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Feature Articles : Apr 15, 2005 ( )
NIH Ethics Regulations
Counter Proposal Aims To Provide Blanket Rules For All NIH Employees
The NIH Assembly of Scientists, an organization formed in response to February's NIH ethics regulations, presented a counter proposal that addresses issues raised in the original NIH document while still safeguarding the agency's integrity.
The Assembly proposal divides staff into five groupsNIH leadership, grants administration, principal and independent investigators, clinicians and research staff, and support staffwith prohibitions commensurate with their extent of influence.
In contrast, the NIH document provides blanket regulations for all NIH employees. It places the same restrictions on a nurse, for example, as a senior scientist or a grants and contracts administrator, with certain exceptions for pension plans from prior employment for the financial holdings of lower-level staff, who were allowed to own up to $15,000 in stock from significantly regulated industries at their time of employment.
Under the Assembly's counter proposal (www.homepage.mac.com/assemblyofscientists/FileSharing20.html), the NIH leadership may have no equity holdings in pharmaceutical, biotechnology, device, health insurer, hospitals, or HMO firms or in mutual or hedge funds primarily focused on health care. Directors and associate directors overseeing obesity-related research may not own holdings in food or beverage companies.
For the leadership, consulting is banned, but they may serve on boards for foundations, professional associations, and advocacy groups that do not receive NIH funding.
They may write and edit, but not speak, for compensation, and may serve with professional organizations without compensation provided they recuse themselves regarding activities related to or funded by the NIH. They may accept awards and honors from any organization that does not receive NIH awards.
Clinicians and research scientists, including visiting fellows, are only prohibited from holdings or consulting activities involving companies sponsoring or involved in their research project, or that may be materially affected by the research results. Publications and public presentations must disclose all holdings in NIH-identified companies.
They are prohibited from speaking for compensation about on-going research, but may receive compensation for research that has been in the public domain at least one year. Writing, editing, and service with professional organizations are permitted with compensation, as long as they recuse themselves regarding activities related to the NIH. Any bona fide honor or award may be accepted from any organization.
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."
Although FDA employees are prohibited from owning stock in significantly regulated organizations, there are several exceptions. One allows ownership, if the total holdings account for less than 50% of the total value of the combined investment portfolios of the employee, his or her spouse, and minor children.
Dr. Kington says he is not familiar with the HHS supplemental regulation, but adds, "The FDA has had pretty stringent rules for a long time. It's hard to compare. The NIH rules are relatively stringent in recognition of the changing world we live in, with important relations in biomedical enterprises and the complex ties with industry and universities."
Bill Pierce, HHS spokesperson, reiterates that sentiment. "In today's world, the relationship between scientists and industry is closer than ever. NIH provides a lot of the horsepower for marketable discovery."
The goal of the regulations was "to ensure a bright line for institutions (and scientists). It was not necessarily a reaction to specific transgressions, but a commonsense attemptto protect the integrity, both real and perceived, of the finest institution in the world."
One wonders how fine that institution will remain if many of its best and brightest leave for greener pastures. Anecdotal reports indicate some senior NIH scientists are looking elsewhere for employment, and some candidates for fellows are skipping over the NIH in favor of other opportunities.
As scientists begin to realize the extent of the regulations, "It's hard to compete for talent at the post doc or tenured levels," Dr. Young says, and colleagues have indicated their intent to begin job searches outside the NIH, while others are retiring earlier than planned. "People can't move fast," he says. "It will be early fall," before the effects are seen.
The issue really isn't about money, as it may initially seem. The scientists themselves freely admit that money is a motivator, but emphasize that their key driver is high-level scientific interaction, the opportunity to be engaged in some of the most exciting research on the planet and the opportunity to share their expertise to advance the field.
The HHS, promulgators of the new ethics rules, is banking on that scientific zeal. "A lot of research is only done there, so if that's what you want to do, that's where you have to be," Pierce says.
Under the new rules, however, much of the scientific interaction outside the NIH is curtailed because it involves positions on boards, lecturing, and other interactions, often for compensation.
Dr. Young tells of consulting for a small biotech company that was developing an immune system modulator. "I said, Wait. Let's look at the full picture,'" he recalls, indicating that the substance wasn't quite what it seemed to be. "I provided a service in interpreting data, but they couldn't have afforded to hire me."
"These restrictions on interactions do not apply just to pharmaceutical companies," Dr. Young wrote in the Assembly's response to the NIH supplemental standards of ethical conduct and financial disclosure requirements.
"Instead, they are broadly constructed with the effect of inhibiting the free exchange of ideas and collaborations with scientists and others at universities, professional societies, and advocacy groups. A colleague," he recounts, "wrote questions for clinical boards. Now he can't be paid."
The prohibitions, he says, "will make people less willing to interact. There have to be some limits, but saying there's no way to use one's expertise and be compensated for it is unreasonable. Such barriers will make it more difficult to effectively and efficiently translate discoveries into therapies."
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