Citing Risk, Government Halts Medical Study on Children - National Institutes of Health
Washington Post 7nov00

Washington -- Federal regulators have suspended a research study involving 193 children on the National Institutes of Health campus in Bethesda, Md., saying the experiment posed a larger risk to the children than is allowed by law and should not have been approved.

The experiments involved children ages 6 to 10. Moreover, none of them stood to benefit directly from participating.

NIH officials sought yesterday to reassure the parents of the children that the study was safe. Led by Jack A. Yanovski of the NIH's National Institute of Child Health and Human Development, it was planned as a 15-year study of the metabolic underpinnings of obesity.

Over the years, each child was to repeatedly undergo a battery of procedures, including psychological testing, X-rays, blood sugar tests, and an abdominal MRI exam. Of most concern, though, were a handful of other comprehensive tests requiring an overnight stay in the hospital, each of which required the insertion of several intravenous blood lines and required the children to experience extremely high and extremely low blood sugar levels for hours at a time.

Such studies pose risks, OHRP investigators concluded, including the risk of more than minimal pain, allergic reactions or, most problematic, dangerous blood clots or phlebitis.

The suspension, imposed Friday, is the fourth research shutdown imposed by the Office for Human Research Protections since it was created in June as part of an effort by the Department of Health and Human Services to beef up its oversight of human research.

Studies in healthy children are allowed under federal regulations only if the research poses no more than a minimal risk of harm. When the review board first looked at the protocol in 1996, it concluded that the research posed more than a minimal risk. But it recommended the study be approved, invoking a federal regulatory clause that allows such risks in children if the research promises to provide information that will help in the fight against the children's ailment.

That decision was controversial because it considered the healthy children of obese parents to have an ``ailment'' by virtue of their having obese parents.

The following month, the review board met again. It heard testimony from Yanovski, who emphasized that no children to his knowledge had been harmed by the tests. Yanovski persuaded the committee that the risks were no greater than those a child might encounter ``while playing in traffic,'' according to the meeting minutes. The board reversed its earlier determination and deemed the experiment no more than a minimal risk.

Experts said the OHRP suspension points out a difficulty in interpreting regulations regarding medical research involving children, since they require researchers and ethics overseers to define ``minimal risk'' on a case-by-case basis. But after consultation with many experts, the OHRP said in its suspension letter to NIH deputy director for on-campus research, it determined that the research clearly exceeded minimal risk.

Moreover, OHRP concluded, healthy children of obese parents ``do not have a disorder or condition'' and thus do not qualify to be in research with more than a minimal risk.