Using central IRBs for multicenter clinical trials in the United States.
Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transf...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2013-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC3559741?pdf=render |
| _version_ | 1818460291656056832 |
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| author | Kathryn E Flynn Cynthia L Hahn Judith M Kramer Devon K Check Carrie B Dombeck Soo Bang Jane Perlmutter Felix A Khin-Maung-Gyi Kevin P Weinfurt |
| author_facet | Kathryn E Flynn Cynthia L Hahn Judith M Kramer Devon K Check Carrie B Dombeck Soo Bang Jane Perlmutter Felix A Khin-Maung-Gyi Kevin P Weinfurt |
| author_sort | Kathryn E Flynn |
| collection | DOAJ |
| description | Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. We found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. We identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document we created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation's capacity to efficiently conduct the large number of high-quality trials. |
| first_indexed | 2024-12-14T23:27:55Z |
| format | Article |
| id | doaj.art-49f9320bae1b4a1a918c3fee016c65d7 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-14T23:27:55Z |
| publishDate | 2013-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-49f9320bae1b4a1a918c3fee016c65d72022-12-21T22:43:46ZengPublic Library of Science (PLoS)PLoS ONE1932-62032013-01-0181e5499910.1371/journal.pone.0054999Using central IRBs for multicenter clinical trials in the United States.Kathryn E FlynnCynthia L HahnJudith M KramerDevon K CheckCarrie B DombeckSoo BangJane PerlmutterFelix A Khin-Maung-GyiKevin P WeinfurtResearch institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. We found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. We identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document we created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation's capacity to efficiently conduct the large number of high-quality trials.http://europepmc.org/articles/PMC3559741?pdf=render |
| spellingShingle | Kathryn E Flynn Cynthia L Hahn Judith M Kramer Devon K Check Carrie B Dombeck Soo Bang Jane Perlmutter Felix A Khin-Maung-Gyi Kevin P Weinfurt Using central IRBs for multicenter clinical trials in the United States. PLoS ONE |
| title | Using central IRBs for multicenter clinical trials in the United States. |
| title_full | Using central IRBs for multicenter clinical trials in the United States. |
| title_fullStr | Using central IRBs for multicenter clinical trials in the United States. |
| title_full_unstemmed | Using central IRBs for multicenter clinical trials in the United States. |
| title_short | Using central IRBs for multicenter clinical trials in the United States. |
| title_sort | using central irbs for multicenter clinical trials in the united states |
| url | http://europepmc.org/articles/PMC3559741?pdf=render |
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