How good does the science have to be in proposals submitted to Institutional Review Boards? An interview study of Institutional Review Board personnel.

ABSTRACT:

Background

Institutional Review Boards (IRBs) have been increasingly criticized for how they review protocols, but how IRBs perceive, and make decisions about, the quality of the science of protocols has not been examined.

Purpose

To explore how and when IRBs view and make decisions about the quality of the science of studies they review.

Methods

I contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding) and interviewed IRB chairs, co-chairs, administrators, and a director from 34 IRBs (response rate = 55%), and an additional 7 members.

Results

Interviewees faced several ambiguities and questions concerning the quality of the science of protocols. IRBs are often not sure how an

SUBMITTER: Klitzman R 

PROVIDER: S-EPMC3918462 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature