2.4: Ethics in Research
- Page ID
- 225739
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\(\newcommand{\avec}{\mathbf a}\) \(\newcommand{\bvec}{\mathbf b}\) \(\newcommand{\cvec}{\mathbf c}\) \(\newcommand{\dvec}{\mathbf d}\) \(\newcommand{\dtil}{\widetilde{\mathbf d}}\) \(\newcommand{\evec}{\mathbf e}\) \(\newcommand{\fvec}{\mathbf f}\) \(\newcommand{\nvec}{\mathbf n}\) \(\newcommand{\pvec}{\mathbf p}\) \(\newcommand{\qvec}{\mathbf q}\) \(\newcommand{\svec}{\mathbf s}\) \(\newcommand{\tvec}{\mathbf t}\) \(\newcommand{\uvec}{\mathbf u}\) \(\newcommand{\vvec}{\mathbf v}\) \(\newcommand{\wvec}{\mathbf w}\) \(\newcommand{\xvec}{\mathbf x}\) \(\newcommand{\yvec}{\mathbf y}\) \(\newcommand{\zvec}{\mathbf z}\) \(\newcommand{\rvec}{\mathbf r}\) \(\newcommand{\mvec}{\mathbf m}\) \(\newcommand{\zerovec}{\mathbf 0}\) \(\newcommand{\onevec}{\mathbf 1}\) \(\newcommand{\real}{\mathbb R}\) \(\newcommand{\twovec}[2]{\left[\begin{array}{r}#1 \\ #2 \end{array}\right]}\) \(\newcommand{\ctwovec}[2]{\left[\begin{array}{c}#1 \\ #2 \end{array}\right]}\) \(\newcommand{\threevec}[3]{\left[\begin{array}{r}#1 \\ #2 \\ #3 \end{array}\right]}\) \(\newcommand{\cthreevec}[3]{\left[\begin{array}{c}#1 \\ #2 \\ #3 \end{array}\right]}\) \(\newcommand{\fourvec}[4]{\left[\begin{array}{r}#1 \\ #2 \\ #3 \\ #4 \end{array}\right]}\) \(\newcommand{\cfourvec}[4]{\left[\begin{array}{c}#1 \\ #2 \\ #3 \\ #4 \end{array}\right]}\) \(\newcommand{\fivevec}[5]{\left[\begin{array}{r}#1 \\ #2 \\ #3 \\ #4 \\ #5 \\ \end{array}\right]}\) \(\newcommand{\cfivevec}[5]{\left[\begin{array}{c}#1 \\ #2 \\ #3 \\ #4 \\ #5 \\ \end{array}\right]}\) \(\newcommand{\mattwo}[4]{\left[\begin{array}{rr}#1 \amp #2 \\ #3 \amp #4 \\ \end{array}\right]}\) \(\newcommand{\laspan}[1]{\text{Span}\{#1\}}\) \(\newcommand{\bcal}{\cal B}\) \(\newcommand{\ccal}{\cal C}\) \(\newcommand{\scal}{\cal S}\) \(\newcommand{\wcal}{\cal W}\) \(\newcommand{\ecal}{\cal E}\) \(\newcommand{\coords}[2]{\left\{#1\right\}_{#2}}\) \(\newcommand{\gray}[1]{\color{gray}{#1}}\) \(\newcommand{\lgray}[1]{\color{lightgray}{#1}}\) \(\newcommand{\rank}{\operatorname{rank}}\) \(\newcommand{\row}{\text{Row}}\) \(\newcommand{\col}{\text{Col}}\) \(\renewcommand{\row}{\text{Row}}\) \(\newcommand{\nul}{\text{Nul}}\) \(\newcommand{\var}{\text{Var}}\) \(\newcommand{\corr}{\text{corr}}\) \(\newcommand{\len}[1]{\left|#1\right|}\) \(\newcommand{\bbar}{\overline{\bvec}}\) \(\newcommand{\bhat}{\widehat{\bvec}}\) \(\newcommand{\bperp}{\bvec^\perp}\) \(\newcommand{\xhat}{\widehat{\xvec}}\) \(\newcommand{\vhat}{\widehat{\vvec}}\) \(\newcommand{\uhat}{\widehat{\uvec}}\) \(\newcommand{\what}{\widehat{\wvec}}\) \(\newcommand{\Sighat}{\widehat{\Sigma}}\) \(\newcommand{\lt}{<}\) \(\newcommand{\gt}{>}\) \(\newcommand{\amp}{&}\) \(\definecolor{fillinmathshade}{gray}{0.9}\)- Describe the historical development and key ethical principles of human research.
- Explain the role of Institutional Review Boards (IRBs) in approving, monitoring, and safeguarding research involving human participants.
- Identify potential risks, conflicts of interest, and safeguarding procedures that must be addressed in the research process.
- Recognize the importance of protecting vulnerable populations and ensuring equitable treatment and participation in research.
Ethics in Research
Once upon a time, research was like the Wild West - there were no rules, limits, or boundaries that researchers had to adhere to. As you can imagine, some researchers did some pretty unethical things.
The first code of principles was established in response to the horrors of WWII - the Nuremberg Code - which outlined principles such as informed consent, absence of coercion, and beneficence toward experimental subjects.
