Summary of NIH-Specific Amendments to Conflict of Interest Ethics Regulations
The Department of Health and Human Services has evaluated the February 3, 2005, supplemental standards of ethical conduct regulations for NIH employees, and has made certain revisions. Three principles guided the crafting of these changes:
- The public must be assured that research decisions made at NIH are based on scientific evidence and not by inappropriate influences.
- Senior management and people who play an important role in research decisions must meet a higher standard of disclosure and divestiture than people who are not decision-makers.
- To advance the science and stay on the cutting edge of research, NIH employees must be allowed interaction with professional associations, participation in public health activities, and genuine teaching opportunities.
Here is a summary of the revised regulations:Divestiture of prohibited financial interests
- Senior employees1 (and their spouses and minor children) may not retain:
- an aggregate interest in a substantially affected organization (SAO)2 in excess of $15,000;
- an aggregate interest in SAO sector funds in excess of $50,000.
- Exceptions may apply for certain types of financial interests such as pensions, diversified mutual funds (including non-healthcare sector funds), technology transfer, and exceptional circumstances.
- Other NIH employees continue to be subject to government-wide laws that require divestiture in cases where it is reasonably necessary to resolve a conflict of interest with the employee’s official duties but will not be subject to a blanket prohibition.
Disclosure of financial interests
- Employees who file either a Public (SF 278) or Confidential (OGE 450) Financial Disclosure Report and those non-filers who serve as clinical investigators identified on an NIH clinical study are required to report the value of any interest in a SAO.
- Employees who do not meet these criteria are generally not required to disclose interests in SAOs.
- Unless an exception applies, NIH employees may not:
- engage in employment with a SAO, supported research institution, or healthcare provider or insurer;
- engage in a self-employed business activity with these types of organizations; or
- teach, speak, write, or edit for compensation for these types of organizations.
- Employment with related trade, professional, or similar associations; on data and safety monitoring boards; in relation to a Grand Rounds program; as a lecturer in an established course; or on grant or scientific review committees is generally permissible with prior approval. Previously established exceptions to the broad prohibitions remain: teaching a course that requires multiple lectures; clinical practice; writing or editing for a peer-reviewed journal; and presenting a CME or CME-like lecture.
- Outside employment that involves manual or unskilled labor, hobbies, artistic endeavors, or interests unrelated to the health and scientific research of the NIH, such as retail sales, coaching a youth team, scouting activities, clerical work, and building trades are generally permissible without prior approval unless the outside entity is a prohibited source.
- With prior approval, employees (including senior level) can accept gifts associated with bona fide awards for meritorious achievement.
- However, if the source of the award can be affected by the employee’s duties or those of any subordinates, gifts valued in excess of $200 may not be accepted.
TrainingEmployees are advised that government and HHS-wide conflict of interest laws and regulations continue to apply in addition to the NIH-specific provisions, and that each employee will be required to receive ethics training in 2005.
1. Senior employees include the NIH Director and Deputy Director, senior staff within the Office of the Director that report directly to the NIH Director; the Directors, Deputy Directors, Scientific Directors, and Clinical Directors of each Institute and Center within NIH; Extramural Program Officials who report directly to an Institute or Center Director; and equivalent employees. 2. Substantially affected organization means: a) a biotechnology or pharmaceutical company; a medical device manufacturer; or a corporation, partnership, or other enterprise or entity significantly involved, directly or through subsidiaries, in the research, development, or manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, treatments, or products; b) any organization a majority of whose members are of this type; and c) any other organization determined by the designated agency ethics official or designee to be substantially affected by NIH’s programs, policies, or operations.