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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism. Run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Nih clinical research trials and you, guiding principles for ethical research.

Pursuing Potential Research Participants Protections

“When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science.

NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:

Social and clinical value

Scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent.

• Respect for potential and enrolled subjects

Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.

A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants  (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.

Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

Respect for potential and enrolled participants

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

• respecting their privacy and keeping their private information confidential
• respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty
• informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating
• monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study
• informing them about what was learned from the research

More information on these seven guiding principles and on bioethics in general

This page last reviewed on March 16, 2016

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Principles of Research Ethics

Research ethics are based on three fundamental principles.

1. Respect for Persons

This principle incorporates two elements that deal with respecting people in regard to research:

People should be treated as autonomous The term autonomous means that a person can make his or her own decisions about what to do and what to agree to.

Researchers must respect that individuals should make their own informed decisions about whether to participate in research. In order to treat people as autonomous, individuals must be provided with complete information about a study and decide on their own whether to enroll.

People with diminished autonomy should be protected Some people in society may not have the capacity to make fully informed decisions about what they do or what happens to them. This could include young children, people who are very ill, or those with mental disabilities. In such cases, these people should be protected and only be included in research under specific circumstances, since they cannot make a true informed decision on their own.

2. Beneficence

The definition of beneficence is action that is done for the benefit of others. This principle states that research should:

Maximize benefits for participants and minimize risks for participants The purpose of much research involving humans is to show whether a drug is safe and effective. This means participants may be exposed to some harms or risks. Researchers are obligated to do their best to minimize those possible risks and to maximize the benefits for participants.

This principle deals with the concept of fairness. Researchers designing trials should consider what is fair in terms of recruitment of participants and choice of location to conduct a trial. This encompasses issues related to who benefits from research and who bears the risks of research. It provides the framework for thinking about these decisions in ways that are fair and equitable.

People who are included in research should not be included merely because they are a population that is easy to access, available, or perhaps vulnerable and less able to decline participating.

An experimental strategy that is likely to be used by many types of people should be tested in the very populations of people who are likely to use it, to ensure that it is safe, effective, and acceptable for all of the potential users. For example, experimental treatments that are intended for use in the general population must be studied not only on men, but on enough women to ensure that they are also safe and effective for women.

The principle of justice also indicates that questions being asked in trials should be of relevance to the communities participating in the study.

Global Encyclopedia of Public Administration, Public Policy, and Governance pp 1–7 Cite as

Ethical Issues in Research

• 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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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

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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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Table of Contents

Collaboration, information literacy, writing process, research ethics.

As an investigator be sure to protect your research subjects and follow ethical standards. As a consumer of research, be mindful of when investigators may be exaggerating results, making claims that exceed the authority of a research method, misrepresenting findings, or plagiarizing.

Research ethics are the moral principles and practices that guide how researchers work with information (especially data/texts), human subjects, and animals.

Since 1947, following the publication of the Nuremberg Code , governments (e.g., see Canada ) and professional organizations (e.g., see American Psychological Association) have created ethical codes of conduct to protect research subjects and society.

Since 1964, following the publication of the Declaration of Helsinki , investigators working with human subjects have been required to write an IRB Board in the U.S. or an Ethics Committee in the European Union before any research is conducted.

Research ethics and moral principles are a major concern across academic disciplines, professions, and consumers. Governments, hospitals, universities, and professional organizations have robust policies that guide how investigators work with texts, other humans, and animals, including

• policies for conducting research, such as prohibitions against plagiarism, misrepresentation of data, or fabrication of data
• policies for collaboration, authorship, peer review
• policies for protecting human subjects or animals involved in studies
• policies to account for, avoid, or ameliorate conflicts of interest
• policies for illustrating the value of funded research from governments, foundations, think tanks, and other organizations.

Even so, problems with research ethics endure.

Sometimes investigators cheat and engage in unethical behavior. Politics, economic interests, corporate interests, personal interests — these factors and more are associated with unethical behavior.

And sometimes investigators may not even be conscious that they are acting unethically. People can be unaware of their own confirmation bias, their tendency to ignore disconfirming evidence and selectively seek out evidence that confirms their thesis or research question .

Consumers of research are wise to consider ethics when weighing a study’s truth claims .

[ The CRAAP Test (Currency, Relevance, Authority, Accuracy, Purpose) ]

In 2009, Dr. Daniele Fanelli, a professor at The University of Edinburgh, conducted a meta analysis of 21 surveys that explored how frequently scientists fabricate, falsify or cook data. Remarkably, she discovered that 33.7% of the scientists surveyed admitted to questionable research practices. When discussing the work of colleagues they assumed 14.12% of scientists falsified data and 72% engaged in questionable research practices:

it is likely that, if on average 2% of scientists admit to have falsified research at least once and up to 34% admit other questionable research practices, the actual frequencies of misconduct could be higher than this. Fanelli, Daniele (5/29/09). How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data . PLOS ONE, https://doi.org/10.1371/journal.pone.0005738

For researchers, research ethics and moral principles are not an ornamental feature, an afterthought. Rather, ethical considerations form the foundation of research protocols , guiding the selection of research methods, the techniques used to gather and interpret data, and the ways data are interpreted and represented in research reports.

Examples of Research Ethics

To learn more about research ethics and moral principles, review the following ethical codes:

• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• World Medical Association’s Declaration of Helsinki
• International ethical guidelines for biomedical research involving human subjects
• International ethical guidelines for epidemiological studies
• European Group on Ethics
• Directive 2001/20/ec of the European Parliament and of the Council
• Council of Europe (Oviedo Convention – Protocol on biomedical research)
• National Institutes of Health (NIH)

Fanelli, Daniele (5/29/09). How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data . PLOS ONE, https://doi.org/10.1371/journal.pone.0005738

Related Articles:

Human subjects research, informed consent, irb (institutional review board), ethics committee, suggested edits.

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Be aware of the moral principles and practices that inform research with human subjects.

Informed Consent is a legal and ethical requirement for research studies engaged in human subjects research.

Prior to conducting research involving human subjects, be sure to seek approval from an IRB (Institional Review Board) or Ethics Committee.

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16 Research ethics

Ethics is defined by Macquarie dictionary [1] as ‘the rules of conduct recognised in respect of a particular class of human actions’. Such rules are often defined at a disciplinary level though a professional code of conduct, and sometimes enforced by university committees called an institutional review board (IRB). However, scientists are also expected to abide by universal ethical standards of behaviour shared by the wider scientific community. For instance, scientists should not manipulate their data collection, analysis, and interpretation procedures in a way that contradicts the principles of science or the scientific method, or advances their personal agenda.

Why are research ethics important? Because, science has often been manipulated in unethical ways by people and organisations engaging in activities that are contrary to the norms of scientific conduct, in order to advance their private agenda. A classic example is pharmaceutical giant Merck’s drug trials of Vioxx, where the company hid the fatal side effects of the drug from the scientific community, resulting in the deaths of 3,468 Vioxx recipients, mostly from cardiac arrest. In 2010, the company agreed to a US$4.85 billion settlement and appointed two independent committees and a chief medical officer (CMO) to monitor the safety of its drug development process. In this instance, Merck’s conduct was unethical and in violation of the scientific principles of data collection, analysis, and interpretation.

