Within the first week of the NIH announcing new ethics regulations, the phone calls to recruiters had started. For some, the regulations, termed both punitive and draconian, were the breaking point that is driving them into industry.
The 96 pages of regulations, in case you haven't heard, are significantly stronger than those proposed last June by NIH director Elias Zerhouni, M.D.
The new regs ban extracurricular activities, which include serving as scientific advisors, officers, directors, or other fiduciary board members; consulting or providing professional services, as well as teaching, speaking, writing, or editing for "substantially regulated" organizations, including hospitals health insurers, and health, science, or health research-related trade professional, consumer, or advocacy association or a supported research institution.
Holding stock or other financial interests (aside from pensions and employee benefits) within "substantially regulated companies" also is prohibited, although employees who are not required to file financial disclosure reports may hold up to $15,000 in such stock. The definition of "substantially regulated companies" also was broadened.
"This has a major impact for the NIH and industry," emphasizes Buster Houchins, vice chairman of recruiter Christian & Timbers (www.ctnet.com).
"This is truly a disruptive change," Houchins says, that affects the way information is transferred. The bans upon extracurricular speaking and teaching activities hamper the flow of information, although even the regulations promise to "consider expanding the availability of scientists" to speak before "relevant audiences at government expense" or by acceptance of travel reimbursement. Compensation for such activities, however, remains barred.
"There has been an effort throughout government to facilitate technology transfer, to make great research available to the public," according to Steven Meltzer, attorney, Shaw Pittman, and general counsel, Technology Council of Maryland.
"I don't know how they plan to provide information to companies, but a creative way is always found," opines Steven A. Kriegs-man, president and CEO, CytRx (Los Angeles).
That way may be the recently announced rules requiring publication of research within 12 months, and the continued use of cooperative research and development agreements (CRADA), Meltzer says.