Institutional Not-for-Cause Compliance Review Programs

[...] institutions that are establishing these programs may be uncertain about the extent of personnel resources to assign to such programs, the number of compliance reviews that should be performed over time, the process for completing the reviews, and the effectiveness of a review program to ensure that investigators comply with research protocols. Undertaking not-for-cause compliance reviews is a relatively new activity at academic institutions that conduct human subjects research. [...] it is not surprising that there is little information about the nature of these programs or about standards that have been accepted or even proposed to determine the effectiveness and/or the quality of such a program.