No Prohibitions for Support Staff
After the comment period ends April 4, the NIH plans to evaluate the responses. "We've gotten a full range of comments. Most are about financial holdings and outside consulting agreements. Some are very supportive and some are very negative," notes Raynard S. Kington, M.D., Ph.D., deputy director of the NIH.
He says he has received the Assembly proposal, but cannot comment on it. "We're looking at all the comments we've received," he continues. "I'd be surprised if the regulations weren't eventually changed."
In fact, some minor changes already have been made. In mid-March, the NIH extended the timeframe for divestiture of financial holdings in significantly regulated industries from April to October, and waived the divestiture requirement for temporary researchers.
"We're open to change," Dr. Kington says, hinting that further change may occur, particularly regarding financial holdings and outside consulting regulations. "We're planning a rigorous analysis regarding the effect of the regulations" on potential job candidates, and are implementing that step now, Dr. Kington says.
Results are expected in several months. According to Howard Young, Ph.D., NCI-Frederick representative, Assembly of Scientists steering committee, Elias Zerhouni, M.D., NIH director, "has informed the Assembly of Scientists that he is planning a national forum on these issues in the near future."
As yet, however, "People aren't putting the new regulations in the proper perspective," Dr. Young says. "It's very clear many people on the outside have no idea of the extent of the new rules," including directors of extramural research programs. "We need to make people realize there are alternatives."
In a letter further outlining the Assembly's position and its rationale, Dr. Young wrote that, "The new regulations appear punitive for bad behavior on the part of a small minority and their rational basis remains unclear.
"The measures are draconian and arbitrary, in particular the stock divestment requirements, and are without precedent in the federal government for employees outside of regulatory agencies, such as the FDA or Securities and Exchange Commission."
The Assembly is combating a widely-held, but erroneous, impression that the NIH regulations are merely bringing the NIH into line with the ethics regulations of other government agencies.
Proponents of the NIH plan, even within the NIH and its parent organization, the Department of Health and Human Services (HHS), cite the FDA regulations as being among the most stringent. Few, however, admit familiarity with either the HHS or FDA ethics regulations.
As background, the Office of Government Ethics (OGE) oversees a uniform ethics code for government agencies, but each agency is free to develop supplemental regulations that exceed those of the OGE.
The HHS revised its supplemental regulations January 1, 2005. Those regulations, available at www.usoge.gov/pages/laws_ regs_fedreg_stats/agy_supp_regs.html, are in effect for the Centers for Disease Control and Prevention, the Office of Consumer Affairs, the NIH, and several other agencies.
They prohibit HHS employees from helping others prepare grant applications or contract proposals for submission to HHS agencies, being employed in other HHS-funded activities, and, for the Chief Counsel's Office, the practice of law outside the HHS.
The FDA has more strenuous requirements limiting outside employment, but they still seem less restrictive than those of the NIH proposal.
For example, FDA employees may be employed by "significantly regulated organizations" providing "the employment consists of the practice of medicine, dentistry, veterinary medicine, pharmacy, nursing, or similar practices and does not involve substantial unrelated non-professional dutiesand does not involve employment by a medical product manufacturer in the conduct of biomedical research or is limited to clerical or similar services in retail stores."