COHORT STUDIES IN CANCER EPIDEMIOLOGY RELEASE DATE: October 20, 2003 PA NUMBER: PAR-04-011 (see addenda NOT-CA-04-021 and NOT-CA-04-001) EXPIRATION DATE: November 2, 2005, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Cancer Institute (NCI) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399 LETTER OF INTENT RECEIPT DATE: May 1, 2004; January 2, 2005; September 1, 2005 APPLICATION RECEIPT DATES FOR NEW APPLICATIONS: June 1, 2004; February 1, 2005; October 1, 2005 APPLICATION RECEIPT DATES FOR COMPETING CONTINUATIONS (TYPE 2), COMPETITIVE SUPPLEMENTS, AND REVISED APPLICATIONS: July 1, 2004; March 1, 2005; November 1, 2005 This Program Announcement (PA) replaces PAS-02-009, which was published in the NIH Guide on October 11, 2001. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Receipt and Review Schedule o Required Federal Citations PURPOSE OF THIS PA The Division of Cancer Control and Population Sciences (DCCPS) of the National Cancer Institute (NCI) announces special receipt dates for R01 grant applications from investigators intending to initiate, competitively supplement, or competitively renew population-based epidemiologic or survivorship cohort studies of human cancers. The purpose of the Program Announcement (PA) is to coordinate the submission, review, and funding of population-based epidemiologic or survivorship cohort studies, and covers applications characterized by their cohort design and direct costs of $500,000 or more in any one study year. This PA represents a continuation of previous NCI policy, in that the NCI does not accept unsolicited applications at these budget levels for population-based cohorts. All usual NIH grants policies apply to these awards. RESEARCH OBJECTIVES Prospective population-based cohort studies are one of the mainstays of epidemiologic inquiry, and have the clear advantage over cross-sectional and case-control study designs of unbiased assessment of multiple pre-diagnostic exposures and the ability to assess multiple outcomes. In the cohort design, information on the study factor is known for all subjects at the beginning of the follow-up period, and they are followed over time to determine who among them develop the disease(s) of interest. Therefore, the study factor of interest, or exposure, is observed and measured before the disease is detected, making it likely that the study factor is related to disease development (i.e., is a risk factor) instead of being part of the disease process. Also, it is much less likely that the presence or absence of the study factor of interest can differentially influence selection of study participants on the basis of disease outcome status. Once a population-based cohort is established, and data and bio-specimens become available, it typically becomes an attractive infrastructure for additions or supplements to address new areas of scientific investigation. Often the cohort is used to study other diseases in addition to cancer. However, these types of population-based cohort studies are usually substantially more time-consuming and expensive than most cross-sectional and case-control approaches, and are usually less suitable for study of more uncommon outcomes unless very large numbers of subjects are followed. Also, because study factor information must be observed at the outset of the study, a cohort study design limits opportunities for generating new etiologic hypotheses requiring information on other, unanticipated exposures. Rigorous scientific inquiry in gene-gene and gene-environment interactions has raised the awareness of the role of prospective population-based cohorts, with a concomitant increase in number, scale, and costs of the research grants. Cohort studies have been tremendously useful tools, particularly in assessment of exposures and capture of multiple outcomes. However, cohort research proposals are frequently submitted without full appreciation of the opportunities for research nested within existing cohorts. Most new cohorts require the passage of years before accumulation of enough endpoints to analyze. Existing cohorts include people who are well characterized, and likely already experiencing the impact of environmental exposures. Issues of key interest to the NCI with regard to these resources include continuity of funding, balance of important cohort characteristics, quality of design, rigor in exposure assessment, response and follow-up rates, bio-specimen collection and storage, bioinformatics, availability of bio-specimen resources to outside qualified investigators, and willingness to collaborate with other investigators in the establishment of research consortia. Potential applicants are encouraged to learn more about extramurally funded, large, population-based epidemiologic and survivorship cohort studies at the NCI at the following website: Coordination of research infrastructure in the arena of population-based cohorts may be expected to yield new and expanded opportunities for study, as the biomedical resources are made available to outside investigators. These large databases will afford the opportunity to study hypotheses that would be underpowered in smaller studies. This is especially true in the study of gene-environment and gene-gene interactions, in which large numbers of study participants followed in a standardized fashion are required. In addition, NCI coordination of population-based epidemiologic and survivorship cohorts will make it possible to identify gaps, whether in special populations, special cancers of high interest, or other special outcomes. Applications pursuant to this PA are limited to population-based epidemiologic and survivorship cohort studies of human cancers. This PA covers population-based epidemiologic and survivorship cohort applications requesting $500,000 or more in direct costs (excluding third- party facility and administrative, formerly indirect, costs) in any one project year. Potential applicants are encouraged to become familiar with existing resources at the address listed above, Examples of applications that MUST be submitted under this solicitation include the following: o applications for new population-based epidemiologic cohort studies of human cancers requesting $500,000 direct costs or more in any one project year o applications for new survivorship cohorts of human cancers requesting $500,000 direct costs or more in any one project year o applications for competitive supplements to an NCI-funded population-based epidemiologic or survivorship cohort study that would result in such study costing $500,000 direct costs or more in any one project year o applications for competitive renewal (Type 2) of an NCI-funded population- based epidemiologic or survivorship cohort study requesting $500,000 direct costs or more in any one project year This solicitation specifically EXCLUDES the following: o 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-03-024, Molecular Epidemiology of Cancers Associated with Acquired Immunodeficiency o applications for new and existing epidemiologic cohort studies of individuals at high genetic risk for cancer o applications for new and existing intervention studies, including randomized controlled trials o administrative supplements, such as those resulting from unexpected loss of equipment or increase in costs of a test MECHANISMS OF SUPPORT This PA will use the NIH investigator-initiated research project grants (R01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to the PA may not exceed FIVE years. The earliest anticipated award date is April 2005. Revisions of unsuccessful applications submitted under this PA will ONLY be accepted in response to future reissuances of this PA. The next submission opportunity for competing continuations, supplements, and revisions is July 1, 2004 . 