Ethics are only moral distinctions between right and wrong, so what is unethical may not necessarily be illegal. If a scientist’s conduct falls within the grey zone between ethics and law, they may not be culpable in the eyes of the law, but may still face severe damage to their professional reputation, lose their job on grounds of professional misconduct, and be ostracised by the scientific community. Since these ethical norms may vary from one society to another, here we refer to ethical standards as applied to scientific research in Western countries.

Ethical Principles in scientific research

Some of the expected tenets of ethical behaviour that are widely accepted within the scientific community are as follows:

Voluntary participation and harmlessness. Subjects in a research project must be aware that their participation in the study is voluntary, that they have the freedom to withdraw from the study at any time without any unfavourable consequences, and they will not be harmed as a result of their participation or non-participation in the project. One of the most flagrant violations of the voluntary participation principle is the forced medical experiments conducted by Nazi researchers on prisoners of war during World War II, as documented in the post-War Nuremberg Trials—these experiments also originated the term ‘crimes against humanity’. Lesser known violations include the Tuskegee syphilis experiments conducted by the U.S. Public Health Service from 1932–1972, in which nearly 400 impoverished African‑American men suffering from syphilis were denied penicillin even after it was accepted as an effective treatment for syphilis. Instead, subjects were presented with false treatments such as spinal taps. Even if subjects face no mortal threat, they should not be subjected to personal agony as a result of their participation. In 1971, psychologist Philip Zimbardo created the Stanford Prison Experiment, where Stanford students recruited as subjects were randomly assigned roles such as prisoners or guards. When it became evident that student prisoners were suffering psychological damage as a result of their mock incarceration, and student guards were exhibiting sadism that would later challenge their own self-image, the experiment was terminated.

If an instructor asks their students to fill out a questionnaire and informs them that their participation is voluntary, students should not fear that their non-participation may hurt their grade in class in any way. For instance, it in unethical to provide bonus points for participation and no bonus points for non-participation, because it places non-participants at a distinct disadvantage. To avoid such circumstances, the instructor could provide an alternate task for non-participants so that they can recoup the bonus points without participating in the research study, or by providing bonus points to everyone irrespective of their participation or non-participation. Furthermore, all participants must receive and sign an Informed Consent form that clearly describes their right to refuse participation, as well as their right to withdraw, before their responses in the study can be recorded. In a medical study, this form must also specify any possible risks to subjects from their participation. For subjects under the age of 18, this form must be signed by their parent or legal guardian. Researchers must retain these informed consent forms for a period of time (often three years) after the completion of the data collection process in order comply with the norms of scientific conduct in their discipline or workplace.

Anonymity and confidentiality. To protect subjects’ interests and future wellbeing, their identity must be protected in a scientific study. This is done using the dual principles of anonymity and confidentiality. Anonymity implies that the researcher or readers of the final research report or paper cannot identify a respondent by their response. An example of anonymity in scientific research is a postal survey in which no identification numbers are used to track who is responding to the survey and who is not. In studies of deviant or undesirable behaviours, such as drug use or illegal music downloading by students, truthful responses may not be obtained if subjects are not assured of anonymity. Further, anonymity assures that subjects are insulated from law enforcement or other authorities who may have an interest in identifying and tracking such subjects in the future.

In some research designs such as face-to-face interviews, anonymity is not possible. In other designs, such as a longitudinal field survey, anonymity is not desirable because it prevents the researcher from matching responses from the same subject at different points in time for longitudinal analysis. Under such circumstances, subjects should be guaranteed confidentiality , in which the researcher can identify a person’s responses, but promises not to divulge that person’s identify in any report, paper, or public forum. Confidentiality is a weaker form of protection than anonymity, because in most countries, researchers and their subjects do not enjoy the same professional confidential relationship privilege as is granted to lawyers and their clients. For instance, two years after the Exxon Valdez supertanker spilled ten million barrels of crude oil near the port of Valdez in Alaska, communities suffering economic and environmental damage commissioned a San Diego research firm to survey the affected households about increased psychological problems in their family. Because the cultural norms of many Native Americans made such public revelations particularly painful and difficult, respondents were assured their responses would be treated with confidentiality. However, when this evidence was presented in court, Exxon petitioned the court to subpoena the original survey questionnaires—with identifying information—in order to cross-examine respondents regarding answers they had given to interviewers under the protection of confidentiality, and their request was granted. Fortunately, the Exxon Valdez case was settled before the victims were forced to testify in open court, but the potential for similar violations of confidentiality still remains.

In another extreme case, Rik Scarce—a graduate student at Washington State University—was called before a grand jury to identify the animal rights activists he observed for his 1990 book, Eco ‑w arriors: Understanding the radical environmental movement . [2] In keeping with his ethical obligations as a member of the American Sociological Association, Scarce refused to answer grand jury questions, and was forced to spend 159 days at Spokane County Jail. To protect themselves from similar travails, researchers should remove any identifying information from documents and data files as soon as they are no longer necessary.

Disclosure. Usually, researchers are obliged to provide information about their study to potential subjects before data collection to help them decide whether or not they wish to participate. For instance, who is conducting the study, for what purpose, what outcomes are expected, and who will benefit from the results. However, in some cases, disclosing such information may potentially bias subjects’ responses. For instance, if the purpose of a study is to examine the extent to which subjects will abandon their own views to conform with ‘groupthink’, and they participate in an experiment where they listen to others’ opinions on a topic before voicing their own, then disclosing the study’s purpose before the experiment will likely sensitise subjects to the treatment. Under such circumstances, even if the study’s purpose cannot be revealed before the study, it should be revealed in a debriefing session immediately following the data collection process, with a list of potential risks or harm to participants during the experiment.

Analysis and reporting. Researchers also have ethical obligations to the scientific community on how data is analysed and reported in their study. Unexpected or negative findings should be disclosed in full, even if they cast some doubt on the research design or the findings. Similarly, many interesting relationships are discovered after a study is completed, by chance or data mining. It is unethical to present such findings as the product of deliberate design. In other words, hypotheses should not be designed in positivist research after the fact based on the results of data analysis, because the role of data in such research is to test hypotheses, and not build them. It is also unethical to ‘carve’ their data into different segments to prove or disprove their hypotheses of interest, or to generate multiple papers claiming different datasets. Misrepresenting questionable claims as valid based on partial, incomplete, or improper data analysis is also dishonest. Science progresses through openness and honesty, and researchers can best serve science and the scientific community by fully disclosing the problems with their research, so that they can save other researchers from similar problems.

Human Research Ethics Committees (HRECs)

Researchers conducting studies involving human participants in Australia are required to apply for ethics approval from institutional review boards called Human Research Ethics Committees (HRECs). HRECs review all research proposals involving human subjects to ensure they meet ethical standards and guidelines, including those laid out in the National statement on ethical conduct in human research 2007. [3] HREC approval processes generally require completing a structured application providing complete information about the proposed research project, the researchers (principal investigators), and details about how subjects’ rights will be protected. Data collection from subjects can only commence once the project has ethical clearance from the HREC.

