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Vol. LVII, No. 18
September 9, 2005
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Ethics Issues Ever Evolving
Final HHS Conflict of Interest Regulations Announced

On the front page...

Reasonable, evenly applied rules and constant conversations about ethics are what will keep NIH's reputation for top science and reliable health research intact, according to NIH director Dr. Elias Zerhouni, who announced the latest and final regulations to prevent conflicts of interest at the agency on Aug. 25. In the works since interim final regulations were published last February, the new revised standards were effective Aug. 31, when they appeared in the Federal Register.

Continued...

"These rules are the most restrictive of any rules we know about in the world of biomedical research," said Zerhouni. "We have done what we said we would. We have a balanced set of conflict of interest rules that protect the integrity of NIH and its ability to provide
"It's impossible to have a one-size-fits-all approach. What we've strived to achieve here is a reasonable balance..." — NIH director Dr. Elias Zerhouni
the American public with an unbiased and trusted source of scientific and health information, while preserving our ability to recruit and retain world-class scientists and staff."

The total ban on outside consulting with substantially affected organizations (SAOs) remains in place, but its impact — on recruitment and retention of scientists at NIH — will be reassessed within a year, Zerhouni pointed out. SAOs are generally defined as pharmaceutical and biotechnology companies, supported research institutions (contractors and grantees), and health care providers and insurers. The final rules feature three significant changes:

  • No longer do all workers who file financial disclosure forms (public SF 278 or confidential OGE 450) have to divest of holdings in SAOs. Only about 200 senior NIH employees must divest of such holdings and only to a certain dollar figure. In other words, the new rules prohibit senior NIH'ers (and their spouses and minor children) from owning stock in any one SAO above a combined total of $15,000. The value of all of their health care sector fund holdings may not exceed $50,000. Senior employees include the NIH director and deputy director; employees who report directly to the NIH director (also called "Office of Director small staff"); institute and center directors and their deputies; scientific directors; clinical directors; and extramural program officials who report directly to IC directors. The effective date for divestiture is Jan. 30, 2006.

    A case-by-case analysis of the holdings of all other employees involved in decision-making will determine what, if any, holdings they will be required to divest, explained NIH deputy director Dr. Raynard Kington.

    All investigators who are not already filers and are listed on clinical protocols will also be required to disclose their SAO holdings. Prior to 2003, about 200 employees were required to file the public form; there are now about 700 public filers. About 5,500 file the confidential forms.
  • In the regulations detailing outside activities, the ban on working with "related trade, professional or similar associations" was lifted. The final regulations added four new exceptions, which permit NIH'ers to serve on the data and safety monitoring boards, and grant or scientific review committees of trade/professional associations, as long as they get approval beforehand. An employee can deliver a "general" lecture as part of a university course, for instance, or could accept an invitation to give a general Grand Rounds talk. "General" means not related to their NIH research.

    Also, outside jobs that involve manual or unskilled labor, hobbies or avocations unrelated to health and scientific research activities do not require approval. "If you want to work at Hecht's, you can now work at Hecht's without telling us," quipped Holli Beckerman Jaffe, director of the NIH Ethics Office.
  • Finally, under the revised rules, with prior approval, all NIH'ers (including senior-level employees) 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 of more than $200 cannot be accepted.

"Our research should be based on scientific evidence that is not influenced by any other factors," Zerhouni stressed. "The trust of the public and the ability for us to provide scientific advice that is untainted is the number one goal of all of our efforts."

The final regulations, a collaborative effort by officials from NIH, HHS and the U.S. Office of Government Ethics, reflect the comments received via hundreds of email messages to the department and NIH following February's Federal Register announcement. In addition, feedback was considered from numerous meetings Zerhouni held formally and informally with various campus groups that included IC directors, scientific and clinical directors, extramural program officials as well as the Assembly of Scientists and other ad hoc employee organizations.

"We've learned a lot from this experience," said Jaffe. "There were deficiencies in our program, which we have fully addressed. In the end, we're going to have a program that will be a model for the federal government."

Meanwhile, attention and vigilance will keep NIH from complacency, Jaffe suggested. Employees are urged to visit the web site http://www.nih.gov/about/ethics_COI.htm, read the new regulations in full and become familiar with the policies expressed there. Afterwards, if you have questions or are unclear about something, contact your IC deputy ethics counselor. Jaffe anticipates more CoI training — and more extensive ethics courses — will be developed and required for employees in the coming months.

"I think we realized very early that going through this process of adjustment of a large agency with very complex function would require tailoring," Zerhouni concluded. "It's impossible to have a one-size-fits-all approach. What we've strived to achieve here is a reasonable balance in collaboration with the Department of Health and Human Services and the Office of Government Ethics, who are ultimately responsible for these rules."

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