Abstract
The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”.
Similar content being viewed by others
References
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.
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.
Office of Science, Technology Policy. (1991). Federal policy for the protection of human subjects. Federal Register, 56, 28002–28032.
21 CFR 50 (1991). Protection of Human Subjects (Informed Consent Requirements, FDA).
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.
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.
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.
Ellis, G. B. (1993) “Dear Colleague” Letter. Human Subjects Protection. OPRR Reports. August 12, 1993; No 93–3.
Biros, M. H. (1996). Development of the Multi-organizational Document Regarding Emergency Ressearch Consent. Academic Emergency Medicine, 3(2), 101–105.
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.
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.
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.
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.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Biros, M.H. Research without Consent: Exception from and Waiver of Informed Consent in Resuscitation Research. Sci Eng Ethics 13, 361–369 (2007). https://doi.org/10.1007/s11948-007-9020-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11948-007-9020-y