Institutional Review Board
It wasn't until 1979 that the National Commission Report started requiring all research to be reviewed by an Institutional Review Board (IRB). IRBs consist of individuals from an organization who are trained in proper research ethics and protocols, and who determine whether proposed research follows federal and institutional ethical guidelines.
Each institutional IRB has its own application, process, and timeline for reviewing and approving or disapproving research. If you decide to pursue research as part of your educational process or employment, you will be subject to its governing IRB.
Conflicts of Interest
The independence of research should be clear, and any conflicts of interest or biases should be explicitly disclosed. A conflict of interest arises where a researcher’s obligation to the institution or a funder to conduct research independently is likely to be compromised, or may appear to be compromised. This can be because they may:
- obtain a personal gain, or a gain to a member of their family or another person to whom they have a close personal relationship, arising from the research. This gain may be financial or otherwise, and/or,
- have commitments and obligations to another person or body that may appear to act as a potential influence over their independent conduct of the research.
There may be an appearance of conflict of interest even when no conflict actually exists. Researchers must disclose anything during the IRB process that others may perceive as a potential conflict of interest (City, 2024).
Respect for Persons
All research participants must participate voluntarily, free from coercion or undue influence, and their rights, dignity, and autonomy should be respected and protected appropriately.
An autonomous person is capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to the considered opinions and choices of autonomous persons, while refraining from obstructing their actions unless they are clearly detrimental to others.
By contrast, when a potential research participant lacks the capacity to make autonomous decisions, respect for persons requires that they be protected from harm. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated. Some people are in need of extensive protection, to the point of excluding them from research that poses a risk of harm (City, 2024).
Figure \(\PageIndex{1}\): Respect for persons needs to be taken into consideration in many different ways. Image is licensed CC BY-NC 4.0.
Informed Consent
Informed consent constitutes four criteria:
- Information disclosure is the process of providing essential research design/methods/protocols information to potential participants and empowers them to make a rational and informed decision about participation (Kadam, 2017)
- Competence refers to a participant's ability to understand the research design, methods, and protocols. Various factors, such as age, cognitive abilities, mental health, etc., can all impact a participant's decision-making capacity and should be taken into consideration as researchers work through the information disclosure process.
- Comprehension refers to a participant's ability to understand the associated risks, benefits, and significance of participating in the study, enabling them to make an informed decision. Researchers need to ensure that what they are communicating during the information disclosure process is being grasped and digested by the sample population. Competence also plays a role in how this information should be expressed.
- Voluntary refers to the participants' willingness to enter the research freely. This also serves as the basis for their right to discontinue participation at any time.
Confidentiality
Depending on the research being conducted, various methods may need to be used to preserve participant confidentiality.
One example is the researcher coding identities numerically. The master key, for which participant is identified by which number, should be kept in a safe and confidential location. What is reported, then, is the correlated identity code.
When submitting a research proposal, the principal investigator would have to detail what the process for maintaining confidentiality would look like.
Beneficence and non-maleficence
Research should be worthwhile and provide value that outweighs any risk or harm. Researchers should aim to maximize the benefit of the research and minimize the potential risk of harm to participants and researchers. Robust precautions should mitigate all potential risks and harm.
The need for a favorable risk/benefit assessment requires an assessment of the probabilities of both the harms and the benefits that may arise. The term ‘risk’ is generally used for harms, but the probability of benefits also needs to be considered. Many kinds of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm, physical harm, legal harm, social harm, and economic harm, as well as the corresponding benefits. While the most likely types of harm to research participants are those of psychological or physical pain or injury, there may be other social costs to consider.
Discovering what will provide a benefit may require exposing persons to some risk. Conducting research without any risk of causing harm would prevent many improvements in human welfare. Where the participant may benefit directly through the research, such risks are more justifiable. However, where the research project will not directly benefit the participants, the wider benefits to others, such as the potential to alleviate disease or other harms in the future, may justify research with some risk, but only after a very careful evaluation (City, 2024).
Safe-Guarding
Safe-guarding against potential harm is an ongoing process. So, before a study can even begin, the researcher or investigators have to spend significant time weighing the benefits vs. risks and how to mitigate them. Safe-guarding procedures are always outlined as part of the proposal that is sent to the Institutional Review Board (IRB) for review.
Some examples of potential risks include: physical, psychological, social/economic, loss of confidentiality, and legal.
However, there are times when research is underway, and the principal investigator learns of an unexpected adverse event during the study. When this happens, research is paused, and the event is reported to the IRB for further evaluation.
Justice
Individual justice in the selection of participants requires researchers to exhibit fairness so that the burdens and benefits of the research are distributed equitably across different groups within the general population. Justice ensures that no one group is disproportionately burdened or excluded from the potential benefits of the research.
Protected Populations
The federal government guidelines also require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, including:
- Children
- Prisoners
- Pregnant women
- Persons who are mentally disabled
- Persons who are economically or educationally disadvantaged
Why? Because individuals in these groups may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.
References, Contributors and Attributions
City, University of London. (2024). Principals of research ethics. Retreived: https://www.city.ac.uk/research/supp...4-header527440
Kadam R. A. (2017). Informed consent process: A step further towards making it meaningful!. Perspectives in clinical research, 8(3), 107–112. https://doi.org/10.4103/picr.PICR_147_16
U.S. Department of Health and Human Services. (2024). The belmont report. Retreived: https://www.hhs.gov/ohrp/regulations....html#xethical