Private sponsors of clinical research studies, such as pharmaceutical companies and medical device manufacturers, rely on the successful recruitment of both treatment subjects to enroll in the study and investigators to conduct the study. With respect to the rules governing the recruitment of treatment subjects, ethicists and lawyers have focused on protections surrounding informed consent and HIPAA compliance. With respect to the recruitment of investigators, commentators typical focus on concerns about conflicts of interest because, if investigators have a financial stake in the results of the research, their independence and objectivity may be compromised.
Recruitment of investigators, however, deserves an additional look. Recently, government enforcement agents monitoring fraud and abuse have begun to scrutinize the financial relationships between investigators and private sponsors of research as well. In April 2003, the Office of the Inspector General (OIG) of the Centers for Medicare and Medicaid (CMS) issued Final Compliance Program Guidance for Pharmaceutical Manufacturers (the Guidance). The Guidance was primarily aimed at gifts to physicians and other health care providers from industry that might influence a physician’s prescribing decisions and thereby increase costs to federal health care programs. However, the Guidance also questioned the validity of research contracts between manufacturers and providers that manufacturers attempt to structure within the personal service exception of the anti-kickback statute. The Guidance indicates post-marketing research contracts would be “especially scrutinized” because of concerns that these contracts are particularly prone to being pretexts to generate unnecessary prescriptions of a drug. However, the Guidance gives no indication that post-marketing contracts will be the only contracts that receive increased federal scrutiny. On September 5, 2003, the OIG published in the Federal Register “Solicitation of Information and Recommendations for Developing Compliance Program Guidance for Recipients of NIH Research Grants.” The notice and comment period closed in November 2003 and final guidance has yet been issued. This proposed guidance signals that the OIG may intend to take a more active role in monitoring the solicitation, receipt and use of federal grant monies through its general fraud and abuse prevention mechanisms.
The Guidance does not prohibit manufacturers from recruiting potential investigators by promising them direct remuneration (i.e. fee for service contracts) or a financial stake in the research. However, the Guidance counsels against certain provisions in these contracts and encourages manufacturers to ensure contracts document the research question and the research is separate and distinct from purchasing or marketing. If contracts between pharmaceutical and medical device companies and investigators are found to contain improper financial relationships, the parties may not only face allegations of an improperly managed conflict of interest (and, therefore, unusable research results for publishing and U.S. Food and Drug Administration approval purposes), but also face investigation for fraud and abuse by the OIG. Pharmaceutical companies and manufacturers, therefore, should review their existing research contracts with health care providers to ensure these contracts incorporate the considerations stated by the OIG in April 2003.