[There follows a list of 22 more general and specific function to be carried out by the Secretary through the Director.]

“(h) Increased participation of women and disadvantaged individuals in biomedical and behavioral research; The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.”

“(i) Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions; (1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the ‘data bank’).”

“(j) Expanded clinical trial registry data bank; (2) Expansion of clinical trial registry data bank with respect to clinical trial information; (A) In general; (i) Expansion of data bank; To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) of this section (referred to in this subsection as the ‘registry data bank’). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet. (B) Inclusion of results; The Secretary, acting through the Director of NIH, shall—[expand the registry data bank and ensure its availability to the public].”

“(5) Coordination and compliance; (C) Quality control; (i) Pilot quality control project; Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D).”



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