Professional code of ethics

Most professional associations have established and published formal codes of conduct describing what constitutes acceptable professional behaviour for their members—for example the Association of Information Systems (AIS)’s Code of research conduct [4] which is summarised in Table 16.1.

The AIS Code of research conduct groups ethical violations into two categories:

Category I includes serious transgressions such as plagiarism and falsification of data, research procedures, or data analysis, which may lead to expulsion from the association, dismissal from employment, legal action, and fatal damage to professional reputation.

Category 2 includes less serious transgressions such as not respecting the rights of research subjects, misrepresenting the originality of research projects, and using data published by others without acknowledgement, which may lead to damage to professional reputation, sanctions from journals, and so forth.

The code also provides guidance on good research behaviours, what to do when ethical transgressions are detected (for both the transgressor and the victim), and the process to be followed by AIS in dealing with ethical violation cases. Though codes of ethics such as this have not completely eliminated unethical behaviour, they have certainly helped clarify the boundaries of ethical behaviour in the scientific community, and consequently, reduced instances of ethical transgressions.

An ethical controversy

Robert Allan ‘Laud’ Humphreys was an American sociologist and author, best known for his PhD thesis, Tearoom trade [5] — an ethnographic account of anonymous male homosexual encounters in public toilets in parks. Humphreys was intrigued by the fact that the majority of participants in ‘tearoom’ activities—also called ‘tea-rooming’ in American gay slang—were outwardly heterosexual men, who lived otherwise conventional family lives in their communities. Therefore, it was important to them to preserve their anonymity during tearoom visits.

Typically, tearoom encounters involved three people—the two males engaging in a sexual act and a lookout person called a ‘watchqueen’. Since homosexual sexual activity was criminalised in the United States at the time, the job of the watchqueen was to alert the men if police or other people were nearby, while deriving pleasure from watching the action as a voyeur. Because it was not otherwise possible to reach these subjects, Humphreys showed up at public toilets, masquerading as a watchqueen. As a participant-observer, Humphreys was able to conduct field observations for his thesis in the same way that he would in a study of political protests or any other sociological phenomenon.

Since participants were unwilling to disclose their identities or to be interviewed in the field, Humphreys wrote down their license plate numbers wherever possible, and tracked down their names and addresses using public databases. Then he visited these men at their homes, disguising himself to avoid recognition and announcing that he was conducting a survey, and collected personal data that was not otherwise available

Humphreys’ research generated considerable controversy within the scientific community. Many critics said that he should not have invaded others’ right to privacy in the name of science, while others were worried about his deceitful behaviour in leading participants to believe that he was only a watchqueen when he clearly had ulterior motives. Even those who deemed observing tearoom activity acceptable because the participants used public facilities thought the follow-up survey in participants’ homes was unethical, not only because it was conducted under false pretences, but because of the way Humphreys obtained their home addresses, and because he did not seek informed consent. A few researchers justified Humphrey’s approach, claiming that this was an important sociological phenomenon worth investigating, that there was no other way to collect this data, and that the deceit was harmless, since Humphreys did not disclose his subjects’ identities to anyone. This controversy was never resolved, and it is still hotly debated today in classes and forums on research ethics.

• Ethics. (n.d.). In Macquarie dictionary online . Retrieved from https://www-macquariedictionary-com-au.ezproxy.usq.edu.au/features/word/search/?word=ethics&search_word_type=Dictionary. ↵
• Scarce, R. (1990). Eco-warriors: Understanding the radical environmental movement . Chicago: The Noble Press, Inc. ↵
• Australian Government, National Health and Medical Research Council. (2018). National statement on ethical conduct in human research 2007 . Retrieved from https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research ↵
• Association of Information Systems. (2014). Code of research conduct . Retrieved from https://aisnet.org/page/AdmBullCResearchCond ↵
• Humphreys, L. (1970). Tearoom trade: A study of homosexual encounters in public places . Chicago: Aldine Publishing Co. ↵

Social Science Research: Principles, Methods and Practices (Revised edition) Copyright © 2019 by Anol Bhattacherjee is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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Your partner for better health, research ethics: definition, principles and advantages.

October 13, 2020 Kusum Wagle Epidemiology 0

Table of Contents

What is Research Ethics?

• Ethics are the set of rules that govern our expectations of our own and others’ behavior.
• Research ethics are the set of ethical guidelines that guides us on how scientific research should be conducted and disseminated.
• Research ethics govern the standards of conduct for scientific researchers It is the guideline for responsibly conducting the research.
• Research that implicates human subjects or contributors rears distinctive and multifaceted ethical, legitimate, communal and administrative concerns.
• Research ethics is unambiguously concerned in the examination of ethical issues that are upraised when individuals are involved as participants in the study.
• Research ethics committee/Institutional Review Board (IRB) reviews whether the research is ethical enough or not to protect the rights, dignity and welfare of the respondents.

Objectives of Research Ethics:

• The first and comprehensive objective – to guard/protect human participants, their dignity, rights and welfare .
• The second objective – to make sure that research is directed in a manner that assists welfares of persons, groups and/or civilization as a whole.
• The third objective – to inspect particular research events and schemes for their ethical reliability, considering issues such as the controlling risk, protection of privacy and the progression of informed consent.

Principles of Research Ethics:

The general principles of research ethics are:

Broad categorization of principles of research ethics:.

Broadly categorizing, there are mainly five principles of research ethics:

1. MINIMIZING THE RISK OF HARM

It is necessary to minimize any sort of harm to the participants. There are a number of forms of harm that participants can be exposed to. They are:

• Bodily harm to contributors.
• Psychological agony and embarrassment.
• Social drawback.
• Violation of participant’s confidentiality and privacy.

In order to minimize the risk of harm, the researcher/data collector should:

• Obtain  informed consent from participants.
• Protecting anonymity and confidentiality of participants.
• Avoiding  misleading practices when planning research.
• Providing participants with the  right to withdraw .

2. OBTAINING INFORMED CONSENT 

One of the fundamentals of research ethics is the notion of  informed consent .

Informed consent means that a person knowingly, voluntarily and intelligently gives consent to participate in a research.

Informed consent means that the participants should be well-informed about the:

• Introduction and objective of the research
• Purpose of the discussion
• Anticipated advantages, benefits/harm from the research (if any)
• Use of research
• Their role in research
• Methods which will be used to protect anonymity and confidentiality of the participant
• Freedom to not answer any question/withdraw from the research
• Who to contact if the participant need additional information about the research

3. PROTECTING ANONYMITY AND CONFIDENTIALITY

Protecting the  anonymity  and  confidentiality  of research participants is an additionally applied constituent of research ethics.

Protecting anonymity: It means keeping the participant anonymous. It involves not revealing the name, caste or any other information about the participants that may reveal his/her identity.

Maintaining confidentiality: It refers to ensuring that the information given by the participant are confidential and not shared with anyone, except the research team. It is also about keeping the information secretly from other people.

