Every year, the federal government awards millions of dollars in grant funds to support clinical research activities at universities and hospitals throughout the United States. In recent months, there has been increased scrutiny of the integrity of the research conducted with these funds and several new initiatives to ensure that investigators maintain their clinical independence when conducting research.
The spotlight on the clinical research community continues to shine. On September 20, 2005 the Chairman of the Committee on Energy and Commerce of the U.S. House of Representatives, Rep. Joe Barton (R-TX-6), and the Chairman of its Subcommittee on Oversight and Investigations ("O&I Subcommittee"), Rep. Ed Whitfield (R-KY-1), requested that the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("DHHS"), Daniel Levinson, conduct an investigation into alleged misuse of federal grant money at major clinical research facilities. The committees have overlapping jurisdiction over DHHS spending on clinical research related spending and oversight activities. A press release issued the same day by the Energy and Commerce Committee indicates the Committee has asked DHHS to do all of the following:
- Determine whether there are widespread disparities between the numbers of projected research activities that grantees anticipated conducting using National Institutes of Health (NIH) grants and the numbers of research activities actually performed with such funds
- Audit the largest NIH clinical research grants to compare the number of research activities each respective grantee anticipated conducting with the number of research activities actually performed
- Investigate funding discrepancies, including false statements, improper accounting, improper charges and alleged double-billing of federal health programs for in-patient fees charges, and
- Review new allegations the Committee has received involving NIH grant money used by named institutions to compensate graduate research assistants at rates allegedly several times the salary of more post-doctoral researchers
Neither the letters to the Inspector General nor the press release clearly define the scope and purpose of this investigation. Accordingly, a wide range of institutions are potential targets of an investigation by the Inspector General and of subsequent Congressional hearings. Institutions eventually identified by the Inspector General will likely face long and costly "fishing expeditions" into their policies, procedures, research-related records and performance. These investigations may potentially stray beyond clinical research funded by federal funds due to the institution’s obligations under their Federal Wide Assurances ("FWAs") to comply with the same human subject protections regardless of the funding source on any individual clinical trial. To the extent the Inspector General’s investigation includes such considerations as human subject safety, conflicts of interest, adequacy of policies and procedures and the status of open clinical trials, institutions with an FWA could find themselves exposed to an even wider investigation.
Once the Inspector General has finished his investigation of the various institutions, it is very possible that the Energy and Commerce Committee, or the O&I Subcommittee at its direction, will further subject targeted institutions to lengthy scrutiny and require institutional leaders to testify publicly before the Congress under oath. In the event that either Congress or the Inspector General believes an institution has engaged in wrong-doing, it can refer the matter to the U.S. Department of Justice for further civil and/or criminal action which may result in fines, program exclusions or other penalties. In addition, regardless of formal civil or criminal penalties, any institution slated publicly by the Inspector General or by Congress for investigation will need to deal with the inevitable reputational damage that results and the likely reluctance by potential subjects to participate in future research projects hosted by those institutions.
As it may be some time before individual institutions are named, large research institutions may find their interests in monitoring this situation are aligned. Institutions may want to consider joining together in an anonymous member organization to more effectively reach out to committee members, to monitor committee movement on this issue and to help structure the tone, direction and purpose of the investigation. In addition, institutions are encouraged to redouble their compliance efforts with the assistance of legal counsel to ensure federal funds are being sought and allocated in compliance with applicable law.