-being of research participants, as well as the integrity and credibility of the research itself

Some of the key ethical considerations in research include:

• Informed consent: Researchers must obtain informed consent from study participants, which means they must inform participants about the study’s purpose, procedures, risks, benefits, and their right to withdraw at any time.
• Privacy and confidentiality : Researchers must ensure that participants’ privacy and confidentiality are protected. This means that personal information should be kept confidential and not shared without the participant’s consent.
• Harm reduction : Researchers must ensure that the study does not harm the participants physically or psychologically. They must take steps to minimize the risks associated with the study.
• Fairness and equity : Researchers must ensure that the study does not discriminate against any particular group or individual. They should treat all participants equally and fairly.
• Use of deception: Researchers must use deception only if it is necessary to achieve the study’s objectives. They must inform participants of the deception as soon as possible.
• Use of vulnerable populations : Researchers must be especially cautious when working with vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive or intellectual disabilities.
• Conflict of interest : Researchers must disclose any potential conflicts of interest that may affect the study’s integrity. This includes financial or personal relationships that could influence the study’s results.
• Data manipulation: Researchers must not manipulate data to support a particular hypothesis or agenda. They should report the results of the study objectively, even if the findings are not consistent with their expectations.
• Intellectual property: Researchers must respect intellectual property rights and give credit to previous studies and research.
• Cultural sensitivity : Researchers must be sensitive to the cultural norms and beliefs of the participants. They should avoid imposing their values and beliefs on the participants and should be respectful of their cultural practices.

Types of Ethical Considerations

Types of Ethical Considerations are as follows:

Research Ethics:

This includes ethical principles and guidelines that govern research involving human or animal subjects, ensuring that the research is conducted in an ethical and responsible manner.

Business Ethics :

This refers to ethical principles and standards that guide business practices and decision-making, such as transparency, honesty, fairness, and social responsibility.

Medical Ethics :

This refers to ethical principles and standards that govern the practice of medicine, including the duty to protect patient autonomy, informed consent, confidentiality, and non-maleficence.

Environmental Ethics :

This involves ethical principles and values that guide our interactions with the natural world, including the obligation to protect the environment, minimize harm, and promote sustainability.

Legal Ethics

This involves ethical principles and standards that guide the conduct of legal professionals, including issues such as confidentiality, conflicts of interest, and professional competence.

Social Ethics

This involves ethical principles and values that guide our interactions with other individuals and society as a whole, including issues such as justice, fairness, and human rights.

Information Ethics

This involves ethical principles and values that govern the use and dissemination of information, including issues such as privacy, accuracy, and intellectual property.

Cultural Ethics

This involves ethical principles and values that govern the relationship between different cultures and communities, including issues such as respect for diversity, cultural sensitivity, and inclusivity.

Technological Ethics

This refers to ethical principles and guidelines that govern the development, use, and impact of technology, including issues such as privacy, security, and social responsibility.

Journalism Ethics

This involves ethical principles and standards that guide the practice of journalism, including issues such as accuracy, fairness, and the public interest.

Educational Ethics

This refers to ethical principles and standards that guide the practice of education, including issues such as academic integrity, fairness, and respect for diversity.

Political Ethics

This involves ethical principles and values that guide political decision-making and behavior, including issues such as accountability, transparency, and the protection of civil liberties.

Professional Ethics

This refers to ethical principles and standards that guide the conduct of professionals in various fields, including issues such as honesty, integrity, and competence.

Personal Ethics

This involves ethical principles and values that guide individual behavior and decision-making, including issues such as personal responsibility, honesty, and respect for others.

Global Ethics

This involves ethical principles and values that guide our interactions with other nations and the global community, including issues such as human rights, environmental protection, and social justice.

Applications of Ethical Considerations

Ethical considerations are important in many areas of society, including medicine, business, law, and technology. Here are some specific applications of ethical considerations:

• Medical research : Ethical considerations are crucial in medical research, particularly when human subjects are involved. Researchers must ensure that their studies are conducted in a way that does not harm participants and that participants give informed consent before participating.
• Business practices: Ethical considerations are also important in business, where companies must make decisions that are socially responsible and avoid activities that are harmful to society. For example, companies must ensure that their products are safe for consumers and that they do not engage in exploitative labor practices.
• Environmental protection: Ethical considerations play a crucial role in environmental protection, as companies and governments must weigh the benefits of economic development against the potential harm to the environment. Decisions about land use, resource allocation, and pollution must be made in an ethical manner that takes into account the long-term consequences for the planet and future generations.
• Technology development : As technology continues to advance rapidly, ethical considerations become increasingly important in areas such as artificial intelligence, robotics, and genetic engineering. Developers must ensure that their creations do not harm humans or the environment and that they are developed in a way that is fair and equitable.
• Legal system : The legal system relies on ethical considerations to ensure that justice is served and that individuals are treated fairly. Lawyers and judges must abide by ethical standards to maintain the integrity of the legal system and to protect the rights of all individuals involved.

Examples of Ethical Considerations

Here are a few examples of ethical considerations in different contexts:

• In healthcare : A doctor must ensure that they provide the best possible care to their patients and avoid causing them harm. They must respect the autonomy of their patients, and obtain informed consent before administering any treatment or procedure. They must also ensure that they maintain patient confidentiality and avoid any conflicts of interest.
• In the workplace: An employer must ensure that they treat their employees fairly and with respect, provide them with a safe working environment, and pay them a fair wage. They must also avoid any discrimination based on race, gender, religion, or any other characteristic protected by law.
• In the media : Journalists must ensure that they report the news accurately and without bias. They must respect the privacy of individuals and avoid causing harm or distress. They must also be transparent about their sources and avoid any conflicts of interest.
• In research: Researchers must ensure that they conduct their studies ethically and with integrity. They must obtain informed consent from participants, protect their privacy, and avoid any harm or discomfort. They must also ensure that their findings are reported accurately and without bias.
• In personal relationships : People must ensure that they treat others with respect and kindness, and avoid causing harm or distress. They must respect the autonomy of others and avoid any actions that would be considered unethical, such as lying or cheating. They must also respect the confidentiality of others and maintain their privacy.

How to Write Ethical Considerations

When writing about research involving human subjects or animals, it is essential to include ethical considerations to ensure that the study is conducted in a manner that is morally responsible and in accordance with professional standards. Here are some steps to help you write ethical considerations:

• Describe the ethical principles: Start by explaining the ethical principles that will guide the research. These could include principles such as respect for persons, beneficence, and justice.
• Discuss informed consent : Informed consent is a critical ethical consideration when conducting research. Explain how you will obtain informed consent from participants, including how you will explain the purpose of the study, potential risks and benefits, and how you will protect their privacy.
• Address confidentiality : Describe how you will protect the confidentiality of the participants’ personal information and data, including any measures you will take to ensure that the data is kept secure and confidential.
• Consider potential risks and benefits : Describe any potential risks or harms to participants that could result from the study and how you will minimize those risks. Also, discuss the potential benefits of the study, both to the participants and to society.
• Discuss the use of animals : If the research involves the use of animals, address the ethical considerations related to animal welfare. Explain how you will minimize any potential harm to the animals and ensure that they are treated ethically.
• Mention the ethical approval : Finally, it’s essential to acknowledge that the research has received ethical approval from the relevant institutional review board or ethics committee. State the name of the committee, the date of approval, and any specific conditions or requirements that were imposed.

When to Write Ethical Considerations

Ethical considerations should be written whenever research involves human subjects or has the potential to impact human beings, animals, or the environment in some way. Ethical considerations are also important when research involves sensitive topics, such as mental health, sexuality, or religion.

In general, ethical considerations should be an integral part of any research project, regardless of the field or subject matter. This means that they should be considered at every stage of the research process, from the initial planning and design phase to data collection, analysis, and dissemination.

Ethical considerations should also be written in accordance with the guidelines and standards set by the relevant regulatory bodies and professional associations. These guidelines may vary depending on the discipline, so it is important to be familiar with the specific requirements of your field.

Purpose of Ethical Considerations

Ethical considerations are an essential aspect of many areas of life, including business, healthcare, research, and social interactions. The primary purposes of ethical considerations are:

• Protection of human rights: Ethical considerations help ensure that people’s rights are respected and protected. This includes respecting their autonomy, ensuring their privacy is respected, and ensuring that they are not subjected to harm or exploitation.
• Promoting fairness and justice: Ethical considerations help ensure that people are treated fairly and justly, without discrimination or bias. This includes ensuring that everyone has equal access to resources and opportunities, and that decisions are made based on merit rather than personal biases or prejudices.
• Promoting honesty and transparency : Ethical considerations help ensure that people are truthful and transparent in their actions and decisions. This includes being open and honest about conflicts of interest, disclosing potential risks, and communicating clearly with others.
• Maintaining public trust: Ethical considerations help maintain public trust in institutions and individuals. This is important for building and maintaining relationships with customers, patients, colleagues, and other stakeholders.
• Ensuring responsible conduct: Ethical considerations help ensure that people act responsibly and are accountable for their actions. This includes adhering to professional standards and codes of conduct, following laws and regulations, and avoiding behaviors that could harm others or damage the environment.

Advantages of Ethical Considerations

Here are some of the advantages of ethical considerations:

• Builds Trust : When individuals or organizations follow ethical considerations, it creates a sense of trust among stakeholders, including customers, clients, and employees. This trust can lead to stronger relationships and long-term loyalty.
• Reputation and Brand Image : Ethical considerations are often linked to a company’s brand image and reputation. By following ethical practices, a company can establish a positive image and reputation that can enhance its brand value.
• Avoids Legal Issues: Ethical considerations can help individuals and organizations avoid legal issues and penalties. By adhering to ethical principles, companies can reduce the risk of facing lawsuits, regulatory investigations, and fines.
• Increases Employee Retention and Motivation: Employees tend to be more satisfied and motivated when they work for an organization that values ethics. Companies that prioritize ethical considerations tend to have higher employee retention rates, leading to lower recruitment costs.
• Enhances Decision-making: Ethical considerations help individuals and organizations make better decisions. By considering the ethical implications of their actions, decision-makers can evaluate the potential consequences and choose the best course of action.
• Positive Impact on Society: Ethical considerations have a positive impact on society as a whole. By following ethical practices, companies can contribute to social and environmental causes, leading to a more sustainable and equitable society.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Addressing ethical issues in your research proposal

This article explores the ethical issues that may arise in your proposed study during your doctoral research degree.

