Level of IRB Approval
The Belmont Report states that, “…the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects” (Office for Human Research Protections, 2018). With this in mind, this study would require an Institutional Review Board (IRB). There are three types of boards: exempt, expedited, and full board. The IRB that would be required for this study would be full board. The reason that a full board IRB is necessary, is that the subjects “…are likely to be vulnerable to coercion or undue influence…” due to their incarceration status (John Carroll University, n.d.). Although their crimes would not be openly discussed, the study would have to be open about the subject pool being inmates from a Midwestern United States correctional facility, and with the answers provided on the questionnaire by the inmates, they could possibly be identified.
This case study poses several risks and benefits for the participants, researcher(s), and society. The following is an analysis of these risks and benefits.
Risks and Benefits for Participants
There are several risks for the participants, which are classified as greater than minimal risk. Participation in the study could lead to the subject having to relive a childhood trauma they have suppressed. Also, dignitary harms could exist as these subjects are incarcerated and most likely have a low morale. The subjects may feel like they must participate in the study even though they were given the option to decline due to fear of retaliation from the correctional facility. Also, there is an issue with whether or not the privacy/confidentiality of the inmates will be maintained, since the questions on the questionnaire provide personal information that could help identify these individuals. There are also several benefits that the participants may reap from participating in the study. The participants may receive information that can help them seek care/treatments/interventions that are more targeted to their needs (i.e. counseling, testing, experimental therapies). Self-awareness/ personal satisfaction may also be achieved from participating in the study. Participants may also benefit from the interaction with the interviewer (social contact). Allowing the participants to decline is an important and beneficial part to carrying out any study, but it is especially important given the fact that the subjects are inmates. Informed consent is also a benefit that the participants have under the IRB guidelines.
Risks and Benefits for Researcher(s)
Several risks are posed for the researchers. Face-to-face interaction poses great risk for the researches, since the interviews will be held at a correctional facility. Most people within correctional facilities have mental health disorders. ”… one study by the US Bureau of Justice Statistics found that 75% of women incarcerated in jails and prisons had a mental illness, as compared with just over 60% and 55% of men, respectively” (Roth, 2018). If the participants are not taking their medications or are put off by the interview, this could lead to unprecedented events that could place the interviewer(s) at risk. The researcher is also at risk of being lied to or manipulated by the participants. There are also benefits though. One of the benefits is knowledge that indicates a correlation between childhood traumas and interpersonal behaviors in adult relationships, which is the purpose of the study. Another benefit, given that the subjects are all incarcerated, is the opportunity to eliminate biases/stereotypes that they themselves or society may have in an objective and controlled manner. Also, the correctional facility provides a controlled environment in which the researcher may feel safer interviewing people with a criminal background.
Risks and Benefits for Society
Most of the risks for society come from them being at risk of receiving information that does not pertain to the general population necessarily. Firstly, all the participants are incarcerated. It would be different if the study stated that its purpose is to analyze the relationship between traumatic childhood experiences and the effect on interpersonal relationships in adulthood in subjects incarcerated in a Midwestern United States correctional facility. Secondly, although the study mentions that it was carried out using random sampling, the study does not indicate if the thirty participants are male, female, or both. I understand that the questionnaire addresses this, but the random sampling may limit/sway the data if there are more females than males vice versa. Also, the study does not set parameters for an age range for participants, unless this does not matter, which would also need to be indicated. A definition for traumatic childhood experiences (i.e. abuse, negligence, death) must be included to allow for moderation of the study. I struggle with understanding how a questionnaire would be able to adequately portray self-reported interpersonal relationship behaviors. These interpersonal relationship behaviors would also require a definition (i.e. honesty, flexibility, acceptance), unless the study plans to leave interpersonal relationship behaviors up to the subjects’ interpretation, which would not be indicative of society as a whole. The primary and most significant benefit for society is knowledge. This study gives society the opportunity to gain knowledge regarding correlations/links between childhood traumas and interpersonal behaviors displayed in adulthood.
References
John Carroll University. (n.d.). STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. Retrieved from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
Office for Human Research Protections (OHRP). (2018, January 15). Read the Belmont Report. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Roth, A. (2018, March 31). A ‘hellish world’: the mental health crisis in America’s prisons. Retrieved from https://www.theguardian.com/society/2018/mar/31/mental-health-care-crisis-overwhelming-prison-jail
Hello!
You have really good information and points. With this type of study I agree that there are a lot of risks especially for the participants. Because there is a possibility that it could potentially be bringing up memories that people may not remember or it could put them at risk of reliving some of these memories. This study is one that the consent process would have to be very important. Also it would be very important to make sure each participant fully understands what this study is about and their rights as a participant. Also that even if they give consent to do the study that at any time they decide they don’t want to participate in the study anymore that they don’t have to. By having the participant aware during the consent process it decreases the risk for the researcher and the participant themselves.
Nusbaum, L., Douglas, B., Damus, K., Paasche-Orlow, M., & Estrella-Luna, N. (2017, September 20). Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5613795/
I agree that the consent process for this particular study would require great detail. This population being in a vulnerable and easily to manipulate setting makes it hard to eliminate the possibility of subjects partaking unwillingly, which could result in false/skewed data.
I agree that one of the greatest risk factors in this study is psychological harm in a vulnerable population. You would also have to ensure that staff inside the correctional facility were not creating influence in the study and that correctional facility staff members are unaware of what inmates were participating in the study and the details of the study. The National Bioethics Advisory Commission (2016) recommends that those inmates who decline to participate remain in the interview room for the same amount of time to maintain anonymity and so that staff cannot tell who did and did not participate based on time in room. Because this study involves prisoners along with risk of psychological harm, I believe it poses non-minimal risk and would require a full IRB review.
National Bioethics Advisory Commission (2016). Exhibit 4.2: using the framework to assess risks and potential benefits. Report of Ethical and Policy Issues in Research Involving Human Participants Volume 1 – Report and Recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx#exhibit4-2
That is a great suggestion from The National Bioethics Advisory Commission. It is something so simple to do, but so easy to overlook when things are already in motion.