4. AVOIDING MISLEADING PRACTICES

• The researcher should avoid all the deceptive and misleading practices that might misinform the respondent.
• It includes avoiding all the activities like communicating wrong messages, giving false assurance, giving false information etc.

5. PROVIDING THE RIGHT TO WITHDRAW

• Participants have to have the right to withdraw at any point of the research.
• When any respondent decides on to withdraw from the research, they should not be  stressed or  forced  in any manner to try to discontinue them from withdrawing.

Apart from the above-mentioned ethics, other ethical aspects things that must be considered while doing research are:

Protection of vulnerable groups of people:

• Vulnerability is one distinctive feature of people incapable to protect their moralities and wellbeing. Vulnerable groups comprise captive populations (detainees, established, students, etc.), mentally ill persons, and aged people, children, critically ill or dying, poor, with learning incapacities, sedated or insensible.
• Their participation in research can be endorsed to their incapability to give an informed consent and to the need for their further safety and sensitivity from the research/researcher as they are in a greater risk of being betrayed, exposed or forced to participate.

  Skills of the researcher:

• Researchers should have the basic skills and familiarity for the specific study to be carried out and be conscious of the bounds of personal competence in research.
• Any lack of knowledge in the area under research must be clearly specified.
• Inexperienced researchers should work under qualified supervision that has to be revised by an ethics commission.

Advantages of Research Ethics:

• Research ethics promote the aims of research.
• It increases trust among the researcher and the respondent.
• It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants.
• Researchers can be held accountable and answerable for their actions.
• Ethics promote social and moral values.
• Promote s the  ambitions of research, such as understanding, veracity, and dodging of error.
• Ethical standards uphold the  values that are vital to cooperative work , such as belief, answerability, mutual respect, and impartiality.
• Ethical norms in research also aid to construct  public upkeep for research. People are more likely to trust a research project if they can trust the worth and reliability of research.

Limitations of Research Ethics:

For subjects:

• Possibilities to physical integrity, containing those linked with experimental drugs and dealings and with other involvements that will be used in the study (e.g. measures used to observe research participants, such as blood sampling, X-rays or lumbar punctures).
• Psychological risks: for example, a questionnaire may perhaps signify a risk if it fears traumatic events or happenings that are especially traumatic.
• Social, legal and economic risks : for example, if personal information collected during a study is unintentionally released, participants might face a threat of judgment and stigmatization.
• Certain tribal or inhabitant groups may possibly suffer from discrimination or stigmatization, burdens because of research, typically if associates of those groups are recognized as having a greater-than-usual risk of devouring a specific disease.
• The research may perhaps have an influence on the prevailing health system: for example, human and financial capitals dedicated to research may distract attention from other demanding health care necessities in the community.

How can we ensure ethics at different steps of research?

The following process helps to ensure ethics at different steps of research:

• Collect the facts and talk over intellectual belongings openly
• Outline the ethical matters
• Detect the affected parties (stakeholders)
• Ascertain the forfeits
• Recognize the responsibilities (principles, rights, justice)
• Contemplate your personality and truthfulness
• Deliberate innovatively about possible actions
• Respect privacy and confidentiality
• Resolve on the appropriate ethical action and be willing to deal with divergent point of view.

References and For More Information:

http://dissertation.laerd.com/principles-of-research-ethics.php

https://researchethics.ca/what-is-research-ethics/

https://www.who.int/ethics/Ethics_basic_concepts_ENG.pdf

https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm

https://research.ku.edu/sites/research.ku.edu/files/docs/EESE_EthicalDecisionmakingFramework.pdf

https://www.who.int/ethics/research/en/

https://www.ufrgs.br/bioetica/cioms2008.pdf

https://www.who.int/ethics/research/en/#:~:text=WHO%20Research%20Ethics%20Review%20Committee,financially%20or%20technically%20by%20WHO .

https://www.who.int/reproductivehealth/topics/ethics/review_bodies_guide_serg/en/

https://www.who.int/ethics/indigenous_peoples/en/index13.html

https://www.who.int/bulletin/archives/80(2)114.pdf

https://www.who.int/about/ethics

https://www.slideshare.net/uqudent/introduction-to-research-ethics

https://libguides.library.cityu.edu.hk/researchmethods/ethics#:~:text=Methods%20by%20Subject-,What%20is%20Research%20Ethics%3F,ensure%20a%20high%20ethical%20standard .

https://www.apa.org/monitor/jan03/principles

https://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.php?aid=3485

https://www.skillsyouneed.com/learn/research-ethics.html

• advantages of research ethics
• difference between confidentiality and anonymity in research
• minimizing the risk of harm in research
• obtaining informed consent in research
• principles of research ethics
• PROTECTING ANONYMITY AND CONFIDENTIALITY
• what are the advantages of research ethics
• what are the limitations of research ethics
• what are the principles of research ethics
• what is obtaining informed consent in research
• what is research ethics
• what is right to withdraw in research
• what is ROTECTING ANONYMITY AND CONFIDENTIALITY in research

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• Indian J Psychiatry
• v.55(1); Jan-Mar 2013

Ethics in medical research: General principles with special reference to psychiatry research

Ajit avasthi.

Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Abhishek Ghosh

Sidharth sarkar, sandeep grover.

Ethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them. Ethics in medical research deals with the conflicts of interest across various levels. Guidelines have been proposed for standardized ethical practice throughout the globe. The four fundamental principles of ethics which are being underscored are autonomy, non-maleficence, beneficence, and justice. Some special ethical issues have particular relevance to psychiatric research arising primarily from the specific vulnerabilities of those with mental illness and the risks posed by some research methodologies. Accordingly, sensitivity is required in the design of psychiatric research. It is suggested that though the value of published guidelines and the help that may be available from research ethics committees is quite great, the primary responsibility for maintaining high standards of practice in research rests with research workers themselves.

INTRODUCTION

The word “ethics” is derived from the Greek word, ethos, which means custom or character. Ethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them.[ 1 ] It deals with the choices we make and our actions in relation to those choices. It deals with the choices made by both clinicians and patients and the duties and obligations of clinicians to their patients. Medical ethics also deals with the choices made by society, the distribution of resources, and access to health care, and the dilemmas arising from them.[ 2 ] An issue, mainly for the developing countries, has been the extent to which ethical principles are considered universal or as culturally relative – the universalist versus the pluralist view. The challenge to international research ethics is to apply universal ethical principles to biomedical research in a multicultural world with a multiplicity of health-care systems and considerable variation in standards of health care.[ 3 ]

History is unfortunately peppered with stories of abuse carried out in the name of medical research. The most dreadful of all atrocities was possibly conducted by Nazi doctors who used convicts for human experimentation. The discovery of these experiments stunned the whole world which led to the formulation of Nuremberg code[ 4 ] to prevent recurrence of such episodes. It was the first international code for ethics in clinical research laying down the guidelines for research on human subjects. It laid down 10 clear principles to be followed by researchers and made voluntary consent essential, allowed subjects to withdraw from the experimentation at any time, banned experiments that could result in major injury or death of the subjects, and made mandatory to have preclinical data before experimenting on humans. Even Nuremberg code failed to terminate unethical research practices. Eventually a set of guidelines was adopted by the 18 th World Medical Association (WMA)[ 5 ] General Assembly, which was called the Declaration of Helsinki. It contained 32 principles, which stress on informed consent, confidentiality of data, vulnerable population, and requirement of a protocol, including the scientific reasons of the study, to be reviewed by the ethics committee. Though Declaration of Helsinki had created a stir in the medical community, medical atrocities continued. The malpractice in the Tuskegee Syphilis Study in the US was possibly the next eye opener which ushered the Belmont Report[ 6 ] in 1979 and laid the foundation for regulations regarding ethics and human subjects’ research in the US. With the increasing interest of pharmaceutical industries in carrying out research experiments in the developing and the underdeveloped countries, the Council for International Organizations of Medical Sciences (CIOMS)[ 3 ] in association with World Health Organization (WHO) developed “International Ethical Guidelines for Biomedical Research Involving Human Subjects” in 1982.

