How does an IRB handle consent for participants with diminished capacity?

When working with participants who have diminished capacity, the IRB mandates that consent must be obtained from legally authorized representatives. This is crucial because individuals with diminished capacity, such as minors or those with cognitive impairments, may not be able to fully understand the implications of participation in research or provide informed consent themselves. By requiring consent from legally authorized representatives, the IRB ensures that the decision to participate in research respects the legal rights and best interests of the vulnerable participants. This process is designed to uphold ethical standards in research and protect those who may not be able to advocate for themselves.

The other choices do not align with ethical guidelines or legal standards. Obtaining consent solely from participants who may lack capacity would not ensure that their rights and welfare are protected. Ignoring consent requirements altogether undermines the ethical foundation of research involving human subjects, and allowing any family member to give consent does not guarantee that the representative is legally authorized to make decisions on behalf of the participant. Thus, the requirement for consent from legally authorized representatives is essential in maintaining the ethical integrity of research involving individuals with diminished capacity.