Business' research funding elicits backlash
New guidelines seek to protect people who volunteer for clinical
trials.
By
Myrle Croasdale, AMNews staff. Oct. 21, 2002.
Additional information
The Assn. of American Medical Colleges and the Institute of Medicine
have released reports aimed at reforming oversight of research involving
human subjects.
The AAMC focused on conflicts of interest within research institutions,
while the IOM recommended broadening federal authority to include research
not currently under the government's jurisdiction
Sen. Edward Kennedy (D, Mass.) has introduced legislation in support of
the IOM recommendations.
Research on human participants gained national attention due to a
series of incidents, including the death of 18-year-old Jesse Gelsinger in
1999 during a gene-therapy experiment at the University of Pennsylvania,
Philadelphia. It was later discovered that the researchers and the school
had financial ties to the study. The university and the lead researcher
denied that their financial involvement had any impact on patient care.
But the brouhaha led to congressional hearings on gene therapy and
research on humans, and an acknowledgement that reform of the oversight
process was sorely needed.
David Korn, MD, senior vice president of the AAMC Division of
Biomedical and Health Sciences Research, explained that the biotech boom
was a significant contributor to the growth in research being done with
private dollars and the increase in conflicts of interest.
The biotech boom is seen as a significant contributor to the growth
of privately funded research.
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"Over the last decade, the amount of commercial interaction with
biomedical research has grown enormously," Dr. Korn said.
"That's a good thing, because it means that much of the scientific
discovery going on has the potential for practical applications, such as
new ways to prevent or treat disease. [The downside is that] in our
country the only pathway, outside of the defense industry, to get a
research discovery into a commercial development path is with private
money."
What the AAMC recommends is that institutions separate their financial
and research management functions as cleanly as possible, and that
institutions should not have a financial interest in research that
involves human subjects if they stand to benefit from the outcome of that
research.
If individual school officials have the power to determine a trial's
fate, such as hiring or firing research staff, they should not have a
financial stake in the trial, either.
The only exception would be if the inventor is the most logical person
to run the clinical trial, Dr. Korn said. For example, a university
develops a new cardiac stent. A company wants to develop it for commercial
use but will invest in the trial only if the inventor leads the clinical
trial. If the development of the device can't be done without the
inventor, that would be grounds for an exception. And participants should
be informed of this conflict of interest.
The AAMC's guidelines are not binding, but Dr. Korn expects heavy
compliance, especially if the newly organized Assn. for the Accreditation
of Human Research Protection Programs makes them a requirement. He also
expects the AAMC to study the impact of its report on institutions to see
if any revisions are needed.
"If something happens, and there was insufficient oversight, the
reaction affects the entire community," he said. "If Congress makes new
laws, the regulations affect all of us. It's in our own self-interest to
have good policies in place."
While both the AAMC and IOM reports attempt to keep privately funded
research from slipping out of the oversight net, the IOM seeks to do this
through broader federal involvement.
Timothy Jost, a professor at Washington and Lee University School of
Law, Lexington, Va., and a member of the committee that produced the IOM
report, said there should be a complete institutional commitment, all the
way from the CEO on down.
There's also the need for Congress to establish an independent advisory
body, with a central registry of all clinical trials being done on humans.
"However, ultimate responsibility for ensuring that essential
protections are in place and followed must rest with the highest levels of
the research organization," Jost said. "We don't propose the establishment
of a new agency. We're appealing to the private sector to become more
responsible."
As part of this effort, research institutions' institutional review
boards should focus afresh on ethics.
"IRBs are asked to do too many things and have lost their focus on
ethics," Jost said. "The heavy lifting of conflict-of-interest review
should be done outside of the IRB."
The committee suggested the creation of a fund to compensate people
hurt in research projects to avoid costly, drawn-out lawsuits and to give
patients immediate relief.
"Our report is the first to say it's time to stop looking at the
problem and to compensate human research participants," he said.
"Institutions expect to have their costs covered when doing research, and
individuals ought to have theirs covered, too."
Also of note in the report was a patient-centered approach to
disclosure. Jost said many patients aren't aware that the research may not
have therapeutic value.
"The feeling is that informed consent forms have turned into risk
management contracts for the institutions, and the focus should be on the
participant understanding the risks/benefits of the research," he said.
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ADDITIONAL INFORMATION:
Weblink
AAMC Task Force on Financial
Conflicts of Interest in Clinical Research (http://www.aamc.org/coitf)
IOM
report, "Responsible Research: A Systems Approach to Protecting
Research Participants," in pdf (http://www.iom.edu/iom/iomhome.nsf/wfiles/responsibleresearchfinal2/$file/responsibleresearchfinal2.pdf)
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Copyright 2002 American Medical Association. All
rights reserved.
