Alternative NIH ethics rules

Intramural researchers suggest fewer restrictions on consulting and stock ownership

Mar 10, 2005
Ted Agres(tedagres@lycos.com)

Arguing that recently announced conflict of interest rules at the National Institutes of Health (NIH) will "severely and irreparably compromise the NIH's mission," a group representing several thousand intramural scientists yesterday (March 9) proposed less restrictive regulations on outside consulting, editing and writing, and stock ownership.

"We're hoping rationality will take hold," said Ezekiel Emanuel, chief of clinical bioethics at NIH's Warren G. Magnuson Clinical Center and one of the architects of the proposed alternative regulations. "We're hoping to negotiate with Dr. Zerhouni and the Department of Health and Human Services. We would hope that they would realize that they have gone too far."

NIH's new ethics rules, announced last month, require most intramural scientists, all senior officials, and those having contracting and grant-making authority—as well as their family members—to divest of all stock in drug and biotech companies. Other NIH employees and their families are limited to no more than $15,000 in stock in any one biotech or drug company. The rules affect all NIH employees, including thousands of secretaries, food handlers, elevator operators, lab technicians, and others having no decision-making authority for grants or research.

The new rules also bar all NIH employees from consulting with or accepting payments from pharmaceutical, biotech, and medical device companies as well as universities, hospitals, and research institutes that receive NIH funds. The "interim final regulations" go into effect in early April, but may be modified later in the year after officials assess their impact in such areas as recruitment and retention.

The Assembly of Scientists, an organization representing NIH intramural researchers, had criticized the new rules as being overly restrictive and preventing scientists "from participating as full members of the scientific community." The group's alternative regulations, posted on its Web site yesterday, would instead impose conflict-of-interest prohibitions based on the "judgments and decision-making authority" entrusted to each employee.

All employees would be permitted to do outside writing and editing for compensation. Service with professional organizations would be permitted for everyone, but those in leadership and grants administration could not be paid for doing so. Such employees would be barred from holding stock in any drug, biotech, or medical device company.

Investigators, clinicians, and research scientists could not own stock in companies sponsoring their research projects or whose products are being evaluated or might be materially affected by the research results. They could own stock in drug and biotech companies not involved in or affected by their research, however.

Those in leadership and grants administration positions could not engage in any consulting, but could serve on boards of professional foundations and associations. Investigators, clinicians, and research scientists would be barred from consulting with companies sponsoring their research or affected by the research results, but could consult with other companies for up to 500 hours per year. Support staff would not be subject to any prohibitions.

"We have a common goal—we want to eliminate conflicts of interest and make sure there is no distortion and that integrity is maintained," Emanuel told The Scientist. "We think that by more carefully crafting the regulations, we can do that and preserve the NIH's ability to recruit and retain top-flight scientists."

NIH Deputy Director Raynard Kington yesterday (March 9) said the NIH welcomes the Assembly of Scientists' suggestions. "We're open to looking at changes, but it would be premature for us to comment on any specific proposal," he told The Scientist. It is "highly unlikely the basic structure of the ethics regulations would be changed" before going into effect next month, Kington said.