Unproven or unsatisfactory versus equipoise in emergency research with waived consent

American Journal of Bioethics

Volumn 6, Issue 3, 2006, Pages 44-45

  Spellecy, Ryan ^a  

^a MEDICAL COLLEGE OF WISCONSIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD SUBSTITUTE; HEMOGLOBIN; POLYMERIZED HEMOGLOBIN;

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; EMERGENCY HEALTH SERVICE; EMERGENCY TREATMENT; ETHICS; FOOD AND DRUG ADMINISTRATION; HEMORRHAGIC SHOCK; HUMAN; INFORMED CONSENT; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS; SHORT SURVEY; UNITED STATES; VULNERABLE POPULATION;

BLOOD SUBSTITUTES; EMERGENCY SERVICE, HOSPITAL; EMERGENCY TREATMENT; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HEMOGLOBINS; HUMANS; INFORMED CONSENT; RANDOMIZED CONTROLLED TRIALS; SHOCK, HEMORRHAGIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VULNERABLE POPULATIONS;

EID: 33745078251     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265160600685952     Document Type: Short Survey

References (4)

1. Code of Federal Regulations. Title 21, Chapter 1 - Food and Drug Administration, DDHS; Part 50 - Protection of Human Subjects, Section 24.
2. Derse, A. R. 2006. Keeping the exception from undermining the rule. American Journal of Bioethics 6(3): 36-37.
3. FDA Information Sheets. 1998. Exception from informed consent for studies conducted in emergency settings: Regulatory language and excerpts from preamble. Available from: http://www.fda.gov/oc/ohrt/irbs/except.html (Accessed March 31, 2006).
4. Kipnis, K., N. M. P. King, and R. M. Nelson. 2006. An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial. American Journal of Bioethics 6(3): 18-21.