TISSUE AND BIOLOGICAL FLUIDS BANKS OF HIV-RELATED MALIGNANCIES Release Date: April 24, 2001 RFA: RFA-CA-02-001 (Reissued as RFA-CA-08-501) National Cancer Institute Letter of Intent Receipt Date: July 13, 2001 Application Receipt Date: August 10, 2001 This RFA is a reissue of RFA-CA-94-003, which was published in NIH Guide Volume 23, Number 2, January 14, 1994. PURPOSE The Office of the Director of the Division of Cancer Treatment and Diagnosis (OD-DCTD), National Cancer Institute (NCI) invites applications from consortia of institutions for cooperative agreements to bank tissue and biological fluids and to maintain associated clinical data from patients with HIV-associated malignancies. The purpose of the proposed awards is to continue cooperative efforts to identify and improve access to tumor tissue, biological specimens, and associated clinical outcome data that could then be utilized for research, by the research community at-large, on the pathogenesis of HIV-associated malignancies and development of more effective therapies. RESEARCH OBJECTIVES Background Congenital and acquired states of immunodeficiency increase the incidence of high-grade B cell non-Hodgkin’s lymphoma (NHL), Kaposi’s sarcoma (KS), and certain types of epithelial malignancies. Individuals infected with human immunodeficiency virus (HIV) have a marked increase in the appearance of intermediate and high-grade B cell NHL and KS, and show trends for an increased incidence for Hodgkin’s disease and anogenital dysplasia and cancer, compared to age-matched controls. The tumors in HIV-infected individuals are generally aggressive and insufficiently sensitive to conventional therapy. Trends in the epidemiology and treatment of HIV have changed. As a result of behavioral changes and highly active anti-retroviral therapy (HAART), the incidence of KS and primary central nervous system lymphoma has decreased. However, the incidence of NHL and intraepithelial neoplasias are not as affected by immune reconstitution. Certain subtypes of NHL, such as T-cell NHL and primary effusion lymphomas, are being detected more frequently. What is not yet known, and needs to be prepared for, is the effect of prolonged moderate immunodeficiency, incomplete or failed response to HAART, and perhaps HAART itself on the establishment and maintenance of cancer. As HIV vaccine trials begin, new questions will arise. Given the association of viruses with many AIDS-related cancers, intense investigations are needed to identify the pathogenic role of these viruses, especially Epstein-Barr virus, human herpesvirus 8/Kaposi’s Sarcoma-associated herpesvirus, and human papillomaviruses. In recent years, the extramural research community has recognized the value of biological fluids and tissue banks in supporting translational research. They recognized that the most efficient method to obtain tumor specimens and bodily fluids would take advantage of the meticulous follow-up and monitoring of patients in the context of clinical trials in the institutions involved in the care of patients with HIV-associated malignancies. Tumor tissue collected during clinical trials would permit research on the pathogenesis of HIV-associated malignancies and on the development of effective therapies. Objectives and Scope The purpose of the proposed awards is to continue the cooperative efforts of the Tissue and Biological Fluids Bank of HIV-associated malignancies and to maintain associated clinical and outcome data. The Banks would provide critical resources to the research community at-large for research studies to gain insight into the pathogenesis of the malignancies that arise in HIV-infected individuals. The current Tissue and Biological Fluids Bank of HIV-associated malignancies is composed of five consortiums each made up of a minimum of two institutions with an Operations Office that provides the necessary coordination of specimen collection, and data management. Collection and storage of specimens are performed at each institutional site that is part of each consortium. Formation of a consortium of institutions is encouraged to maximize specimen accession. All applicants must provide evidence of availability and access to patient specimens, and each Consortium (made up of a minimum of two institutions) must have an Operations Office that is capable of providing the necessary coordination of specimen collection, data management, and storage of specimens at a central location. Banked specimens may consist of fixed or frozen tumor tissue and biological fluids. All specimens are collected and banked according to common procedures developed up by the Tissue and Biological Fluids Banks of HIV-associated malignancies. The awardees will provide to the research community at-large tissue and biological fluids of high quality from patients with HIV-associated malignancies for high priority research studies. This task will be accomplished through the workings of two committees, the Steering Committee and the Research Evaluation and Decision Panel (REDP). The duties of these two committees are described below under SPECIAL REQUIREMENTS. SPECIAL REQUIREMENTS Definitions CONSORTIUM - a consortium must include a minimum of two institutions, which join together under the guidance and direction of a single Principal Investigator. Each consortium must have clinical laboratory and pathology components representing diverse scientific disciplines. AWARDEE - the organization to which a cooperative agreement is awarded and which is responsible and accountable to NCI for the use of funds provided and for performance of the cooperative agreement-supported project. PRINCIPAL INVESTIGATOR (PI) - the single individual at the awardee institution