Which statement is true about the members of the IRB/IEC?

Prepare for the Certified National Pharmaceutical Representative Exam. Utilize flashcards and multiple-choice questions, each with hints and explanations. Ace your exam!

Members of the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) are required to have expertise relevant to the studies they review, particularly concerning ethical issues, scientific integrity, and the protection of participant rights and welfare. This expertise is essential to ensure that the research is conducted ethically and that the potential risks to human subjects are minimized while the benefits are maximized.

Having individuals with specialized knowledge helps the IRB/IEC make informed decisions about research protocols, which can involve complex medical, scientific, and ethical considerations. These members often include healthcare professionals, ethicists, and legal experts, ensuring that various perspectives are represented. The commitment to having experts on the board helps maintain rigorous review standards and protects participant interests.

While community members can be included in an IRB/IEC to ensure a diverse perspective, the primary focus on having knowledgeable members about the study is crucial. Administrative personnel can assist in the process but do not typically perform the decision-making role that experts play. Conversely, the appointment of IRB/IEC members by pharmaceutical companies is not conducive to maintaining an unbiased review process, as it might raise concerns about conflicts of interest. Therefore, the importance of having experts in the topic of study ensures that the board functions effectively in oversight roles.

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