| 2006D-0331 | Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research | ||||||||||||||||||||||
| FDA Comment Number : | EC47 | ||||||||||||||||||||||
| Submitter : | Dr. Howard Dickler | Date & Time: | 10/30/2006 11:10:36 | ||||||||||||||||||||
| Organization : | Association of American Medical Colleges | ||||||||||||||||||||||
| Category : | Association | ||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| Association of American Medical Colleges
2450 N Street NW, Washington, DC 20037-1127 T 202-828-0460 F 202-862-6161 www.aamc.org Darrell G. Kirch, M.D. President October 26, 2006 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville MD 20852 RE: Docket No. 2006D-0331 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research Conveyed electronically to: http://www.fda.gov/dockets/ecomments The Association of American Medical Colleges (AAMC) is a nonprofit association that seeks to improve the nation's health by enhancing the effectiveness of academic medicine. It represents all 125 U.S. and 17 Canadian accredited allopathic medical schools, nearly 400 major teaching hospitals and health systems, 96 academic societies, and the nation's 67,000 medical students and 104,000 residents. The AAMC is pleased to comment on this important issue, and is strongly supportive of the overall goal of the proposed guidance, namely to assist those conducting important research to improve the treatment of patients with critical illness and injury, while at the same time protecting the rights of human subjects. With this comment letter, AAMC affirms its support of the comments appended at the end of this letter of two other groups. One is the Society for Academic Emergency Medicine (SAEM), a constituent organization of the AAMC, and the other is the network of investigators supported by NIH/NINDS for Neurological Emergencies Treatment Trials (NETT). The comments of both of these organizations indicate that the proposed guidance does not address a number of important issues including: | |||||||||||||||||||||||
| " Patient populations that are not considered in the Final Rule, such as children;
" Definition of unsatisfactory or unproven and the need for incremental risk assessment; " Guidance for out of hospital research; " Guidance for multi-center trials and the use of central IRBs; " Defining the purpose and criteria for assessment of community consultation; " Defining the purpose and criteria for assessment of public notification. The NETT investigators have proposed specific guidance language to address some of these areas. While we commend their efforts as thoughtful and well reasoned, we are also mindful of the need for the development of a broad consensus on these issues. Thus, we strongly support the suggestion from SAEM for convening a stakeholders meeting to revisit the requirements of the Final Rule. Please contact Howard B. Dickler, M.D. (hdickler@aamc.org; 202-828-0567) of the AAMC staff for questions or clarification of these comments. We thank you again for the opportunity to express our concerns. Sincerely, Darrell G. Kirch, M.D. Conduct of Emergency Research FDA Public Hearing, Oct 11, 2006 Michelle H. Biros, MD, MS Professor of Emergency Medicine Department of Emergency medicine Hennepin County Medical Center and University of Minnesota 701 park Avenue South Minneapolis, Minnesota 55415 612-873-5683 FAX; 612 -904-4241 Michelle.Biros@gmail.com Affiliation; Society for Academic Emergency Medicine and The Coalition of Acute Resuscitation Researchers Introduction The Society for Academic Emergency Medicine (SAEM) is grateful for the opportunity to provide comments from its membership to the FDA related to The Exception from Informed Consent (EFIC) in Emergency Research Circumstances. The Coalition of Acute Resuscitation Researchers (the Coalition) joins SAEM in this presentation, and we include comments from members of the American Academy of Emergency Medicine (AAEM). In 1994, SAEM took the lead in discussions related to issues of consent in emergency research circumstances. The Coalition was developed at the request of SAEM to broaden these discussions and included thought leaders from throughout the research community | ||