USC Crucial Events in the Ethical Principles Discussion and Peer Responses

**Discussion:** * How do you think two crucial research events—the creation of the Nuremberg Code and the U.S. Public Health Service Syphilis study at Tuskegee—influenced the role of Institutional Review Boards (IRBs) in the study design process? * Respond to at least two of your classmates’ or instructor’s posts. Comment on their initial posts and describe how you think the _Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research_ also influences IRBs. * **Peer# 1** The creation of the Nuremberg code was the first investigation into the world of investigative research on studies that involved human test subjects. Derived from the Nazi crimes against concentration camp prisoners, the Nuremberg code set out the establish that when it comes to doing research on humans, there needs to be ethical, judicial, and beneficent standards involved in the treatment of the individuals (Shuster, 1997). Likewise, in the study of African American men in the Tuskegee study, there was no informed consent by the individuals in the study (Heintzelman, 2003). There were also blatant lies that were told to the participants that put their lives in danger when they thought they were getting proper medical treatments (Heintzelman, 2003). To combat the atrocities that have been committed in the past, the US has established ethical review committees to make sure that all potential research is being conducted ethically, but also to assure that the research continues to be ethically ran as the study goes on (Jacobsen, 2017). In my opinion, it is great to have a checks and balances system to try and make sure that the research being done is being done as respectfully as possible for all participants. Much like the checks and balances in the federal government’s three main branches, the ethics committees are there to make sure that there are many individuals looking at the study from a non-biased perspective to assure that everything is being conducted ethically. So often, individuals who are in the thick of developing research plans can get stuck into what is needed for their study and can become blinded to other potential options or decisions that could be more ethical ways of managing the study. These committees look at the study from every angle and have many different individuals giving their perspective on the matter. As we cannot change the past and take back the atrocities that occurred in the concentration camps, or in Tuskegee, we can learn from the mistakes and try to rectify it for the future. These studies coming to light to the mass public leads the medical research community to want to do better for the future. **Peer# 2** The Nuremberg Code was one of the first ethical standards created. Starting in 1947, this Code “mandated voluntary consent for experimental studies of humans” (Jacobsen, 2017, p. 181). It was created in response to “the horrors of human experimentation by Nazi physicians and investigators” (Ghooi, 2011, p. 72). The U.S. Public Health Service at Tuskegee is just as tragic. A little over 600 Black men were chosen in 1932 in the Tuskegee area (Morris, 2016). They were told they had “Bad Blood” and were promised free medical treatment and food if they participated in a study (Morris, 2016). What the doctors were reluctant to share was that 2/3 of the group had syphilis, with the remaining third without (and served as the control). This is in addition to many other ailments all of the Black men were diagnosed with (Morris, 2016). After four years of this study, the doctors decided the men would be subjects until their death to review the long-term effects of syphilis (Morris, 2016). Based on these two events, it is clear that Institutional Review Boards were made a critical checkpoint before any voluntary research study was conducted. Not only that but IRBs are required to “review and revise protocols” as they see ethically fit (Jacobsen, 2017, p. 195). IRBs generally contain at least five members, all with their own diverse backgrounds (Jacobsen, 2017). The number of people reviewing the prospective study may take at least a month to approve the study (Jacobsen, 2017). I can see why—my research topic focuses on mental health and requires sensitive questions and possibly even a consent form to protect the participants’ well-being. According to the textbook, exemptions are extremely hard to come by. So long as no biological specimen can be linked to the individuals, the study may be exempted (Jacobsen, 2017). In some cases, reviews must be taken by multiple committees! My point is that IRBs have been created to be extremely rigorous, which can only protect both the researcher and their participants.

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