IRB Case Study Assignment – Case Study 1
Risks and benefits related to the researcher
Benefits of this study for the researcher include the fact that this is anonymous demographic data. This may make this study less likely to have issues passing an IRB review. Because it is anonymous and there is no actual experimentation, the risk is low and for the researcher and the participant at the same time. The researcher would need to ensure that this information was truly anonymous, and the data cannot be linked to any patient identifying factors at any point in time. One of the risks involved for researchers is the potential for a small sample size or that data for the purpose of this particular study (race differences in HIV positive patients) is limited because the study is only applicable to the Midwest, where diversity is much different than on the coasts or elsewhere.
Risks and benefits related to the participant
The risk of physical harm to the participant would be low as this study is more of a data analysis. The researchers should ensure that appropriate consent was obtained from participants when the data was collected and well documented and that their anonymity be ensured. However, during my research, I found several articles stating that if data is anonymous that researchers may not particularly need signed consent. The American Association for Public Opinion Research (2020) states that IRB’s may waive the need for consent if there is little risk or if the biggest risk is related to anonymity or connecting the participant to the research. There is little direct benefit to the participant other than that offered at the government-funded clinic which would have been many years prior. With regard to the potential for ethical issues with consent, it would be essential for this study to undergo some sort of institutional review board (IRB) process.
Risks and benefits related to society
Potential benefits for society would be if the study results somehow were able to contribute to HIV/AIDS research in a positive way. Potential risks would include partiality of the researchers or the potential for evidence of bias, particularly regarding race since that is what is being analyzed but to any of the variables within the study. I would also want to consider social vulnerabilities such as how participants were drawn to these government funded clinics for testing and if there was a lot of variability of demographics. How will this be looked at and considered by researchers? The National Bioethics Advisory Commission (2016) discussed economic and social vulnerabilities for study participants including the questions of how participants were recruited to the government-funded clinics. Was this testing completely voluntary and unsolicited? Again, another reason for an IRB to play a role in the study process.
The Need for IRB Approval
The risk for this study is likely to be low given that the participants are at low risk of harm. Therefore, the level of the IRB process could be “expedited.” I think that there could be advantages of a local IRB for this study if the research team is in the Midwest as the data for the analysis is from the Midwest. The local IRB could better assess how this data could affect local communities.
References
American Association for Public Opinion Research (2020). IRB FAQ’s for survey researchers. Retrieved from https://www.aapor.org/Standards-Ethics/Institutional-Review-Boards/IRB-FAQs-for-Survey-Researchers.aspx#question4
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
This level of IRB review could arguably be expedited. This research may present no more than minimal risk and does not involve any vulnerable populations such as children, prisoners, or individuals with impaired decision-making capacity, and/or economically or educationally disadvantaged persons.
However, this research could also require a full board review because it is a collection of information about a highly sensitive topic, such as HIV positive test results. Additionally, this case study collected information of HIV positive patients which could seriously harm the participant legally, socially, or financially if other people could identify the participant.
A risk for participants is psychological harm. Participants may suffer emotional anxiety or shame from discovering the results of the HIV test. Moreover, participants may feel distress, anger, or guilt related to the disclosure of sensitive or embarrassing information and distress and fear upon learning of one’s likelihood of developing AIDS for which there is no cure at this current time. Participant may also suffer from social harm after discovering the positive HIV results. Social harms involve negative effects on one’s interactions or relationships with others (National Bioethics Advisory Commission, 2016). Participants may be exposed to social stigmatization from the discovery of their positive HIV results. Lastly, participants may suffer from dignitary harm when they are not treated as persons with their own values, preferences, and commitments, but rather as mere means, not deserving of respect (National Bioethics Advisory Commission, 2016). This type of harm may have been present in this research study if informed consent was not properly obtained.
National Bioethics Advisory Commission. (2016, February 1). Chapter 4: assessing risks and potential benefits and evaluating vulnerability (research involving human participants v1). https://www.onlineethics.org/cms/8033.aspx#exhibit4-2
Thank you for your response. The researchers are looking at existing data from almost a decade ago and the participants involved in this study were not particularly obtaining HIV testing for the purpose this study. I feel it would not be the current researcher’s and IRB’s responsibility to consider psychological harm from learning about HIV positive test results themselves but rather should focus on consent and securing anonymity of those individuals with respect to psychological harm. The Office for Human Research Protections (1984) states that when studies are based on existing data, that it is enough for the IRB is to ensure there is no connection between any participating member and the research.
U.S. Department of Health and Human Services, Office for Human Research Protections. (1984). AIDS research, guidance for IRBs (1984). Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/aids-research-guidance-for-irbs/index.html