CARDINAL PRINCIPLES OF ETHICS IN RESEARCH

The four principles of Beauchamp and Childress – autonomy, non-maleficence, beneficence, and justice – have been extremely influential in the field of medical ethics, and are fundamental for understanding the current approach to ethical assessment in health care. Respect for autonomy stands for acting intentionally after being given sufficient information and time to understand the information. Beneficence is directed to promote the well-being of patients and society. On the other hand, non-maleficence implies first do no harm which can be achieved by careful decision making and having adequate training. Justice deals with the equitable distribution of social benefits.[ 7 , 8 ]

MEDICAL RESEARCH – DEFINITION, TYPES, AND ISSUES

The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health. Those who support the need for research argue that no new treatment should be offered outside the context of a controlled trial, so that treatments’ effectiveness and efficacy can be measured ab initio , not only for the sake of the patients currently receiving it but also for all future patients. Research involving human subjects includes:[ 1 , 9 ]

• Studies of a physiological, biochemical, or pathological process, or of the response to a specific intervention – whether physical, chemical, or psychological – in healthy subjects or patients;
• Controlled trials of diagnostic, preventive, or therapeutic measures in larger groups of persons, designed to demonstrate a specific generalizable response to these measures against a background of individual biological variation;
• Studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and
• Studies concerning human health-related behavior in a variety of circumstances and environments.

Conflicts of interest are inherent to the majority of relationships among individuals and of those with companies and institutions and, certainly, research involving human beings is no exception. In relation to clinical research, conflicts of interest occur at different levels and usually permeate through various lines (e.g., in the pharmaceutical industry, about their decisions to invest and develop new products, especially vaccines and drugs, and also in relation to marketing of these products). Among the investigators, the conflicts may be related to the financial gains to participate in pharmacy sponsored trials, or to the expected academic career boost attained with the publication of the results of the trials and also to personal interests such as the financial support for trips to international conferences.[ 10 ]

Therefore, medical research which is absolutely necessary and fundamental for acquiring and propagating worthwhile novel knowledge is equally controversial because of the conflicts of interest of the researchers or the sponsors. Both universal and regional guidelines have been proposed to strike a balance between these two opposing interests and to ensure standardized ethical research.

PRINCIPLES OF ETHICS IN MEDICAL RESEARCH

Principles of essentiality.

Refers to whether the research is considered to be absolutely essential after a due consideration of the existing scientific knowledge in the proposed area of research. This should be scrutinized by an independent and responsible body of persons who, after careful consideration, come to the conclusion that the research is likely to benefit the humanity or environment.[ 11 ]

Principles of voluntariness, informed consent, and community agreement

Research participants should be fully apprised of the research and the associated risks and benefits. The participants should be informed of the right to abstain from the research or withdraw consent at any time. Where research entails treating any community, the principles of voluntariness and informed consent apply to the community as a whole and to each individual member. In case a person is incapable of giving consent, a legally acceptable guardian should give the informed consent.

Principles of non-exploitation

The participants should be fully apprised of all the possible dangers that may arise during the research so that they can appreciate all the physical and psychological risks. Each research should include an in-built mechanism for compensation for the human participants either through insurance cover or by any other appropriate means to cover foreseeable and unforeseeable risks, and provide remedial action and comprehensive aftercare.

Principles of privacy and confidentiality

The identity and records of the participants are as far as possible kept confidential (except when required for legal reasons). This is to avoid any form of hardship, discrimination or stigmatization as a consequence of having participated in the research.

Principles of precaution and risk minimization

Due care and caution should be taken at all stages of the research and experiment to ensure that the research participant and those affected by it including the community are put to the minimum risk, suffer from no known irreversible adverse effects, and generally, benefit from the research or experiment. There should be a plan for interim reviews to detect whether any intervention arm (active or control) is associated with increased risks, so that undue harms are avoided by stopping the research.

Principles of professional competence

Research should be conducted by competent and qualified persons who act with total integrity and impartiality and who have been made aware of the ethical considerations to be borne in mind in respect of such research or experiment.

Principles of accountability and transparency

The research or experiment should be conducted in a fair, honest, impartial, and transparent manner after full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist. Full and complete records of the research should be retained for such reasonable period as may be prescribed or considered necessary for the purposes of post-research monitoring, evaluation of the research, conducting further research, and scrutiny by the appropriate legal and administrative authority, if necessary.

Principles of the maximization of the public interest and of distributive justice

The research or experiment and its subsequent application should be conducted and used to benefit all human kind (and not just those who are socially better off), in particular, the research participants themselves and or the community from which they are drawn.

Principles of public domain

The research findings should be brought into the public domain so that its results are generally made known through scientific and other publications. This would help in consolidating the scientific knowledge base of the field being studied and would prevent the undue replication of studies which pose risks to some subjects.

Principles of totality of responsibility

Professional and moral responsibility should be observed, for the due observance of all the principles, guidelines, or prescriptions of those directly or indirectly connected with the medical research. This extends to the institutes where this research is carried out, as well as the sponsors of the research. The research should be duly monitored and constantly subject to review and remedial action at all stages.[ 11 ]

SPECIAL REFERENCE TO PSYCHIATRY RESEARCH

Neuropsychiatric disorders are highly prevalent conditions with significant morbidity, yet only modestly effective treatments are available. The suffering and loss caused by these diseases call for the development of truly innovative interventions. Testing such innovative approaches can carry risks of significant harm[ 12 ] even while raising hopes for future benefits.[ 13 ] Furthermore, the very nature of many neuropsychiatric disorders creates ethical complexity because many persons with such disorders have impaired cognition or emotion. If a patient's impairment is severe enough, he or she will be incompetent to give informed consent for research.[ 14 ] In our society, surrogate or proxy consent-based research remains an area of unsettled policy. Finally, at a more speculative level, interventions that alter behavior, or even knowledge that can predict or explain behaviors, can challenge traditional norms of social regulation and interaction.[ 15 ]

Methods for solving these dilemmas have included the development of more objective rules to guide the practitioner, such as utilitarianism and deontology. Deontological approaches possibly cannot resolve moral conflicts, and so the psychiatrist is “denied an available remedy.” Utilitarianism is seen by the authors as too difficult to calculate benefits and risks, and demands an impartiality that clinicians would find difficult to achieve. Both deontology and utilitarianism, a respect for patient autonomy, and utility, a measurement of consequences, are seen as theories that do not help clinicians in practice. This is particularly the case in conflict situations as in psychiatric research.[ 16 ] Therefore, research in psychiatry demands a special attention.

