This Program Announcement expires on February 22, 2003, unless otherwise specified. COHORT STUDIES IN CANCER EPIDEMIOLOGY Release Date: October 11, 2001 (see addenda NOT-CA-02-026, NOT-CA-03-030) PA NUMBER: PAS-02-009 (see replacement PAR-04-011) National Cancer Institute Letter of Intent Dates: January 18, 2002, and January 17, 2003 Application Receipt Dates: February 21, 2002, and February 21, 2003 PURPOSE The Division of Cancer Control and Population Sciences (DCCPS) of the National Cancer Institute (NCI) announces an annual receipt date for R01 grant applications from investigators intending to initiate, competitively supplement, or competitively renew epidemiologic cohort studies of human cancers. The purpose of this Program Announcement (PA) is to coordinate the submission, review, and funding of epidemiologic cohort studies, and covers applications characterized by their cohort design and direct costs of $500,000 or more in any study year. This PA represents a change in NCI policy, in that NCI will no longer accept unsolicited applications at these budget levels for epidemiologic cohorts. All usual NIH Grants policies apply to these awards. It is anticipated that this PA will be issued annually. RESEARCH OBJECTIVES There has been a rapid increase in the average costs of grants submitted to the NCI as well as similar growth in the number of grants with direct costs of $500,000 and higher. A substantial number of these more expensive grants are cohort studies. This research is increasingly expensive and may vary widely in terms of cost per year per participant. In light of recent acceleration in the number of applications submitted to establish new cohorts and their escalating costs, the NCI is instituting a new approach for acceptance of such applications. Cohort designs are one of the mainstays of epidemiologic inquiry, and have the clear advantage over retrospective study designs of unbiased assessment of pre-diagnostic exposures and the ability to assess multiple outcomes. They are, however, substantially more time-consuming and expensive than most case-control approaches and less suitable for study of more uncommon outcomes, which may include certain cancers. Once an epidemiologic cohort is established, and data and biospecimens become available, it typically becomes an attractive infrastructure for additions or supplements to address new areas of scientific investigation. Sometimes, the cohort can be used to study diseases in addition to cancer. Rigorous scientific inquiry in gene-gene and gene-environment interactions has raised the awareness of the role of cohorts, with a concomitant increase in number, scale, and costs of the research grants. While cohort studies have been tremendously useful tools, cohort research proposals are frequently submitted without full acknowledgement of existing cohorts. For these reasons, integrating, prioritizing, and funding epidemiologic cohort studies has become an issue for the NCI. Issues of key interest to the Institute with regard to these population resources include continuity of funding, balance of important cohort characteristics, quality of design, rigor of exposure assessment, response and follow-up rates, biospecimen collection and storage, bioinformatics, availability of biospecimen resources to outside qualified investigators, and other areas. Because of constraints on the NCI budget resulting from the existence of numerous epidemiologic cohort studies, and the necessity for consistency in the review of these large projects, the NCI has decided to accept applications once a year in response to an annually issued PA. RESEARCH OBJECTIVES This PA covers epidemiologic cohort applications requesting $500,000 or more in direct costs (including third-party facility and administrative, formerly indirect, costs) in any project year. Examples of applications that MUST be submitted under this solicitation include the following: --applications for new epidemiologic cohort studies of human cancers requesting $500,000 direct costs or more in any one project year --applications for competitive supplements to an NCI-funded epidemiologic cohorts that would result in a cohort study costing $500,000 direct costs or more in any one project year --requests for competitive supplements to an NCI-funded epidemiologic cohort study currently funded for $500,000 direct costs or more in any one project year --applications for competitive renewal (Type 2) of an NCI-funded epidemiologic cohort study requesting $500,000 direct costs or more in any one project year This solicitation specifically EXCLUDES the following: --applications for new and existing epidemiologic cohort studies of HIV- related malignancies, which will continue to be submitted and reviewed under existing NIH guidelines for AIDS-related research and under PA-00-086, Molecular Epidemiology of HIV-Associated Cancers --requests for administrative supplements such as those resulting from unexpected loss of equipment or increase in costs of a test MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) investigator- initiated (R01) grant mechanism. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the PA may not exceed FIVE years. The earliest anticipated award date is December, 2002. Revisions of unsuccessful applications submitted under this PA will ONLY be accepted in response to future re-issuances of this PA. The next submission date is February 21, 2003. Revised versions of unsuccessful applications may NOT be submitted under other mechanisms, including submission of revised applications to the NIH Center for Scientific Review (CSR) for the standard R01 receipt dates. NCI will no longer accept unsolicited applications, including revisions, for cohort studies costing $500,000 or more in any study year. Applicants are strongly encouraged to discuss revisions with program staff. Though the size of award may vary with the scope of research proposed, applications must stay within the NCI budgetary guidelines for R01 investigator-initiated competing projects. Applications for competitive renewal of existing cohorts (Type 2 applications) will be limited to a 20 percent increase (including third-party facility and administrative, formerly indirect, costs) over the most-costly Type 5 year. Further information on NCI policy in this area may be found at Budgets will be an important consideration