Using Central IRBs for Multicenter Clinical Trials in the United States

PLoS ONE

Volumn 8, Issue 1, 2013, Pages

  Flynn, Kathryn E ^a,b   Hahn, Cynthia L ^c   Kramer, Judith M ^a,b   Check, Devon K ^a   Dombeck, Carrie B ^a   Bang, Soo ^d   Perlmutter, Jane ^e   Khin Maung Gyi, Felix A ^f   Weinfurt, Kevin P ^a,b  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH   (United States)

^d CELGENE CORPORATION   (United States)

^e Gemini Group   (United States)

^f Chesapeake IRB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; HUMAN; INSTITUTIONAL ETHICS; INSTITUTIONAL REVIEW; LEGAL LIABILITY; MEDICAL ETHICS; MULTICENTER STUDY (TOPIC); PATIENT ADVOCACY; PROFESSIONAL COMPETENCE; PROFESSIONAL DEVELOPMENT; PUBLIC-PRIVATE PARTNERSHIP; PUBLICATION; QUALITATIVE ANALYSIS; UNITED STATES;

CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; HUMANS; INTERNET; MULTICENTER STUDIES AS TOPIC; PATIENT ADVOCACY; TRUST; UNITED STATES;

EID: 84873849027     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0054999     Document Type: Article

References (8)

1. Menikoff J, (2010) The paradoxical problem with multiple-IRB review. N Engl J Med 363: 1591-1593.
2. Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J, (2010) Costs and benefits of the national cancer institute central institutional review board. J Clin Oncol 28: 662-666.
3. Department of Health and Human Services (2011) Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Fed Regist 76: 44512-44531.
4. US Food and Drug Administration (2006) Guidance for industry: using a centralized IRB review process in multicenter clinical trials. Available: http://www.fda.gov/cber/gdlns/irbclintrial.pdf. Accessed 2012 Jul 31.
5. Menikoff J (2010) OHRP Correspondence. Available: http://www.hhs.gov/ohrp/policy/Correspondence/mcdeavitt20100430letter.html. Accessed 2012 Aug 6.
6. Emanuel EJ, Wood A, Fleischman A, Bowen A, Getz KA, et al. (2004) Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med 141: 282-291.
7. Jansen LA, (2005) Local IRBs, multicenter trials, and the ethics of internal amendments. IRB 27: 7-11.
8. National Institute of Neurological Disorders and Stroke. NeuroNEXT: Network for Excellence in Neuroscience Clinical Trials. Available: http://www.ninds.nih.gov/news_and_events/proceedings/20101217-NEXT.htm. Accessed 2012 Aug 24.