Issues in relation to competence and consent

Participation in research usually involves some degree of risk, discomfort, or sacrifice of the personal care that patients enjoy when they receive ordinary treatment.[ 17 ] Ordinarily, we allow research subjects to incur these discomforts or sacrifice personal care because we believe that people have the right to run certain risks for rewards that seem to them worthwhile. These rewards may include the pride that comes from altruistic behavior, the hope that they themselves might benefit from the results of the study at some point in the future, and the more immediate possibility that they may have access through the study to assessment techniques or therapeutic approaches that would not otherwise be available to them. But when subjects’ capacities to make decisions are impaired, they may materially misconstrue the situation into which they are entering.[ 18 ]

To resolve these conflicts, proposals have been made that range from banning certain types of research with psychiatric patients to requiring independent evaluation of the capacities of potential subjects, to appointing representatives to remove subjects from studies when the risk–benefit ratio appears to be swinging against them.[ 19 , 20 ]

As per WMA guidelines for ethical research, “In research involving subjects who are mentally incapable of giving consent, the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for their inability to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative” (WMA 2008; clause 29). An additional caveat in clause 28 reads, “When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject's dissent should be respected.”[ 21 ] It should always be remembered that impairments exist on a spectrum, and some degree of dysfunction is not incompatible with competent decision making. Thus, although the presence of cognitive and related impairments in schizophrenia, for example, warrants concern about subjects’ abilities to decide whether to enter a research project, by no means does it call for the exclusion of all persons with schizophrenia from investigational studies. Individuals who have severe mental disorder and lack adequate decision-making capacity may improve significantly with educational remediation.[ 22 , 23 ] Patients can be given information through conversation, lectures, pamphlets, articles, medication groups, instruction sheets, books and videotapes, consent forms, and interactive videodiscs. Repeated disclosure of information is another technique which can be followed.[ 24 ]

However, systematic evaluation, even in non-psychiatric populations and in high-income countries, has shown that participants in randomized trials recall information poorly, are not often aware that placebos form one arm of treatment, demonstrate inadequate comprehension of the process of chance in treatment allocation, understand and use only a proportion of what is presented in consent forms, do not really understand the issue of equipoise, and participate not for altruistic reasons but because they expect some improvement by participation.[ 25 ] Cognitive dysfunction and the symptoms shown to be associated with impaired decisional capacity are not unique to schizophrenia and may occur with many other forms of illness.[ 26 ] Furthermore, studies have also shown that many people with schizophrenia are able to give informed consent and retain related information across time. So, diagnosis of mental illness itself does not disqualify a person to enter into a research as competence of decision making is case specific and variable across the time.

Issues in relation to confidentiality

Patients, health-care providers, and patient advocacy organizations have expressed increasing concern about the confidentiality of clinical information stored in large computerized databases.[ 27 – 30 ] The accumulation of ever-larger stockpiles of sensitive information raises reasonable concerns about inappropriate access and unauthorized disclosure. Given the stigma often attached to psychiatric disorders and psychiatric treatment, confidentiality of information on mental health and substance abuse treatment is especially critical. A few occurrences of inappropriate use or disclosure of clinical information have been well publicized.[ 28 , 30 ]

Firstly, continued research access to population-based records data is essential to protecting the rights and interests of people with psychiatric illness. Investigators conducting any such research should take all possible steps to limit access to confidential information, minimize risks of disclosure, and (when possible) obtain informed consent for research use of clinical data. The most effective strategy for preventing disclosure of confidential information is to remove all identifying information from medical records data before any research use.[ 31 ] Secondly, when potential research uses are anticipated at the time of data collection, those collecting clinical information should be obligated to advise patients regarding possible research use. However, obtaining individual informed consent for each specific research use is impossible or extremely impractical.[ 32 ] Lastly, research intended to increase public domain medical knowledge should be clearly differentiated from proprietary activities. If legitimate public domain research activities were clearly distinguished from other uses of large clinical databases, efforts to regulate storage and disclosure of clinical data could concentrate on the activities that are now largely unregulated.[ 33 ]

However, advances in mental health science promise great benefits for those who suffer, or will come to suffer, from mental illness and, in some cases, for research subjects themselves. While persons with mental illness may be vulnerable in several ways, research regulations that focus primarily on their vulnerabilities and deficits could encourage and possibly exacerbate the stigmatization already felt by this population.[ 34 , 35 ] Further, it may be unjust to exclude, by overly restrictive regulation, those people with mental illness who could benefit from research participation. An ethically appropriate framework for psychiatric research ethics balances rigorous protections for human subjects with recognition of the enormous social and individual benefits arising from well-designed and ethically conducted scientific research.[ 36 – 38 ] How this balance is struck has important implications for research ethics generally, particularly for research involving vulnerable persons.

Though a number of ethical guidelines have been formulated for clinical research, malpractice is still widely acknowledged. It could be understood by the fact that ethical guidelines in many countries like India are just the recommendations and not a law. For proper enforcement, guidelines should be made a part of the law as has been done in the US and some other countries of the world.[ 39 ] We need better research, and research done for the right reasons. The second intriguing issue is the cross-cultural applicability of ethical guidelines.[ 40 ] In this era of advanced globalization, the problems of medical ethics can no longer be viewed only from the perspective of wealthy countries. Global bioethics seeks to identify key ethical problems faced by the world's 6 billion inhabitants and envisages solutions that transcend national borders and cultures. The relevance of global bioethics is obvious with respect to international research ethics (as evidenced by the controversy over changes to the Declaration of Helsinki), global vaccine initiatives, or global health equity.[ 41 ] Last but not the least; doctors are specially trained to be good clinicians but are seldom taught even the fundamentals of ethical clinical research. The post-graduate dissertation or the PhD thesis is a precious opportunity to train tomorrow's investigators in the elements of ethical clinical research.[ 42 ] The attributes of a clinical researcher like truthfulness and accountability toward integrity are expected to propagate standardized ethical practice.

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Conflict of Interest: None declared

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Principles of research ethics

There are a number of ethical principles that should be taken into account when performing undergraduate and master's level dissertation research. At the core, these ethical principles stress the need to (a) do good (known as beneficence ) and (b) do no harm (known as non-malfeasance ). In practice, these ethical principles mean that as a researcher, you need to: (a) obtain informed consent from potential research participants; (b) minimise the risk of harm to participants; (c) protect their anonymity and confidentiality ; (d) avoid using deceptive practices ; and (e) give participants the right to withdraw from your research. This article discusses these five ethical principles and their practical implications when carrying out dissertation research.

When you look at these five basic ethical principles, it may appear obvious that your dissertation should include these. However, there are many instances where it is not possible or desirable to obtain informed consent from research participants. Similarly, there may be instances where you seek permission from participants not to protect their anonymity . More often than not, such choices should reflect the research strategy that you adopt to guide your dissertation.

