Additional safeguards for vulnerable subjects. Members who are affiliated with the protocol must recuse themselves from the IRB discussion and vote, and leave the room during the discussion and when the vote is taken. If a quorum is lost because members recuse themselves, no action may be taken on the protocol. The Chair should provide a brief explanation of any expedited actions. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reason- ably be expected to result.
Subject selection is equitable.
Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence. Subject safety is maximized. Additional considerations 1. The research involves no more than minimal risk to subjects. The research involves more than minimal risk to subjects.