Final answer:
Under Subpart A of Title 45 (45 CFR 46), the requirements for IRB membership include specific criteria and a minimum number of members. The goal is to have a diverse and knowledgeable IRB to protect research participants.
Step-by-step explanation:
Under Subpart A of Title 45 (45 CFR 46), the requirements for IRB membership include specific criteria that individuals must meet to become members. This includes having sufficient experience, expertise, and diversity to review and approve research protocols. Additionally, the IRB must be comprised of at least five members, with varying backgrounds, knowledge, and qualifications. Specific requirements for IRB membership can vary depending on the type of research being conducted. For example, if the research involves special populations such as prisoners or children, the IRB must include at least one individual with knowledge or experience in these areas. The IRB may also include non-scientific members who represent the community perspective. The primary goal of these requirements is to ensure that IRBs have the necessary expertise and diversity to protect the rights and welfare of research participants.