Assignment: Final Project: Stage III—The Institutional Review Board Process

Assignment: Final Project: Stage III—The Institutional Review Board Process

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The medical practice rule of “first do no harm” can be applied to health science research as “first do no harm to your study participants.” Harm in this instance means not only physical harm but also the emotional harm that might be caused by unethical research practices.

Despite such lofty ideals, until the 1960s and 1970s, many studies centered on the use of uninformed human subjects. According to Moon and Khin-Maung-Gyi, even after the Nuremberg trials exposed the Nazi war crimes and the Nuremberg Code provided a clear statement of standards for research on human subjects, unethical research programs continued to be designed and conducted (Moon & Khin-Maung-Gyi, 2009). Well-known examples of egregious unethical research in the United States include the Willowbrook study of hepatitis transmission in a hospital for “mentally impaired” children and the Jewish Chronic Disease Hospital case in which chronically ill patients were injected with cancer cells to monitor rejection. In each of these studies, investigators were confident that the ends of research justified the means (Walkup & Bock, 2009).

These and other studies led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and its seminal Belmont Report, which cited three foundational principles of ethical research on humans: respect for persons, beneficence, and justice (Moon & Khin-Maung-Gyi, 2009). These studies also led to the development of Institutional Review Boards, or IRBs, which were designed to provide oversight on all government-funded research studies. IRBs are in wide use today.

To prepare

Review the Keiser Institutional Review (IRB) process and requirements described in the Keiser Center for Research Quality. Consider how these IRB processes and requirements for ethical practice might apply to your Final Project, which is a proposal for an intervention that addresses a health problem identified in a particular community and that is of interest to you. (H.I.V/AIDS In lower income communities)

Submit a 2-page paper in which you do the following: (ANSWER THESE QUESTIONS)

· Explain ethical issues related to your Final Project research program intervention.

· Explain whether these issues are actual or potential and provide a rationale for your answer.

· Explain the level of privacy that would be required according to an IRB for participants in your Final Project research program intervention, and explain why.