What ethical principles apply when planning and conducting research?

Research ethics are the moral principles that govern how researchers conduct their studies (Wellcome Trust, 2014). As there are elements of uncertainty and risk involved in any study, every researcher has to consider how they can uphold these ethical principles and conduct the research in a way that protects the interests and welfare of participants and other stakeholders (such as organisations).  

You will need to consider the ethical issues that might arise in your proposed study. Consideration of the fundamental ethical principles that underpin all research will help you to identify the key issues and how these could be addressed. As you are probably a practitioner who wants to undertake research within your workplace, consider how your role as an ‘insider’ influences how you will conduct your study. Think about the ethical issues that might arise when you become an insider researcher (for example, relating to trust, confidentiality and anonymity).  

What key ethical principles do you think will be important when planning or conducting your research, particularly as an insider? Principles that come to mind might include autonomy, respect, dignity, privacy, informed consent and confidentiality. You may also have identified principles such as competence, integrity, wellbeing, justice and non-discrimination.  

Key ethical issues that you will address as an insider researcher include:

• Gaining trust
• Avoiding coercion when recruiting colleagues or other participants (such as students or service users)
• Practical challenges relating to ensuring the confidentiality and anonymity of organisations and staff or other participants.

(Heslop et al, 2018)

A fuller discussion of ethical principles is available from the British Psychological Society’s Code of Human Research Ethics (BPS, 2021).

You can also refer to guidance from the British Educational Research Association and the British Association for Applied Linguistics .

Ethical principles are essential for protecting the interests of research participants, including maximising the benefits and minimising any risks associated with taking part in a study. These principles describe ethical conduct which reflects the integrity of the researcher, promotes the wellbeing of participants and ensures high-quality research is conducted (Health Research Authority, 2022).  

Research ethics is therefore not simply about gaining ethical approval for your study to be conducted. Research ethics relates to your moral conduct as a doctoral researcher and will apply throughout your study from design to dissemination (British Psychological Society, 2021). When you apply to undertake a doctorate, you will need to clearly indicate in your proposal that you understand these ethical principles and are committed to upholding them.  

Where can I find ethical guidance and resources? 

Professional bodies, learned societies, health and social care authorities, academic publications, Research Ethics Committees and research organisations provide a range of ethical guidance and resources. International codes such as the Universal Declaration of Human Rights underpin ethical frameworks (United Nations, 1948).  

You may be aware of key legislation in your own country or the country where you plan to undertake the research, including laws relating to consent, data protection and decision-making capacity, for example, the Data Protection Act, 2018 (UK).  If you want to find out more about becoming an ethical researcher, check out this Open University short course: Becoming an ethical researcher: Introduction and guidance: What is a badged course? - OpenLearn - Open University  

You should be able to justify the research decisions you make. Utilising these resources will guide your ethical judgements when writing your proposal and ultimately when designing and conducting your research study. The Ethical Guidelines for Educational Research (British Educational Research Association, 2018) identifies the key responsibilities you will have when you conduct your research, including the range of stakeholders that you will have responsibilities to, as follows:   

• to your participants (e.g. to appropriately inform them, facilitate their participation and support them)
• clients, stakeholders and sponsors
• the community of educational or health and social care researchers
• for publication and dissemination
• your wellbeing and development

The National Institute for Health and Care Research (no date) has emphasised the need to promote equality, diversity and inclusion when undertaking research, particularly to address long-standing social and health inequalities. Research should be informed by the diversity of people’s experiences and insights, so that it will lead to the development of practice that addresses genuine need. A commitment to equality, diversity and inclusion aims to eradicate prejudice and discrimination on the basis of an individual or group of individuals' protected characteristics such as sex (gender), disability, race, sexual orientation, in line with the Equality Act 2010.  

The NIHR has produced guidance for enhancing the inclusion of ‘under-served groups’ when designing a research study (2020). Although the guidance refers to clinical research it is relevant to research more broadly.  

You should consider how you will promote equality and diversity in your planned study, including through aspects such as your research topic or question, the methodology you will use, the participants you plan to recruit and how you will analyse and interpret your data.    

What ethical issues do I need to consider when writing my research proposal?

You might be planning to undertake research in a health, social care, educational or other setting, including observations and interviews. The following prompts should help you to identify key ethical issues that you need to bear in mind when undertaking research in such settings.  

1.     Imagine you are a potential participant. Think about the questions and concerns that you might have:

• How would you feel if a researcher sat in your space and took notes, completed a checklist, or made an audio or film recording?
• What harm might a researcher cause by observing or interviewing you and others?
• What would you want to know about the researcher and ask them about the study before giving consent?
• When imagining you are the participant, how could the researcher make you feel more comfortable to be observed or interviewed? 

2.     Having considered the perspective of your potential participant, how would you take account of concerns such as privacy, consent, wellbeing and power in your research proposal?  

[Adapted from OpenLearn course: Becoming an ethical researcher, Week 2 Activity 3: Becoming an ethical researcher - OpenLearn - Open University ]  

The ethical issues to be considered will vary depending on your organisational context/role, the types of participants you plan to recruit (for example, children, adults with mental health problems), the research methods you will use, and the types of data you will collect. You will need to decide how to recruit your participants so you do not inappropriately exclude anyone.  Consider what methods may be necessary to facilitate their voice and how you can obtain their consent to taking part or ensure that consent is obtained from someone else as necessary, for example, a parent in the case of a child. 

You should also think about how to avoid imposing an unnecessary burden or costs on your participants. For example, by minimising the length of time they will have to commit to the study and by providing travel or other expenses. Identify the measures that you will take to store your participants’ data safely and maintain their confidentiality and anonymity when you report your findings. You could do this by storing interview and video recordings in a secure server and anonymising their names and those of their organisations using pseudonyms.  

Professional codes such as the Code of Human Research Ethics (BPS, 2021) provide guidance on undertaking research with children. Being an ‘insider’ researching within your own organisation has advantages. However, you should also consider how this might impact on your research, such as power dynamics, consent, potential bias and any conflict of interest between your professional and researcher roles (Sapiro and Matthews, 2020).  

How have other researchers addressed any ethical challenges?

The literature provides researchers’ accounts explaining how they addressed ethical challenges when undertaking studies. For example, Turcotte-Tremblay and McSween-Cadieux (2018) discuss strategies for protecting participants’ confidentiality when disseminating findings locally, such as undertaking fieldwork in multiple sites and providing findings in a generalised form. In addition, professional guidance includes case studies illustrating how ethical issues can be addressed, including when researching online forums (British Sociological Association, no date).

Watch the videos below and consider what insights the postgraduate researcher and supervisor provide  regarding issues such as being an ‘insider researcher’, power relations, avoiding intrusion, maintaining participant anonymity and complying with research ethics and professional standards. How might their experiences inform the design and conduct of your own study?

Postgraduate researcher and supervisor talk about ethical considerations

Your thoughtful consideration of the ethical issues that might arise and how you would address these should enable you to propose an ethically informed study and conduct it in a responsible, fair and sensitive manner. 

British Educational Research Association (2018)  Ethical Guidelines for Educational Research.  Available at:  https://www.bera.ac.uk/publication/ethical-guidelines-for-educational-research-2018  (Accessed: 9 June 2023).

British Psychological Society (2021)  Code of Human Research Ethics . Available at:  https://cms.bps.org.uk/sites/default/files/2022-06/BPS%20Code%20of%20Human%20Research%20Ethics%20%281%29.pdf  (Accessed: 9 June 2023).

British Sociological Association (2016)  Researching online forums . Available at:  https://www.britsoc.co.uk/media/24834/j000208_researching_online_forums_-cs1-_v3.pdf  (Accessed: 9 June 2023).

Health Research Authority (2022)  UK Policy Framework for Health and Social Care Research . Available at:  https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/uk-policy-framework-health-and-social-care-research/#chiefinvestigators  (Accessed: 9 June 2023).

Heslop, C., Burns, S., Lobo, R. (2018) ‘Managing qualitative research as insider-research in small rural communities’,  Rural and Remote Health , 18: pp. 4576.

Equality Act 2010, c. 15.  Available at:   https://www.legislation.gov.uk/ukpga/2010/15/introduction   (Accessed: 9 June 2023).

National Institute for Health and Care Research (no date)  Equality, Diversity and Inclusion (EDI) . Available at:  https://arc-kss.nihr.ac.uk/public-and-community-involvement/pcie-guide/how-to-do-pcie/equality-diversity-and-inclusion-edi  (Accessed: 9 June 2023).

National Institute for Health and Care Research (2020)  Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project.  Available at:   https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435  (Accessed: 9 June 2023).

Sapiro, B. and Matthews, E. (2020) ‘Both Insider and Outsider. On Conducting Social Work Research in Mental Health Settings’,  Advances in Social Work , 20(3). Available at:  https://doi.org/10.18060/23926

Turcotte-Tremblay, A. and McSween-Cadieux, E. (2018) ‘A reflection on the challenge of protecting confidentiality of participants when disseminating research results locally’,  BMC Medical Ethics,  19(supplement 1), no. 45. Available at:   https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0279-0

United Nations General Assembly (1948)  The Universal Declaration of Human Rights . Resolution A/RES/217/A. Available at:  https://www.un.org/en/about-us/universal-declaration-of-human-rights#:~:text=Drafted%20by%20representatives%20with%20different,all%20peoples%20and%20all%20nations . (Accessed: 9 June 2023).

Wellcome Trust (2014)  Ensuring your research is ethical: A guide for Extended Project Qualification students . Available at:  https://wellcome.org/sites/default/files/wtp057673_0.pdf  (Accessed: 9 June 2023).

