Fw: IOM Panel Misses the Point Test Subjects

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Sunday, October 06, 2002 8:32 PM

Subject: IOM Panel Misses the Point Test Subjects

> IOM Panel Misses the Point Test Subjects

>

> October 3, 2002

>

> 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. "

>

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

>

>

http://www.nytimes.com/aponline/national/AP-Research-Protection.html?ex=1034

658206 & ei=1 & en=cc8f6b7315239fba

>

> Panel Urges Help for Test Subjects

>

> October 3, 2002 By THE ASSOCIATED PRESS

>

> 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 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 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

>

> Copyright 2002 The New York Times Company ~~~~~~~~~~~~

>

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