Response of the Department of Health and Human Services to NBAC's Report 'Research Involving Human Biological Materials: Ethical Issues and Policy Guidance'. General Comments


In preparing this response to NBAC’s report, the Working Group recognizes that, until such time as federal regulations are revised through legislation or rulemaking, any enhancements to federal oversight of human subjects protection must be carried out within the construct of existing regulations. Furthermore, the Working Group is mindful that NBAC has spent considerable time conducting a major examination of the current framework, regulations and policies for the protection of human subjects in research and has published for public comment a draft report entitled Ethical and Policy Issues in Research Involving Human Participants. When completed, this report is expected to make recommendations for broad regulatory changes whose scope probably will include research involving human biological materials. However, since the nature and extent of the eventual regulatory changes, if any, are not predictable now, the Working Group believes that a number of important NBAC recommendations should be implemented as soon as feasible. Therefore, for certain of NBAC’s recommendations, the Working Group considered not only what enhancements could be made under current regulations but also what changes could be implemented by investigators and institutions on a voluntary basis. The actions the Working Group proposed in response to NBAC’s report can be implemented without the complex and time consuming efforts involved in promulgating new regulations.

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