Anderson, Christopher. "White House Seeks Uniform Policy," Science 261 (17 September

 

Anderson, Christopher. "White House Seeks Uniform Policy," Science 261 (17 September
1993), p. 1516.

The Clinton Administration has sent the two leading science agencies back to the drawing board
in search of a single, government-wide policy on financial conflicts of interest by federally
funded researchers. White House officials have asked the National Institutes of Health (NIH) and
the National Science Foundation (NSF) to rewrite proposals that have been years in the making,
with the goal of developing one set of regulations that apply to any researcher, regardless of the
source of funding.

The new plan, spearheaded by the White House Office of Science and Technology Policy
(OSTP) and the Office of Management and Budget (OMB), would reconcile differences in
current draft regulations written by NSF and NIH. It would jettison NSF's proposal to require
institutions to inform the funding agency of the financial holdings of every federally funded
researchers as well NIH's plan to collect such information only for those whose holdings exceed
a certain level. The new guidelines would give institutions the authority to review all financial
holdings and resolve any potential conflicts before submitting grant proposals, and to certify to
the funding agency that they have done so. Each agency would conduct random audits to ensure
that the policy is working.

The new polities, if adopted, would mark a change for both agencies. NIH, in its latest draft, had
intended to ask institutions to clear with the agency any instance in which an investigator held
stock valued at more than $50,000 in a company related to his ow her research., The draft,
written as a formal rule that had gone through more than a dozen incarnations over the past 5
years (including the release and subsequent retraction of one version), has not yet been published
for public comment.

NSF was closer to issuing a final policy. The agency has already published a version for public
comment in which it proposed to review grant requests internally for potential conflict, based on
financial disclosures supplied by the individual applicants. But NSF received hundreds of letters
from researchers and institutions objecting to the effort needed to satisfy such a detailed reporting
requirement. In response, the agency has revised its policy to allow institutions to certify their
own investigators as conflict-free.

Both agencies submitted their proposed drafts for Administration clearance earlier this year with
the hope of publishing them in September. But last month OMB, with OSTP's prodding, decided
instead to revisit the entire conflict issue and called in officials from both agencies. Armed with
new marching orders, NSF and NIH officials are rewriting their versions of the guidelines to
conform to one another and to the outlines of the proposed common federal policy.

This process is being hailed by research organizations such as the Association of American
Medical Colleges as a long-needed clarification of federal conflict policies and a simplification
of the reporting requirements for individual scientists. Under the proposal, researchers would
typically disclose their financial holdings only to their own institutions, which would review
them and resolve any potential problems before certifying to funding agencies that they have
done so. Agency officials are likewise pleased with the idea of uniform policies, says NSF
associate general counsel Miki Leder.

The initial reaction from Congress was generally positive. Steve Jennings, an aide to
Representative Ron Wyden (D-OR), said that the broad outline of institutional screening backed
by federal oversight :is a vast improvement over what we have now - which is nothing."
Jennings, who investigated research conflict of interest in the course of taking the Scripps
Research Institution to task for a proposed $300 million agreement that would have given Sandor
Corp, first rights to NIH-funded research at Scripps, says NIH must still set some clear guidelines
on what constitutes a potential conflict. But once that is done, he says, "it makes more sense for
NIH to monitor each institution than to monitor [the financial holdings of] each and every grant
recipient."

The revised rules are expected to be issued around the end of the year and serve as a model for
future conflict-of-interest rules issued by any agency that awards research grants. This schedule
could push NIH past a 7 December deadline imposed by Congress imposed last spring. But NIH
officials believe the delay is a fair tradeoff for a government-wide conflict policy and they do not
expect trouble from Congress. But even as the two research agencies join hands on a common
policy, at least one other agency is heading off in quite a different direction. Last week, the Food
and Drug Administration (FDA) science advisory board recommended that the agency develop
conflict-of-interest rules requiring full financial disclosure by individual investigators whose
research data is submitted as part of an application for FDA drug or product approval. FDA holes
to issue draft regulations covering such research later this year; research that FDA itself funds
would fall under the NIH rules, which will apply to all research sponsored by the Public Health
Service.

FDA's harder line on clinical research, agency officials and congressional staffers say, reflects
the fact that it, unlike NSF and NIH, is a regulatory agency that must protect the public from the
consequences of a scientist testing a product in which he or she holds a financial interest. "FDA's
is going to have to make material judgments on the basis of data submitted by these researchers,"
says Jennings. "It's a matter of public health, and that ratchets up to the level of oversight
needed."