Broadly speaking, your dissertation research should not only aim to do good (i.e., beneficence ), but also avoid doing any harm (i.e., non-malfeasance ). Whilst ethical requirements in research can vary across countries, these are the basic principles of research ethics. This is important not only for ethical reasons , but also practical ones, since a failure to meet such basic principles may lead to your research being (a) criticised, potentially leading to a lower mark, and/or (b) rejected by your supervisor or Ethics Committee , costing you valuable time. In the sections that follow, we discuss the five of the main practical ethical principles that stem from these basic principles. Each of these basic principles of research ethics is discussed in turn:

• PRINCIPLE ONE: Minimising the risk of harm
• PRINCIPLE TWO: Obtaining informed consent
• PRINCIPLE THREE: Protecting anonymity and confidentiality
• PRINCIPLE FOUR: Avoiding deceptive practices
• PRINCIPLE FIVE: Providing the right to withdraw

PRINCIPLE ONE Minimising the risk of harm

Dissertation research should not harm participants. Where there is the possibility that participants could be harmed or put in a position of discomfort, there must be strong justifications for this. Such scenarios will also require (a) additional planning to illustrate how participant harm (or discomfort) will be reduced, (b) informed consent, and (c) detailed debriefing.

There are a number of types of harm that participants can be subjected to. These include:

Physical harm to participants.

Psychological distress and discomfort.

Social disadvantage.

Harm to participants? financial status.

An invasion of participants? privacy and anonymity.

Typically, it is not harm that we need to think about since a researcher does not intentionally go out to cause harm. Rather, it is the risk of harm that you should try to minimise. In order to minimising the risk of harm you should think about:

Obtaining informed consent from participants.

Protecting the anonymity and confidentiality of participants.

Avoiding deceptive practices when designing your research.

Providing participants with the right to withdraw from your research at any time.

We discuss each of these ethical principles in the sections that follow, explaining (a) what they mean and (b) instances where they should (and should not) be followed.

PRINCIPLE TWO Obtaining informed consent

One of the foundations of research ethics is the idea of informed consent . Simply put, informed consent means that participants should understand that (a) they are taking part in research and (b) what the research requires of them. Such information may include the purpose of the research, the methods being used, the possible outcomes of the research, as well as associated demands, discomforts, inconveniences and risks that the participants may face. Whilst is it not possible to know exactly what information a potential participant would (or would not) want to know, you should aim not to leave out any material information ; that is, information that you feel would influence whether consent would (or would not) be granted.

Another component of informed consent is the principle that participants should be volunteers , taking part without having been coerced and deceived . Where informed consent cannot be obtained from participants, you must explain why this is the case. You should also be aware that there are instances informed consent is not necessarily needed or needs to be relaxed. These include certain educational , organisational and naturalistic research settings. We discuss these in more detail under the section: Avoiding deceptive practices .

PRINCIPLE THREE Protecting anonymity and confidentiality

Protecting the anonymity and confidentiality of research participants is another practical component of research ethics. After all, participants will typically only be willing to volunteer information, especially information of a private or sensitive nature, if the researcher agrees to hold such information in confidence. Whilst it is possible that research participants may be hurt in some way if the data collection methods used are somehow insensitive , there is perhaps a greater danger that harm can be caused once data has been collected. This occurs when data is not treated confidentially, whether in terms of the storage of data, its analysis, or during the publication process (i.e., when submitting your dissertation to be marked). However, this does not mean that all data collected from research participants needs to be kept confidential or anonymous. It may be possible to disclose the identity and views of individuals at various stages of the research process (from data collection through to publication of your dissertation). Nonetheless, permissions should be sought before such confidential information is disclosed.

An alternative is to remove identifiers (e.g., vernacular terms, names, geographical cues, etc.) or provide proxies when writing up. However, such a stripping of identifiable information may not always be possible to anticipate at the outset of your dissertation when thinking about issues of research ethics. This is not only a consideration for dissertations following a qualitative research design , but also a quantitative research design [for more information, see the article: Research strategy and research ethics ].

For example: Imagine that your dissertation used a quantitative research design and a survey as your main research method . In the process of analysing your data, it is possible that when examining relationships between variables (i.e., questions in your survey), a person's identity and responses could be inferred. For instance, imagine that you were comparing responses amongst employees within an organisation based on specific age groups. There may only be a small group (or just one employee) within a particular age group (e.g., over 70 years old), which could enable others to identify the responses of this individual (or small group of employees).

Therefore, you need to consider ways of overcoming such problems, such as: (a) aggregating data in tables and (b) setting rules that ensure a minimum number of units are present before data/information can be presented.

A further alternative is to seek permission for access to data and analysis to be restricted to the published material, perhaps only allowing it to be viewed by those individuals marking your work. If the work is later published, adjustments would then need to be made to protect the confidentiality of participants.

There are also a wide range of potential legal protections that may affect what research you can and cannot perform, how you must treated the data of research participants, and so forth. In other words, you don?t simply have a duty to protect the data you collect from participants; you may also have (in some cases) a legal responsibility to do so. Since this varies from country-to-country, you should ask your dissertation supervisor or Ethics Committee for advice (or a legal professional).

PRINCIPLE FOUR Avoiding deceptive practices

At first sight, deceptive practices fly in the face of informed consent . After all, how can participants know (a) that they are taking part in research and (b) what the research requires of them if they are being deceived ? This is part of what makes the use of deceptive practices controversial. For this reason, in most circumstances, dissertation research should avoid any kinds of deceptive practices. However, this is not always the case.

Deception is sometimes a necessary component of covert research , which can be justified in some cases. Covert research reflects research where (a) the identity of the observer and/or (b) the purpose of the research is not known to participants. Cases where you may choose to engage in covert research may include instances where:

It is not feasible to let everyone in a particular research setting know what you are doing.

Overt observation or knowledge of the purpose of the research may alter the particular phenomenon that is being studied.

Let's take each of these in turn:

It is not feasible to let everyone in a particular research setting know what you are doing

By feasibility , we are not talking about the cost of doing research. Instead, we mean that it is not practically possible to let everyone in a particular research setting know what you are doing. This is most likely to be the case where research involves observation , rather than direct contact with participants, especially in a public or online setting . There are a number of obvious instances where this may be the case:

Observing what users are doing in an Internet chat room.

Observing individuals going about their business (e.g., shopping, going to work, etc.).

Clearly, in these cases, where individuals are coming and going, it may simply be impossible to let everyone known what you are doing. You may not be intentionally trying to engage in deceptive practices , but clearly participants are not giving you their informed consent .

Overt observation or knowledge of the purpose of the research may alter the particular phenomenon that is being studied

Where observations or a participants? knowledge of the true purpose of the research have the potential to alter the particular phenomenon that you are interested in, this is a major concern in terms of the quality of your findings .

Therefore, when you think about whether to engage in covert research and possibly deceptive practices , you should think about the extent to which this could be beneficial in your dissertation, not research in general; that is, everything from the research paradigm that guides your dissertation through to the data analysis techniques you choose affect issues of research ethics in your dissertation [see the article: Research strategy and research ethics ].

