Using Central IRBs for Multicenter Clinical Trials in the United States

Author:

Flynn Kathryn E.,Hahn Cynthia L.,Kramer Judith M.,Check Devon K.,Dombeck Carrie B.,Bang Soo,Perlmutter Jane,Khin-Maung-Gyi Felix A.,Weinfurt Kevin P.

Publisher

Public Library of Science (PLoS)

Subject

Multidisciplinary

Reference8 articles.

1. The paradoxical problem with multiple-IRB review;J Menikoff;N Engl J Med,2010

2. Costs and benefits of the national cancer institute central institutional review board;TH Wagner;J Clin Oncol,2010

3. Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators;Fed Regist,2011

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.

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