ESTABLISHED INVESTIGATOR AWARD IN CANCER PREVENTION, CONTROL, BEHAVIORAL, AND POPULATION SCIENCES RELEASE DATE: July 8, 2003 PA NUMBER: PAR-03-149 (This PAR has been reissued, see PAR-05-145) EXPIRATION DATE: June 2, 2005, unless reissued. National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.393, 93.398, 93.399 This Program Announcement (PAR) replaces PAR-00-039, which was published in the National Institutes of Health (NIH) Guide on January 10, 2000. THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of this PAR o Objectives of the PAR o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Allowable Costs o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The purpose of the NCI Established Investigator Award in Cancer Prevention, Control, Behavioral and Population Research (K05) is to provide established investigators protected time to devote to research and to act as mentors for new investigators and junior faculty members. The target candidates are outstanding established scientists who have demonstrated a sustained, high level of research productivity and significant contributions to cancer prevention, control, behavioral and/or population cancer research. They must demonstrate the need to develop and enhance their own research and a commitment to serve as mentors to new scientists. The award provides salary support for up to five years and it is renewable for one additional five-year period. The NCI is especially interested in training and retaining scientists who conduct high-quality research in cancer prevention, control, behavioral, and population sciences. Accordingly, this award is an important part of the NCI Strategic Training Plan to relieve researchers from administrative and/or clinical responsibilities in order to help them focus on mentoring and research. Examples of disciplines relevant to this PAR include any aspect of human cancer prevention (health promotion, modifiable risk factors, new animal models and extrapolation of these models to human cancer, genetic predisposition to cancer, detection of precursor lesions, chemoprevention trials in human populations, behavioral research and behavioral intervention trials), epidemiology (classic, genetic, molecular), biostatistics, human cancer genetics, human nutrition, health services and health policy research, medical decision analysis, survivorship and quality of life as they relate to cancer, and basic and applied research in the behavioral sciences that independently or in combination with biomedical approaches, reduces cancer risk, incidence, morbidity, and mortality over the lifespan and across the entire process of carcinogenesis from primary behavioral prevention in youth, to screening, treatment, and survivorship. OBJECTIVES A. Background: In 1998, the National Cancer Institute completed major external reviews of its cancer prevention and control sciences programs. The scientific experts conducting these reviews recommended strengthening the NCI-supported cancer prevention program by increasing support of research on modifiable risk factors, new animal models and extrapolation of these models to human cancer, genetic predisposition to cancer, detection of precursor lesions, chemoprevention trials in human populations, and behavioral research and behavioral intervention trials in cancer prevention. Recommendations made by the scientific experts for research areas of emphasis in cancer control included: basic behavioral and social research, communications and informatics, rehabilitation and survivorship, quality of life, screening research, and applied cancer control research, including health services and health policy research. These groups also recommended bringing senior scientists into the NCI for short periods of time to collaborate with the NCI researchers and program staff. The cancer prevention and cancer control review groups independently identified the current level of support for training in cancer prevention and cancer control as being inadequate to take full advantage of the new opportunities for reducing cancer incidence, morbidity and mortality. The scientific experts on these review groups recommended expanding current NCI support of education/training programs in cancer prevention and cancer control, and multidisciplinary training of basic and clinical scientists in highly interdisciplinary and collaborative environments. Other NCI advisory groups have made similar recommendations. The NCI Cancer Training Branch responded to these recommendations in 1998 with the NCI Strategic Training Plan. A major focus of this plan was to provide new training and career development opportunities for young investigators in the cancer prevention, control and population sciences. Additionally, to address the projected needs of the mentors for these young investigators, the strategic plan proposed the use of a career award grant mechanism to provide senior investigators "protected" time to stabilize their research programs and for mentoring new investigators. B. Program: The award provides five consecutive 12-month appointments. At least 25 percent and up to 50 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. C. Environment: The institution must have a well-established research and career development program in cancer prevention, control, and population sciences. The institution must be able to demonstrate a commitment to the candidate as a productive, independent investigator. The candidate and institution must certify that the candidate will be released from other duties and be able to devote 25 to 50 percent effort to achieve the research and mentoring objectives of this award. The institution must also document an adequate pool of candidates for mentoring. MECHANISM OF SUPPORT This PAR will use the NIH K05 award mechanism. The Established Investigator Award in Cancer Prevention, Control, Behavioral and Population Research is a special NCI modification of the NIH Senior Scientist Award or K05 grant mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. In addition, the institution must demonstrate a commitment to the candidate and the candidate's goals for career development. The project period may be for up to five years (at least three years are required). Awards are renewable for one additional five-year period if the candidate still meets the stated requirements. This PAR uses the "just-in-time" application procedures and the Streamlined Non-competing Application Process (SNAP). ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Domestic non-federal o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Candidates for this award must meet the following requirements: o Must be established cancer scientists with a strong track record of publications and successful competition for cancer research support. o Must have peer-reviewed, independent research support at the time of, and during the entire duration of, the award. This support could include NIH awards (e.g., R01) or awards from other sources, as long as they are equivalent to NIH R01 type grants in complexity and duration. Individuals holding small grants (R03s) or developmental grants (R21s) are not eligible. However, scientists whose work is primarily theoretical may apply for this award in the absence of research grant support, if the institutional commitment includes stability of salary and research support. o Must have a record of supervising junior researchers. o Must demonstrate the need for protected time to advance their research careers and mentoring activities. o Must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but under U.S. sovereignty, jurisdiction or administration. Individuals on temporary or student visas are not eligible. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. A candidate for this award may not concurrently apply for any other PHS award that duplicates the provisions of this award. ALLOWABLE COSTS 1. Salary: The NCI will provide salary for the award recipient up to the current Federal salary rate limit plus commensurate fringe benefits for up to 50 percent effort. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. The total salary requested must be based on a full-time, 12-month staff appointment and the level of effort proposed. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The award will also provide fringe benefits on the calculated base salary at the established institutional rate. Recipients of this award may derive additional compensation for the effort associated with other federal sources or awards provided the total salary derived from all Federal sources does not exceed the current Federal salary rate limit and their total percent effort on all awards does not exceed 100 percent. Direct salary is exclusive of fringe benefits, indirect costs/ facilities, and administrative expenses. 2. Research Development Support: It is expected that candidates for a K05 award will have active, independent research support at the time of the award (see eligibility requirements). However, the K05 award provides additional funds up to $25,000 direct costs per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) statistical and computational services including personnel and computer time; and (d) travel to research meetings or training. 3. Ancillary Personnel Support: Salaries for secretaries, administrative assistants and other ancillary personnel are not allowed. 4. Facilities and Administration Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. 5. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such funds must be assigned to the grantee institution for disposition by any of the following methods: o The funds may be expended by the grantee institution in accordance with NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. o The funds may be used for health-related research purposes. o The funds may be paid to miscellaneous recipients of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services (DHHS), NIH, and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for payment. o Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. SPECIAL REQUIREMENTS 1. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Awardees planning a period of leave must submit a written request to the NCI in advance of the leave. This request must be countersigned by the appropriate business official at the grantee's institution and at the new institution/facility. This request must include the reasons for the leave and must provide a description of the provisions that will be made to ensure that the awardee will be able to continue meeting the special requirements of this award for a suitable research environment and for opportunities to mentor junior investigators during the period of leave. NCI staff will review the request and notify the principal investigator and the new grantee institution of the results of this evaluation. If the request is approved, support will continue during the leave period. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. 2. Termination or Change of Institution: When the grantee institution plans to terminate the award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: o A new application for a K05 award is submitted by the new institution. o All conditions of the award are met at the new institution. o The period of support requested is no more than the time remaining within the existing award period. o The new application is submitted far enough in advance of the requested effective date to allow the necessary time for NCI review. Review of these materials is usually carried out by NCI staff. However, depending upon the circumstances, the NCI may also require a review by an initial review group and/or the National Cancer Advisory Board. The NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event that an award is terminated, the Director of the NIH shall notify in writing the grantee institution and the career award recipient of this determination, of the reasons thereof, the effective date, and the right to appeal the decision. 3. Final Progress Report: A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. 4. Evaluation by NCI: In carrying out its stewardship of human resource related programs, NCI may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Maria Agelli Cancer Training Branch National Cancer Institute Building 6116, Room 7021 Bethesda, MD 20892 Rockville, MD 20852 (express courier) Telephone: (301) 496-8580 FAX: 301-402-4472 Email: ma215e@nih.gov o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncirefof@dea.nci.nih.gov o Direct your questions about financial or grants management matters to: Ms. Catherine Blount National Cancer Institute Grants Administration Branch 6120 Executive Blvd. Room EPS 243 Bethesda, MD 20892 Phone: (301) 496-3179 Fax: (301) 496-8601 E-mail: blountc@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Form PHS 398 gives specific instruction for Research Career Awards (section IV, pages 55-62) and provides an alternative table of content that should be used. In general, the instructions provided by PHS 398 should be followed. To make sure that the application is identified as a response to this program announcement, check "YES" on item 2 of the face page (page 1) of the application and enter the title and the number of this PAR. Following the alternative table of content provided by PHS, specific suggestions are given to clarify NCI specific requirements for this award. Section I: Basic Administrative Data Point 6: indicate all other support of applicant. Please note that to be eligible for the K05 award the candidate must have other research support when s/he applies and for the entire period of the award. A complete list of all sources of active research support and pending research support must be provided. Section II: Specialized Information Point 2: Letters of reference are not required. Point 3A: Candidate background