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Clinical Trial Watch

Emergency Research With Waiver of Informed Consent (21 CFR 50.24 and 21 CFR 312.54(a)): Information about emergency research studies with waiver of informed consent is posted to FDA Docket 1995s-0158. The original index of FDA Docket 1995s-0158 has documents submitted between 1996 and September 2007: http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s0158.htm

Updated 2010-02-04: FDA Docket 1995s-0158 submissions are available via Regulations.gov at: http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-1995-S-0036

Find FDA Dockets by searching at: http://www.regulations.gov/search/Regs/home.html#advancedSearch

For background readers may be interested in:

Wall Street Journal; Winslow, A. FDA Halts Test on Device That Shows Promise for the Victims of Cardiac Arrest. 19940511/P. Bates: 2046936882. Available from http://tobaccodocuments.org/pm/2046936882.html. Accessed 2006-03-17.

FDA Enforcement Report. Ambu Incorporated Firm-Initiated Recall. Product: CardioPump ACD. Reason: The firm was using data from an unapproved clinical investigation on human subjects to support a 510(k) application. 1994-04-19. Available from http://www.fda.gov/bbs/topics/ENFORCE/ENF00325.html

FDA Warning Letter to Ambu Incorporated. 1996-11-13. Available from http://www.fda.gov/foi/warning_letters/d1655b.pdf

FDA Import Alert #89-08 Detention Without Physical Examination of Class III Devices W/O Approved PMAs or IDEs and Other Devices Not Equivalent or No 510K. 2001-08-13 (revised 2006-02-09). Available from http://www.fda.gov/ora/fiars/ora_import_ia8908.html

FDA Circulatory System Devices Panel. PMA P970041, Ambu International A/S, CardioPump ACD. 1998-06-29. Available from http://www.fda.gov/ohrms/dockets/ac/98/transcpt/34331t.pdf

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research. Draft Guidance. 2000-03-30. Available from http://www.fda.gov/ora/compliance_ref/bimo/emrfinal.pdf

21 CFR 50 et. al. 45 CFR 46. Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Requirements. Final Rules. Department of Health and Human Services, Food and Drug Administration. 61 FR 191 (1996-10-02) pp. 51498-51531. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-nfr00001-vol1.pdf. Accessed 2006-03-17.

Examples of Emergency Research With Waiver of Informed Consent

RESUS (currently subject to FDA clinical hold): Review of a Proposed Clinical Trial of HBOC-201 in Trauma. Accessed on 2007-01-24 at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4270B1-01.pdf

Naval Medical Research Center's Briefing Book for the 14 December 2006 Blood Products Advisory Committee (BPAC) Meeting. Accessed on 2007-01-24 at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4270B1-11.pdf

Briefing Documents, 14 December 2006 Blood Products Advisory Committee (BPAC) Meeting. Accessed on 2007-01-24 at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4270B1-index.htm

Transcript pp. 1-100, 14 December 2006 Blood Products Advisory Committee (BPAC) Meeting. Accessed on 2007-01-24 at: http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4270t1-01-BPAC.pdf

Transcript pp. 101-200, 14 December 2006 Blood Products Advisory Committee (BPAC) Meeting. Accessed on 2007-01-24 at: http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4270t1-02-BPAC.pdf

Transcript pp. 201-300, 14 December 2006 Blood Products Advisory Committee (BPAC) Meeting. Accessed on 2007-01-24 at: http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4270t1-03-BPAC.pdf

Transcript pp. 301-416, 14 December 2006 Blood Products Advisory Committee (BPAC) Meeting. Accessed on 2007-01-24 at: http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4270t1-04-BPAC.pdf

IDE G980067: Automated External Defibrillators. Public Access Defibrillation. Yearly Report 2003. 1995s-0158. Rpt. 11. Vol. 19. 2003-06-05. Available from http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/061203/95s-0158-rpt0011-01-vol19.pdf

Ornato JP, for the PAD Trial Investigators. The Public Access Defibrillation (PAD) Trial study design and rationale. Resuscitation. 2003;56:135-147. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-rpt0011-02.pdf. Accessibility verified 2006-03-21.

IND 66463: Vasopressin in Cardiac Arrest. 1995s-0158. Rpt. 10. Vol. 5. 2003-06-06. Available from http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/061003/95s-0158-rpt0010-vol5-web.pdf

IND 10292: The Effect of Hypertonic Resuscitation for Blunt Trauma. Amendment No:1 to Protocol Version I September, 2003. 1995s-0158. Rpt. 16. Vol. 19. 2004-01-28. Available from http://www.fda.gov/ohrms/dockets/dailys/04/feb04/020504/95s-0158-rpt00016-vol19.pdf

Research With Waiver of Informed Consent / Upcoming

Rescuscitation Outcomes Consortium (ROC) Overview. Available from https://roc.uwctc.org/tiki/roc-background

New Federally Funded Research Program Aims to Improve Survival from Cardiac Arrest and Severe Trauma. National Institutes of Health Press Release. 2006-03-24. Available from http://www.nhlbi.nih.gov/new/press/06-03-24.htm

Clinical Research Consortium to Improve Resuscitation Outcomes, Frequently Asked Questions. National Heart, Lung, and Blood Institute (NHLBI). Available from http://www.nhlbi.nih.gov/funding/inits/resus_faq.htm

RFA: HL-04-001. Clinical Research Consortium to Improve Resuscitation Outcomes. National Institutes of Health. 2003-07-02. Available from http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-04-001.html

Common Rule Faux-Pas

Carome MA. OHRP Determination Letter to Toxicology Associates and Orphan Medical Inc. 2000-10-26. Available from http://www.hhs.gov/ohrp/detrm_letrs/oct00o.pdf


Last Updated: 2010-02-04

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