Research without consent: Exception from and waiver of informed consent in resuscitation research

Science and Engineering Ethics

Volumn 13, Issue 3, 2007, Pages 361-369

  Biros, Michelle H ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Emergency research; Exception from consent; Waiver of consent

Indexed keywords

ARTICLE; ETHICS; GOVERNMENT REGULATION; HUMAN; INFORMED CONSENT; LEGAL ASPECT; PRACTICE GUIDELINE; RESEARCH ETHICS; RESUSCITATION; UNITED STATES;

ETHICS, RESEARCH; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INFORMED CONSENT; RESUSCITATION; UNITED STATES;

EID: 38349164742     PISSN: 13533452     EISSN: 16605454     Source Type: Journal    
DOI: 10.1007/s11948-007-9020-y     Document Type: Article

References (13)

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.
6. Prentice, E. D., Antonson, D. L., Leibrock, L. G., Kelso, T. K., & Sears, T. D. (1994). An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements. IRB, 16(1,2), 16-18.
7. Abrahamson, N. S., Meisel, A., & Safar, P. (1986). Deferred Consent: A New Approach for Resuscitation Research on Comatose Patients. The Journal of the American Medical Association, 255, 2466-2471.
8. Ellis, G. B. (1993) "Dear Colleague" Letter. Human Subjects Protection. OPRR Reports. August 12, 1993; No 93-3.
9. Biros, M. H. (1996). Development of the Multi-organizational Document Regarding Emergency Ressearch Consent. Academic Emergency Medicine, 3(2), 101-105.
10. Biros, M. H., Lewis, R. J., Olson, C. M., Runge, J. W., Cummins, R. O., & Frost, N. (1995). Informed Consent in Emergency Research. Consensus Statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. The Journal of the American Medical Association, 273, 1283-1287.
11. National Commission for the Protection of Human Subjects of Biomedical, Behavorial Research (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. OPRR Publication, Washington, DC., 887-806.
12. Baren, J. M., Anicetti, J. P., Ledesma, S., Biros, M. H., Mahabee-Gittens, M., & Lewis, R. J. (1999). An Initial Approach to Community Consultation Prior to Initiating and Emergency Research Study Incorporating a Waiver of Informed Consent. Academic Emergency Medicine, 6(12), 1210-1215.
13. Biros, M. H., Fish, S. S., & Lewis, R. J. (1999). Implementing the Food and Drug Administration's Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances. Academic Emergency Medicine, 6(12), 1272-1282.