The U.S. Office of Inspector General (OIG) published "Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards" in the Monday, November 28, 2005 Federal Register.
The draft guidance, which targets recipients of biomedical and behavioral research awards, is not mandatory. Instead, it is intended as a suggestion for establishing internal controls to enhance compliance with Public Health Service (PHS ) extramural research awards rules and standards. In it, the OIG lists eight elements fundamental to effective compliance programs. Seven of the eight are the same as those identified in other OIG health care compliance guidance. The eighth, defining roles and responsibilities and assigning oversight responsibility, is defined specifically as "especially important for research institutions." Among the issues on which the guidance focuses are those relating to allowable costs (time and effort reporting, proper allocation of costs to research awards, and reporting of other sources of support) and the associated risks of civil or criminal fraud.
The text of the "Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards" can be found at http://www.oig.hhs.gov/fraud/docs/complianceguidance/PHS%20Research%20Awards%20Draft%20CPG.pdf.
Comments are solicited and are due no later than 5 p.m. on December 28, 2005.
This draft guidance concerning PHS grants is one of several significant research compliance reform measures initiated by the federal government in the last two to three years. Other recent reform initiatives include the following:
DHHS (Department of Health and Human Services) regulations providing guidance on conflicts of interest in research (69 Federal Register 26393, May 12, 2004)
DHHS regulations governing research integrity (scientific integrity and scientific misconduct) (Public Health Service Policies on Research Misconduct, 42 CFR Part 93 (June 2005))
U.S, House of Representatives Committee on Energy and Commerce's call for OIG examinations of alleged university misuse of NIH (National Institutes of Health) grants
April 2003 "Compliance Program Guidance for Pharmaceutical Manufacturers," published by the Office of the Inspector General, in which the OIG notes the potential violation of the Anti-Kickback Law (42 U.S.C. § 1320a-7b; 42 C.F.R. § 1001.952) if pharmaceutical companies that sponsor research pay health care providers more than the fair market value of the services rendered by those providers in connection with the research project