AIDS MALIGNANCY BANK NIH GUIDE, Volume 24, Number 40, November 24, 1995 P.T. 34 Keywords: AIDS Biological Resources National Cancer Institute The National Cancer Institute (NCI) announces that the AIDS Malignancy Bank (AMB) is accepting requests for tissues and biological fluids from investigators at-large. This notice provides a description of the AMB, application instructions, and directions to access the database listing the available specimens. The NCI established centers in the United States and its territories for the collection and distribution of tissues, blood, and secretions from patients with clinically characterized HIV-related malignancies in 1994. The AMB makes these tissues available to qualified investigators in the United States for research on HIV-related malignancies. It is hoped that by providing access to these high quality specimens, research in HIV-related malignancies will be encouraged and facilitated. The AMB contains formalin-fixed paraffin embedded tissues, fresh frozen tissues, malignant cell suspensions, fine needle aspirates, and cell lines from patients with HIV-related malignancies. The bank also contains serum, plasma, urine, bone marrow, cervical and anal specimens, saliva, semen, and multi-site autopsy tissues from patients with HIV-related malignancies including those who have participated in clinical trials. The bank has an associated database that contains prognostic, staging, outcome, and treatment data on patients from whom tissues were obtained. Researchers who use the specimens pay for shipping of specimens. A listing of the available specimens can be obtained on the internet at http://wwwicic.nci.nih.gov/amb/amb.html. APPLICATION PROCEDURES The AMB Steering Committee solicits Letters of Intent (LOI) from investigators with a short lead time and with a minimum of paper work that facilitates NIH AIDS grant submission deadlines. The NCI AMB will make public the specimens that are available for study in a request for LOIs. An investigator obtains and completes an LOI and returns it to the NCI AMB by specified dates. Application forms are also available on the internet. REVIEW CONSIDERATIONS The LOIs are reviewed by an independent Research Evaluation and Decision Panel (REDP) composed of experts in the field of HIV-related malignancy research. The scientific merit of the application, the experience of the investigator and the statistical validity of the study are some of the factors that are used in the review of the LOI. A priority score is attached and forwarded to the AMB Steering Committee to confirm that the specimens are available. Low priority studies will not receive specimens and even high priority studies will not receive specimens if unavailable. Investigators who request samples in excess of that required to accomplish the study, those who have not correctly determined the sample size necessary to complete the study, or have not provided sufficient detail to assess the validity of the sample requests will be denied the samples. If the specimens requested are available, the LOIs with the highest priority are provided a letter of approval that commits the AMB to provide the necessary specimens once funding of the study has been approved. This letter of approval may be incorporated into NIH or other grant applications. After a notification is received by the AMB Steering Committee that funding exists or was obtained, specimens are released to the investigator. Investigators who fail to obtain funding within six months of receiving the letter of approval will have the approval voided and those tissues will become available to other investigators in the next cycle. Since this LOI is not meant to provide an extensive review of the science involved, a detailed analysis of the LOI and the reason for denial will not be provided. INQUIRIES Additional Information and application forms may be obtained from: Ellen Feigal, M.D. Division of Cancer Treatment National Cancer Institute 6130 Executive Boulevard, Room 741 MSC 7436 Bethesda, MD 20892 Telephone: (301) 496-4844 FAX: (301) 402-0556 Email: feigale@dct.nci.nih.gov .
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