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 standard R01 receipt dates not specified as submission opportunities in this PA. NCI will not accept applications, including revisions, for population-based epidemiologic and survivorship cohorts costing $500,000 or more direct costs in any one study year that are not submitted in response to this PAR. 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. Application for competitive renewal of existing cohorts (Type 2) will be limited to a 20 percent increase over the last non-competing (Type 5) year. In cases where the last non-competing year budget was substantially lower than other previous years, and if the nature of the new research requires budget increases for one or more years above the 20 percent rule for the last non-competing year, applicants may cite the average yearly direct cost as a base for the new cap. Applicants interested in this option are required to contact the NCI program director for the currently funded grant before submitting applications. Requests for exceptions to the 20 percent cap on Type 2 applications will NOT be granted. Further information on NCI policy in this area may be found at Letters of Intent are strongly recommended, and are due May 1, 2004 (for the first receipt date), January 2, 2005 (for the second receipt date), or September 1, 2005 (for the third receipt date). This PA uses just-in-time concepts. It also uses the non-modular budgeting formats (see This program does not require cost sharing as defined in the current NIH Grants Policy Statement at ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Effective with the October 1, 2003, receipt date for NIH applications, NIH expects timely release and sharing of final research data for use by other researchers. Grant applications must include a plan for data sharing, or state why data sharing is not possible. Data sharing plans must be discussed with NIH Institute/Center staff for all applications submitted under this PA. Information on data sharing must be included in relevant sections of the grant application, including a data sharing plan at the end of the Research Plan, Budget and Budget Justification if asking for funds, and in Background and Significance sections if creating an important scientific resource. Institute/Center program staff will be responsible for assessing the appropriateness and adequacy of the data sharing plan, and program concerns must be resolved prior to making an award. Reviewers will review the data sharing plan, but it will not be included in determinations of the scientific merit or priority score for an application. Further information on the NIH data sharing requirements may be found at WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, financial or grants management, and review issues: o Direct your questions about scientific/research issues to: Sandra L. Melnick, Dr.P.H. 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: o Direct your inquiries regarding peer review issues to: Denise Wiesch, 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: o Direct your questions about financial or grants management matters to: Crystal Wolfrey Division of Extramural Activities National Cancer Institute Executive Plaza South, Room 234, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this PA Although a letter of intent is not required, is strongly recommended, not binding, and does not enter into the review of a subsequent application, the information that it includes allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Sandra L. Melnick, Dr.P.H. 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: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: The title, Cohort Studies in Cancer Epidemiology, and the number of the program announcement (PAR-04-011) must be typed on line 2 of the face page of the application form and the YES box must be marked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted by the receipt dates listed on the first page of this program announcement ONLY. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at The 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 a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o 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 and assigned a priority score o Receive a written critique o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have 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. 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? 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? 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? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See Federal Citation below.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities Because the nature and scope of the research proposed will vary, it is anticipated that the size of each award also will vary. Other things being equal, cost and program relevance may be considered in making awards. If several applications are of similarly high scientific and technical merit, preference for funding may be given to competitive continuation of existing resources. RECEIPT AND REVIEW SCHEDULE Letter of Intent May 1, 2004 New Applications June 1, 2004 Competing Continuations, Supplements, and Revisions July 1, 2004 Scientific Merit Review Oct-Nov, 2004 Advisory Council Review Jan-Feb, 2005 Earliest Anticipated Start Date April 2005 Letter of Intent January 2, 2005 New Applications February 1, 2005 Competing Continuations, Supplements, and Revisions March 1, 2005 Scientific Merit Review June-July, 2005 Advisory Council Review Sept-Oct, 2005 Earliest Anticipated Start Date December 2005 Letter of Intent September 1, 2005 New Applications October 1, 2005 Competing Continuations, Supplements, and Revisions November 1, 2005 Scientific Merit Review Feb-March, 2006 Advisory Council Review May-June, 2006 Earliest Anticipated Start Date July 2006 REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. SHARING RESEARCH DATA Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (; a complete copy of the updated Guidelines are available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 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 is available at REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at A continuing education program in the protection of human participants in research is 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 PA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at 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. Furthermore, we caution reviewers 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 PA 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 at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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