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.

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.