Liability issues for data monitoring committee members.

In randomized clinical trials, a data monitoring committee (DMC) is often appointed to review interim data to determine whether there is early convincing evidence of intervention benefit, lack of benefit or harm to study participants. Because DMCs bear serious responsibility for participant safety, their members may be legally liable for their actions. Despite more than three decades of experiences with DMCs, the issues of liability and indemnification have yet to receive appropriate attention from either government or industry sponsors. In industry-sponsored trials, DMC members are usually asked to sign an agreement delineating their responsibilities and operating procedures. While these agreements may include language on indemnification, such language sometimes protects only the sponsor rather than the DMC members. In government-sponsored trials, there has been even less structure, since typically there are no signed agreements regarding DMC activities. This paper discusses these issues and suggests sample language for indemnification agreements to protect DMC members. This type of language should be included in DMC charters and in all consulting agreements signed by DMC members.

Duke Scholars

Author Frank Wesley Rockhold Biostatistics & Bioinformatics, Division of Biostatistics