U.S. Health Officials Bolster Protections for Study Participants

From the WebMD Archives

May 19, 2000 (Washington) -- Under pressure from the president and dogged by congressional hearings concerning the failure of scientists to protect individuals participating in medical experiments, U.S. health officials Tuesday announced several initiatives aimed at strengthening the protections for research subjects, including individuals in gene therapy studies.

"Today's actions are designed to further strengthen government oversight of all biomedical research," said Health and Human Services (HHS) Secretary Donna Shalala, while noting that the recent explosion in research has created a need to at least reinforce medical researchers' understanding of the existing ethical standards.

"By maintaining high standards and requiring that all investigators adhere to them, we can be sure that the nation's biomedical research enterprise will continue to earn the trust of research subjects," added FDA Commissioner Jane Henney, MD, whose agency will play a prominent role in enforcing the new initiatives.

But while these actions are a step in the right direction, there is some question as to whether the HHS initiatives are sufficient.

In terms of specifics, the HHS will require clinical investigators receiving NIH funds receive training in the ethics of medical research as a condition of the award, and that investigators conducting smaller human studies submit their monitoring plans for review by both the NIH and their institutional review board. The NIH and FDA will also issue guidance to clarify what must be revealed to study participants, while the HHS pursues legislation to allow the FDA to punish violators with fines.

"It moves in a number of constructive directions, but it is one step in hundreds of miles that still must be traveled," says LeRoy Walters, PhD, director of the Kennedy Institutes of Ethics at Georgetown University. Although reluctant to criticize an initiative that heads in the right direction, Walters says the reforms could be considered somewhat piecemeal without a major investment in the existing infrastructure.

The changes are not meaningful if more work is created without the funding and extra staff to make it work, he says. The effort may also be undermined by the failure to create independent monitoring committees not related to either the government or the researchers to digest and interpret the safety data while the study is still ongoing, Walter adds.


A recent Office of Inspector General (OIG) report has raised similar concerns. The report concluded that institutional review boards simply have too much work and too little staff to handle the job.

"[They] can't do it alone ... other pieces in the system really need to take responsibility for protections as well, including sponsors and investigators themselves," Laura McBride, MS, an analyst that worked on the report, told WebMD in an interview.

The importance of the role played by universities and academic medical centers in overseeing patient safety has also not been lost on federal officials. "Protecting patient safety, and ensuring informed consent, is a shared responsibility. I want to urge university presidents, leaders of our academic medical centers, and others involved in biomedical research to take a hard look at the oversight of clinical trials," said Shalala.

It has also not been lost on medical centers. "I think the academic medical community has recognized the fact that we need to take this issue seriously," says John Parker, spokesperson for the Association of American Medical Colleges, who adds that the announced initiatives are in "lockstep" with a number of initiatives already underway in the research community.

But that's not surprising. Ultimately, everyone agrees it is in the best interests of researchers and their patients. This fact is well lauded by a number of federal officials, including the president.

"We are on the brink of discoveries that are astonishing in their complexity and implications for human life in the decades ahead," said Clinton in response to Tuesday's announcement. "But as committed as we are to further progress, we must be as committed to ensuring that we enter this new age of discovery in a manner that protects the safety of those making these new discoveries possible."

At question now is only whether a joint effort will be sufficient without devoting further resources. "It sounds great, but that is a loophole," Walter assures WebMD.


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