OHRP Suspends NIH Child Obesity Study

In its fourth research "shutdown" since June, the Office of Human Research Protections on Nov. 3 suspended an NIH obesity study involving 200 children, saying the study "posed a larger risk to the children than is allowed by law," the Washington Post reports. The study, led by Jack Yanovski of the NIH's National Institute of Child Health and Human Development, was intended to be a 15-year investigation of the "metabolic underpinnings of obesity." Researchers were hoping to determine how to identify children at risk for developing obesity later in life. An NIH review board in 1996 approved the study on obese youngsters and normal children with obese parents. Throughout the study, children were to "repeatedly undergo a battery of procedures," including psychological testing, X-rays, blood sugar tests and an MRI of the abdomen. The Post reports that of "most concern" were "comprehensive" tests involving overnight hospital stays, the insertion of IV blood lines and hours-long durations of extremely high and low blood sugar levels. OHRP investigators determined that such studies pose "more than minimal risk of pain, allergic reactions or, most problematic, blood clots or phlebitis." Under federal regulations, studies in healthy children are allowed only if the research poses no more than a "minimal risk of harm." The Post reports that in 1996 the NIH review board acknowledged an excess of "minimal risk" posed by the research protocol, but recommended the study under a "federal regulatory clause" that permits such risk to children if the research "promises to provide information that will help in the fight against the children's ailment." The children's "ailment," in this case, was their risk of developing obesity by virtue of having obese parents. Yanovski was later able to "convince" the NIH committee to reverse its determination that the study posed more than minimal risk, describing risks associated with the study as "no greater than those a child might encounter 'while playing in traffic,'" and adding that "no children to his knowledge had ever been harmed by the tests in question." 'Feeding Frenzy' for Children in Research In a letter to Michael Gottesman, NIH deputy director for intramural research, the OHRP stated the research "clearly exceeded minimal risk," concluding that healthy children of obese parents "do not have a disorder or condition," and thus are not eligible to participate in research posing more than minimal risk. In defense of the research, Gottesman said, "I have absolute faith in Dr. Yanovski. As far as we know there's been absolutely no risk to anyone in the study." Gottesman added that children of obese parents may be "abnormal" as they face a "substantially increased risk of becoming obese." But Vera Hassner Sharav, president of Citizens for Responsible Care and Research, called the research "just one of a growing number of inappropriate studies involving healthy children." Sharav added, "There's a feeding frenzy for children in research now. And now the federal government has contributed to the erosion of research ethics by giving its seal of approval to experiments that inflict pain on helpless children and by putting them in harm's way." Gottesman said the NIH review board will reconvene in the next two weeks to "reconsider the protocol" and decide whether to appoint a "special committee of experts," as suggested by OHRP, to determine whether the study "really poses more than minimal risk" (Weiss, Washington Post, 11/7).