designated by the awardee in the cooperative agreement application, who is responsible for the scientific and technical direction of the project. OPERATIONS OFFICE - the central office at the Applicant/Awardee Institution that handles all the clinical data and the tissue and biological fluids repository data. The Principal Investigator serves as The Head of the Operations Office and is responsible for supplying specimen update information to the Central Operations and Data Coordinating Center at least 4 times/year. CENTRAL OPERATIONS AND DATA COORDINATING CENTER The administrative unit that coordinates all the Consortium activities. Responsibilities include administrative management and coordination of the workings of all awardee Operations Offices, developing and maintaining a central database of available tissue and clinical data, maintaining a database of repository samples from the AIDS Malignancy Consortium and other NIH-funded cooperative groups, responding to approved Letters of Intent, coordinating shipment and ensuring receipt of samples, tracking progress reports of sample recipients, developing a national outreach program, and ensuring adherence to the Office of Human Research Protection regulations. The Central Operations and Data Coordinating Center will be located at the same site as a Bank Consortium. NCI PROGRAM DIRECTOR - The OD-DCTD extramural grants Program Director, who interacts scientifically with the Applicant/Awardee Institutions regarding basic science issues. The Program Director will also be coordinating DCTD"s interactions and administering and providing guidance for the overall program within the NCI. He/she is available for consultation during preparation of applications as well as the duration of research conducted through this cooperative agreement. He/she is the Executive Secretary of the Review and Evaluation Decision Panel. NCI COORDINATOR - The Deputy Director, DCTD, who interacts scientifically with the Applicant/Awardee Institutions regarding clinical science issues. STEERING COMMITTEE - a single Committee whose membership includes the NCI Coordinator, the NCI Program Director, the PI and one other investigator from each awarded cooperative agreement, and one research scientist with expertise in the field of HIV-associated malignancies who is not affiliated with any of the Awardee Institutions/Consortia. This research scientist on the Steering Committee will be appointed by mutual agreement of the NCI Coordinator, the NCI Program Director and the PIs. The Steering Committee will serve as the governing board of the Tissue and Biological Fluids Banks of HIV-Related Malignancies (see under "Terms and Conditions of Award" for function of Steering Committee). REVIEW AND EVALUATION DECISION PANEL (REDP) - A panel composed of the NCI Program Director and six to eight scientists with clinical/basic research expertise in the field of HIV-associated malignancies. The members of the panel will evaluate all research (those of the awardees as well as proposals from the research community at-large) proposing to utilize the specimen and data Banks according to the evaluation and review criteria provided by the Steering Committee. The panel will provide a recommendation to the Steering Committee regarding the priority of the proposed research. The membership of the REDP may vary, depending on the scientific areas of the proposed research to be reviewed and evaluated. Except for the NCI Program Director, all members will be selected by the Steering Committee (see under "Terms and Conditions of Award" for function of REDP). Study Organization and Function The current overall structure of the Tissue and Biological Fluids Banks of HIV-Related Malignancies consists of five funded Consortia that are governed and coordinated through the Steering Committee. Each Bank or funded Consortium is composed as follows: two or more member institutions of the Consortium who are responsible for contributing specimens, biological fluids and clinical data, an Operations Office at the awardee institution, and one PI who is responsible for providing the scientific and administrative leadership for the Consortium and serves as the Head of the Operations Office. A separately funded Central Operations and Data Coordination Center will provide administrative oversight to the consortia as described under Definitions. The overall function of the Tissue and Biological Fluids Banks of HIV-Related Malignancies is to continue to serve as a national resource to the research community at-large. The Tissue and Biological Fluids Banks of HIV-Related Malignancies will provide tissue specimens and clinical outcome data after the requests for such specimens and data have been reviewed and prioritized by the REDP and approved by the Steering Committee. Requests for specimens and data from the awardees and their collaborators will be reviewed, prioritized by the REDP and approved by the Steering Committee along with all other requests from investigators in the research community at-large. The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of award. Terms and Conditions of Award These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U01), an assistance mechanism in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the NCI Program Director and the NCI Coordinator. 