Institutional Review Board Responsibilities at Study Initiation
Responsibilities of the IRB in the initiation of the trial
IRB is charged with the responsibility of protecting the safety and rights of participants in the clinical trial (Woodin and Schneider, 2008). Some IRB responsibilities like a trial investigator, monitoring, auditing research records and research participant education are likely to be shifted to special units under the Human Research Protection program (HRPP). Such responsibilities promote sponsor-investigator relationships promoting ethical and safe research practices. In the U.S., IRB also serves as the 1996 Health Insurance Portability and Accountability Act (HIPPA) privacy committee dealing with research-associated activities. IRB is especially useful for multicenter studies as it handles approving informed consent and protocol forms (Schultz, 2008). This makes meeting the regulatory requirements efficient. The responsibility of protecting human study participants is multifaceted. Belmont Report, Helsinki Declaration, and Nuremberg Code stipulate the underlying standards of protecting research subjects. IRB is charged with applying these standards in evaluating all aspects of the proposed study activities to ensure the safety, well-being and rights of research subjects. Concurrently, the IRB helps investigators in the upholding adherence to institutional policies and regulatory mandates.
IRB...
Social and Cultural Theory Study Guide Karl Marx Karl Marx was a prolific German social philosopher who is renowned for his exceptional theories related to modern socialism and communism. Marx strongly believed that the recent times have changed the value of man. According to Marx, people are no longer valued for who they are, but they are categorized assessing their importance and participation in the production of products/goods. In the present time,
Podiatry Study Guide Study Guide: Keenan, A.M., and Redmond, A.C. (2002). Integrating research into the clinic: What evidence-based practice means to the practising podiatrist. Journal of the American Podiatric Medical Association 92(2), pp. 115-122. Podiatrists must be discerning as they keep current with the literature to best meet the needs of their patients as well as requirements by administering bodies such as private health insurance agencies; recent initiatives have attempted to integrate research
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