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.

"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.

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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