1. Awardee Rights and Responsibilities The Awardee will have primary and lead responsibilities for the project as a whole, including the following: The Awardee will establish a bank, collect specimens and clinical data. The Awardee Principal Investigator, and one other investigator from the Consortium, will serve on the Steering Committee. The Awardee Principal Investigator will ensure that a database of specimen information is kept current, using software compatible with the Central Operations and Data Coordinating Center database software. The Awardee Principal Investigator will provide updated database information on a quarterly basis as defined by the Steering Committee. The Awardee will work together with the other Awardees and the Central Operations and Data Coordinating Center through the Steering Committee to establish uniform collection methods and policies, and to assure quality control of specimens and data. The Awardee will be required to accept and implement the common policies and procedures approved by the Steering Committee. The Awardee agrees to provide access to specimens and data to investigators both within and outside of the awardees" institutions based on the prioritization of research proposals set by the REDP and final approval by the Steering Committee. The Awardee will abide by the decisions of the Steering Committee based on recommendations from the REDP. The Awardee will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The Awardee will ensure that all cooperating institutions must have an approved assurance of compliance for the protection of human subjects on file with the Office of Human Research Protection and that necessary IRB reviews are conducted by the IRBs of the appropriate institutions in accordance with 45 CFR part 46 prior to the involvement of human subjects. The Awardee must provide an annual progress report in its continuing application to OD-DCTD, NCI, and a copy to the chairperson of the Steering Committee, in a format that is standardized and compatible with the annual progress reports from the other Awardees. Information on the operations of the bank, specimen accrual and dispersement, are to be included. The Awardee must cooperate with the following groups by serving as a resource for either repository or donation functions: the AIDS-Malignancies Consortium, a national clinical trials cooperative group funded by the NCI under separate granting mechanism, the NCI-sponsored Clinical Trials Cooperative Groups, and with the NCI-sponsored Epidemiology Cohort studies, the latter two also funded by the NCI under separate granting mechanisms. 2. National Cancer Institute Staff Responsibilities The NCI Coordinator and the NCI Program Director will have substantial scientific-programmatic involvement during conduct of this activity through participation in the Steering Committee and the REDP, respectively. They will provide technical assistance, advice and coordination, assure that the Steering Committee and the REDP follow the NIH guidelines on conflict of interest issues and play critical roles in promoting the availability and use of the Banks. The roles of the NCI Coordinator and the NCI Program Director are to assist and facilitate, but not to direct activities of the Tissue and Fluids Banks of HIV-related Malignancies. The NCI Coordinator and Program Director will serve as a voting member on the Steering Committee, may attend meetings of the REDP as an observer and will serve as an information resource on the relevant NCI extramural awardees likely to require the resources of the proposed banks. The NCI Program Director will serve as the non-voting executive secretary of the REDP. He/she will advise the ad hoc REDP members on the Steering Committee"s algorithm for reviewing the proposals requesting biological specimens and clinical data and will provide information on other relevant on-going NCI activities and help answer any programmatic issues. Both NCI staff will serve on subcommittees of the Steering Committee and the REDP as required. The National Cancer Institute reserves the right to reduce the budget, to withhold support, and to suspend, terminate or curtail a study or an award in the event of substantial shortfall in specimen accrual, data reporting, inadequate quality control in specimens or clinical data collection, non-adherence to biohazard precautions, refusal to carry out the recommendations of the REDP and Steering Committee, or substantial failure to comply with the terms of award. 3. Collaborative Responsibilities a. Steering Committee The Steering Committee will serve as the governing board of the Tissue and Biological Fluids Banks of HIV-Related Malignancies. The Steering Committee is composed of the NCI Coordinator and Program Director, the PI and one other investigator from each awarded Consortium, and one research scientist with expertise in the field of HIV-associated malignancies who is not affiliated with any of the Awardee Institutions/Consortia. This research scientist on the Steering Committee will be appointed by mutual agreement of the Steering Committee. The Steering Committee has primary responsibility for developing and evaluating policies for quality control of the specimens, and uniformity of procedures across institutions, for promoting the availability and the uses of the specimen bank, and for developing an algorithm for review and prioritization of research proposals, to be used by the REDP, utilizing the banked specimens and clinical data (e.g., based on scientific merit with high priority awarded to investigators with funded grants). The NCI Coordinator and Program Director will assist the other members of the Steering Committee in all these tasks. Furthermore, the NCI Coordinator and Program Director will serve as the scientific liaisons between the awardees and other program staff of NCI who have previous experience in the establishment of tumor banks. Each member of the Steering Committee will have one vote. One Chairperson will be selected by the Steering Committee, and be someone other than the NCI Coordinator or Program