A couple weeks ago, in class we had a discussion about the Institutional Review Board (IRB) and its role in research. For a second I was like, where have I heard this acronym before, and then it clicked. Part of my major requirement is to take Psychology 452: Advanced Research Method, a senior seminar, which basically consists of learning how to conduct your own research, with real subjects, data, and analysis. Since we are using students in our research, we had to get our experiment approved by the IRB. The IRB is basically a “constituted group that has been formally designated to review and monitor biomedical research involving human subjects.” The IRB has the authority to approve, require modifications in, or disapprove research. Ultimately, it serves to protect the rights and welfare of the research subjects.
Professional codes of conduct and individual conscience predominately controlled research ethics prior to the twentieth century. Human involvement in scientific experimentation has been frequently raised as an ethical issue, which helped to advance the production of conduct codes and government regulations against unethical behavior. Researchers have considered notions such as informed consent and risk versus benefit, but the codes they have implemented are not yet popularized, and the ones that are have broad definitions of the ethical guidelines.
Therefore, the need for an organization to enforce strict guidelines in order for the research to be considered both ethical and beneficial has been created: the IRB. Unfortunately, even with regulation there have been several cases where humans were mistreated in the name of science. For example, Medical Apartheid by Harriet Washington, explains in great detail of the mistreatment black Americans went through from the era of slavery to the present day. For instance, in the Tuskegee Syphilis Study in 1932, the PHS physicians actively injected the black American subjects with syphilis in order to study the symptoms and in hope to find the cure (pg. 178). Researchers were deliberately harming if not killing black syphilitics in order to test a theory of treatments (pg. 181).
There were many similar cases where black Americans were used in research without consent. Thus, towards the end of the book, Washington gives her opinion on the Institutional Review Board and how she believes it has failed to live up to its position. She states that the IRB “failed to preform their role of protecting the public, and African Americans in particular” (pg. 401). Some of her reasons were that the IRB staff were “inadequately trained,” primarily scientists, and “subject to conflicts of interest” (pg. 401). She insists that each IRB include a medical ethicist and a medical historian, ban any exceptions to informed consent, and for researchers to receive training in ethical and practical conduct in biomedical research.
During class we looked over the FDA webpage and at their most updated Frequently Asked Questions (FAQ) about the IRB. While doing this, I have noticed that there were some facts that made me wonder about how progressive our country really is in regards to this issue. The United States has progressed in so many ways, yet it could be possible that some aspects of our system may keep us from advancing and need to be corrected. For example, the expedited review in FAQ #20 mentioned, “certain kinds of research may be reviewed and approved without convening a meeting of the IRB.” Also that the IRB regulation “permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk.” The problem with these statements is that it allows for exceptions. No research project should be an exception to the rules and regulation that serves to protect the rights and welfare of humans. Every research project should go through a routine check with the IRB to make sure there are no risks at all. Another example is FAQ #45, which discusses when it is necessary to mention any changes in the study to the subjects. According to the protocols the subjects will only be informed of the change if “it might relate to the subjects’ willingness to continue their participation of the study.” The problem with this statement is that it allows for the researcher to make the judgment call of whether the subject should be informed or not. The researcher might be biased in not telling the subject at all because it might affect the outcome of their overall study.
Although there were certain aspects of the FAQ that makes us question the most updated IRB intensions, we must remind ourselves that the website is only there to be used as a guidance, not their final constitution or protocol. If we were to see any faults in the information sheet, such as ambiguous statements, all we can do is further our research to better understand and hope that rights and welfare of the people are protected.
In my opinion from where we started as a nation with regards to research for new medical accomplishments, we have progressed in our techniques of approaching and exploring our curiosity. In relation to my own experience with the IRB, in my PSYC 452 class, there are a few qualities that I have noticed that make me feel confident with the IRB. Prior to even being able to conduct the study, my professor had us do a training course online for the National Institute of Health (NIH), since the Geneseo IRB board requires this for all research involving human subjects. The course is designed to provide the minimum level of knowledge that we are supposed to know prior to conducting a study that involves human subjects, in order to understand what is ethically correct in terms of protecting the rights and welfare of subjects in research.
In summary, I believe it is important to increase our knowledge about the human wellness and the best way to do that is through research. A guideline like the IRB prevents researchers from crossing a line that could do more harm than good.