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Erika Check,WashingtonA high-profile investigation into conflict-of-interest policies at the National Institutes ofHealth (NIH) is having an impact waybeyond Washington, as universities aroundthe United States work out how it mightaffect their medical research centres.
So far, the congressional investigationhas focused on policies governing the con-duct of the 6,000 intramural scientists whowork directly for the agency, mostly at itsmain campus in the Washington suburb ofBethesda, Maryland.
And investigators have not publiclyannounced that they plan to extend the inves-tigation to university medical centres, where200,000 scientists at all levels are supported byalmost $20 billion in annual funding from theNIH (see chart). But an official at the agency,who did not want to be named, says that questions about the universities’ conflict-of-interest policies havealready been raised bythe investigators.Andcampus officials aretracking the subjectclosely, because Congressis clearly concernedabout the issue andNIH policy changesare likely to affect universities, directlyor indirectly.
“It matters that Congress is taking aninterest,” says Julie Gottlieb, assistant deanfor policy coordination at the Johns HopkinsUniversity School of Medicine in Baltimore,Maryland. “It will result in changes at NIH,and it may signal changes for NIH granteeinstitutions.”
The agency has already said it will changeits own policies, requiring more disclosureand reducing the amount of paid consultingthat its senior scientists are permitted to do.It is also planning to enact a one-year mora-torium on paid consulting for all of its scien-tists (see Nature 431, 497; 2004).
This moratorium is more drastic thanany measure a university is likely to contem-plate. Still, such changes could affect univer-sities in many ways. When the NIH’s rules
on conflicts of interest are finalized, forexample, the agency could decide tocreate new rules for grantees.Or universities could choose to fol-
low the lead and adopt rules that aremore in line with those of the agency.“When you see the body responsible for
regulation changing its own rules,you have tolook at its changes,” says Theresa Colecchia,associate general counsel at the University ofPittsburgh.“It can be an indication of wherethose grant-funding agencies will go withregulations for grant recipients in the future.”
Policies strengthenedAccording to a survey released last monthby the Association of American MedicalColleges (AAMC), most medical schoolshave adopted conflict-of-interest policiesfor faculty involved in human research. And63% of these schools have strengthenedtheir policies since 2001. Although the Pub-lic Health Service, the division of the federalhealth department that includes the NIH,issues broad guidelines for these policies,the specifics vary across universities.
For instance,40% of medical schools sur-veyed by the AAMC do not require faculty
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NATURE | VOL 431 | 14 OCTOBER 2004 | www.nature.com/nature 725
members to disclose potential financial con-flicts in verbal presentations. Three-quartersof the schools have set up standing commit-tees to evaluate conflicts of interest, but only21% of these schools require communityrepresentation on the committee. And justslightly more than half of the schools sur-veyed require the standing committees toreview technology-licensing agreementsthat may influence future research under-taken by individual faculty members.
Most university officials say that thepolicies at their own institutions are soundand that they are not planning alterations.“We have one of the broadest conflict-of-interest policies of any institution,” saysBarbara Flynn, manager of the conflict-of-interest review programme at StanfordUniversity School of Medicine in Califor-nia.“I don’t think there’s anything more wecan do.”
For the moment, US universities are notin line for a direct grilling by Congress: staffmembers on the committee leading the NIHinvestigation say they do not plan to spreadtheir net to campuses.But university officialswill not rest easy until the investigation ends,and the NIH rules are set. ■
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Universities fear repercussionsas NIH tunes conflicts policy
GE
TT
Y I
MA
GE
SSO
UR
CE
:NIH
Extramural grants
NIH spending 2004:
Total = $27.8bn
Intramural work
Other
$19.3 bn
$5.8 bn
$2.7 bn
Side-effects: revisions to the National Institutes of Health’s conflict-of-interest policy could affectconditions on the outside grants that account for three-quarters of the agency’s spending.
14.10 news 725 AM 12/10/04 2:30 pm Page 725
© 2004 Nature Publishing Group
© 2004 Nature Publishing Group