TERRY BEIRN COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ON AIDS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: NIH-NIAID-DAIDS-94-11 P.T. 34 Keywords: AIDS Clinical Medicine, General National Institute of Allergy and Infectious Diseases The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), has a requirement for the continuation of the Terry Beirn Community Programs for Clinical Research on AIDS (TB CPCRA). The purpose of these contracts is to expand and strengthen the HIV clinical research effort, support community participation in HIV research, enhance the participation of women, minorities and injection drug users in HIV clinical research and to ensure the prompt translation of research findings to primary care providers. This is a recompetition of an ongoing program. Proposals must describe the offeror organization and document the availability of patient population, recruitment and follow-up plans appropriate for the conduct of community-based trials. The offeror must be able to initiate a minimum of three, but not to exceed a maximum of ten community based research projects per year, depending on size and complexity and designed in conjunction with NIAID staff. Offerors are expected to enroll at least 30 to 50 patients into studies. These may be investigator-initiated or NIAID-initiated multicenter collaborative trials. All CPCRA research must be approved by the DAIDS Clinical Trials Review Committee prior to being implemented. The successful offerors to this Request for Proposal (RFP) must have the demonstrated or potential ability to implement and manage a clinical research program based in primary care settings. Proposals will be accepted from domestic organizations made up of licensed physicians and nurses with access to a substantial patient population infected with HIV. Particular emphasis will be given to organizations which serve minorities, women at risk for HIV infection and persons who use IV drugs and/or organizations composed of women and minorities. Evidence of substantial experience by the members of the organization in the care and treatment of persons with HIV infection must be documented in the proposal. Mandatory Criterion: Offeror's must document, e.g., by including letters of commitment from the organization, that, with respect to the CPCRA scientific and clinical issues, the overall direction and decision processes rest with the primary care clinicians. Proposals must also demonstrate support from the community served by the offering organization, such as endorsement by relevant community organizations, and community participation in the decision process of the provision of clinical care, clinical management or research priorities and conduct of research. Offerors must demonstrate relationships with community health care facilities such as hospitals, public health departments, and regional tertiary care centers, to ensure integration of the offeror clinicians within the local medical care structure. This must include affiliations with local hospitals so participating patients can be followed by offeror physicians if hospitalization is required. Offerors must have access to a clinical laboratory competent to perform the studies required for community-based clinical trials. Offerors in cities that include one or more AIDS Clinical Trial Unit (ACTU), must describe a formalized communication link with an NIAID supported ACTU(s). This should include relevant researchers, clinicians, and/or administrators of both the community organization and the ACTU and should provide a forum for discussion of goals, protocols, and entry criteria of clinical research at both the ACTU and the Community Program for Clinical Research on AIDS. This is an announcement for an anticipated RFP. RFP NIH-NIAID-DAIDS- 94-11 will be available on or about June 30, 1993 and proposals will be due by 4:30 p.m., local time, on November 3, 1993. It is anticipated that fifteen to twenty contracts will be awarded as a result of this solicitation. It is expected that the contract will have a five year period of performance, and a completion cost- reimbursement type contract is anticipated. INQUIRIES To receive a copy of the RFP, provide this office with five self- addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short-form version of the RFP will be provided first, which includes only the Statement of Work, Reporting Requirements and the Evaluation Criteria to be used for selection of the awardees. After examining this, a full-text version of the RFP must be requested, in writing, for those offerors interested in responding. FAX requests are acceptable for the full text versions of the RFP only. Requests for the RFP may be directed in writing to: Nancy Hershey Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-0972 All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. .
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