The NIH Announces Final Ethics Regulations

August 25, 2005 – The National Institutes of Health (NIH) has announced final regulations "regarding reporting of certain financial interests, stock divestiture, outside activities, and awards" by NIH scientists and staff.

The final rule, scheduled to take effect August 30 when it is published in the Federal Register, represents a final version of tough ethics policies originally announced in February. The final conflict-of-interest policy continues to ban scientists from working as consultants with industry-related companies, but loosens restrictions on divestiture and allow for more interaction with academia and professional organizations.

Under the final rule, NIH will maintain the February policy's feature of prohibiting staff members from consulting with pharmaceutical or biotechnology firms, medical device manufacturing companies, health care providers, insurers, or supported research institutions, which the agency described as "substantially affected organizations."

While the consulting ban stays in place, the final rule on investments and stock holdings place greater emphasis on disclosure and a case-by-case review, rather than an all-out ban on investing in substantially related organizations.

The final rule states that senior NIH employees – about 200 employees who have decision-making authority, their spouses, and minor children – can now have up to $15,000 in holdings in substantially related organizations. NIH employees who must file a financial disclosure form or are involved in clinical research – about 6,000 employees – may have to divest, but the agency will determine any conflicts on a case-by-case basis. About 18,000 employees will not specifically be asked to disclose their financial holdings under the final rule.

The interim rule announced in February had required all employees filing a financial disclosure form to divest industry-related stock to zero, while instituting a $15,000 limit for everyone else. After evaluating the rule, Zerhouni said, the agency determined the interim rule placed unnecessary restrictions on employees and their families who did not have the ability to impact the integrity of the science or the ability of NIH to provide untainted advice.

The final rule also relaxes restrictions on involvement by NIH scientists in outside activities with scientific and professional organizations, such as sitting on data and safety monitoring boards, giving lectures, and providing scientific grant review, as long as the scientist receives prior approval from the agency. Academic interaction, such as teaching, editing scientific journals, authoring textbooks, and participating in a continuing medical education program, also would be allowed under the final rule.

The final rule also lifts the prohibition on senior employees accepting awards, unless they were of an exceptional caliber such as the Nobel Prize. However, it prohibits all employees from accepting awards valued at more than $200.

The final rule has been met with a much more positive reaction from NIH scientists than the February proposal, however, there are still concerns that the prohibition of almost all outside activities with medical and pharmaceutical companies will affect NIH’s recruitment and retention of senior clinicians and scientists.