Management Issue 13:
Oversight and Enforcement of the Department's Ethics Programs
Why This Is a Challenge
Conflicts of interest in the health care system generally, and specifically in the Department, have been the subject of scrutiny by Congress, the medical community, and the media. With a heightened focus on transparency in the federal government and the need to use resources efficiently and appropriately, the Department must ensure that internal and external stakeholders (e.g., employees, grantees) are free of conflicts of interest or other ethics concerns. However, results of our work indicate that the Department can do more to ensure that ethics vulnerabilities are identified and addressed.
OIG work has found that the Department provides limited oversight of conflicts of interest of FDA clinical investigators, NIH grantees, and federal employees. For example, in a 2011 report, we found that 56 percent of the HHS employees' conflict-of-interest waivers reviewed were not documented as recommended in Governmentwide federal ethics regulations, guidance, and the Secretary's instructions. In another review, we found that only 70 of 156 responding NIH grantee institutions had written policies and procedures for addressing institutional conflicts of interest (these policies are not required by law). Increased reliance on contract personnel raises additional conflict concerns. For instance, we found inappropriate use of contractor personnel at CDC (i.e., contractors' supervising federal employees). To ensure public trust in Department programs and operations, the Department must be steadfast in its oversight and enforcement responsibilities regarding ethics matters.
Progress in Addressing the Challenge
CDC has taken significant steps to improve the process for granting waivers for identified conflicts of interest to Special Government Employees (SGE). CDC now ensures that SGEs' Confidential Financial Disclosure Reports are complete before certifying them. CDC also has a policy for tracking SGEs' compliance with ethics requirements, including recusal procedures for upcoming meetings in which an SGE might have a conflict.
FDA has also taken steps to address identified vulnerabilities related to its clinical investigators. FDA now requires companies applying to market drugs, devices, and biologics (sponsors) to submit a complete list of clinical investigators and either certify the absence of a financial conflict of interest or disclose the nature of the financial arrangement to FDA for each clinical investigator. Additionally, FDA updated the Compliance Program Guidance Manual chapter on clinical investigator inspections to help ensure that clinical investigators submit required financial information to sponsors.
Similarly, NIH has taken actions to address conflict-of-interest vulnerabilities identified among NIH grantees. For instance, NIH published a final rule on August 25, 2011, revising 1995 regulations covering financial conflicts of interest for investigators. It addresses a number of issues related to promoting objectivity in research and addresses our recommendation to require grantee institutions to provide details regarding the nature of financial conflicts of interest and the ways in which they are managed, reduced, or eliminated.
What Needs To Be Done
OIG has recommended that NIH develop regulations governing institutional conflicts of interest, but the final rule does not address our concerns regarding institutional conflicts. Instead, in the final rule, NIH States that "[w]e continue to believe that further careful consideration is necessary before PHS [Public Health Service] regulations could be formulated that would address the subject of institutional conflict of interest." OIG continues to recommend that NIH issue regulations requiring institutions to have a written policy on institutional conflicts. This would provide consistency and clarity to institutions.
The Office of the General Counsel should provide guidance to OPDIVs and Staff Divisions and ensure that they document conflict-of-interest waivers in accordance with the Secretary's guidance. FDA and CDC should continue to build upon the actions they have undertaken to improve oversight of clinical investigators and SGEs.
Key OIG Resources
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Priority recommendations summarized.
FY 2016 Work Plan
OIG projects planned for 2016.
Significant OIG activities in 6-month increments.