Case Study 2: Analysis of the level of IRB review and potential risks/benefits of the study for researcher, participant, & society
There are three broad ethical principles that guide research involving human participants: respect for persons, beneficence, and justice. These three principles will be used to analyze the potential risks and benefits to the participants, researcher, and society in reference to Case Study 2. Through review of this case study the level of IRB review will also be determined.
Respect for Persons
In The Belmont Report the Department of Health, Education, & Welfare (HEW, 1979) concluded that individuals could lack self-determination in “circumstances that severely restrict liberty” and should be protected. In the Belmont Report prisoners exemplified the population of research volunteers who would need protection under the umbrella of respect for persons because “under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer” (HEW, 1979).
Researchers could inadvertently provide a benefit to potential volunteers that would be irresistible to an inmate, such as financial gain, food or “treats”, or simply time out of the cell. These types of benefits may entice an inmate to volunteer for something that they wouldn’t normally agree to do (HEW, 1979). This violates one of the three key elements of informed consent, voluntariness, and it also violates the ethical principle of respect for persons. Voluntariness can be affected by undue influence, which is when a researcher provides rewards to get volunteers to participate and comply (HEW, 1979).
Beneficence
To adequately protect any participant in this study the researcher would also need to bring participants into an “awareness of possible adverse consequences” (HEW, 1979) of an interview that could bring up painful memories of childhood trauma and broken or dysfunctional interpersonal relationships and behaviors. The rules of beneficence require that the researcher doesn’t harm participants. To accomplish this, the researcher must identify and minimize risks to the volunteer while at the same time maximize the benefits (HEW, 1979). Based off of the information given, Case Study 2 seems to maximize psychological and social harm to the volunteer and doesn’t seem to provide any benefit to the participant.
Informed consent is disregarded again in this scenario because two of its three key elements have been violated: Information and Comprehension (HEW, 1979). The researcher needs to give potential volunteers adequate information about the research study to make an informed decision before choosing to participate. In the Belmont Report it is recommended that researchers divulge information to potential subjects such as: “the research procedure, their purpose, risks and anticipated benefits…and a statement offering the subject the opportunity to ask questions” (HEW, 1979). The element of comprehension as it relates to informed consent may be in jeopardy of violation by the researcher because it is unclear if the researcher attempted to adequately explain the risks and benefits of the study and it is unclear if the researcher attempted to test volunteers for comprehension. If it is found that some participants are incompetent “respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm” (HEW, 1979). For a researcher it is easier to assume that the inmate comprehends information told to them and to forgo comprehension testing. Leaving out details of the study that could dissuade inmates from volunteering could be seen as a benefit to an unethical researcher, because adhering to informed consent guidelines could lead to a deficit in the number of volunteers.
Justice
To provide justice in any research study The Belmont Report cautions researchers to select human subjects “for reasons directly related to the problem being studied” (Department of Health, Education, & Welfare, 1979). In the example of Case Study 2, participants should be randomly selected from the general population instead of the prison population. This is not a study on the relationship between traumatic childhood experiences and future imprisonment; it is supposed to be a study on the relationship between said trauma and interpersonal relationships in adulthood. In this case the potential subjects are being chosen from the prison population because it is more convenient for the researcher. It is unclear if the results of the study would lead to the development of interventions or therapies, but those advancements would need to be applied directly to the benefit of inmates, not just to the general public or those who could afford it in order for justice to prevail in Case Study 2 (Department of Health, Education, & Welfare, 1979).
The Community
The community may benefit from the knowledge obtained through the study, but the data gained may not reflect the reality of the general population. There are plenty of people who have never been incarcerated who have had traumatic childhood experiences and their interpersonal relationships in adulthood may overall be very different from a prisoner’s interpersonal relationships in adulthood. Numerous other factors that contribute to an inmate’s interpersonal relationship struggles could be non-issues in the general population. Overall, the benefits of the study don’t outweigh the potential risk of harm to the inmates, who have a “frequently compromised capacity for free consent” (HEW, 1979) and doesn’t justify ignoring the rights of inmates, which include the right to participate in research that embodies respect for persons, beneficence, and justice (HEW, 1979).
