|
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.researchprotection.org
e-mail: veracare@...
FYI
Redflagsweekly is the first online health news service to
pick up on a news item provided in
yesterday's AHRP Infomail about a proposed experiment (whose
researcher seeks government
funding) to be conducted on 450 children (aged 8 to 10)Â who
would undergo painful (so-called)
pre-diabetes tests--without any evidence that the children
are even at risk of diabetes.
The announcement was posted in The Federal Register in the
dog days of August.
It indicated that the federal Office of Human Research
Protection (OHRP) is recommending that the
Secretary of Health and Human Services use section 407--an
obscure section of
the federal regulations that has been used only 2, at most,
3 times since 1983--
to approve an experiment on healthy children that is
otherwise
"unapprovable under federal regulations."
In 2000, OHRP suspended a similar pr-diabetes study
conducted at the National Institute
of Child and Human Development because federal regulations
prohibit exposing children to
greater than minimal risks if there is no potential benefit
for them.
See: http://ohrp.osophs.dhhs.gov/detrm_letrs/nov00a.pdf
"Once you digest the information and get beyond what is
stated in the Federal Register,
the story begins to get quite intriguing, and frankly, quite
appalling." [Redflagsweekly]
The Alliance for Human Research Protection will be
submitting our official comments
before tomorrow's deadline.
~~~~~~~~~~~~~~~~~~~
REDFLAGSWEEKLY
http://www.redflagsweekly.com/regush/2002_august20.html
August 20, 2002
MEDICAL SCIENCE VIOLATING CHILDREN
By Nicholas Regush
There are signs that the floodgates are opening for a new
type of medical research: the violation of children.
And there isn’t even anything secretive about this. Look at
the PDF File for the August 7 edition of the U.S. Federal
Register. http://ohrp.osophs.dhhs.gov/references/youth.pdf
The information under the heading of Department of Health
And Human Services doesn’t call too much attention to
itself, simply referring to a proposed study - "Proposed
Recommendations Regarding Support of Research Protocol:
Precursors to Diabetes in Japanese American Youth."
Once you digest the information and get beyond what is
stated in the Federal Register, the story begins to get
quite intriguing, and frankly, quite appalling.
Last year, Dr. Wilfred Y. Fujimoto, a researcher at the
University of Washington in Seattle was turned down by his
university’s Institutional Review Board (IRB) when he
proposed a pediatric study.
One of the problems with the research proposal was that the
risk to the children who were to be tested would be greater
than "minimal" and they would also not directly benefit from
the research. This gate on research with children was
established in federal regulations going back to 1983. The
goal was to protect children from harm in studies.
Fujimoto seemed to be on what might be termed politely as a
"fishing expedition." He was interested in the notion that
Asian adults have a "predisposition" to accumulate some
central tummy fat and also have an increased risk for type 2
diabetes, and apparently that risk was greater around
puberty.
So Fujimoto wanted to run tests on 450 children, ages 8 to
10 (300 of Japanese ancestry and 150 Caucasians). He hoped
to gain an understanding of the kinds of metabolic changes
that occur before the onset of type 2 diabetes in his
subjects and learn about how being Asian might raise the
risk of developing diabetes.
In other words, the children in the experiment would not
directly benefit themselves, but their participation might
lead to knowledge that might be of benefit to others.
That’s what his university’s IRB thought and therefore asked
the federal government to convene an expert panel to
determine whether the research could be launched on the
basis of it providing wider knowledge.
One of the sections of the federal regulations on
experimentation with children allows for research to be
approved after both the IRB and expert panel agree that it
can lead to "generalizable knowledge of vital importance."
And that’s what happened. This is why the recommendation to
approve the research is in the Federal Register. Only the
Department of Health and Human Services posted it on August
7 and wanted all comments on the recommendations to close on
August 21 (tomorrow) at 5 PM.
Now here is some crucial information: Between 1983 and the
end of the year 2000, there were only two or three instances
where an expert panel was called upon to consider a research
proposal that would only provide "generalizable knowledge of
vital importance."
In 2001, there were 26 requests for this type of expert
panel.
Vera Hassner Sharav, President of The Alliance For Human
Research Protection (AHRP), an advocacy group, says that the
build-up of such requests signals that the "gates are
opening for a great widening of experimentation with
children, and of research of no direct benefit to these
children."
She is also angry that the Department of Health and Human
Services has allowed only two weeks for comment on the
recommendation to approve the research proposed by Fujimoto.
"What’s the rush, why are they trying to get this through so
fast during the dog days of summer?
Sharav, who also is a member of the Children’s Workgroup of
the National Human Research Protections Advisory Committee,
says that upon closer inspection of the research proposal,
"there is a lot that is wrong with it."
AHRP plans to submit a detailed comment strongly criticizing
the approval of Fujimoto’s study.
Among the key points that she will raise are the following:
* Where is the solid evidence that Asian adults have an
ethnic "predisposition" to diabetes?
* Why isn’t a survey done first about the true incidence of
diabetes in this population?
* This study is being proposed on the basis of vague
generalities about the Asian-American population and their
risk for diabetes.
* There is no evidence that the proposed study comes even
close to meeting the ethical standards required for approval
under federal regulations.
On the last point, Sharav notes that the federal regulations
allow for this type of research which will not directly
benefit the children being tested when there is an
opportunity to obtain vitally important knowledge that will
lead to information that may prevent or alleviate a health
condition in children.
Sharav does not believe Fujimoto’s proposal meets that
standard.
One member of the expert panel convened by the Department of
Health and Human Services made it very clear that the
proposal was almost worthless, emphasizing that the study
had serious design flaws and would provide little in the way
of knowledge about "the problem it intends to address."
And according to Sharav, "The federal regulations were not
intended as some kind of escape hatch from restrictions
protecting children from possible harm."
But it seems on the basis of similar research proposals
being filed that IRBs and researchers alike are finding a
way to expand the scope of research with children.
I would imagine that most of the members of these expert
panels that will be convened to review these research
requests will be sure to pack their rubber stamps, if the
Fujimoto case is any example of what’s to come.
Subscribe Free To The RFW Newsletters!
Subscribe To The Nicholas Regush Health News Analyzer
FAIR USE NOTICE: This may contain copyrighted (© ) material
the use of which has not always been specifically authorized
by the copyright owner. Such material is made available to
advance understanding of ecological, political, human
rights, economic, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this
constitutes a 'fair use' of any such copyrighted material as
provided for in section 107 of the US Copyright Law. In
accordance with Title 17 U.S.C. Section 107, this material
is distributed without profit to those who have expressed a
prior general interest in receiving similar information for
research and educational purposes. For more information go
to: http://www.law.cornell.edu/uscode/17/107.shtml If you
wish to use copyrighted material for purposes of your own
that go beyond 'fair use', you must obtain permission from
the copyright owner.
|
Having problems with message search?
Fill out this form to ensure your group is one of the first to be migrated to the new message search system.
Send Email