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Amendment would require additional reporting
Following the release last year of a National Bioethics Commission Report on biomedical research involving people with diminished capacity to give informed consent, U.S. Rep. Edolphus Towns (D-NY) has introduced legislation calling for the creation of a program to collect information on the use of children and individuals with mental disabilities as subjects in biomedical and behavioral research.
Specifically, H.R. 299 calls for an amendment to the Public Health Service Act that would require the Secretary of Health and Human Services to establish a program to gather information about research involving those vulnerable populations.
According to the bill summary filed with the U.S. House of Representatives, the bill stipulates that — for studies that fall under the jurisdiction of the Public Health Service Act or are subject to chapter five of the Food, Drug and Cosmetic Act — the program may require the submission of reports by the institutional review boards at each institution.
Information collected by the program would include a description of the research subjects, the nature of the research, the objective of the research, the reasons for the use of such subjects, and the source of funding for the research.
Although the legislation only calls for the collection of information, it could be an important step in establishing protections for children and the mentally ill or disabled, says David Magnus, PhD, director of graduate studies at the University of Pennsylvania Center for Bioethics in Philadelphia.
"There is a set of values that says we ought to be involving children [and the mentally disabled] more in research trials so that we can make sure that things are going to be safe and effective for them," he says.
"But, on the other hand, we should not do research on these populations when there is no clear benefit to them and there is more than minimal risk. So, you have both sets of well-established values, yet they really do conflict.
"In the end, you cannot do research on children of the sort that is really called for unless you do Phase 1 trials. But, Phase 1 trials are not likely to meet the standard that has been established. So, there is going to have to be more thinking about those issues, and maybe this will help."