42 U.S.C. § 300cc–13 — Terry Beirn Community-Based AIDS Research Initiative

(a) In general: After talking with the Commissioner of Food and Drugs, the Director of the National Institutes of Health — acting through the Director of the National Institute of Allergy and Infectious Diseases — may give grants to public and nonprofit private groups, and may sign contracts with public and private groups, that work on AIDS. The money is for planning and running clinical trials, in the community, of experimental AIDS treatments that the FDA Commissioner has approved for investigational (test) use. (b) Requirement of certain projects: (1) This financial assistance must include help for community-based organizations and community health centers to (A) keep proper medical supervision in place, (B) handle administration, data collection, and record-keeping, and (C) train community doctors, nurse practitioners, physician assistants, and other health workers to run clinical trials. (2)(A) The assistance must also include money for demonstration projects designed to bring community-based clinical trials to every part of the affected community — including minorities, people with hemophilia, people exposed through transfusions, women, children, people who inject drugs, and people who don't yet have symptoms. (B) The Director of NIH cannot give this particular assistance unless the application is approved by (i) the Commissioner of Food and Drugs, (ii) a properly set-up Institutional Review Board that meets the federal ethics rules in part 56 of title 21 of the Code of Federal Regulations, and (iii) the Director of the National Institute of Allergy and Infectious Diseases. (c) Participation of private industry, schools of medicine and primary providers: Programs funded under (a) must be designed to draw in and encourage support from private industry, medical and osteopathic schools, and existing groups of primary care providers who do AIDS research. (d) Requirement of application: The Secretary cannot give financial assistance under (a) unless (1) an application is submitted, (2) the application gives the Secretary satisfactory assurances that the money will be used for its stated purpose, and (3) the application is in whatever form, made in whatever manner, and contains whatever agreements, assurances, and information the Secretary decides are necessary. (e) Authorization of appropriations: Congress could appropriate whatever money was necessary, for each fiscal year 1989 through 1996, to carry out both (1) the community organization and training work described in (b)(1) and (2) the demonstration projects described in (b)(2).