Institutional Review Board: Policies And Procedures (Essay Sample)
Describe the central responsibilities of an Institutional Review Board (IRB). Then describe a situation that could present a difficult decision for an IRB.source..
Institutional Review Board
Institutional Review Board
The Institutional Review Board (IRB) is a body that protects individuals who participate in research and minimizes any risk of harm to the participants by providing oversight and guidance, which will ensure that the research is done in accordance with the policies, regulations, and laws (Grady, 2015). Any research that involves human subjects should, therefore, be reviewed by the International Review Board. The board is responsible for reviewing all the research activities that require the participation of human subjects and record its findings concerning adherence to IRB policies and procedures, federal regulations, scientific merit and ethical considerations. The IRB is responsible for reviewing the activities of the research to ensure that the risks to the individuals who are participating are minimized, the criteria for selecting subjects is fair and just, and the human subjects and the risks to the human subjects are reasonable in relation to the benefits being anticipated by the subjects. This would require the IRB to have adequate information about the subject’s entire population as well as other factors, which can eventually lead to the determination of the benefit to risk ratio to the individuals and the individuals’ informed consent. The board should provide clear information concerning the accuracy and adequacy of the information provided in the materials that are handed over to the subjects, such as advertising and the informed consent document. The information that is provided to the subjects as part of the informed consent should be in accordance with the international standards, regulations, and laws. Also, the welfare and rights of the subjects should also be considered in the information provided in other materials.
The IRB also ensures that the privacy and confidentiality of the participants are protected and that the research protocol also states an appropriate safety and data monitoring. In the case of vulnerable participants, the IRB should also ensure that adequate safeguards are included in the research protocol. In case the research protocol does not meet these requirements, the IRB is also responsible for deciding whether to approve or disapprove the research, or make certain proposals for modifying the research protocol. Nonetheless, whenever the IRB disapproves a research, it should clearly state its reasons for disapproving and give the researcher a chance to respond to the statement either through a written letter...
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