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Many IRB members have financial relationships
with companies
While most avoid conflicts of interest,
clearer policies and more oversight may be needed
BOSTON - November 29, 2006 - 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 percent
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 percent 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 percent of respondents reported that their
IRBs had reviewed studies that posed conflicts of interest for them,
almost half of them - 7 percent 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.
Media Contact: Sue
McGreevey, MGH Public Affairs
Physician Referral Service: 1-800-388-4644
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