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Ethical considerations in research: Best practices and examples

To conduct responsible research, you’ve got to think about ethics. They protect participants’ rights and their well-being - and they ensure your findings are valid and reliable. This isn’t just a box for you to tick. It’s a crucial consideration that can make all the difference to the outcome of your research.

In this article, we'll explore the meaning and importance of research ethics in today's research landscape. You'll learn best practices to conduct ethical and impactful research.

Examples of ethical considerations in research

As a researcher, you're responsible for ethical research alongside your organization. Fulfilling ethical guidelines is critical. Organizations must ensure employees follow best practices to protect participants' rights and well-being.

Keep these things in mind when it comes to ethical considerations in research:

Voluntary participation

Voluntary participation is key. Nobody should feel like they're being forced to participate or pressured into doing anything they don't want to. That means giving people a choice and the ability to opt out at any time, even if they've already agreed to take part in the study.

Informed consent

Informed consent isn't just an ethical consideration. It's a legal requirement as well. Participants must fully understand what they're agreeing to, including potential risks and benefits.

The best way to go about this is by using a consent form. Make sure you include:

• A brief description of the study and research methods.
• The potential benefits and risks of participating.
• The length of the study.
• Contact information for the researcher and/or sponsor.
• Reiteration of the participant’s right to withdraw from the research project at any time without penalty.

Anonymity means that participants aren't identifiable in any way. This includes:

• Email address
• Photographs
• Video footage

You need a way to anonymize research data so that it can't be traced back to individual participants. This may involve creating a new digital ID for participants that can’t be linked back to their original identity using numerical codes.

Confidentiality

Information gathered during a study must be kept confidential. Confidentiality helps to protect the privacy of research participants. It also ensures that their information isn't disclosed to unauthorized individuals.

Some ways to ensure confidentiality include:

• Using a secure server to store data.
• Removing identifying information from databases that contain sensitive data.
• Using a third-party company to process and manage research participant data.
• Not keeping participant records for longer than necessary.
• Avoiding discussion of research findings in public forums.

Potential for harm

​​The potential for harm is a crucial factor in deciding whether a research study should proceed. It can manifest in various forms, such as:

• Psychological harm
• Social harm
• Physical harm

Conduct an ethical review to identify possible harms. Be prepared to explain how you’ll minimize these harms and what support is available in case they do happen.

Fair payment

One of the most crucial aspects of setting up a research study is deciding on fair compensation for your participants. Underpayment is a common ethical issue that shouldn't be overlooked. Properly rewarding participants' time is critical for boosting engagement and obtaining high-quality data. While Prolific requires a minimum payment of £6.00 / $8.00 per hour, there are other factors you need to consider when deciding on a fair payment.

First, check your institution's reimbursement guidelines to see if they already have a minimum or maximum hourly rate. You can also use the national minimum wage as a reference point.

Next, think about the amount of work you're asking participants to do. The level of effort required for a task, such as producing a video recording versus a short survey, should correspond with the reward offered.

You also need to consider the population you're targeting. To attract research subjects with specific characteristics or high-paying jobs, you may need to offer more as an incentive.

We recommend a minimum payment of £9.00 / $12.00 per hour, but we understand that payment rates can vary depending on a range of factors. Whatever payment you choose should reflect the amount of effort participants are required to put in and be fair to everyone involved.

Ethical research made easy with Prolific

At Prolific, we believe in making ethical research easy and accessible. The findings from the Fairwork Cloudwork report speak for themselves. Prolific was given the top score out of all competitors for minimum standards of fair work.

With over 25,000 researchers in our community, we're leading the way in revolutionizing the research industry. If you're interested in learning more about how we can support your research journey, sign up to get started now.

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A guide to ethical considerations in research

Last updated

12 March 2023

Reviewed by

Miroslav Damyanov

Whether you are conducting a survey, running focus groups , doing field research, or holding interviews, the chances are participants will be a part of the process.

Taking ethical considerations into account and following all obligations are essential when people are involved in your research. Upholding academic integrity is another crucial ethical concern in all research types. 

So, how can you protect your participants and ensure that your research is ethical? Let’s take a closer look at the ethical considerations in research and the best practices to follow.

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• The importance of ethical research

Research ethics are integral to all forms of research. They help protect participants’ rights, ensure that the research is valid and accurate, and help minimize any risk of harm during the process.

When people are involved in your research, it’s particularly important to consider whether your planned research method follows ethical practices.

You might ask questions such as:

Will our participants be protected?

Is there a risk of any harm?

Are we doing all we can to protect the personal data and information we collect?

Does our study include any bias?

How can we ensure that the results will be accurate and valid?

Will our research impact public safety?

Is there a more ethical way to complete the research?

Conducting research unethically and not protecting participants’ rights can have serious consequences. It can discredit the entire study. Human rights, dignity, and research integrity should all be front of mind when you are conducting research.

• How to conduct ethical research

Before kicking off any project, the entire team must be familiar with ethical best practices. These include the considerations below.

Voluntary participation

In an ethical study, all participants have chosen to be part of the research. They must have voluntarily opted in without any pressure or coercion to do so. They must be aware that they are part of a research study. Their information must not be used against their will. 

To ensure voluntary participation, make it clear at the outset that the person is opting into the process.

While participants may agree to be part of a study for a certain duration, they are allowed to change their minds. Participants must be free to leave or withdraw from the study at any time. They don’t need to give a reason.

Informed consent

Before kicking off any research, it’s also important to gain consent from all participants. This ensures participants are clear that they are part of a research study and understand all of the information related to it.

Gaining informed consent usually involves a written consent form—physical or digital—that participants can sign.

Best practice informed consent generally includes the following:

An explanation of what the study is

The duration of the study

The expectations of participants

Any potential risks

An explanation that participants are free to withdraw at any time

Contact information for the research supervisor

When obtaining informed consent, you should ensure that all parties truly understand what they are signing and their obligations as a participant. There should never be any coercion to sign.

Anonymity is key to ensuring that participants cannot be identified through their data. Personal information includes things like participants’ names, addresses, emails, phone numbers, characteristics, and photos.

However, making information truly anonymous can be challenging, especially if personal information is a necessary part of the research.

To maintain a degree of anonymity, avoid gathering any information you don’t need. This will minimize the risk of participants being identified.

Another useful tool is data pseudonymization, which makes it harder to directly link information to a real person. Data pseudonymization means giving participants fake names or mock information to protect their identity. You could, for example, replace participants’ names with codes.

Confidentiality

Keeping data confidential is a critical aspect of all forms of research. You should communicate to all participants that their information will be protected and then take active steps to ensure that happens.

Data protection has become a serious topic in recent years and should be taken seriously. The more information you gather, the more important it is to heavily protect that data.

There are many ways to protect data, including the following:

Restricted access: Information should only be accessible to the researchers involved in the project to limit the risk of breaches.

Password protection : Information should not be accessible without access via a password that complies with secure password guidelines.

Encrypted data: In this day and age, password protection isn’t usually sufficient. Encrypting the data can help ensure its security.

Data retention: All organizations should uphold a data retention policy whereby data gathered should only be held for a certain period of time. This minimizes the risk of breaches further down the line.

In research where participants are grouped together (such as in focus groups), ask participants not to pass on what has been discussed. This helps maintain the group’s privacy.

Data falsification

Regardless of what your study is about or whether it involves humans, it’s always unethical to falsify data or information. That means editing or changing any data that has been gathered or gathering data in ways that skew the results.

Bias in research is highly problematic and can significantly impact research integrity. Data falsification or misrepresentation can have serious consequences.

Take the case of Korean researcher Hwang Woo-suk, for example. Woo-suk, once considered a scientific leader in stem-cell research, was found guilty of fabricating experiments in the field and making ethical violations. Once discovered, he was fired from his role and sentenced to two years in prison.

All conflicts of interest should be declared at the outset to avoid any bias or risk of fabrication in the research process. Data must be collected and recorded accurately, and analysis must be completed impartially.

If conflicts do arise during the study, researchers may need to step back to maintain the study’s integrity. Outsourcing research to neutral third parties is necessary in some cases.

Potential for harm

Another consideration is the potential for harm. When completing research, it’s important to ensure that your participants will be safe throughout the study’s duration. 

Harm during research could occur in many forms.

Physical harm may occur if your participants are asked to perform a physical activity, or if they are involved in a medical study.

Psychological harm can occur if questions or activities involve triggering or sensitive topics, or if participants are asked to complete potentially embarrassing tasks.

Harm can be caused through a data breach or privacy concern.

A study can cause harm if the participants don’t feel comfortable with the study expectations or their supervisors.

Maintaining the physical and mental well-being of all participants throughout studies is an essential aspect of ethical research.

• Gaining ethical approval

Gaining ethical approval may be necessary before conducting some types of research. 

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) advise that approval is likely required for studies involving people.

To gain approval, it’s necessary to submit a proposal to an Institutional Review Board (IRB). The board will check the proposal and ensure that the research aligns with ethical practices. It will allow the project to proceed if it meets requirements.

Not gaining appropriate approval could invalidate your study, so it’s essential to pay attention to all local guidelines and laws.

• The dangers of unethical practices

Not maintaining ethical standards in research isn’t just questionable—it can be dangerous too. Many historical cases show just how widespread the ramifications can be.

The case of Korean researcher Hwang Woo-suk shows just how critical it is to obtain information ethically and accurately represent findings.

A case in 1998, which involved fraudulent data reporting, further proves this point.

The study, now debunked, was completed by Andrew Wakefield. It suggested there may be a link between the measles, mumps, and rubella (MMR) vaccine and autism in children. It was later found that the data was manipulated to show a causal link when there wasn’t one. Wakefield’s medical license was removed as a result, but the fraudulent study was still widely cited and continues to cause vaccine hesitancy among many parents.

