A Conflicts-of-Interest Handbook for Universities Unveiled

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A Conflicts-of-Interest Handbook for Universities Unveiled

Science Now - Washington,DC

By Jocelyn Kaiser

28 February 2008

http://sciencenow.sciencemag.org/cgi/content/full/2008/228/1

A group of universities today unveiled its answer to public concerns

about drug company payments to biomedical researchers: a manual to

help schools navigate these conflicts of interest in clinical

research. Although there have been other reports released on this

topic, this one contains more detailed guidance as well as some new

hard-hitting recommendations.

In 2004, revelations of unreported financial conflicts of interest

in the intramural program at the U.S. National Institutes of Health

prompted a ban on industry consulting by NIH scientists. Hoping to

stop Congress from imposing such drastic measures in academia, the

Association of American Medical Colleges (AAMC) and the Association

of American Universities (AAU) have now produced a guidebook for

universities on how to handle conflicts of interest in clinical

research, which might arise, for example, when a researcher consults

for a company whose drug she wants to test. Penned by a 21-member

committee of deans and others at major research institutions around

the United States, the roughly 80-page report* elaborates on

recommendations the two groups released in 2001 and 2002.

The advice is more detailed and more pointed than in the past. For

example, the report gives schools a 2-year deadline for implementing

a conflict-of-interest policy and provides a model of what one might

look like. (A recent study found that 62% of medical schools

surveyed still don't have such a policy; see Science, 15 February,

p. 889). It also includes 10 case studies of real situations to help

schools manage various conflicts that might arise, such as a

researcher who invented a medical device and wants to help a company

test it in people.

In addition, AAMC and AAU now recommend that researchers report all

industry payments to their institution--not just those above a

$10,000 or 5% equity threshold set by the government for NIH

grantees. The reason for this " major change " is that interest from

the public and Congress " is so keen right now, " says AAMC Senior

Vice President Korn. He notes that a half-dozen states have

passed laws requiring that all payments from drug companies to

physicians be made public, and Senator Grassley (R–IA) has

introduced similar federal legislation. The proposed legislation

would mandate such reporting; the guidebook's recommendations are

voluntary, and schools need not follow them.

Reporting all drug company payments " is certainly a positive step,

because even small gifts can distort one's objectivity, " says

conflict-of-interest expert Sheldon Krimsky of Tufts University in

Medford, Massachusetts. He calls the AAMC-AAU report " a serious

effort " but notes that it has some limitations. For instance, it

doesn't say that conflict-of-interest decisions should be made

public.

Related site

* Protecting Patients, Preserving Integrity, Advancing Health:

Accelerating the Implementation of COI Policies in Human Subjects

Research, AAMC/AAU