HMS Report: Study Subjects Need Protection

Researchers need to better protect patients in clinical trials and tighten oversight of medical studies, a national advisory panel headed by a Harvard Medical School (HMS) dean concluded in a report published last week.

The panel from the Institute of Medicine said the boards that approve medical research need to monitor conflicts of interest more closely, provide insurance to research participants and make sure participants know the risks of a study before they agree to join it.

The recommendations came at the request of the federal Department of Health and Human Services in response to three deaths at major research institutions during the last three years, said Daniel Federman ’49, senior dean of alumni affairs and clinical teaching at HMS and chair of the panel.

He called for institutional review boards (IRBs), which approve and oversee clinical research at hospitals and medical schools, and others involved in medical studies to “reassert the critical role of ethical standards.”

But Vera Hassner Sharav, president of the Alliance of Human Research Protection (AHRP), a national advocacy group for participants in medical studies, said more drastic change is needed.

“The oversight is so tainted with conflict of interest that really there is no accountability at all,” she said. “The watchdogs have become lapdogs.”

IRBs are typically made up of both physicians and community members. According to Richard E. Kuntz, chief scientific officer of the Harvard Clinical Research Institute, the boards balance the potential risks and benefits for research participants in order to ensure patient safety.

In the high-profile deaths that inspired the panel’s work, Kuntz said the researchers were well-meaning individuals but said there may have been “inattention to critical factors, that in retrospect, caused tragic harm.”

Professor John H. Noble Jr., a social justice professor at the Catholic University of America and a member of the AHRP board of directors s, said he disagrees.

He said the way clinical research is monitored is “structurally flawed.

“There is no incentive for anybody not to take chances,” he added. “The worst that will happen is that you will get your hand slapped.”

According to Federman, the panel is responding to these complaints. One of the central ideas of the report is the panel’s recommendation that the federal government create a Human Research Participant Protection Program to review protocols for medical research and to monitor studies on an ongoing basis.

The program would also work to ensure that participants know all the risks and benefits of a study before they give their consent to join it.

The report also recommends renaming IRBs as Research Ethics Review Boards and shifting the voting structure to give the boards’ community members more power over approving research projects.

But Sharav says the review panels must be completely independent of the institutions they oversee so they can prevent conflicts of interest among researchers and institutions from jeopardizing participant safety. Whether or not the report’s recommendations are implemented will be up to the Department of Health and Human Services, which Federman said would likely approve some, but not all, of his panel’s suggested changes.