Large organizational bodies have also been a part of unethical research. The alcohol industry, for example, was found to be highly influential in a major public health study in an attempt to prove that moderate alcohol consumption had health benefits. Five major alcohol companies pledged approximately $66 million to fund the study.

However, the World Health Organization (WHO) is clear that research shows there is no safe level of alcohol consumption. After pressure from many organizations, the study was eventually pulled due to biasing by the alcohol industry. Despite this, the idea that moderate alcohol consumption is better than abstaining may still appear in public discourse.

In more extreme cases, unethical research has led to medical studies being completed on people without their knowledge and against their will. The atrocities committed in Nazi Germany during World War II are an example.

Unethical practices in research are not just problematic or in conflict with academic integrity; they can seriously harm public health and safety.

• The ethical way to research

Considering ethical concerns and adopting best practices throughout studies is essential when conducting research.

When people are involved in studies, it’s important to consider their rights. They must not be coerced into participating, and they should be protected throughout the process.

Accurate reporting, unbiased results, and a genuine interest in answering questions rather than confirming assumptions are all essential aspects of ethical research.

Ethical research ultimately means producing true and valuable results for the benefit of everyone impacted by your study.

What are ethical considerations in research?

Ethical research involves a series of guidelines and considerations to ensure that the information gathered is valid and reliable. These guidelines ensure that:

People are not harmed during research

Participants have data protection and anonymity

Academic integrity is upheld

Not maintaining ethics in research can have serious consequences for those involved in the studies, the broader public, and policymakers.

What are the most common ethical considerations?

To maintain integrity and validity in research, all biases must be removed, data should be reported accurately, and studies must be clearly represented.

Some of the most common ethical guidelines when it comes to humans in research include avoiding harm, data protection, anonymity, informed consent, and confidentiality.

What are the ethical issues in secondary research?

Using secondary data is generally considered an ethical practice. That’s because the use of secondary data minimizes the impact on participants, reduces the need for additional funding, and maximizes the value of the data collection.

However, secondary research still has risks. For example, the risk of data breaches increases as more parties gain access to the information.

To minimize the risk, researchers should consider anonymity or data pseudonymization before the data is passed on. Furthermore, using the data should not cause any harm or distress to participants.

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Ethical Issues in Research

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• First Online: 05 March 2021
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• Juwel Rana 2 , 3 , 4 ,
• Segufta Dilshad 2 &
• Md. Ali Ahsan 5  

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The most important human endeavor is the striving for morality in our actions. Our inner balance and even our very existence depend on it. Only morality in our actions can give beauty and dignity to life – Albert Einstein.

Ethics ; Methodology ; Mixed-method research ; Observation ; Qualitative research ; Quantitative research ; Research ; Research design ; Research ethics

Ethics is a set of standards, a code, or value system, worked out from human reason and experience, by which free human actions are determined as ultimately right or wrong, good, or evil. If acting agrees with these standards, it is ethical, otherwise unethical.

Scientific research refers to a persistent exercise towards producing new knowledge to unveil a new stream of ideas in academia for humankind.

Research ethics refer to some of the genres that researchers follow to protect the rights in developing research strategies and building a trusted relationship between the...

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Bulmer M (1982) Social Research Ethics: An Examination of the Merits of Covert Participant Observation. Holmes & Meier Publishers

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Butler I (2002) A Code of Ethics for Social Work and Social Care Research. Br J Soc Work [Internet]. 32(2):239–48. Available from: https://doi.org/10.1093/bjsw/32.2.239

Fisher CB, Anushko AE (2008) The SAGE Handbook of Social Research Methods [Internet]. London: SAGE Publications Ltd; p. 95–109. Available from: https://methods.sagepub.com/book/the-sage-handbook-of-socialresearch-methods

Hill J, Wright LT (2001) A qualitative research agenda for small to medium-sized enterprises. Mark Intell Plan 19(6):432–443

Homan R (1991) The ethics of social research. Addison-Wesley Longman Limited

Israel M, Hay I (2006) Research ethics for social scientists. Sage

Kimmel AJ (1988) Ethics and values in applied social research. 1st ed. SAGE Publications Inc

Orb A, Eisenhauer L, Wynaden D (2001) Ethics in qualitative research. J Nurs Scholarsh 33(1):93–96

Principles of research ethics [Internet]. Lund Research Ltd. 2012 [cited 2020 Dec 15]. Available from: https://dissertation.laerd.com/principles-of-research-ethics.php

Robley LR (1995) The ethics of qualitative nursing research. J Prof Nurs 11(1):45–48

Wiles R, Charles V, Crow G, Heath S (2006) Researching researchers: lessons for research ethics. Qual Res. 6(3):283–99

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Department of Public Health, School of Health and Life Sciences, North South University, Dhaka, Bangladesh

Juwel Rana & Segufta Dilshad

Department of Biostatistics and Epidemiology, School of Health and Health Sciences, University of Massachusetts Amherst, Amherst, MA, USA

Department of Research and Innovation, South Asia Institute for Social Transformation (SAIST), Dhaka, Bangladesh

Space and Environment Research Center (SERC), Rajshahi, Bangladesh

Md. Ali Ahsan

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Rana, J., Dilshad, S., Ahsan, M.A. (2021). Ethical Issues in Research. In: Farazmand, A. (eds) Global Encyclopedia of Public Administration, Public Policy, and Governance. Springer, Cham. https://doi.org/10.1007/978-3-319-31816-5_462-1

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What Are the Ethical Considerations in Research Design?

When I began my work on the thesis I was always focused on my research. However, once I began to make my way through research, I realized that research ethics is a core aspect of the research work and the foundation of research design.

Research ethics play a crucial role in ensuring the responsible conduct of research. Here are some key reasons why research ethics matter:

Let us look into some of the major ethical considerations in research design.

Ethical Issues in Research

There are many organizations, like the Committee on Publication Ethics , dedicated to promoting ethics in scientific research. These organizations agree that ethics is not an afterthought or side note to the research study. It is an integral aspect of research that needs to remain at the forefront of our work.

The research design must address specific research questions. Hence, the conclusions of the study must correlate to the questions posed and the results. Also, research ethics demands that the methods used must relate specifically to the research questions.

Voluntary Participation and Consent

An individual should at no point feel any coercion to participate in a study. This includes any type of persuasion or deception in attempting to gain an individual’s trust.

Informed consent states that an individual must give their explicit consent to participate in the study. You can think of consent form as an agreement of trust between the researcher and the participants.

Sampling is the first step in research design . You will need to explain why you want a particular group of participants. You will have to explain why you left out certain people or groups. In addition, if your sample includes children or special needs individuals, you will have additional requirements to address like parental permission.

Confidentiality

The third ethics principle of the Economic and Social Research Council (ESRC) states that: “The confidentiality of the information supplied by research subjects and the anonymity of respondents must be respected.” However, sometimes confidentiality is limited. For example, if a participant is at risk of harm, we must protect them. This might require releasing confidential information.

Risk of Harm

We should do everything in our power to protect study participants. For this, we should focus on the risk to benefit ratio. If possible risks outweigh the benefits, then we should abandon or redesign the study. Risk of harm also requires us to measure the risk to benefit ratio as the study progresses.

Research Methods

We know there are numerous research methods. However, when it comes to ethical considerations, some key questions can help us find the right approach for our studies.

i. Which methods most effectively fit the aims of your research?

ii. What are the strengths and restrictions of a particular method?

iii. Are there potential risks when using a particular research method?

For more guidance, you can refer to the ESRC Framework for Research Ethics .

Ethical issues in research can arise at various stages of the research process and involve different aspects of the study. Here are some common examples of ethical issues in research:

Institutional Review Boards

The importance of ethics in research cannot be understated. Following ethical guidelines will ensure your study’s validity and promote its contribution to scientific study. On a personal level, you will strengthen your research and increase your opportunities to gain funding.

To address the need for ethical considerations, most institutions have their own Institutional Review Board (IRB). An IRB secures the safety of human participants and prevents violation of human rights. It reviews the research aims and methodologies to ensure ethical practices are followed. If a research design does not follow the set ethical guidelines, then the  researcher will have to amend their study.

Applying for Ethical Approval

Applications for ethical approval will differ across institutions. Regardless, they focus on the benefits of your research and the risk to benefit ratio concerning participants. Therefore, you need to effectively address both in order to get ethical clearence.

Participants

It is vital that you make it clear that individuals are provided with sufficient information in order to make an informed decision on their participation. In addition, you need to demonstrate that the ethical issues of consent, risk of harm, and confidentiality are clearly defined.

Benefits of the Study

You need to prove to the panel that your work is essential and will yield results that contribute to the scientific community. For this, you should demonstrate the following:

i. The conduct of research guarantees the quality and integrity of results.

ii. The research will be properly distributed.

iii. The aims of the research are clear and the methodology is appropriate.

Integrity and transparency are vital in the research. Ethics committees expect you to share any actual or potential conflicts of interest that could affect your work. In addition, you have to be honest and transparent throughout the approval process and the research process.

The Dangers of Unethical Practices

There is a reason to  follow ethical guidelines. Without these guidelines, our research will suffer. Moreover, more importantly, people could suffer.

The following are just two examples of infamous cases of unethical research practices that demonstrate the importance of adhering to ethical standards:

• The Stanford Prison Experiment (1971) aimed to investigate the psychological effects of power using the relationship between prisoners and prison officers. Those assigned the role of “prison officers” embraced measures that exposed “prisoners” to psychological and physical harm. In this case, there was voluntary participation. However, there was disregard for  welfare of the participants.
• Recently, Chinese scientist He Jiankui announced his work on genetically edited babies . Over 100 Chinese scientists denounced this research, calling it “crazy” and “shocking and unacceptable.” This research shows a troubling attitude of “do first, debate later” and a disregard for the ethical concerns of manipulating the human body Wang Yuedan, a professor of immunology at Peking University, calls this “an ethics disaster for the world” and demands strict punishments for this type of ethics violation.

What are your experiences with research ethics? How have you developed an ethical approach to research design? Please share your thoughts with us in the comments section below.

