In case study two, researchers examined the sequelae of traumatic childhood experiences on interpersonal relationships in adulthood. The study comprised of thirty participants selected randomly from the Midwestern United States correctional facility. Inmates had the option not to participate, and those who opted to join gave written consent. Face to face interview was conducted using a questionnaire. Information gathered includes personal demographic data, type of trauma experienced, and interpersonal relationship behaviors.
According to John Caroll University (2019), based on the Criteria for IRB Review found in the federal regulations 45CFR46.111., the above study can be categorized as non-minimal risk requiring a full board review because it employs the use of individuals classified as vulnerable. And based on the current regulatory requirements relating to ethical issues per the recommendations of the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report) by National Commission, the study required the application of three ethical principles, respect, beneficence, and justice (Online Ethics Center,2006).
As deduced from case study 2, there are identifiable risks to the participants and investigators. The participants are exposed to significant psychological and social harms, which according to OEC (2006), include distress, anger, or guilt related to the disclosure of sensitive and embarrassing information or refusal to participate in the study. There also exist the risks of privacy and confidentiality associated with the transmission and storage of data. On social grounds, there is a possibility of social stigmatization from the knowledge of personal data, trauma experienced, and relational issues. The investigator may be exposed to direct attack of violence from the participant who might be re-living their experience. This risk could be minimized by modifying the research design. It is unclear, however, if the researchers put additional safeguards in place to protect the prisoners’ rights and welfare as recommended in the federal regulations 45 CFR 46.111.; 21 CFR 56.111.
As noted by NBAC, benefits to participants in this study include resulting interventions or awareness that can positively influence individual behavior and relationships. Participants may also experience relief from sharing the information with another person or gain personal satisfaction from contributing to the study (OEC, 2006). The researcher benefits from enhanced capacity to conduct research or by receiving resources to improve a program as a result of a research study. The main benefit of this study to society is the knowledge base. The importance of the knowledge gained may result in the emergence of new products, treatments, or cures. Communities can also benefit through improved access to programs or the development of programs targeted to specific groups within the community.
Risks must, however, be weighed to potential benefits to direct deliberations and determine judgments by IRB and should be acceptable by investigators, IRBs, and the public at large. Hence, An IRB may approve a research proposal only if it judges that the risks are ‘reasonable’ to potential benefits (OEC, 2006).
References
John Caroll University. (2019). Step one: Before you begin. Retrieved February 2, 2020, from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
Online Ethics Center. (2006). Report on Ethical and Policy Issues in Research Involving Human Participants (Chapter 4, Vol. 1). Retrieved from https://www.onlineethics.org/cms/8033.aspx
As you stated, bringing up negative childhood experiences can produce feelings of distress, anger and guilt. I would like to know if disclosing this type of information results in higher self injurious behaviors and violence among inmates once released back into population after study has ceased.
I agree it would require a full board level of review. According to the University of Southern California Office for the Protection of Research Subjects, research with prisoners is permissible but often requires full review and approval from several agencies. Report documents such as the Belmont report were drafted to prevent abuse and exploitation. The Belmont Report contains three ethical principles for human subject research which are especially relevant to prisoner research. (n.d) As you stated in your analysis, autonomy, beneficence and justice are pertinent to a successful case study. The components of this study pose more than minimal risk to the prisoners who are considered a vulnerable population.
I too feel participants would benefit from the initial questionnaire, given the ability to open up about their experiences to a non correctional employee. The release of feelings and pent up aggression surrounding their traumatic experience has potential to affect participant in a positive way, by increasing relationships, reestablishing trust and reintroducing self love.
I too would like to see modification in the research design not only to add safeguards eliminating physical harm to the researcher, but to also further assist the participant in dealing with the recent disclosure of trauma. I find it would be extremely hard to expose that type of emotion and not have follow up.
The Belmont Report. (1979, April 18). hhs.gov. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
Office for Protection of Research Subjects.(n.d). oprs.usc.edu Retrieved from https://oprs.usc.edu/irb-review/research-with-prisoners/
Thank you, jlcarter7, for your contribution. To your question, I agree that individuals can experience distress, anger, and guilt when relating ordeals experienced in childhood as purported by the Online Ethics Center (2006). As a psychiatric nurse, I can say that I have watched people relive their past experiences resulting in varying degrees of health repercussions depending on severity. Some of the after-effects of childhood traumatic experiences include Post Traumatic Stress Disorder, Anxiety, and depression (Paterson, 2018). I believe that breakthrough in research regarding knowledge of the long-term effect of traumatic experiences on people brought about the practice of Trauma-Informed Care (TIC), which involves understanding and recognizing traumatized individuals and avoiding re-traumatization during care.
