Anderson, Christopher. "Federal Conflict Rules Nearing Completion," Science 259 (12 February

 

Anderson, Christopher. "Federal Conflict Rules Nearing Completion," Science 259 (12 February
1993), p. 885.

This is a small "boxed" item accompanying a longer story about the Draconian rules being
adopted by the Hughes' Institute regarding conflict of interest. It is a logical accompaniment in
that Hughes is ahead of the government which has been dawdling on its rules for years now. Here
it is in its entirety:

After several false starts, the National Institutes of Health (NIH) and the National Science
Foundation (NSF) are finally getting ready to issue guidelines of what constitutes conflict of
interest among their grantees. With a final shove from Congress, the rules should be in place by
summer.

NIH, in particular, has had a tough time drafting acceptable guidelines. Its first attempt, unveiled
more than 3 years ago, was buried under an avalanche of some 800 angry letters from researchers
and scientific organization, complaining that the rules were too touch (Science, 12 January 1990,
p. 247). NIH's legal office came up with another version - now configured as a full-blown
regulation - in mid-1991, only to be sent back to the drawing board by NIH Director Bernadine
Healy, who thought the revised rules on equity holdings were too weak. Late last year, NIH
officials finished yet another drift, but this time eight different offices in the Department of
Health and Human Services objected for various reasons and back it came for more work.
Finally, just as the agencies reached agreement, the administration changed and the rules are
again in limbo, waiting for the new administration to get around to them.

Congress , however, is about to step in. The Senate version of the NIH reauthorization bill ...
directs NIH to release final conflict regulations within 180 days after the bill becomes law. Given
that the bill in on a fast track and could be passed by the full Congress as early as this month, that
language may force NIH into overdrive. If the language becomes law, the agency would have to
release a notice of proposed rule-making, receive and evaluate comments, and issue a final rule,
all within 6 months - warp speed for a federal agency.

The 3-year delay, concedes Claudia Blair, an NIH official who worked on the rules, "is
appalling." But on the other hand, she says, "it's preferable in an area this complicated and
evolving to consider many perspectives. It's better to do it slowly and right."

At NSF, the transition to a new administration has also slowed progress on conflict rules. NSF
published proposed guidelines in July last year and some 70 letters before the comment period
closed in October. Like NIH's rules, they are now awaiting review by the new administration.
That means at least a 4-month delay before NSF could come up with final rules, says Micki
Leder, the agency's assistant general counsel. And NSF director Walter Massey's impending
departure won't help matters. NSF officials say the rules will probably have to await approval by
the new director."