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Ethical Considerations

Ethical Considerations can be specified as one of the most important parts of the research. Dissertations may even be doomed to failure if this part is missing.

According to Bryman and Bell (2007) [1] the following ten points represent the most important principles related to ethical considerations in dissertations:

• Research participants should not be subjected to harm in any ways whatsoever.
• Respect for the dignity of research participants should be prioritised.
• Full consent should be obtained from the participants prior to the study.
• The protection of the privacy of research participants has to be ensured.
• Adequate level of confidentiality of the research data should be ensured.
• Anonymity of individuals and organisations participating in the research has to be ensured.
• Any deception or exaggeration about the aims and objectives of the research must be avoided.
• Affiliations in any forms, sources of funding, as well as any possible conflicts of interests have to be declared.
• Any type of communication in relation to the research should be done with honesty and transparency.
• Any type of misleading information, as well as representation of primary data findings in a biased way must be avoided.

In order to address ethical considerations aspect of your dissertation in an effective manner, you will need to expand discussions of each of the following points to at least one paragraph:

1. Voluntary participation of respondents in the research is important. Moreover, participants have rights to withdraw from the study at any stage if they wish to do so.

2. Respondents should participate on the basis of informed consent. The principle of informed consent involves researchers providing sufficient information and assurances about taking part to allow individuals to understand the implications of participation and to reach a fully informed, considered and freely given decision about whether or not to do so, without the exercise of any pressure or coercion. [2]

3. The use of offensive, discriminatory, or other unacceptable language needs to be avoided in the formulation of Questionnaire/Interview/Focus group questions.

4. Privacy and anonymity or respondents is of a paramount importance.

5. Acknowledgement of works of other authors used in any part of the dissertation with the use of Harvard/APA/Vancouver referencing system according to the Dissertation Handbook

6. Maintenance of the highest level of objectivity in discussions and analyses throughout the research

7. Adherence to Data Protection Act (1998) if you are studying in the UK

In studies that do not involve primary data collection, on the other hand, ethical issues are going to be limited to the points d) and e) above.

Most universities have their own Code of Ethical Practice. It is critically important for you to thoroughly adhere to this code in every aspect of your research and declare your adherence in ethical considerations part of your dissertation.

My e-book,  The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance  offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline. John Dudovskiy

[1] Bryman, A. &  Bell, E. (2007) “Business Research Methods”, 2nd edition. Oxford University Press.

[2] Saunders, M., Lewis, P. & Thornhill, A. (2012) “Research Methods for Business Students” 6th edition, Pearson Education Limited.

Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

Affiliations.

• 1 a Department of Tropical Hygiene, Faculty of Tropical Medicine , Mahidol University , Bangkok , Thailand.
• 2 b Office of Research Services, Faculty of Tropical Medicine , Mahidol University , Bangkok , Thailand.
• PMID: 30987450
• DOI: 10.1080/08989621.2019.1608190

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations - risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups' perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.

Keywords: Ethical consideration; ethics committee; informed-consent form; informed-consent process; perception.

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Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand

Pornpimon adams.

Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Sukanya Prakobtham

Chanthima limphattharacharoen, pitchapa vutikes, srisin khusmith.

Department of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Krisana Pengsaa

Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Polrat Wilairatana

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Jaranit Kaewkungwal

Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand.

Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members’ reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk–benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population.

All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not. Those involving vulnerable populations were more likely to attract concerns related to study rationale and design.

Conclusions

This study stratified ethical issues raised in a broad spectrum of research proposals. The Faculty of Tropical Medicine at Mahidol University is a significant contributor to global malaria research output. The findings shed light on the ethical review process that may be useful for stakeholders, including researchers, RECs and sponsors, conducting malaria research in other endemic settings.

Malaria research is predominantly conducted in developing countries, corresponding to endemic areas of the disease. Over the past few decades, there have been ongoing concerns and arguments on research ethics. These issues are related to the over- or under-protection of human subjects in drug and vaccine clinical trials, as well as non-clinical studies carried out in disease burden areas [ 1 – 6 ]. Concerns raised include the balance between ethics and science, patient risks and benefits, individuals’ educational background and local concepts of health and disease, ethical justice principles at the community and country level, and even arguments around the Hippocratic dictum ‘ primum non nocere’ [ 1 , 2 , 5 ]. Regarding research ethics in developing countries, it is a reasonable notion that regardless of where the research is conducted, not only should the quality be the same, but also that study participants are equally valued and respected [ 7 ]. Despite the generic ethical principles that can be applied to healthcare-related research, there has been debate about the application of such principles in different research settings because socio-cultural and economic contexts vary considerably around the world [ 2 , 7 ].

In attempting to prohibit malpractice of human experiments in the medical community, the “Declaration of Helsinki” was initially adopted in 1964 and has undergone several revisions since. The Declaration introduced the concept of an independent committee; it stated explicitly that the research protocol must be submitted to the concerned research ethics committee for consideration, comment, guidance, and approval before the study begins [ 8 ]. The research ethics committee (REC) must be qualified, independent, and have no conflict of interest when reviewing the research protocol. This evolved into the term “institutional review board” (IRB) used in the US. The IRB concept was established after the U.S. National Research Act (1974), and the Belmont Report (1979), stating its purpose to protect human subjects involved in both clinical and behavioural research [ 9 ]. The IRB Guidebook [ 10 ] was developed by the US Office for Human Research Protections (OHRP) and is one of the resources that ethics committees across the globe adopt for their own operations. It includes issues of IRB administration, regulation and policies, protocol review mechanisms and other ethical principles. Similarly, the European Union Clinical Trials Directive regards the research ethics committee as an independent body with responsibility to protect the rights, safety, and well-being of human subjects involved in a research study [ 11 ]. The terms IRB and REC are often used interchangeably, but arguably have somewhat different meanings; according to the ICH Guideline [ 12 ]: IRB could be a subsection of REC (a review board or a committee, institutional, regional, national, or supranational), but the IRB or REC plays a major role in regulating the ethical conduct of research by reviewing research proposals before the research is carried out. While judging whether the proposal is worthwhile and ethical, part of the committee’s role may also be to provide constructive recommendations to researchers in an attempt to maintain high-quality, ethical research [ 8 , 10 – 12 ].

With its role in ethical review of research proposals, questions have been raised about whether the REC is facilitating or impeding the advancement of scientific research, and there have been comments from researchers regarding the quality of the REC review itself [ 13 ]. Some investigators in international or multicentre studies have complained of substantial inefficiencies in REC review, and have requested that RECs pay more attention to scientific integrity alongside the protection of human subjects involved in the study [ 14 ]. Investigators have also raised concerns that REC review burdens have grown to include studies involving interviews, secondary use of public-use data and similar activities, most of which involve minimal risks [ 9 ]. Criticism has also been raised regarding the REC requirement for paperwork and mechanical monitoring, which may undermine the main goal of the protection of human subjects [ 9 ]. With the emergence of new fields in biomedical research and technology, particularly in genetics and genomics, a range of views exist within and between RECs and the research groups in these evolving fields [ 15 ]. This reflects the complexity and diversity and lack of common ground surrounding many ethical issues related to this type of research [ 15 , 16 ].

In assessing ethical quality in protocol review—particularly the oversight of human subject research—RECs and other stakeholders, including sponsors, regulators and the public, need to have evidence-based information [ 17 , 18 ]. Several proxy indicators of ethical quality assessment have been proposed. Some suggest using measurement parameters and/or quality metrics including objective and subjective quality assessment, which can be used to improve REC review and deliberation processes, and strengthen relationships between the REC and researchers [ 13 , 19 ]. It has been suggested that ethnographic studies on REC meetings and minutes could help identify the critical ethical issues that the REC considers when reviewing proposals, thus determining whether ethical principles have been thoroughly considered [ 14 ].

An analysis of malaria publication data (2010–2014) in the SciVal database, to which Mahidol University subscribes, found that Mahidol University (Thailand) ranked #4 (with 450 papers) for number of research studies. Of these, the Faculty of Tropical Medicine, Mahidol University contributed 87 % (with 391 papers), correlating to a ranking of #6 if counted as an independent institute. To promote the conduct of research at FTM, the Office of Research Services (ORS) provides administrative services to the faculty’s research community. One of its major functions is as the Secretariat to the FTM Ethics Committee (FTM-EC), managing the operations of Ethics Committee meetings. The FTM-EC has been continuously registered with the Federal-wide Assurance (FWA) of the US OHRP since 2002. The FTM-EC comprises one clinical and one non-clinical panel, which convene at monthly meetings.

Given the level of malaria research output and ethics committee activity at the FTM, it is an ideal location to examine the REC review process for malaria research. Therefore, this study attempts to reveal how malaria research studies conducted in Southeast Asia (along the Thai borders) were reviewed by the local REC, the FTM-EC. In particular, the purpose of this study was to identify the ethical considerations for different types of malaria research proposals submitted to the FTM-EC during the period 2010–2014.

Dimensions of ethical consideration

In reviewing research proposals, REC members should base their judgment on international standards of ethical concerns pertaining to moral values including dignity, bodily integrity, autonomy, and privacy. Such ethical concerns are listed in several guidelines for REC review, and although they might be expressed differently in varying circumstances, similar principles are often cited [ 11 , 20 – 24 ]. The World Health Organization (WHO) [ 22 ] states in its standards for ethical review that the approval or disapproval of the protocol should be based on the ethical acceptability of the research while accounting for its social value, scientific validity, and applicable laws. As stated in the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) [ 21 ], all research involving human subjects should be in accordance with the moral weight of the three basic ethical principles: respect for persons, beneficence, and justice. The European guidelines [ 11 ] suggest four main components of a research ethics committee: dignity, bodily integrity, autonomy, and privacy. The European Commission [ 23 ] even suggests that researchers pre-check their proposal to ensure that it follows the principles of human dignity, fair distribution of research benefits and burden, and protection of the values, rights, and interests of the research participants. The UK Health Department [ 24 ] provides guidance in governance arrangements for RECs in reviewing research proposals to act as part of an efficient, accountable, and independent body in protecting the dignity, rights, safety, and well-being of people who take part in research. The US IRB Guideline on basic IRB review [ 25 ] discusses issues of human subject research, in particular for risk–benefit analysis, monitoring and observation, informed consent and additional safeguards, selection of subjects, incentives for participation, and privacy and confidentiality.

