Clinical research aims to advance human health by making new treatment discoveries and ensuring that medications used for therapy provide adequate benefits to the general public. However, when conducting research, the researchers need to ensure that they observe the established ethical guidelines to maintain the integrity of the participants. The initial step to conducting clinical research is acquiring IRB approval, a regulatory body tasked with ensuring the welfare and integrity of research participants is maintained. Dr. Sowers, however, seemed not to be mindful of the requirement. For a study to be approved by IRB, it must show that subjects will be exposed to minimal risks relative to the expected benefits, there was equitable subject selection, data will be collected adequately and safely, among others. (Research Administration, 2021).
Response 2: (Jean)
Among the ethical principles of research is informed consent, which requires that research subjects decide whether to participate or not without any coercion; for participants to make the decision, they have to be fully informed. The CRCs are usually tasked with explaining to the subjects the methods, purpose, benefits, and risks associated with the research process. The CRC should also inform the participant of other alternatives if they choose not to participate in the study. The process is of informed consent is usually tiring for both the participant and the CRC; however, all details must be explained and participants’ understanding assessed before they can be allowed to sign an informed consent form. The CRC has other roles such as documentation and coordinating the research effort among all those involved to ensure that all ethical principles are followed (National Institutes of Health, 2021).
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