Centralized IRB models for emergency care research

IRB Ethics and Human Research

Volumn 36, Issue 2, 2014, Pages 1-9

  Goldkind, Sara F ^a   Brosch, Laura Ruse ^b   Biros, Michelle ^c   Silbercleit, Robert ^d   Sopko, George ^e  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b U S ARMY MEDICAL RESEARCH AND MATERIEL COMMAND   (United States)

^c UNIVERSITY OF MINNESOTA   (United States)

^d UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^e NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; EMERGENCY HEALTH SERVICE; ETHICS; HUMAN; MEDICAL RESEARCH; NONBIOLOGICAL MODEL; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD;

BIOMEDICAL RESEARCH; EMERGENCY MEDICAL SERVICES; ETHICS COMMITTEES, RESEARCH; HUMANS; MODELS, ORGANIZATIONAL;

EID: 84898644057     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. A "disaster" in the context of a public health emergency denotes an event of low probability but high impact that causes a large number of individuals to become ill or injured. Institute of Medicine. Hospital-Based Emergency Care: At the Breaking Point. Washington, DC: National Academies, 2006, p. 265.
2. See ref. 1; Institute of Medicine. Emergency Medical Services: At the Crossroads. Washington, DC: National Academies, 2006, p. 208.
3. Lurie N, Manolio T, Patterson A.P., Collins F., Frieden T. Research as a part of public health emergency response. NEJM 2013; 368: 1251-1255.
4. Resuscitation Outcomes Consortium. https://roc.uwctc.org/tiki/tiki-index. php.
5. Tisherman, SA, Powell, JL, Schmidt, TA, et al. Regulatory challenges for the resuscitation outcome consortium. Circulation 2008; 118: 1585-1592.
6. ASPR Workshop: Scientific Preparedness and Response for Public Health Emergencies. 25 September 2012. http://www.phe.gov/Preparedness/legal/Documents/ scientific-prep-report.pdf.
7. U.S. Food and Drug Administration. Protection of Human Subjects: Exception from Informed Consent Requirements for Emergency Research. 21 CFR 50.24.
8. U.S. Department of Health and Human Services. Secretarial waiver of informed consent requirements in certain emergency research. Federal Register, 61: 192 (2 October 1996) pp. 51531-51533. http://www.hhs.gov/ohrp/policy/hsdc97- 01.html
9. OHRP's Frequently Asked Questions, #30, http://www.hhs.gov/ohrp/policy/ consentfaqsmar2011.pdf
10. U.S. Food and Drug Administration. Using a Centralized IRB Review Process in Multicenter Clinical Trials, March 2006, http://www.fda.gov/ RegulatoryInformation/Guidances/ucm127004.htm.
11. U.S. Department of Health and Human Services. Use of a Centralized Institutional Review Board, April 30, 2010, http://www.hhs.gov/ohrp/policy/ Correspondence/cirb20100430.html.
12. U.S. Food and Drug Administration. 21 CFR 56.107(f) and 56.114; U.S. Department of Health and Human Services. 45 CFR 46.107(f) and 46.114. See also, U.S. Food and Drug Administration Guidance. Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for Industry-Using a Centralized IRB Review Process in Multicenter Clinical Trials. March 2006. http://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm.
13. Menikoff, J. The paradoxical problem with multiple IRB reviews. NEJM 2010; 363: 1591-1592
14. Resnik, D.B. Centralized institutional review boards: Assessing arguments and evidence. Journal of Clinical Research Best Practices 2012; 8(11): 1-13.
15. By community, the FDA means the community (or communities) in which the study will take place and the community from which the study subjects will be drawn. The FDA interprets the phrase "community in which the research will be conducted" to mean the geographical area, for example, a hospital or other facility or a city or region where the hospital or clinical investigator study site is located. The FDA interprets the phrase "community from which subjects will be drawn" to mean the group of patients who share a particular medical or other characteristic that increases the likelihood that they (or a family member) may be enrolled in the study. For more information, see questions 54-56 in the FDA's Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors on Exception from Informed Consent Requirements for Emergency Research, March 2011. http://www.fda.gov/downloads/ RegulatoryInformation/Guidances/UCM249673.pdf.
16. These institutions are performance sites engaged in emergency care research. OHRP, Engagement of Institutions in Human Subjects Research, 16 October 2008. http://www.hhs.gov/ohrp/policy/engageo8.html.
17. Flynn KE, Hahn CL, Kramer J.M., Check DK, Dombeck CB, et al. Using central IRBs for multicenter clinical trials in the United States. PLOS One 2013; 8(1): e54999.
18. Icenogle, DL. IRBs, conflicts and liability: Will we see IRBs in court? Or is it when? Clinical Medical & Research 2003; 1(1): 63-68
19. Robertson v. J. Michael McGee, No. 4: 01-cv-00060 (N.D. Ok. filed Jan. 2001)
20. Scheer v. Burke et al., No. 000375 (Philadelphia County Court of Common Pleas filed July 2003
21. Aller v. University of California at Los Angeles, No. SC015698 (Los Angeles County Superior Court filed Mar. 1992).
22. U.S. Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office for Human Research Protections. ACTION: Advanced notice of proposed rulemaking; request for comments. Federal Register Notice: March 5, 2009 (Volume 74, number 42): 9578-9583. http://www.gpo.gov/fdsys/pkg/FR-2009-03-05/html/E9-4628.htm.
23. U.S. Department of Health and Human Services. 45 CFR Parts 46, 160, and 164; U.S. Food and Drug Administration. 21 CFR Parts 50 and 56, Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, Advance notice of proposed rulemaking. Federal Register Notice: July 26, 2011 (Volume 76, number 143): 44512-44531. http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm.
24. The FDA has issued compliance letters to IRBs related to human subjects protection regulations and on some occasions related to 21 CFR 50.24 regulations specifically. U.S. Food and Drug Administration warning letters are publicly available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ default.htm.
25. National Institute of Neurological Disorders and Stroke (NINDS) NeuroNEXT: Network for Excellence in Neuroscience. http://www.neuronext.org/.