Ethics is not about prescribing a specific set of rules or policies, rather it is about providing a framework for evaluating problems and determining an appropriate course of action [ 26 ]. According to the WHO manual for capacity training for RECs [ 26 ], the ethical analysis is to identify a set of governing principles reflecting both internationally accepted norms and locally relevant cultural values, and then apply such principles to evaluate the research. Several frameworks for ethical research conducted in developing countries have been proposed, focusing on collaborative partnerships and sharing responsibilities with researchers, policy-makers and the community [ 2 , 21 , 26 , 27 ]. The framework should be based on the notation set forth in the Declaration of Helsinki so that ethical principles could be effectively identified and applied, particularly in developing countries in regards to each country’s socioeconomic circumstances, laws and regulations, and executive and administrative arrangements [ 21 ]. Proposed basic ethical principles include: (1) considering social value by specifying the beneficiaries of the research, (2) ensuring scientific validity through the scientific design and research objectives, (3) fair study population selection to ensure scientific validity, (4) assessment of the risk–benefit ratio by comparing the net risks of the research project with the potential benefits, (5) ensuring public accountability through independent reviews mandated by laws and regulations, (6) ensuring informed consent while involving the community in establishing recruitment procedures and incentives, and (7) respecting study participants and communities [ 2 , 26 , 27 ].

In particular, ethical issues that should be considered as part of malaria field studies in developing countries have been discussed as lessons learned in a community-based clinical trial of rectal artesunate conducted in a few developing countries [ 28 ]. Issues to consider include the ethical review process, standard of care, incentives and reimbursement, and insurance and indemnity. It has also been suggested that local ethical review should consider the vulnerability of patients with no or poor access to healthcare, specific cultural attitudes, literacy, and both local written and oral languages [ 28 ]. A study on convergent ethical issues in HIV/AIDS, TB, and malaria vaccine trials in Africa revealed that sharing simple and effective consent form templates and procedures across diseases was achievable [ 29 ]. Comprehension testing of subjects prior to and during study participation, to ensure understanding of the important study concepts, has also been proposed [ 28 ]. Moreover, it has been suggested that the REC should also examine the suitability of the investigators and the adequacy of facilities and the methods and documentation to be used in the study [ 11 ].

At the FTM-EC, individual REC members are provided with a review form prior to every convened meeting. The review form outlines certain ethical issues similar to those described above. Each member uses this form as a guide to ethical issues to consider when reading the proposal. They then complete each part that he/she considers relevant and requires explanations from the researchers. The form also has an open-ended component, where the REC can note other ethical considerations. The review form used during the study period (currently the form has been revised) guiding the REC members in reviewing each protocol was composed of 19 check boxes for close-ended items on being a human research subject study: types of study (clinical, epidemiological, social science, or behavioural); reasonable scientific questions/objectives; proper sampling techniques/data collection methods; quality of investigators/facilities; project budget; compensation; justification of the involvement of vulnerable populations; rationale for use of human specimen; adequate toxicological/pharmaceutical information; sufficient provision of information and proper informed consent process and forms; rating on level of risk and benefit of the study; and the overall ethical acceptability of the proposal. The review form also consists of 9 open-ended comment items regarding project summary (to be filled in by two primary reviewers) and other ethical issues (to be filled by all REC members) including major points of concern, levels of risk, comments on the title, proposal content (objectives, research methodology, protection of privacy and confidentiality), participation information sheet, informed consent/assent form, questionnaire/advertisement/case record form, attached document (investigator’s brochure, material transfer, etc.), and other comments/suggestions. For the purpose of this study, the ethical issues were divided into six dimensions, as follows: (1) study rationale and validity; (2) study design; (3) study participants; (4) informed consent process; (5) data collection and analysis; and (6) facility and support. Each dimension thus covers its related ethical considerations in the review form (as presented in the “ Results ” section).

Classification of malaria research studies

Research protocols reviewed by RECs can be categorized according to different schemes [ 22 , 30 , 31 ]. The European Science Foundation [ 31 ] reviews health research classification systems in different countries across continents. The UK Health Research Classification System (HRCS) for classifying and analyzing biomedical and health research funding applies a two-dimensional framework. Codes on health categories are used to classify the type of health or disease being studied, covering 21 categories encompassing all diseases, conditions and areas of health. Research activity codes are used to classify the type of research activity being undertaken (from basic to applied), covering 48 codes of eight subgroups: (1) Underpinning, (2) Aetiology, (3) Prevention, (4) Detection and Diagnosis, (5) Treatment Development, (6) Treatment Evaluation, (7) Disease Management, and (8) Health Services. The Australian and New Zealand research classification scheme has been developed and updated over the years. The three constituent classifications in use are: (1) Type of Activity (ToA)—pure basic research, strategic basic research, applied research and experimental development; (2) Field of Research (FoR)—methodology used in research and development (R&D) fields of the research investigated by institutions and organizations as well as emerging areas of study; and (3) Socio-economic objective (SEO) consisting of discrete economic, social, technological or scientific domains for identifying the principal purposes of R&D.

On the other hand, the WHO [ 22 ] simply classifies different types of research studies to be reviewed by RECs, including, but not limited to, the following: (1) clinical trials, (2) epidemiological research, (3) social science research, (4) research on medical records or other personal information, (5) research on stored samples, (6) health systems research, and (7) implementation research. The US Office for Human Research Protections [ 30 ] categorized research reviewed by IRBs as either biomedical or behavioural studies. Biomedical research covers two types of studies: (1) those designed primarily to generate scientific knowledge about the natural history of the disease and normal or abnormal physiology, and (2) studies designed primarily to evaluate the development of medical products and the efficacy, effectiveness, efficiency and safety of a medical intervention. Behavioural research includes studies of the epidemiology and social science of individual or group behaviour. As part of the biomedical research study, clinical trials, which often originate in the laboratory to develop new therapies or procedures, are tested in animal studies, then subsequently on human subjects [ 32 ]. The US National Institutes of Health (NIH) distinguishes between different types of clinical trials including, for example, natural history studies, prevention, screening, diagnostic, treatment, or quality of life trials [ 32 ]. Biomedical research can be sub-classified as basic/pre-clinical research or clinical research [ 33 ].

Many RECs face challenges in the protocol review of studies in the fields of molecular and genetic or genomic research. Lack of clarity on how researchers should respond to RECs has been reported, particularly concerning issues of informed consent and the use of archived specimens [ 20 , 34 ]. Confusion and debate remains within and across RECs around studies involving the collection and use of non-identifiable stored tissue specimens. There is disharmony among regulatory requirements in different countries and REC bodies within countries, but there is a growing international agreement on the provision and access to research data and bio-specimen collections in order to optimize their long-term value and potential for health discovery and validation [ 35 – 37 ]. The UK Medical Research Council [ 35 ] proposed operational and ethical guidelines for the use of human tissue and biological samples, such that samples of human biological material should be treated as donations, and research involving these should be conducted with respect and transparency. The research study should be planned with respect to the trust of the potential donors with individual, cultural, or religious differences in the meaning and significance attached to samples for use.

With contradictory legal and ethical frameworks across national borders, there has been an attempt to set up an international charter of principles for sharing bio-specimens and data [ 36 ]. The following five principles include major ethical considerations: (1) respect for privacy and autonomy, (2) reciprocity, (3) freedom of scientific enquiry, (4) attribution, and (5) respect for intellectual property. In the US, the Food and Drug Administration has set rules and regulations regarding the use of identifiable and unidentifiable specimens for clinical investigators, sponsors, and RECs. The US Health Insurance Portability and Accountability Act privacy rule has set less restrictive rules for the use of stored specimens and tissue repositories (such as biobanks), when released data have been de-identified [ 20 ]. The UK Medical Research Council [ 35 ] emphasizes custodianship as the responsibility of researchers for safe keeping of samples and control of their use and eventual disposal, defining “anonymized samples or data” where all identifying information is removed, either as linked or unlinked anonymous data and samples; and “coded samples or data” where a code is used in place of identifiers to protect the confidentiality of the individual during routine use. The American Society of Human Genetics distinguishes between retrospective and prospective studies, such that the “retrospective research studies” utilise previously obtained samples collected for a purpose that is different from that of the current proposal and the “prospective research studies” are those in which the collection of the new samples is part of the current study design [ 37 ]. Similarly, four types of sample identification were defined: (1) anonymous, no identifiers and impossible to link with their sources, (2) anonymised, originally with identified information but irreversibly stripped off and are impossible to link to their sources, (3) identifiable, unidentified for the current research purposes, but can be linked to their sources, and (4) identified, with identifiers and are attached and available to the researchers [ 37 ]. In Thailand, however, the use of specimens or medical records, either identifiable or unidentifiable, is considered to be human subject research. Studies involving such material commonly require REC review, either full-board or expedited, and very few receive exemption.

The two panels of the FTM-EC comprise different sets of members. The “clinical panel” reviews clinical research studies involving the application of any clinical interventions in human research subjects, while the “non-clinical panel” reviews other types of biomedical study, including research conducted in clinical settings but where no clinical intervention was applied, epidemiological studies, and studies that use stored specimen or secondary data. Malaria study proposals submitted to the FTM-EC fall into either of the categories and are reviewed by the relevant panel. Because these two broad categories of research might be subject to different constraint levels of ethical consideration, reviewed studies were classified for the purposes of this study in two ways. For classification based on research study design, there are four categories: (1) clinical (drug) trials; (2) biomedical studies; (3) laboratory studies, and (4) epidemiological/social science studies. For classification based on the use and non-use of specimens, there are four categories: (1) new specimen collection; (2) use of archived un-identifiable/un-linked specimens; (3) use of archived/identifiable/linked specimens; and (4) use of medical records and new data collection.

