Research involving critically ill subjects in emergency circumstances: New regulations, new challenges

Neurology

Volumn 48, Issue 5, 1997, Pages 1151-1155

  Wichman, Alison ^a   Sandler, Alan L ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CRITICAL ILLNESS; EMERGENCY MEDICINE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; PRIORITY JOURNAL; REVIEW;

EID: 0031004337     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/WNL.48.5.1151     Document Type: Review

References (13)

1. Protection of human subjects; informed consent and waiver of informed consent in emergency research; final rule. Federal Register 1996;61:51498-51531.
2. Waiver of informed consent requirements in certain emergency research. Federal Register 1996;61:51531-51533.
3. 21 CFR Parts 50 and 56. Food and Drug Administration Regulations for the Protection of Human Subjects. Revised June 18, 1991.
4. 45 CFR Part 46. Department of Health and Human Services Regulations for the Protection of Human Subjects. Revised June 18, 1991.
5. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles for the protection of human subjects of research. Washington, DC: Government Printing Office, April 18, 1979. [U.S. Department of Health and Human Services Publication GPO 887-809.]
6. Karlawish HT, Hall JB. The controversy over emergency research. Am J Respir Crit Care Med 1996;153:499-506.
7. Prentice ED, Antonson DL, Leibrock LG, Prabhu VC, Kelso TK, Sears TD. An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements. IRB 1994;16:16-18.
8. McCarthy CR. To be or not to be: waiving informed consent in emergency research. Kennedy Inst Ethics 1995;5:155-162.
9. Action related to emergency research activity. Federal Register 1995;60:38353.
10. Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 1995;273:1283-1287.
11. Public forum on informed consent in clinical research in emergency circumstances. Sponsored by the Food and Drug Administration and the National Institutes of Health, Bethesda, MD, DHHS, January 9-10, 1995.
12. Protection of human subjects: informed consent; proposed rule. Federal Register 1995;60:49086-49103.
13. FDA Information Sheet. Exception from informed consent for studies conducted in emergency settings: regulatory language and excerpts from preamble. Rockville, MD: Food and Drug Administration. Office of Health Affairs, November 7, 1996.