April 4, 2002. Boston Globe. Institute of Medicine worries that public trust is threatened by deaths. By Michael Kranish and Alice Dembner.

The IOM report did not satisfy some longtime observers. ”The IOM committee, headed by a Harvard University dean, disingenuously recommended entrusting `the responsibility for ensuring that protective rules are followed’ to `the leadership of the organization doing the study,’ Vera Hassner Sharav, president of the Alliance for Human Research Protection, said in a statement. ”That is an example of conflicts of interest.”

George Annas, chairman of the health law department at Boston University’s School of Public Health, said ”We need a lot more reform than the IOM seems to recognize. This is but another voice crying in the wilderness. All their major recommendations have been made over and over again.”

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http://www.boston.com/dailyglobe2/277/nation/Panel_urges_changes_in_research_on_humansP.shtml

THE BOSTON GLOBE

Panel urges changes in research on humans Institute of Medicine worries that public trust is threatened by deaths

By Michael Kranish and Alice Dembner, Globe Staff, 10/4/2002 p. A-2.

WASHINGTON – Medical research institutions should make ”fundamental changes” in the way they conduct experiments on human beings in order to stop a string of accidental deaths, an influential advisory panel said yesterday.

The Institute of Medicine panel also recommended that federal oversight of human research include privately funded experiments; currently, the government regulates federally financed experiments and those conducted at institutions that receive federal dollars. The panel also said a no-fault insurance program should be established to compensate people who are harmed during the experiments.

But some critics said the report failed to address what they called the fundamental conflict of interest inherent in much medical research – the fact that universities and hospitals set up boards to review their own experiments.

In making the recommendations, the Institute of Medicine, or IOM, said that public trust in medical research is endangered because of deaths at high-profile universities and the lack of uniform oversight of the experiments. Between 2 million and 20 million people participate in such research, the panel said, acknowledging that the government has no solid estimate of how many volunteers are involved.

”It is understandable that the public has come to perceive that research institutions put more emphasis on insulating themselves from liability than on protecting people from harm,” said Dr. Daniel Federman, senior dean of clinical teaching at Harvard Medical School, who chaired a committee that produced the report. ”A combination of stresses, weaknesses, and lack of accountability have strained the current hodgepodge of protections to the point that fundamental changes are needed to protect all participants and keep public trust from being irrevocably eroded.”

Three recent deaths have focused attention on the dangers of human research: Jesse Gelsinger died during a 1999 gene therapy experiment at the University of Pennsylvania; last year Ellen Roche died during an asthma experiment at Johns Hopkins University, and retired nurse Elaine Holden-Able died during a methionine experiment at a hospital affiliated with Case Western University.

Human research is a major business in Boston, with thousands of experiments performed at local institutions, including Harvard, Boston University, and the teaching hospitals. Boston institutions receive more federal research dollars than those in any other US city.

Under the current system of human research protection, a university, hospital or company sets up an institutional review board to review experiments involving human beings. The over-arching change urged yesterday was that universities and hospitals conduct separate reviews on ethics and patient safety, conflict of interest, and scientific merit. Patients would receive a clearer explanation of potential dangers and research would be monitored more closely by experts and the federal government.

The report did not satisfy some longtime observers.

”The IOM committee, headed by a Harvard University dean, disingenuously recommended entrusting `the responsibility for ensuring that protective rules are followed’ to `the leadership of the organization doing the study,’ Vera Hassner Sharav, president of the Alliance for Human Research Protection, said in a statement. ”That is an example of conflicts of interest.”

George Annas, chairman of the health law department at Boston University’s School of Public Health, said ”We need a lot more reform than the IOM seems to recognize. This is but another voice crying in the wilderness. All their major recommendations have been made over and over again.”

But Dr. Michael Kagel, who oversees institutional review boards at Johns Hopkins University, said the recommendations were reasonable. A board composed entirely of outsiders ”may not understand the special needs and concerns of the community where research is done,” Kagel said.

The release of the report comes as Congress this year has failed to come to an agreement on legislation to tighten protection in human experiments.

The Institute of Medicine is part of the National Academy of Sciences, an independent organization set up by Congress to advise the government.

Michael Kranish can be reached at kranish@globe.com; Alice Dembner can be reached at dembner@globe.com

This story ran on page A2 of the Boston Globe on 10/4/2002. © Copyright 2002 Globe Newspaper Company.

The Instittute of Medicine report, “Responsible Research: A System’s Approach to Protecting Research Participants,” Oct 5, 2002: http://books.nap.edu/books/0309084881/html/29.html#pagetop

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