Creating effective research compliance programs in academic institutions.

There are compelling reasons for academic medical centers to expand their present institutional compliance programs (which are for their hospitals and faculty practice plans) into their other programs, including research. Similarly, other academic institutions with research programs (e.g., universities) should expand or institute programs of compliance for research. Such research compliance programs should be established because (1) the culture in academic institutions, specifically in academic medical centers, has several characteristics (e.g., undefined roles and responsibilities, decentralized administration, possible conflict-of-interest situations) that can create compliance risks; and (2) several academic institutions, including academic medical centers, have experienced compliance issues related to their research enterprises. The authors set forth these and other reasons in detail, answer key questions about the risks and benefits of a research compliance program, explain how to establish a program, discuss its elements, describe the experiences of academic institutions that have such programs, and comment on the other positive outcomes that research compliance programs can foster for an academic institution.