Institutional Review Boards
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IRB is an abbreviation for the institutional review board. Informed by the need to review human biomedical and behavioral research to the mutual benefit of the researcher and the sample population oversight, responsibilities have to be designated to an impartial body. In light of this, the IRB is also commonly referred to as the independent ethics committee or the ethical review board. Indeed, biomedical and behavioral research on humans is not a light discipline as some of the research tenets border on life and death. It is thus important to evaluate whether the research being conducted has manageable or no risk to the human being. The IRB thus comes in by performing a risk benefit analysis aimed at identifying whether or not the research in question should be conducted or not (Byerly, 2009).
It is therefore noteworthy that IRB is informed by facts in terms of risk to determine whether the research in question is worthwhile and can be conducted. As earlier identified, the priority for IRB is to protect the human subjects involved or ensure that those involved in the research do not face physical or psychological harm. In the United States for example, the IRB has divided the mandate to the food and drug administration (FDA) and the department of health and human services. The IRB has three identifiable methods of review namely: exempt review, expedited review and full review. The exempt review invoked by IRB is where the research that the party wants to conduct is exempt from the regulations.
Given the fact that IRB draws her regulatory authority through law and policies in place, these policies and laws also provide situations where the researcher is exempt from these requirements. It is noteworthy that despite the exemption requirements, the researcher has to seek the exempt review from IRB to ascertain whether the tenets of research fall on the laid out categories of exemption. The second category is the expedited review where certain research informed by the tenets of research does not require the review of the IRB full interrogation because they mainly present minimal risk for participants. Thus, two of the board members conduct the review for presentation to the full board at the earliest opportunity (Grady, 2010). In the event that a researcher was to create a plan to evaluate a program or intervention, the expedited review presents the best option for review by the board.
This is because the process is much swifter compared to the full review and given the fact that most of the interventions have timelines, it comes in handy. This is among other benefits of the review. The full review is the third category where the whole board is involved and intense interrogation of the research is done, when the research has to meet all the laid out requirements.For research that requires the utility of special populations like patients that have been diagnosed with certain diseases, some ethical risks are present. They may include the endangering of the life of the patient and adverse side effects of the treatment.
In most cases, for this type of research, risk assessment in terms of statistics come in handy where the possibilities are explained to the participant and well recorded in liability forms (Millum & Menikoff, 2010). If a program has research projects and does not follow the IRB review, the repercussions may include: bearing the burden of liability if the project harms the life of human beings, the individual researcher may face jail term under law, and the recommendations of IRB are heavily considered in the revocation of licenses from professional bodies among many others.
Byerly, W. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy: AJHP: Official Journal Of The American Society Of Health System Pharmacists, 66(2), 176-184. Retrieved from http://library.kaplan.edu/content.php?pid=150035 Grady, C. (2010). Do IRBs protect human research participants? JAMA, 304(10), 1122-1123. Retrieved from http://jama.jamanetwork.com/article.aspx?articleid=186530 Millum, J., & Menikoff, J. (2010). Streamlining Ethical Review. Annals of Internal Medicine, 153(10), 655-W.219. Retrieved fromhttp://library.kaplan.edu/content.php?pid=150035