1. 21 CFR 50.24 and 45 CFR 46.101(i) (1996). Protection of human subjects; informed consent, and waiver of informed consent requirements in certain emergency research; final rules. Federal Register. 61 (192, Oct 2): 51498–51533.
2. Waiver of Informed Consent Requirements in Certain Emergency Research Circumstances DHHS Regulations (45CFR Part 46): Informed Consent Requirements in Emergency Research; OPRR Reports: October 31, 1996, 97–101.
3. Office of Science, Technology Policy. (1991). Federal policy for the protection of human subjects. Federal Register, 56, 28002–28032.
4. 21 CFR 50 (1991). Protection of Human Subjects (Informed Consent Requirements, FDA).
5. Prentice, E. D., Antonson, D. L., Leibrock, L. G., Prabhu, V. C., Kelso, T. K., & Sears, T. D. (1993). IRB review of a Phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury. IRB, 15(5), 1–8.