IRB Review
Case Study 2 requires a Full Board IRB Review because it “posses greater than minimal risk to research participants” (John Carroll University, n.d.). John Carroll University (n.d.) gave several examples of certain elements of a research study that would make it qualify for a full board IRB review such as studies exploring “sexual orientation, substance abuse, eating disorders, religious identity, illegal activities, veteran or wartime experiences or which reveal….criminal history”. All of these topics may come up in the questionnaire and interview process and be significant factors in determining the link between childhood abuse and interpersonal relationships in adulthood. John Carroll University (n.d.) also specifies that “research with the homeless, the handicapped, or prisoners” will require a full board IRB review.
References
Department of Health, Education, and Welfare. (1979). The belmont report: Ethical principles and guidelines for the protection of human subjects of research (DHEW Publication No. (OS) 78-0013. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
John Carroll University. (n.d.). Things to do and know before preparing your IRB application. Retrieved from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
Great post. I agree with your analysis that participants face a risk in this research. As incarcerated individuals, they may be subtly coerced or unduly influenced to participate or volunteer to answer questions about traumatic childhood experiences and how it has affected their interpersonal relationships as an adult. The principle of beneficence states that persons should be treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also making efforts to secure their well-being (National Bioethics Advisory Commission, 2016). These participants may suffer from psychological harm from the detailed questionnaire about painful memories of childhood trauma. The researchers should take steps to ensure the well-being of the participants before, during, and after the face-to-face interview.
You are correct that there is a potential for abuse with obtaining informed consent from the incarcerated participants. They may not even comprehend what they are consenting to.
The benefit to society and participants seems to be limited based on your analysis. You bring up a good point that participants should be randomly selected from the general population instead of the prison population. However, if the results of the study were to create new programs in the prison system that may help participants cope with the traumatic childhood experience, then this study may benefit incarcerated participants.
I agree with you that the experiences of incarcerated individuals greatly differ from the general population thus limiting the benefits to society. IRBs should identify potential benefits associated with a research study (National Bioethics Advisory Commission, 2016). Generally, IRBs consider potential benefits as accruing either to society or to participants (National Bioethics Advisory Commission, 2016). The knowledge learned from this study may not even relate to or be applicable to the general population. Therefore, your viewpoint is well understood.
The level of review should be a Full Board IRB Review because it involves research with prisoners.
National Bioethics Advising Commission. (2016). Report on ethical and policy issues in research involving human participants volume I report and recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx
Thank you for the thoughtful response. I think it would be best for the researchers to allow the participants to see the questionnaire before agreeing to be a part of the study. This would give participants a better idea of what they are agreeing to. You are right, if this study is designed to create programs in the prison to help prisoners cope with trauma and interpersonal relationships, it would make more sense to use prisoners as volunteers, although using the general population as volunteers would probably give the researchers the information they need to develop these prison programs without using volunteers from a vulnerable population.
I agree with you analysis. doing research with prisoners can be tricky. I was surprised in my research to find out that the IRB for research that involved prisoners, has special requirements. Not only is a full IRB required, the board must contain at least one member that is a prisoner or a prisoner’s representative and the majority of the board can have no relationship to the prison (“Protection of human subjects: Code of Federal Regulations, 45 CFR 46, 2009). Finding out this information made me wonder how easy and IRB for prisoner related research would be. What would the process be for a university that wants to do research in a prison? would the university then have to reach out to the prison to have a representative or inmate set on the board or or would there be some other qualifying individual that could fulfill that requirement, such as a court-appointed liaison. It also made me wonder what the process was for the prison to allow research within their facility. I wonder if the prison has its own board that has to approve this kind of research.
This is definitely an assignment that provided me a lot of opportunity to think and reflect on the difficulties surrounding research in general. I’m very thankful that there are those who are willing to take on those challenges, because without them we wouldn’t have evidence-based practice guidelines that make our individual nursing practice safer and more effective for our patients.
Resources:
NIH, PHS, HHS. Protection of human subjects: Code of Federal Regulations, 45 CFR 46, 1-14 (2009). Bethesda, MD. Retrieved from https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/ohrpregulations.pdf