Director. The Chairperson, together with the Central Operations and Data Coordinating Center, is responsible for coordinating the Steering Committee"s activities, for preparing meeting agendas, for scheduling and chairing meetings, and preparing an annual progress report, which will include individual reports from each Awardee. Each Awardee is responsible for timely preparation of this report, which will be submitted to the Central Operations and Data Coordinating Center. The Central Operations and Data Coordinating Center (CODCC) is responsible for providing documentation as to the availability and accessibility of specimens and data for scientific investigations (e.g., the PI of the CODCC will send the principal investigator of an REDP reviewed high priority proposal a letter as to the availability of the specimens, with a final letter to be sent stating that specimens and/or data will be made available as requested when funding for the REDP reviewed high priority proposal is documented. If the proposal is already funded at the time it is submitted to the REDP and reviewed as high priority, then the PI will send the final letter at that time). The only occurrence in which the Steering Committee can overturn the recommendations of the REDP is when specimens and/or data are not available. Subcommittees will be established by the Steering Committee, as it deems appropriate. The NCI Coordinator and Program Director will serve on subcommittees as appropriate. The Steering Committee will meet at a minimum of twice per year in conjunction with the NCI Coordinator and the Program Director, to map strategies to fulfill the objectives of their function, to develop operating procedures and to evaluate progress. The initial meeting will occur immediately after funding. The Steering Committee will also meet with the REDP once per year. The NCI Program Director will attend the joint meeting of the Steering Committee and REDP as a non-voting member. The Steering Committee will select members of the REDP. The Steering Committee in the conduct of all business matters will pay particular attention to conflict of interest issues, especially in actions regarding recommended prioritizations of the REDP. b. Research Evaluation and Decision Panel The REDP will serve the Steering Committee by reviewing and evaluating all research submitted by the research community at-large as well as by the awardees proposing to utilize the specimen and clinical data Banks A recommendation in terms of priority of the proposed research will be provided to the Steering Committee. The only occurrence in which the Steering Committee can overturn the recommendations of the REDP is the unavailability of the requested specimens and/or clinical data. The REDP will meet with the Steering Committee at least once yearly, at one of the two scheduled Steering Committee meetings. The REDP will be composed of the NCI Program Director and six to eight scientists with clinical/basic research expertise in the field of HIV-associated malignancies. The members of the panel will evaluate all research (those of the awardees as well as proposals from the research community at-large) proposing to utilize the specimen and data Banks according to the evaluation and review criteria provided by the Steering Committee. The panel will provide a recommendation to the Steering Committee as to the priority of the proposed research. The membership of the REDP may vary, depending on the scientific areas of the proposed research to be reviewed and evaluated. All members will be selected by the Steering Committee. The Chairperson of the REDP will always be someone other than the NCI Program Director. The review of proposals can be conducted either in person, by conference call or by mail at a minimum of twice per year. All reviews will be conducted according to rules pertaining to conduct of reviewers for NIH grants, contracts, and cooperative agreements, paying special attention to issues of conflict of interest, whether real or apparent. The NCI Program Director will serve as the executive secretary (non-voting role) for the review and will forward the final recommendation to the Central Operations and Data Coordinating Center for distribution to the Steering Committee. The NCI Program Director in the role of executive secretary of review will inform and advise the ad hoc REDP members on the Steering Committee"s algorithm for review and prioritization of proposals, will provide information to the ad hoc REDP members on the studies that have already been approved and on other relevant on-going NCI activities so that redundant studies are not performed, and will help answer any programmatic issues. The NCI Program Director also plays an important role in the whole review process by lending a degree of continuity with the Steering Committee, as the ad hoc REDP composition may change depending on the expertise required to review the submitted research proposals. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the NCI member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NCI, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR part 16. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will remain a cooperative agreement (U01), an assistance mechanism, in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study to be funded under this cooperative agreement are discussed later in this RFA under the section "Terms and Conditions of Award." Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Because of the variation in numbers of patients to be accrued, and specimens to be accessed, it is anticipated that the size of awards will vary also. The total project period for applications submitted in response to the RFA may not exceed five years. The anticipated award date is June 1, 2002. