Institutional Review Board
The Institutional Review Board (IRB) may be defined as a specific administrative body established to protect the welfare and rights of the subjects of human research. These subjects are traditionally recruited under the affiliated institution’s auspices to participate in conducted research activities. The IRB is responsible for the review of all researches that involve human participants before their initiation. In general, the establishment of the IRB was determined by the necessity of strict regulations and rules for research studies as multiple crimes against humanity during experiments have occurred throughout history (Kawar, et al., 2016). For instance, horrific Nazi Medical Experiments were conducted as legitimate research in Europe during World War II (Kawar, et al., 2016). Human subjects were exposed to high altitudes, freezing temperatures, poisons, physical traumas, and burns against their will as they were the Nazis’ prisoners (Kawar, et al., 2016). In addition, the Syphilis Study at Tuskegee, the Jewish Chronic Disease study, and the Texas Contraceptive study may be regarded as other peculiar examples of scientific misconduct (Kawar, et al., 2016). All these experiments resulted in the creation of appropriate research standards based on ethical principles.
The IRB is currently concerned with the protection of rights, privacy, and welfare of the participants of any scientific research. This administrative body has the legal authority to monitor, approve, or disapprove all research activities and require their modifications if necessary based on its jurisdiction specified by institutional policy and federal regulations. In general, The IRB’s adequate, accurate and complete review of research and its legal, scientific, social, and institutional implications is provided by a group that consists of 5 five persons of different backgrounds. Although the members of the IRB represent different scientific disciplines, the group should include one nonscientist academic and at least one individual not affiliated with the university, college, or another institution. Moreover, the IRB’s consultants may be involved in the process of review.
NIH Clinical Center
The NIH Clinical Center is the United States clinical research hospital situated on the campus of the National Institutes of Health in Bethesda, Maryland (“About the Clinical Center,” n.d.). The hospital aims to improve the citizens’ health through clinical research conducted by clinician-investigators who translate experimental and laboratory discoveries into developed therapies, treatments, and interventions. In the present day, the NIH additionally funds ten outside research teams with approximately $500,000 annually and provides them direct access to the unique resources of the Clinical Center (Kuehn, 2014). As a hospital exclusively devoted to scientific medical research, the NIH Clinical Center is attended by several thousands of new research participants every year (Kuehn, 2014). Traditionally, human subjects of the Clinical Center include patients, adults, and children who want to improve their health and healthy volunteers. The NIH currently has 1500 scientific studies in progress, and a particular number of them monitor the progression of rare serious diseases (Kuehn, 2014). The center’s peculiar concept that implies the design of patient care units in proximity to laboratories supports collaboration and interaction of specialists and their consolidation with patients for efficient research and positive outcomes.
In the NIH Clinical Center, adults and children currently participate in clinical studies that cover a substantial range of medical conditions, diseases, and rare disorders. They include aging, allergy, alcohol abuse, AIDS, cancer, kidney, and digestive problems, eye disorders, diabetes, genetics, infectious diseases. Mental health, stroke, and neurological disorders (“Are clinical studies for you?” n.d.). Patients who take part in studies are supervised by a competent team of expert physicians, nurses, technicians, dentists, and support staff. Participants help other people who suffer from the same disease, and participation in research may be highly beneficial for them as they frequently receive new treatments before their general availability for the community.
In 2019, the NIH transitioned from Human Subjects Protections Program (HRPP) Standard Operating Procedures (SOPs) to HRPP policies that will apply to the reviewing NIH IRB, NIH IRB operations, and clinical investigators (“Policies & guidance,” n.d.). In addition, the NIH supports the adequate representation of racial and ethnic minorities in research studies. That is why, in 1993, Congress passed the NIH Revitalization Act which mandates that women and minorities “be included in representative numbers for all studies conducted or supported by the NIH” (Michaels, et al., 2018, p. 4). NIH IRB reviews the center’s all multi-site studies related to the development of innovative therapeutics for cognitively impaired subjects and patients with dementia, Alzheimer’s disease, and other mental disorders that affect movement, memory, and mood.
In general, the NIH’s principle of justice implies equal opportunity for people to participate in research. However, the inclusion of women, children, and minorities into studies is acceptable in case of the prevalence of a particular disease, condition, or disorder in these populations. In addition, clinical investigators consider how intervention or therapy affects women, children, or minority groups in comparison with other participants for better outcomes. And the involvement of children in studies requires parental permission.
References
About the Clinical Center. (n.d.). NIH Clinical Center. 2020, Web.
Are clinical studies for you? (n.d.). NIH Clinical Center. 2020, Web.
Kawar, L. N., Pugh, D. M., & Scruth, E. A. (2016). Understanding the role and legal requirements of the Institutional Review Board. Clinical Nurse Specialist, 30(3), 137-140. Web.
Kuehn, B. M. (2014). NIH expands access to Clinical Center. JAMA, 311(16), 1603. Web.
Michaels, T. I., Purdon, J., Collins, A., & Williams, M. T. (2018). Inclusion of people of color in psychedelic-assisted psychotherapy: A review of the literature. BMC Psychiatry, 18(245), 1-14. Web.
Policies & guidance. (n.d.). NIH Office of Intramural Research. 2020, Web.