Sources of information and statistical analysis

This study adopts the process of internal audits on quality systems of independent ethics committees in Europe [ 38 ], by conducting documentation reviews. The reviewed documentation included minutes of meetings and agendas, each individual REC member’s reviewing form, and the notifications to researchers informing them of the review outcome for the submitted proposal. This study was conducted by the office managing the submitted proposals and the REC members at the FTM-EC. Information was extracted by personnel authorized to access these documents. To avoid bias, three office employees (non-voting members of the FTM-EC), were assigned to identify the main ethical considerations noted by each REC member on his/her review form, while cross-checking with each other. Ethical considerations raised were counted quantitatively whether the ethical issues (e.g. scientific merit, risk and benefit, sample size, or informed-consent process) were noted/discussed, both in the pre-specified and open-ended items, on each individual REC member’s review form as well as all other documents related to the submitted proposal. It should be noted that for the open-ended items, very little subjective judgment was required by the person extracting the data, because most of the major ethical issues raised by the reviewers could be obviously categorized. All proposals related to malaria research submitted to FTM-EC over a period of 5 years, from January 2010 to December 2014, were reviewed. Analyses of ethical considerations were presented according to study classification, study design and specimen uses; Chi square tests were performed on each ethical issue separately. In addition, analyses were performed according to study location (multi-site, international, approval together with other REC study) and study population (minority or vulnerable population involved). To further investigate the relationship between ethical considerations and different study types, additional statistical analyses were performed using simple crude odds ratios (ORs). Logistic regression was performed for each ethical issue by different type of study separately.

Types of malaria research studies

During the study period, 114 research proposals on different malaria species were submitted to the FTM-EC for review. These comprised 19 (17 %) biomedical studies, 15 (13 %) drug trials, 28 (24 %) laboratory studies and 52 (46 %) epidemiological/social science studies. Drug trials adopted atypical phase classification of the drug development process including 12 studies on investigational new drug ranging from Phase I to Phase III, and 3 Phase IV drug safety studies. No malaria vaccine trial proposals were submitted to the FTM-EC during the study period. Biomedical studies included eight studies comparing different malaria treatments/regimens and/or with different indications in clinical settings, and 11 bioequivalence or pharmacokinetic studies. Laboratory studies covered pure basic science and genetic studies. Epidemiology/social science studies included retrospective study using medical records and social/behavioural research. Approximately one-third of studies required FTM-EC approval together with that of other RECs, within Thailand and/or internationally. Approximately 13 % were multi-site and 4 % were international studies. Most malaria studies were conducted at malaria-endemic areas along the Thai borders; therefore, 28 % involved minority (hill tribe and cross-border) populations. Seventeen percent involved children and 7 % involved pregnant women (Table  1 ).

Table 1

Malaria study proposals submitted to the FTM-EC during the study period

FTM - EC Faculty of Tropical Medicine Ethics Committee and IRB institutional review board

Overall ethical considerations on malaria proposals

Of the 114 proposals, the ethical issues raised by REC members on “study rationale and significance of the study” included 12 % on research questions and 17 % on research objectives. As shown in Fig.  1 , regarding the “study design and methodology” dimension, approximately 30 % were related to study schedule and activities, and 37 % to risk–benefit balance. For the ethical considerations concerning “research study participant”, 52 % were related to inclusion and exclusion criteria, 26 % to sample size, 27 % to recruitment procedures, and 23 % to participant compensation. Higher percentages were shown for the “informed consent process” dimension, with 57 % on the participation information sheet, 50 % on the informed consent form/process, and 24 % on the privacy and confidentiality of the information. Regarding the “data collection and analysis” dimension, approximately 61 % related to the specimen and data collection procedure, 17 % to case record form (CRF) design and use and 13 % to data analysis methods. For “study facility and supporting information”, 4 % were on study site location, 2 % on study budget, and 15 % on supporting documentation (e.g. material transfer agreement, and approval of authorities in the community where the study was taking place).

Overall ethical considerations on malaria research proposals (n = 114)

Comparisons of ethical considerations by proposal type

When comparing ethical considerations according to study design, almost all ethical issues were statistically significantly different across the four study designs. Proposals for drug trials had higher percentages for most ethical issues, followed by proposals of for biomedical/clinical research then laboratory or basic science research (Table  2 ). Proposals for epidemiology studies had fewer ethical issues raised by the FTM-EC. Interestingly, ethical issues for “privacy and confidentiality” specifically showed an opposite but non-statistically significant trend, being higher for laboratory and epidemiology studies than biomedical studies or drug trials. Other non-statistically significant differences among different study designs were for CRFs, data analysis, study budget and supporting documents.

Table 2

Comparisons of ethical considerations by study design

When comparing ethical considerations by different types of specimen/data collection and use, again almost all ethical issues were statistically significantly different across the four types of study proposal. Proposals involving new specimen collection had higher percentages for most ethical issues, followed by proposals using medical records or collecting new data using CRFs or questionnaires (Table  3 ). The proposals involving the use of stored specimens, either linked (identifiable) or unlinked (un-identifiable) had a smaller percentage of ethical issues raised by the FTM-EC. Again, ethical issues for “privacy and confidentiality” showed an opposite but non-statistically significant trend, with the percentage higher for studies involving stored specimens. Other non-statistically significant differences among different study designs were study rationale, data analysis, and study facility and supporting documents.

Table 3

Comparisons of ethical considerations by type of specimen/data use

CRF case record form

Strength of relationship between ethical considerations and different types of malaria proposals

Regarding study location, proposals that required other REC review had higher ORs compared with proposals that required only FTM-EC review for the following ethical issues: study design and methodology; study participants; the informed consent process; and study facility and supporting documents. For comparisons between international vs. local studies, and between multi- vs. single-site studies, higher ORs were found for the dimension study facility and supporting documents (Table  4 ).

Table 4

Comparisons of ethical considerations by different study characteristics

Italics denotes statistically significant values

CI confidence interval, IRB institutional review board, OR odds ratio

Regarding study populations, proposals involving minority populations had higher ORs than proposals that did not involve such populations, for all ethical issues apart from study rationale and significance. In contrast, proposals involving vulnerable populations had higher ORs than proposals that did not, for study rationale/significance and study design/methodology.

When comparing the four study designs using epidemiology studies as a reference group, higher ORs were reported for biomedical/clinical research for all ethical issues except study facility and supporting documents. For drug trials, higher ORs were reported for all ethical issues except study participants and informed consent process. This was because 100 % of drug trial researchers were asked for clarifications on these two ethical issues. For laboratory studies, higher ORs were reported for three ethical issues: study design and methodology, study participants, and the informed consent process.

When comparing the four types of specimen/data use using proposals with medical records/CRFs as the reference group, higher ORs were reported for studies that collected new specimens for all ethical issues except study rationale, data collection and analysis, and research facility and supporting documents. Interestingly, when comparing proposals for studies using medical records/CRFs with those using identifiable or unidentifiable stored specimens, no statistically significant differences were reported.

The roles and responsibilities of an REC are to ensure protection of the safety, well-being and basic rights of potential participants and participants of a research study. The REC should review the protocol and associated documents and provide opinions on three different ethical considerations, i.e. science, ethics, and data quality [ 33 ]. The classical view of research ethics is governed by four ethical principles: respect for persons, beneficence, justice, and respect for communities [ 39 , 40 ]. Ethical foundations to be considered and addressed include issues on research subjects, the informed consent process, study design concept, risk–benefit ratio, vulnerable group protection and research gatekeepers [ 10 , 41 ]. In this study, the ethical issues raised in malaria research proposals fell within these common principles. Approximately half of the proposals required revision and clarification on the informed consent process and study participant protection; and, for those studies that required specimen collection, the process to obtain the specimen from the study participants. Approximately one-third required information about risk–benefit and study schedule-activities. Less than one-fifth required explanation of the research objectives and a few proposals required clarification or revision of research questions and supporting documents.

Although only approximately 12 % of the proposals in the present study needed elaboration or provision of more robust information about the research questions (study rationale and significance), debate remains whether the FTM-EC has gone beyond its designated roles. The highest percentage of ethical issues raised by the FTM-EC regarding the malaria research proposals in the study related to the specimen and data collection schedule and activities. At times, some investigators have also questioned whether the ethics committee should comment on research methodology. These scientific merit and research procedure issues remain controversial internationally. It has been reported that REC members are pressured to review a wide range of issues in research proposals, needing to provide opinions ranging from research design to patient privacy and budgeting matters [ 9 , 33 ]. Some research investigators believe that these are beyond the scope of research protection [ 9 ]. Others have suggested that researchers should have already thought carefully about the nature of how the study results can be generated and how they are aligned with the aims of the research. Heterogeneity of bioethics ought to be welcomed, but those involved should engage meaningfully and explicitly with questions concerning normative justification and the methodological process and about the coherence of components of their study [ 42 ]. The OHRP also notes that REC members very often ask to what degree it is his/her responsibility to review the underlying science of the proposal [ 43 ]. It has long been argued that “if it is not good science, it is not ethical” and the US federal regulations do not clearly call for REC review of the scientific validity of the research design. However, if the underlying science is inadequate, then it follows that the study is unlikely to yield important knowledge [ 43 ]. To mitigate this controversial ethical consideration made by RECs, the ORHP guideline suggests that if the REC lacks expertise in the scientific matter of the particular proposal, the REC should recognise its limits. Although REC members are not required to be experts in scientific methodology or statistics, they should have certain basic knowledge about study design, and they should consult experts if they have concerns about the research rationale and methodology that seem to pose a significant problem [ 43 ]. At the FTM, besides some FTM-EC members who have been working in malaria research over decades, there is a pool of expertise in malaria research, ranging from molecular to field studies, and several of them have been consulted for advice for any unclear or controversial matter before issuing the letter to investigators or making a final decision on the submitted proposals.