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. At this time the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. If it is determined that there is a sufficient continuing program need, the NCI will either invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review or re-issue the RFA for re-competition. If the NCI does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. FUNDS AVAILABLE Approximately $3.5 million in total costs per year for five years will be committed to fund applications submitted in response to this RFA. It is anticipated that 6 awards for the Tissue and Biological Fluids Banks of HIV-Related Malignancies will be made, including one for the Central Operations and Data Coordinating Center, and 5 for Bank Consortia. It is anticipated that the award for the Central Operations and Data Coordinating Center will be made for approximately $500,000 (including direct and Facilities and Administrative costs) per year. ELIGIBILITY REQUIREMENTS This is a recompetition of a previously issued RFA. Domestic and Canadian for-profit and non-profit organizations, public and private such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government are eligible to apply. Foreign institutions other than Canadian are not eligible to apply or be a collaborating institution. Canadian institutions are included because many of them are members of the NCI-Sponsored Clinical Trials Cooperative Groups and the NIAID-sponsored AIDS Clinical Treatment Units. Applications must be from a consortium of no less than two institutions, which can include, but are not limited to, the NCI-Sponsored Clinical Trials Cooperative Groups, the NIAID-Sponsored AIDS Clinical Treatment Units, or a coalition of Cancer Centers. New and experienced investigators are encouraged to apply. Applications from minority individuals, women, and persons with disabilities, are encouraged to apply as principal investigators. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding clinical scientific issues to: Ellen G. Feigal, M.D. Deputy Director Division of Cancer Treatment and Diagnosis National Cancer Institute Building 31, Room 3A44 Bethesda, MD 20892 Telephone: (301) 496-6711 Fax: (301) 496-0828 Email: ef30d@nih.gov Direct inquiries regarding basic science or programmatic issues to: Jodi B. Black, Ph.D. Program Director Office of the Director, Division of Cancer Treatment and Diagnosis National Cancer Institute Building 31, Room 3A44 Bethesda, MD 20892 Telephone: (301) 402-6293 Fax: (301) 496-0828 Email: blackj@mail.nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8326 Rockville, MD 20852 (express courier) Bethesda MD 20892-8326 Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Kelli Oster Grants Administration Branch National Cancer Institute 6120 Executive Boulevard Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8627 FAX: (301) 496-8601 Email: osterk@GAB.NCI.NIH.GOV LETTER OF INTENT Prospective applicants are asked to submit by July 13, 2001, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows the NCI staff to estimate the potential review workload and to plan the review. The Letter of Intent is to be sent to Dr. Jodi Black, listed above under INQUIRIES. SCHEDULE Letter of Intent Receipt: July 13, 2001 Application Receipt Date: August 10, 2001 Review by NCAB Advisory Board: February 22, 2002 Earliest Anticipated Start Date: June 1, 2002 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, E-mail: grantsinfo@nih.gov. For those applicants with Internet access, the 398 kit may be found at http://grants.nih.gov/grants/funding/phs398/phs398.html. Additional Materials to Include in the Application It is critical that applicants clearly describe plans to accommodate stated criteria and staff involvement as listed in the Terms and Conditions of Award, and in the Review Criteria section. Re-Competing Applicants One Applicant should present the overview of the entire Consortium in its current form. Individual applicants should state how their formed Consortium composed of no less than two institutions will maintain and enhance their specimen bank. This should be divided into two parts: 1) The investigators should demonstrate their productivity during the previous 4 years of funding. This should include documenting the types, quantities, and quality of specimens and clinical/demographic data that have been obtained. Also, state the numbers, types, and progress of proposals that have utilized their resources. The investigators should list the projects proposed, and the projects that are actually provided specimens, as well as the number of specimens that are provided for the projects. The investigators should list the publications (abstracts and papers) from such projects that have utilized the specimens. The investigators should list their cost per specimen. The investigators should detail how they have set up a common database for the Banks. 