What review criteria must the IRB abide by?
IRBs are required to review and approve protocols against the following criteria according to federal regulations at 45 CFR 46.111 and 21 CFR 56.111: • Procedures and research design do not unnecessarily expose subjects to risks. • Risks to subjects are reasonable in relation to anticipated benefits, if any. • Selection of subjects is equitable, taking into account special problems of research involving vulnerable populations (e.g. pregnant women, prisoners, handicapped persons, etc.) • Informed consent will be sought from each prospective subject or subject’s guardian. • Informed consent will be documented in writing (except in special circumstances). • Where appropriate, adequate provisions are in place to monitor the collected data to ensure safety of subjects. • Adequate provisions are in place to protect the privacy of subjects and maintain confidentiality of data.
