October 26

IOM Panel Misses the Point Test Subjects

Institute of Medicine (IOM) Panel Misses the Point re Test Subjects

October 3, 2002

See also the following Institute of Medicine of the National Academy of Sciences documents:
IOM Report: Responsible Research: A Systems Approach to Protecting Research Participants. Oct. 3, 2002 (Adobe Acrobat document)
IOM Public Briefing – October 3, 2002
IOM Report: Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct – Executive Summary of a July 15 IOM Report

A report issued by an Institute of Medicine committee acknowledged the need for greater federal oversight in research: "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.”

However the report made only minor recommendations to protect people from harm or to change that insularity. They recommend: (1) bringing all research under federal oversight; (2) creating a clinical trial registry of all trials; (3) compensating those who are harmed; (4) creating a congressional advisory committee.

However, the report failed to address the heart of the problem undermining the safety of human subjects of research. Conflicts of Interest are at the root of most of the ethical / legal violations in medical research. There are high financial stakes to speed up clinical trials–but there are neither effective enforcement mechanisms nor meaningful penalties. Therefore, the system continues to be plagued by repeat offenders who put commercial interests ahead of the safety of human subjects.

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.” That is an example of conflicts of interest.

The committee even absolved the ethics review boards from noticing conflicts of interest, stating: “ethics review boards should focus primarily on protecting human participants, leaving conflict-of-interest and other questions to others. ”



Panel Urges Help for Test Subjects


Filed at 11:03 a.m. ET

WASHINGTON (AP) — More federal oversight is needed to protect the health of people who submit to experimental medical treatment and restore public confidence in the research, an advisory committee says.

The Institute of Medicine panel recommended a federal committee to advise doctors and scientists on ethical matters, creation of a central registry of trials and compensation for participants who are harmed.

The suggestions are in a report Thursday by the institute, an arm of the National Academy of Sciences.

"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 Daniel Federman, a Harvard Medical School dean who headed the committee that produced the report.

"There is no single cause for the errors and mishaps that unfortunately have resulted in the deaths of some research participants in recent years,” said Federman. "Rather a combination of stresses, weaknesses, and lack of accountability have strained the current hodgepodge of protections to the point that fundamentals changes are needed to protect all participants and keep public trust from being irrevocably eroded.”

The study was done at the request of the Health and Human Services Department because of increasing concerns about the safety of trials participants, such as the death in 1999 of 18-year-old Jesse Gelsinger during a gene therapy experiment at the University of Pennsylvania.

That was a federally assisted trial, but the rules were not properly followed. The agency overseeing human trials, the Office for Protection from Research Risks, has since been renamed the Office for Human Research Protection and transferred from the National Institutes of Health to HHS.

The report said responsibility for ensuring that protective rules are followed should rest with the leadership of the organization doing the study.

It also recommends federal jurisdiction be extended to all human trials, not only ones funded by the government. That would add trials paid for by drug companies and private foundations, among others.

Other recommendations included:

  • Institutional review boards overseeing each trial should be renamed ethics review boards and should focus primarily on protecting human participants, leaving conflict-of-interest and other questions to others.
  • Informed consent should be a continuing process with the emphasis on keeping the participant up-to-date on the trials and any questions that arise.

  • Participants harmed as a result of taking part in trials should be compensated, at least to the extent of their medical care and rehabilitation, regardless of whether the injury resulted from negligence.

  • Congress should create an independent advisory committee to provide advice on the development and management of human clinical trials.

  • The National Library of Medicine’s clinical trials registry should be expanded to include all trials, whether funded with public or private money.

The National Academy of Sciences is an independent organization chartered by Congress to advise the government on scientific matters.

On the Net:

National Academy of Sciences: http://www.national-academies.org

© 2002 The Associated Press


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