in funding decisions, and applicants are strongly encouraged to discuss their budgets with program staff. Letters of Intent are due January 18, 2002 (for the first receipt date), and January 17, 2003 (for the second receipt date), and are strongly encouraged. FUNDS AVAILABLE The NCI intends to allocate up to $12 million (total costs) in first-year costs for this initiative in this solicitation cycle, with the allocation for first-year costs in the second cycle still to be determined. Other things being equal, cost may be considered in making awards. Because the nature and scope of the research proposed will vary, it is anticipated that the size of each award also will vary. Although the financial plan of NCI provides support for this program, awards pursuant to this PA are contingent upon the availability of funds and receipt of a sufficient number of applications of high scientific and technical merit. ELIGIBILITY REQUIREMENTS Applications pursuant to this PA are limited to epidemiologic cohort studies of human cancers. Applications may be submitted by foreign and domestic 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. Racial/ethnic 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 programmatic issues to: Sandra L. Melnick, Dr. P.H. Chief, Analytic Epidemiology Research Branch Epidemiology and Genetics Research Program Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Room 5100, MSC 7324 Bethesda, MD 20892-7324 Telephone: (301) 435-4914 Fax: (301) 402-4279 Email: Direct inquiries regarding fiscal matters to: Crystal Wolfrey Lead Grants Management Specialist, BPS Section Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243, MSC 7150 Bethesda, Maryland 20892-7150 Telephone: (301) 496-8634 Fax: (301) 496-8601 Email: Direct inquiries regarding review issues to: David Monsees, Ph.D. Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 3150, MSC 7770 Bethesda, MD 20892-7770 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 435-0684 Fax: (301) 480-3962 Email: LETTER OF INTENT Prospective applicants are strongly encouraged to submit, by January 18, 2002 (for the first receipt date), and January 17, 2003 (for the second receipt date), a Letter of Intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, the number and title of the PA to which the application is being submitted. Although a Letter of Intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. The Letter of Intent is due by January 18, 2002 (for the first receipt date), and January 17, 2003 (for the second receipt date), to Dr. Sandra L. Melnick, listed under INQUIRIES. SCHEDULE 1st Letter of Intent Receipt: January 18, 2002 1st Application Receipt: February 21, 2002 1st Peer Review Date: June/July, 2002 1st Review by National Cancer Advisory Board: September, 2002 1st Earliest Anticipated Start Date: December, 2002 2nd Letter of Intent Receipt: January 17, 2003 2nd Application Receipt: February 21, 2003 2nd Peer Review Date: June/July, 2003 2nd Review by National Cancer Advisory Board: September, 2003 2nd Earliest Anticipated Start Date: December, 2003 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at must be used in applying for these grants and will be accepted at the standard application deadlines ( as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: Consistent with NCI policies, funds requested in the budgets for competitive renewals of existing cohorts (Type 2 applications) will be limited to 20 percent above the highest Type 5 year. Further information may be obtained at Budget will be an important consideration in funding decisions Submit a signed, typewritten original of the application, including the checklist, and five signed, exact, single-sided 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) Applications must be received by February 21, 2002 (for the first receipt date), and February 21, 2003 (for the second receipt date). If an application is received after that date, it will be returned to the applicant without review. The NCI will no longer accept unsolicited applications for epidemiologic cohorts costing $500,000 or more in direct costs in any study year. The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for adherence to the guidelines of this PA by the NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit by the Center for Scientific Review, National Institutes of Health 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 of the National Cancer Institute. Review Criteria 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. The five criteria to be used in the evaluation of NIH grant applications are listed below. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any). 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 6. The initial review group will also examine the appropriateness of the proposed budget and duration of the study; the adequacy of plans to include both genders and minorities, and their subgroups, as well as children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. 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 ( A complete copy of the updated Guidelines is available at 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: Investigators also may obtain copies of the policy 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 NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: A continuing education program in the protection of human participants in research is now available online at PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. REQUIREMENTS FOR SHARING RESEARCH RESOURCES NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published. All investigators should read the Guidelines available at the following url address: See also: NIH Grants Policy Statement ( and Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts: Final Notice, December 1999 ( It is expected that biomaterials and other patentable research resources (examples could be, but are not limited to, vectors, embryonic cell lines, mutant mice, etc.) produced in projects funded by this initiative will be made available and distributed to the broader scientific community. 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 Program Announcement (PA), Cohort Studies in Cancer Epidemiology, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393. 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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