Date Published:
29 November 2006 |
Many IRB members have financial relationships with companies - Conflict of interest ?
Many IRB members have financial relationships with companies and while
most avoid conflicts of interest, clearer policies and more oversight may be
needed ...
More than one-third of the members of Institutional
Review Boards (IRBs) - committees at medical research organizations charged
with ensuring that clinical studies uphold patient rights and follow ethical
guidelines - have financial relationships with commercial firms. In the Nov.
30 New England Journal of Medicine, investigators from the Massachusetts General
Hospital (MGH) Institute for Health Policy report the results of a survey of
IRB members from academic institutions across the U.S. While most IRB members
did not believe that industry relationships have compromised the review process,
a few reported that they had participated in discussions or voted on studies
despite having industry relationships that could be conflicts of interest.
" The IRB process must be independent and objective," noted Eric
G. Campbell, PhD, of the MGH Institute for Health Policy, the study's principal
investigator.
" Financial relationships with study sponsors create competing
interests that could undermine the objectivity of the IRB process. Policies
and practices regarding the disclosure and management of such relationships
among IRB members need to withstand intense scrutiny, and our results suggest
that we can do much better."
Every institution in the U.S. that conducts research involving human participants
must have an IRB, which is responsible for reviewing proposed studies to make
sure the rights and safety of participants are protected and that study protocols
are scientifically valid and follow ethical and regulatory guidelines. IRBs
also monitor the conduct of studies to make sure that appropriate practices
are maintained. While researchers' industry relationships have been an area
of concern for several years, no previous studies have examined the extent
and impact of such relationships among IRB members.
During 2005, the MGH research team conducted an anonymous survey of almost
900 members of IRBs at medical schools and research hospitals across the country.
Questionnaires were sent to a random sample of IRB members asking whether they
had specific relationships with companies - including paid consultant, officer
or director, scientific advisory board or speakers bureau member, and recipient
of royalties or research funds. Some respondents noted the potential benefits
to the research process of industry relationships - such as giving IRB members
a better understanding of industry standards and how products may relate to
others currently on the market.
Survey respondents also were asked if their IRBs had established processes
for disclosing industry relationships and written standards defining when those
relationships become conflicts of interest. They were asked whether in the
previous year their IRBs had reviewed protocols sponsored either by companies
with which they had relationships or by competitors. Those faced with reviewing
such studies were asked to indicate whether they had disclosed the relationship,
how fully they had participated in discussions of the protocols, and whether
or not they had voted.
Among the 574 IRB members who responded to the survey, 36% reported
having some kind of industry relationship. The great majority of respondents
did not believe that other IRB members' relationships had an inappropriate
impact on their decisions or on how protocols had been presented. However,
only 67% of respondents said their IRBs had a procedure for disclosing
industry relationships, and only half were aware of written definitions of
conflicts of interest. While only 15% of respondents reported that
their IRBs had reviewed studies that posed conflicts of interest for them,
almost
half of them - 7% of all respondents - said they had either freely
participated in IRB discussions of those protocols or voted on such studies.
" While many IRB members have financial relationships with sponsors,
those relationships are not presently seen by IRB members as having a major
impact
on their activities," said Greg Koski, MD, PhD, a senior member
of the MGH research team and formerly director of the Office for Human Research
Protections
at the U.S. Department of Health and Human Services.
"The bad news
is that our policies and procedures, as well as our efforts to educate IRB
members
about conflicts of interest, are clearly inadequate."
Additional co-authors of the NEJM report are Joel S. Weissman, PhD, Christine
Vogeli, PhD, Melissa Abraham PhD, and Jessica Marder of the MGH Institute for
Health Policy and Brian Clarridge, PhD, of the University of Massachusetts,
Boston. The study was supported by a grant from the National Institutes of
Health.
Massachusetts General Hospital, established in 1811, is the original and largest
teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based
research program in the United States, with an annual research budget of nearly
$500 million and major research centers in AIDS, cardiovascular research, cancer,
computational and integrative biology, cutaneous biology, human genetics, medical
imaging, neurodegenerative disorders, regenerative medicine, transplantation
biology and photomedicine. MGH and Brigham and Women's Hospital are founding
members of Partners HealthCare HealthCare System, a Boston-based integrated
health care delivery system.
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Massachusetts General Hospital (MGH) on 29 November
2006 and may have been edited (e.g. in style, length, and/or for
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