should be split in: a) candidate research background and b) candidate mentoring background Point 3C: Career development activities during Award period. Justification of the need for this award should be included. It is important to convey to the reviewers your reasons for needing protected time to continue a vital research program and continue to engage in the mentoring of new scientists. It should be clear that this award will allow you to spend more time on research and mentoring and less time on administrative and clinical responsibilities for the institution. Point 4: Statement by sponsor(s), consultant(s), and collaborator(s) is not required. Point 5: Environmental and Institutional Commitment to Candidate It will be helpful to the reviewers to understand what duties and responsibilities in the institution you are being relieved of to focus on research and mentoring AND how the institution will accommodate these activities with other staff. Point 6: Research Plan Candidate must specify the overall percent of effort that s/he will dedicate to research and the specific percent effort on this award (K05) that will be committed to currently supported research. Candidate should present such effort as instructed in form PHS 398. There is no need to provide extensive detail with regard to ongoing, funded research. However, enough information should be provided in the areas of Hypothesis and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods for the reviewers to evaluate the extent, special features, and general quality of the research activities. In addition, candidate should describe a research plan for new research to be specifically supported by this grant (K05), inclusive of - Hypothesis and Specific Aims - Significance and Rationale - Research Design and Methods It is likely that most of the described research will be ongoing; however, the candidate must provide documentation that all issues related to human subjects and/or to vertebrate animals have already been adequately addressed in ongoing research. For each new research project, the candidate must provide the information required and described in the General Instructions in PHS Form 398 and demonstrate that the inclusion of women, members of minority groups and their subpopulations, and children, has been adequately addressed. If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) should be addressed. ADD new point 7: Mentoring Plan Specify the percent effort to be committed to mentoring on this grant (K05), including: - Availability of candidates that will be recruited for mentoring. Please describe: degree, specialization, and previous training of these individuals. - A plan for recruitment and supervision. - Educational and research experiences that will be provided. - Specific role as mentor for trainees and for junior faculty members to guide them in achieving a successful, independent research career in cancer prevention, control, behavioral, and population sciences. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PAR 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 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 Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and for adherence to the guidelines of this PAR by NCI staff. Applications that are incomplete, as determined by the Center for Scientific Review, and that do not adhere to the guidelines of this PAR, as determined by NCI staff, will not receive further consideration. Applications that are complete and adhere to the guidelines of this PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Cancer Advisory Board to ensure that the proposed program meets the broad programmatic needs of the NCI and the National Cancer Program. 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: 1. Candidate: o Quality of the candidate's academic and research record, and track record as a leader of a productive research program. o Evidence of ongoing high-quality research in cancer prevention, control, behavioral, or population sciences and the relationship of that research to the proposed K05 program. o A strong track record of obtaining research support in the cancer prevention, control, behavioral, or population sciences. o A demonstrated record of mentoring or training of investigators, or a demonstration of the capability to provide mentoring to junior investigators. 2. Justification: o Demonstration that the proposed program and protected time will relieve the candidate of existing administrative (and where appropriate, clinical) duties to permit additional time for research and mentoring. 3. Career and research plan: o Appropriateness of the research plan as a vehicle for developing and refining skills and capabilities in cancer prevention, control, behavioral, and population sciences research. o Scientific and technical merit of the ongoing and newly proposed research. o Likelihood of research contributing significantly to the scientific knowledge base. o Appropriateness of the duration of the proposed research program. o Availability of adequate resources to conduct the research program. o Appropriateness of proposed level of effort committed to the Research Plan. 4. Mentoring Plan: o Experience and potential of the candidate to serve as a mentor. o Adequacy of the plans for mentoring or supervising junior investigators in cancer prevention, control, behavioral, or population sciences research. o Appropriateness of the proposed level of effort committed to the Mentoring Plan. 5. Environment and Institutional Commitment: o Quality and relevance of the environment for scientific and professional development of the candidate and trainees pursuing research in cancer prevention, control, behavioral, and population sciences. o Adequacy of the applicant institution's commitment to provide protected time for conduct of the research and the mentoring programs and to the career development of the candidate. 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). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. 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 PAR 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 REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) 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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 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 http://grants.nih.gov/grants/funding/children/children.htm. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PAR 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 (http://www.hhs.gov/ocr/) 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. 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 PAR is related to one or more of the priority areas. 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 at http://www.cfda.gov/ 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 http://grants.nih.gov/grants/policy/policy.htm 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.