2) The investigators should state how they will enhance their specimen bank, e.g., in the operations center, the database, plans to incorporate new research opportunities, as well as describe future contributions of specimens in the upcoming years of funding. This should include documenting the types, quantities, and quality of specimens and clinical/demographic data that will be obtained, how they have utilized the feedback from the proposals that are currently utilizing specimens and data on future specimens and data that should be made available. The investigators should state and describe how they intend to enhance their operations and database to incorporate new research endeavors (e.g., AIDS Malignancy Consortium, NCI sponsored Clinical Trials Cooperative Groups, NCI sponsored Epidemiology Cohorts, the NIH sponsored VA Aging Cohort Study), and their anticipated cost per specimen. The applicant for the Central Operations and Data Coordination Center should budget for all administrative duties listed under Definitions and Terms of Award, for computer needs and software upgrades, and for REDP and Bank Advisors travel expenses. New Applicants The applicant should form a Consortium composed of no less than two institutions to design and develop a specimen bank and document their access to and numbers of HIV infected oncology patients in clinical trials. Details on the mechanism for tissue accession and storage and procedures for clinical data collection and storage need to be provided. The application should also address quality control issues for the specimens and clinical data collected. The application needs to address the types of specimens (frozen and fixed tumor tissue, biological fluids) planned for inclusion in the bank. Tissues and fluids to be collected should come from groups of patients that are treated uniformly on standard therapeutic regimens or clinical trials where clinical and outcome data are available. Examples of pathology and clinical data forms that will be used should be provided in the appendix of the application. The application should propose an approach to setting up a common database for the consortium. Applicants should clearly describe the Operations Office, the facilities for banking and data collection, the investigators" experience and expertise in banking and the applicants" ability to obtain tumor tissue and biological specimens from HIV-infected patients with malignancies. The application must provide details on the appropriate facilities and biohazard precautions and comply with all applicable Federal, State and Local regulations, laws and ordinances in the operation of the Banks. Applicants must maintain a database compatible with the existing Bank database and budget funding for necessary computers and software. The applicants must state a willingness to cooperate with other awardees in developing policies for quality control and to share data with other awardees. The applicants must state a willingness and should discuss their approach to cooperate with the Steering Committee and the REDP in evaluating research proposals utilizing specimens obtained in their bank(s) and to abide by the decisions of the REDP in prioritizing such proposals, after final approval by the Steering Committee based on specimen availability. All Applicants Each applicant must provide the name and qualifications for the second investigator from the consortium on the Steering Committee. Each applicant must also provide the name and qualifications of one scientist not affiliated with its institution/consortium as a potential member of the Steering Committee. In addition, each applicant must provide the names and qualifications of two scientists not affiliated with its institution/consortium as potential members of the REDP. Travel funds for two investigators to attend two Steering Committee meetings per year should be included in the budget. All costs required for the proposed Banks must be included in the application and must be fully justified. These costs include the collection and storage of specimens, quality assurance, data management and analysis, and travel. An estimate and explanation based on cost per specimen is required. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8326 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8326 Applications must be received by August 10, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the National Cancer Institute. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the National Cancer Institute in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria The criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Extent to which the application address the goals and objectives of the RFA, Adequacy of applicant"s plans for addressing the special scientific and technical program requirements presented in the RFA, Merit of the proposed activities and organizational plans for implementing the proposed Tissue and Biological Fluids Banks of HIV-Related Malignancies, Qualifications and experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the banking facilities and procedures and clinical data collection, Adequacy of existing physical facilities and resources of the organization, Demonstration of the numbers of patients with HIV-associated malignancies accessible to the investigators for clinical data and specimen collection, Adequacy of plans for effective cooperation and coordination among participating awardees, the NCI Program Director and the NCI Coordinator, as per Special Requirements of the RFA, Past contributions of specimens to the Tissue and Biological Fluids Banks of HIV-Related Malignancies if applicable, The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit of the application based on priority score, (b) availability of resources, and study populations, and (c) availability of funds. Furthermore, the applicant organization must indicate a commitment to accept provisions outlined under the SPECIAL REQUIREMENTS section, terms and Conditions of Award. The anticipated date of award is June 1, 2002. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups, if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA, Tissue and Biological Fluids Bank of HIV-Related Malignancies, is related to priority area of AIDS and cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395, Cancer Treatment Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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