References
Online Ethics Center. (2006). Report on Ethical and Policy Issues in Research Involving Human Participants (Chapter 4, Vol. 1). Retrieved from https://www.onlineethics.org/cms/8033.aspx
Peterson, S. (2018, June 11). Effects. Retrieved February 8, 2020, from https://www.nctsn.org/what-is-child-trauma/trauma-types/complex-trauma/effects
Are you a psychiatric nurse currently? How do you like it? My first career choice was social work, I worked with pediatrics age 2-18. Unfortunately coming in contact with many young children affected by trauma. I remember when Trauma Informed Care came onto the scene. I found it very interesting and believe it has developed over time to become a valuable part of treatment. Thanks for your input, good luck this semester.
Yes, I currently work in a behavioral-mental health unit, mostly adults, but have to float to the Geri unit sometimes. So far so good and although filled with challenges, I like the turn around the patients get after treatment. Trauma-informed care is exciting because it helps better understand and meet the needs of the patients, and according to Tello (2019), the first step is to recognize how common trauma is and to know that every patient may have experienced severe trauma. I did work with the pediatric oncology population in the past, and I do not know if I am still up to it.
Reference
Tello, M. (2019, March 25). Trauma-informed care: What it is, and why it’s important. Retrieved February 9, 2020, from https://www.health.harvard.edu/blog/trauma-informed-care-what-it-is-and-why-its-important-2018101613562
Thirty participants can be considered small for a sample size. With a small size bears the risk of having participants identity discovered proving for a lack of privacy. Judging by if the given risks are proportional and reasonable for potential gains in the eyes of the community is what will further their knowledge. Researchers may vouch that participants will feel more at ease when opening up over their feelings after the survey. Though expressing feelings may allow relief, it should not be measured as a benefit of the study( National Bioethics Advisory Commission, 2006). I do agree that this investigation should receive full IRB review because of the less occurring sensitivities.
National Bioethics Advisory Commission. (2006, June 13). Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). https://www.onlineethics.org/cms/8033.aspx
Thanks for your observation, Awkaaya. In my opinion, a sample size of 30 is small but relative depending on if it is an accurate representation of the population under study. The risks involved in this type of research can be minimized by assuring the study design is valid (Online Ethics Center, 2006). The process includes ensuring the benefits of the study outweigh the risks and taking into cognizance the possibility of nonphysical harm occurring. Also, researchers need to understand their obligation in protecting the participants’ privacy and keeping their information in confidence per the federal regulation requirements irrespective of sample size. However, changing the method of research can take care of all these concerns.
Reference
Online Ethics Center. (2006). Report on Ethical and Policy Issues in Research Involving Human Participants (Chapter 4, Vol. 1). Retrieved from https://www.onlineethics.org/cms/8033.aspx
My ethical concern was also regarding the questionnaire potentially evoking traumatic memories and events in the minds of the subjects. The case study does not stipulate whether the participants were being offered any type of aftercare treatment in the event that they experienced a post-traumatic stress response to participating in the study. I have been unable to find any legislation which requires study hosts to offer aftercare as it is perceived that this may be incentivizing individuals who cannot afford treatment or who do not have health insurance to participate in studies which may not be in his or her best interest (Doval,2015).
Doval, D., Shirali, R., Sinha, R. (2015). Post trial access to treatment for patients participating in clinical trials. Perspectives in Clinical Research, 6(2), 82-85. doi: https://10.4103/2229-3485.154003
I agree with you on that, Mdpelkey. I also did not find any supporting literature addressing traumatic stress response. However, Labott M. et al. (2014) corroborates our concerns that the steps that can be taken to alleviate emotional reactions experienced by survey subjects are not fully understood.
Reference
Labott, S. M., Johnson, T. P., Fendrich, M., & Feeny, N. C. (2013, October). Emotional risks to respondents in survey research. Retrieved February 9, 2020, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3996452/