 |
 |

Local vs Central Institutional Review Boards for Multicenter Studies
 |
 |
| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
|
 |
 |
To the Editor: Dr McWilliams and colleagues1 found that review of a protocol for a multicenter genetic epidemiology study by local institutional review boards (IRBs) was highly variable. They concluded that multiple-site IRB review is inconsistent and inefficient, and thus they recommended centralized review for such studies.
The data, however, also reveal considerable consistency between IRBs, judging by the 94% of sites that refused to waive written consent, and by the 77% that found the protocol "nonexpeditable." The data also suggest that there is variability in resources available to IRBs, as well as in standards that address the readability of consent documents. The latter factor appears to result in cycles of revisions and rebuttals, thereby lengthening time to approval.
The function of IRBs is to protect human participants through analysis of risks and benefits, and this seemed alive and well among the IRBs in the study of McWilliams et al. . . . [Full Text of this Article]
Carlos D Rosé, MD, CIP
Alfred I. duPont Hospital for Children Wilmington, Del
CiteULike Connotea Del.icio.us Digg Reddit Technorati Twitter
What's this?
RELATED ARTICLES
Local vs Central Institutional Review Boards for Multicenter StudiesReply
Rita McWilliams, Julie Hoover-Fong, Ada Hamosh, Suzanne Beck, Terri Beaty, and Garry R. Cutting
JAMA. 2003;290(16):2126-2127.
EXTRACT
| FULL TEXT
Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study
Rita McWilliams, Julie Hoover-Fong, Ada Hamosh, Suzanne Beck, Terri Beaty, and Garry Cutting
JAMA. 2003;290(3):360-366.
ABSTRACT
| FULL TEXT
|