Trials and errors: Barriers to oversight of research conducted under the emergency research consent waiver

IRB Ethics and Human Research

Volumn 28, Issue 2, 2006, Pages 16-19

  Kipnis, Ken ^a   King, Nancy M P ^b   Nelson, Robert M ^c  

^a UNIVERSITY OF HAWAII   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD SUBSTITUTE; HEMOGLOBIN;

AMBULANCE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL PROTOCOL; CLINICAL TRIAL; EMERGENCY HEALTH SERVICE; ETHICS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; LEGAL ASPECT; NOTE; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

AMBULANCES; BLOOD SUBSTITUTES; CLINICAL PROTOCOLS; CLINICAL TRIALS; EMERGENCY MEDICAL SERVICES; EMERGENCY SERVICE, HOSPITAL; ETHICS COMMITTEES, RESEARCH; GOVERNMENT REGULATION; GUIDELINE ADHERENCE; HEMOGLOBINS; HUMANS; INFORMED CONSENT; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33645462375     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (20)

1. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Volume I, Report and Recommendations of the National Bioethics Advisory Commission. Rockville, MD: National Bioethics Advisory Commission, 1998:61-63. http://www.georgetown.edu/research/nrcbl/nbac/capacity/ Moving. htm#Informed; see also sec. __.116(c) (the Common Rule) and 45 CFR 46.116(c) (DHHS) on minimal risk waivers of consent.
2. Food and Drug Administration. 21 CFR Parts 50, 56, 312, 314, 601, 812, and 814. Protection of Human Subjects; Informed Consent. Federal Register 1996;61(192):51498-51531.
3. Department of Health and Human Services. 45 CFR Part 46. Waiver of Informed Consent Requirements in Certain Emergency Research. Federal Register 1996;61(192.):51531-51533.
4. Sloan EP, Koenigsberg M, Brunett PH, et al. Post hoc mortality analysis of the efficacy trial of diaspirin cross-linked hemoglobin in the treatment of severe traumatic hemorrhagic shock. Journal of Trauma-Injury Infection & Critical Care 2002;52:887-895.
5. Hallstrom AP, Ornato JP, Weisfeldt M, et al. Public Access Defibrillation Trial Investigators. Public-access defibrillation and survival after out-of-hospital cardiac arrest. NEJM 2004;351(7):637-646.
6. See ref. 2.
7. More extensive discussion of the ER waiver rule's history and implementation may be found elsewhere, including: Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration's final rule for waiver of informed consent in certain emergency circumstances. Academic Emergency Medicine 1999;6:1272-1282;
8. Biros MH. Research without consent: Current status. Annals of Emergency Medicine 2003;42:550-564;
9. Shah AN, Sugarman J. Protecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community. Annals of Emergency Medicine 2003;4:72-78;
10. Proceedings of the 2005 AEM Consensus Conference on Ethical Conduct of Resuscitation Research. Academic Emergency Medicine 2005;12:1019-1139.
11. Northfield Laboratories Inc. Press Release: Northfield Laboratories Announces Patient Enrollment in Phase III Urban Ambulance Trial to Begin Monday, December 22. Evanston, IL, Dec. 22, 2003. http://phx.corporate-ir.net/phoenix. zhtml?c=91374&p=irol-newsArticle&ID=599107&highlight.
12. We set out a more detailed examination and critique of the design and conduct of the PolyHeme trial in: An open letter to IRBs considering Northfield Laboratories' PolyHeme trial. American Journal of Bioethics, forthcoming.
13. See ref. 8.
14. Every study site must have an IRB-approved consent form available, in case informed consent can be obtained from a subject or an LAR. See ref. 2; Japsen B. Paper barred from using data: Northfield Labs sues on blood substitute. Chicago Tribune, January 7, 2006. http://www.chicagotribune.com/ business/chi-0601070106jano7, 1,5904816.story?ctrack=1&cset=true.
15. See ref. 2.
16. Pub. L. 105-115, 105th Congress, Nov. 21, 1997.
17. Food and Drug Administration. Guidance for Industry: Special Protocol Assessment. May 2002. http://www.fda.gov/cber/gdlns/protocol.pdf.
18. "Community consultation refers to ensuring that the community(ies) is (are) involved in the IRB's decision-making process. As such, the IRB needs to provide an opportunity for the community(ies) to discuss the proposed clinical investigation and its risks and potential benefits, and to provide feedback to the IRB. The IRB should consider this community discussion when reviewing the protocol." Food and Drug Administration. Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research. March 30, 2000, p. 6. http://www.fda.gov/ora/compliance_ref/bimo/emrfinal.pdf.
19. Mann H. Clinical trial protocols: Agreements between the FDA and industrial sponsors. Lancet 2002;360:1345-1346.
20. See ref. 3.