Imagine some of the following scenarios where covert research may be considered justifiable:

You are conducting a piece of research looking at prejudice . Whilst participants are given a questionnaire to complete that measures their prejudice, it is not obvious from the questions that this is the case. Furthermore, participants are not told that the research is about prejudice because it is felt that this could alter their responses. After all, few people would be happy if other people thought they were prejudice. As a result, if participants knew that this is the purpose of the study, they may well provide responses that they think will make them appear less prejudice.

You are interested in understanding the organisational culture in a single firm. You feel that observation would be an appropriate research method in such a naturalistic setting . However, you feel that if employees knew that you were monitoring them, they may behave in a different way. Therefore, you may have received permission to go undercover or provide a story to explain why you are there, which is not the truth.

Whilst such covert research and deceptive practices, especially where used intentionally , can be viewed as controversial, it can be argued that they have a place in research.

PRINCIPLE FIVE Providing the right to withdraw

With the exception of those instances of covert observation where is not feasible to let everyone that is being observed know what you are doing, research participants should always have the right to withdraw from the research process. Furthermore, participants should have the right to withdraw at any stage in the research process. When a participant chooses to withdraw from the research process, they should not be pressured or coerced in any way to try and stop them from withdrawing.

If your supervisor and/or Ethics Committee expect you to complete an Ethics Consent Form , it is likely that you will have to let participants know that they have the right to withdraw at any time [see the article: Ethics consent form ].

Now that you have read these basic principles of research ethics , you may want to understand how the research strategy you have chosen affects your approach to research ethic s [see the article: Research strategy and research ethics ]. You will need to understand the impact of your research strategy on your approach to research ethics when writing up the Research Ethics section of your Research Strategy chapter (usually Chapter Three: Research Strategy ).

Research ethics guidance - ESRC

Our framework for research ethics helps you to consider ethics issues during the complete lifecycle of a project and includes information and guidelines on good research conduct and governance.

Our policy and guidelines for good research conduct

Find out about your responsibilities to carry out research to the highest scientific and ethical standards

Framework for research ethics

Find out about our principles, commitment, terms and conditions and when to contact us

Researchers and research teams

Our principles and expectations for research collaboration

What to expect as a research participant

Find out how researchers should treat you if you are participating in their research

Risk and benefit

Answers to commonly asked questions about risk and benefit

Answers to commonly asked questions about consent

Internet mediated research

Learn about the specific ethical considerations when using the internet and social media for research

Research with children and young people

Considerations when using children in research

Research with potentially vulnerable people

Considerations when using vulnerable people in research

International research

What should you consider if your research has an international dimension

Data requirements

Your responsibilities when gathering and sharing data

Research organisations and research ethics committees

Build and maintain appropriate structures and support for good practice

Ethics reviews

Ensure your ethical approach is properly reviewed

Ethics statement examples

Read ethics statements from successful applications

Useful resources

Useful links to ethical codes, forms and templates and guidance

This is the website for UKRI: our seven research councils, Research England and Innovate UK. Let us know if you have feedback or would like to help improve our online products and services .

AI ethics are ignoring children, say researchers

Researchers from the Oxford Martin Programme on Ethical Web and Data Architectures (EWADA), University of Oxford, have called for a more considered approach when embedding ethical principles in the development and governance of AI for children.

In a perspective paper published today in Nature Machine Intelligence , the authors highlight that although there is a growing consensus around what high-level AI ethical principles should look like, too little is known about how to effectively apply them in principle for children. The study mapped the global landscape of existing ethics guidelines for AI and identified four main challenges in adapting such principles for children's benefit:

• A lack of consideration for the developmental side of childhood, especially the complex and individual needs of children, age ranges, development stages, backgrounds, and characters.
• Minimal consideration for the role of guardians (e.g. parents) in childhood. For example, parents are often portrayed as having superior experience to children, when the digital world may need to reflect on this traditional role of parents.
• Too few child-centred evaluations that consider children's best interests and rights. Quantitative assessments are the norm when assessing issues like safety and safeguarding in AI systems, but these tend to fall short when considering factors like the developmental needs and long-term wellbeing of children.
• Absence of a coordinated, cross-sectoral, and cross-disciplinary approach to formulating ethical AI principles for children that are necessary to effect impactful practice changes.

The researchers also drew on real-life examples and experiences when identifying these challenges. They found that although AI is being used to keep children safe, typically by identifying inappropriate content online, there has been a lack of initiative to incorporate safeguarding principles into AI innovations including those supported by Large Language Models (LLMs). Such integration is crucial to prevent children from being exposed to biased content based on factors such as ethnicity, or to harmful content, especially for vulnerable groups, and the evaluation of such methods should go beyond mere quantitative metrics such as accuracy or precision. Through their partnership with the University of Bristol, the researchers are also designing tools to help children with ADHD, carefully considering their needs and designing interfaces to support their sharing of data with AI-related algorithms, in ways that are aligned with their daily routes, digital literacy skills, and need for simple yet effective interfaces.

In response to these challenges, the researchers recommended:

• increasing the involvement of key stakeholders, including parents and guardians, AI developers, and children themselves;
• providing more direct support for industry designers and developers of AI systems, especially by involving them more in the implementation of ethical AI principles;
• establishing legal and professional accountability mechanisms that are child-centred; and
• increasing multidisciplinary collaboration around a child-centred approach involving stakeholders in areas such as human-computer interaction, design, algorithms, policy guidance, data protection law, and education.

Dr Jun Zhao, Oxford Martin Fellow, Senior Researcher at the University's Department of Computer Science, and lead author of the paper, said:

"The incorporation of AI in children's lives and our society is inevitable. While there are increased debates about who should ensure technologies are responsible and ethical, a substantial proportion of such burdens falls on parents and children to navigate this complex landscape."

'This perspective article examined existing global AI ethics principles and identified crucial gaps and future development directions. These insights are critical for guiding our industries and policymakers. We hope this research will serve as a significant starting point for cross-sectoral collaborations in creating ethical AI technologies for children and global policy development in this space.'

The authors outlined several ethical AI principles that would especially need to be considered for children. They include ensuring fair, equal, and inclusive digital access, delivering transparency and accountability when developing AI systems, safeguarding privacy and preventing manipulation and exploitation, guaranteeing the safety of children, and creating age-appropriate systems while actively involving children in their development.

Professor Sir Nigel Shadbolt, co-author, Director of the EWADA Programme, Principal of Jesus College Oxford and a Professor of Computing Science at the Department of Computer Science, said:

"In an era of AI powered algorithms children deserve systems that meet their social, emotional, and cognitive needs. Our AI systems must be ethical and respectful at all stages of development, but this is especially critical during childhood."

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Story Source:

Materials provided by University of Oxford . Note: Content may be edited for style and length.

Journal Reference :

• Ge Wang, Jun Zhao, Max Van Kleek, Nigel Shadbolt. Challenges and opportunities in translating ethical AI principles into practice for children . Nature Machine Intelligence , 2024; 6 (3): 265 DOI: 10.1038/s42256-024-00805-x

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