The REC has a responsibility to consider the balance between the risks and benefits of the research proposal. International standards clearly state that the REC must safeguard the rights, safety and well-being of all study participants [ 10 , 33 , 44 ]. Based on the classic ethics principle of beneficence, researchers have an obligation not to harm needlessly and to promote the good of the study participants where possible. Regarding justice, researchers have an obligation to ensure that study procedures for the selection of research subjects are equitable [ 44 ]. It is also agreed that researchers neither exploit the vulnerable nor exclude unreasonably those who could be receive benefit from the study. This means that eligibility criteria listed in the proposal must be clearly justified [ 45 ]. Among all 114 malaria proposals submitted for FTM-EC review, about 28 % involved minority populations along the country borders, and 27 % involved other vulnerable groups (pregnant women, children, the elderly or unconscious patients). Thus, the finding that over one-third of proposals required clarification on the risk–benefit balance is not surprising.

As clearly stated in international standards on ethical review of research protocols [ 12 , 23 – 25 , 46 ], the informed consent process is one of the main ethical considerations that must be observed by RECs. Indeed, it could be said that the informed consent process is a legal, ethical, and regulatory requirement for most research and healthcare transactions [ 20 , 47 ]. The informed consent process is based on the classic ethical principle of respect for persons, such that researchers must ensure that potential study participants make their own decisions whether or not to take part [ 44 ]. It should also be noted that, by signing informed consent documents, the study participants have agreed to a controlled breach of their privacy/confidential information for a specific purpose mentioned in the study protocol, and for use over a specific period of time [ 14 ]. It is thus important that participants are clearly informed about the methods of handling and use of their personal data, the justification for requesting or obtaining their data from different sources, and the duration of data use and storage, while maintaining their right to withdraw their consent at any time [ 14 ]. All guidelines suggest that special attention should be paid to studies involving vulnerable participants who may be unable or have limited capacity to make a decision [ 10 , 21 , 48 , 49 ]. In a study on ethical dilemmas in malaria drug and vaccine trials [ 1 ], it was stated that, in most cases, obtaining informed consent was problematic because the studies were usually conducted with patients or surrogates with limited educational attainment levels in developing countries, and thus were not able to fully understand the study protocol. Potential participants may not understand the science underlying the study and therefore be able to make proper informed decisions. The finding in that study suggests the need for a better consent processes. As suggested elsewhere in the literature, a consent process considered valid or truly informed should have the following characteristics: (1) provision of adequate information, (2) capacity to understand that information, (3) decision making voluntarily, (4) understanding of information provided, and (5) agreement to the proposed treatment or procedure [ 50 ]. It has also been suggested that the informed consent forms are usually too long and complex for a layperson to read and comprehend, but there are various methods to simplify such forms [ 51 ]. Researchers are obliged to ensure that they plan their informed consent process with care, even the complicated aspects of research, by having the information explained simply and comprehensibly to the potential study participants. In the present study, over half the malaria research proposals and all malaria drug trial proposals submitted to FTM-EC required revision of the informed consent process to meet such requirements.

When examining different research designs, it was found that proposals on laboratory-based (usually using archived specimens) and epidemiological studies had fewer ethical issues raised by the FTM-EC than clinical research and drug trials. However, “privacy and confidentiality” showed an opposite, albeit non-statistically significant, trend. This concurs with one of the main ethical considerations in all international guidelines, that possible invasions of privacy of individuals and breaches of confidentiality may arise in biomedical and behavioural/social research [ 22 , 24 , 25 , 27 , 46 ]. As suggested in the guideline on ethics of research related to healthcare in developing countries, one of the RECs’ primary tasks is to review the ethical acceptability of research proposals with special attention to the provisions for protecting the security and confidentiality of data about patients [ 7 ]. From a data protection and privacy issues point of view, all study participants must be informed about not only what they have to do in the research, if they decide to participate, but also what and how the research plans to use the data that they provide [ 46 ]. There were reports of potential improper use or misuse of the collected data; even in case studies showing that what seems to be unlinked information can sometimes be taken for use out of context and lead to a personal data breach [ 46 ]. This could be because study procedures in clinical and drug trial proposals tended to be stated clearly by the study investigators in protecting participants’ personal information, whereas proposals of laboratory (predominantly using stored specimens) and epidemiology studies (predominantly using medical records and CRFs in healthcare settings) were generally not as clear. As suggested in the literature about ethical and legal issues of research using human specimens and clinical data, materials should be provided to the investigator with the minimal clinical information needed for the study and specimens should not be individually identifiable where applicable [ 15 , 16 , 20 ].

The malaria proposals that required additional review by other RECs, whether international or local, appeared to raise more ethical issues regarding study design and methodology, study participants, informed consent processes and study facility and supporting documents. This might be because such proposals are likely to be developed by non-local investigators and thus there might be certain local sensitive issues that were overseen by the proposal developers. As suggested in the literature regarding ethical principles in conducting clinical research in developing countries, investigators should consider the principle of collaboration by developing partnerships with local researchers, policy makers and the community [ 2 ]. It is recommended that the study should respect the community’s values, culture, traditions, and social practices. Even regarding scientific validity, the research team should ensure that the scientific design and methodology has recognized social value for the primary beneficiaries of the research, and is feasible within the social, political, and cultural context, or provides sustainable improvements in the local healthcare and physical infrastructure [ 2 ].

Ethical issues that should be considered, as part of field studies of malaria in developing countries, were also discussed in terms of practical problems that arise in the course of research. These include differing circumstances in developing countries, such as standards of care, incentives and reimbursement, insurance and indemnity [ 28 ]. The local REC should ensure that local context is adequately addressed and convey their knowledge of local factors that affect human subject protection [ 52 ]. The issues raised by the FTM-EC for these international studies confirm the notion that local ethical review should consider the vulnerability of study participants, particularly in remote border areas with no or poor access to healthcare services, alongside cultural beliefs and attitudes, literacy and language [ 25 , 28 ]. As has also been suggested by others, the REC should provide public assurance of such protection by ensuring that investigator(s) are suitable to conduct the study, facilities are adequate, and that the methods and materials and informed consent process are appropriate [ 33 ].

Malaria research studies conducted along the Thai borders generally involved minority populations in endemic areas. These populations are considered vulnerable, with poor/limited educational attainment and cross-border/migrant status. Therefore, it is not surprising to observe that all ethical issues (except study rationale) were raised for such proposals by FTM-EC. The principle of fair selection of study population is important to minimize risks while enhancing other critical principles of collaborative partnership and social value when the research study is taking place in local communities [ 2 ]. Balancing risk–benefit considerations, informed consent processes and having respect for recruited participants and study communities, especially among vulnerable populations, remain the major concerns of all RECs [ 2 , 25 ].

There were more ethical considerations in almost all aspects for drug trials and clinical studies compared with proposals for epidemiological studies. Clinical research studies usually directly involve human subjects, either with preventive, therapeutic, or non-therapeutic procedures. In general, the study procedures in such study designs put human subjects at higher risks, thus there are more ethical concerns. The primary ethical considerations of clinical studies are competent medical treatment and care, alongside an acceptable risk–benefit balance [ 40 , 41 , 44 ]. However, many laboratory research studies use stored specimens, with less invasive procedures, and epidemiology studies usually employ data collection through medical records, CRFs or questionnaires. Ethical issues for the latter, therefore, mainly concern confidentiality and privacy of the study participants [ 25 ]. However, it was found that studies that collect new specimens received more comments on ethical issues. There remains debate among RECs about solutions for issues around sample export, storage, and reuse [ 15 , 16 , 34 ]. However, it is recommended that in order to ensure adequate protection of human research subjects participating in scientific research, RECs bear the responsibility of guaranteeing that participants are provided with sufficient detail to be able to provide informed consent as well as to understand the reality of genetic research as it is practiced [ 53 ].

Limitations of the study

The main limitation of this study is that it is based on information from only one institution, the Faculty of Tropical Medicine, Mahidol University. It may, therefore, not be representative of RECs elsewhere in Thailand or around the world where malaria proposals are submitted. However, the top five institutions publishing malaria research papers during 2010–2014 were the London School of Hygiene and Tropical Medicine (882), the University of Oxford (766), the University of Liverpool (485), Mahidol University (450, including 391 from the FTM), and Johns Hopkins University (409). The proposals under the FTM affiliation were all reviewed by the FTM-EC. This study examined all 114 malaria research proposals submitted to an REC in Thailand during a five-year period. Overall, the FTM makes a considerable contribution to malaria research globally. Identifying the ethical issues considered during the protocol review process at the FTM may inform the planning of future malaria research studies in endemic countries in Southeast Asia and/or beyond.

Regardless of study design and setting, the REC focus is on the science, ethics and quality assurance of each study protocol. Several important ethical issues were identified for protocol approval, ranging from study design to supporting documents. Ethical considerations, particularly for clinical research and drug trials appeared to be mainly focused on the risk–benefit balance, vulnerable participants, and informed consent process, whereas the main considerations for laboratory and epidemiology studies were the confidentiality and privacy of data and use of specimens. As with studies subject to review by any REC, generic ethical principles are applied to malaria research, such that research validity and quality must be maintained while respecting study participants within the social, cultural and economic contexts where the research is conducted. Ethics and bioethics represent large domains of their own in balancing both theoretical and practical aspects of human research study conduct. While stakeholders, including researchers, sponsors and RECs, have to consider the practicability of research conduct within malaria-endemic settings, which are commonly populated with those who are poor and vulnerable, they cannot violate the classic ethical principles of autonomy, beneficence, and justice.

Authors’ contributions

All authors discussed and agreed upon the content, contributed to the development and revision of the draft manuscripts. PA, JK drafted the initial version. PW, SK, KP contributed useful criticism and suggestions. CL, SP, PV extracted unlinked study data from the secured documents of the FTM-EC. All authors read and approved the final manuscript.

Acknowledgements

The authors would like to thank the FTM-EC members in both panels for their kind support for this study.

Compliance with ethical guidelines

Competing interests The authors declare that they have no competing interests.

Abbreviations

Contributor information.

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