1. Success in Spite of Failure: Why IRBs Falter in Reviewing Risks and Benefits
2. 24. 45 C.F.R. §§ 46.101-.409 (1983)
3. and 21 C.F.R. §§ 50.20-.48 (1993). More guidance at the national level on the meaning of these terms is necessary.
4. “Surrogate Decision Making for Severely Cognitively Impaired Research Subjects: The Continuing Debate,”;DeRenzo;Cambridge Quarterly of Healthcare Ethics,1993
5. 36. Additional protections may also be necessary when the research presents a high risk of harm to the subjects, or when the subject population is considered unusually vulnerable to coercive tactics designed to induce participation.