SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPOREs) IN HUMAN CANCER FOR THE YEAR 2004 RELEASE DATE: August 4, 2003 PA NUMBER: PAR-03-158 (This PA has been reissued, see PAR-05-042) (see addendum NOT-CA-04-031, NOT-CA-04-023 and NOT-CA-05-001) EXPIRATION DATE: February 02, 2005. National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.397, 93.121 LETTER OF INTENT RECEIPT DATE: Myeloma and Genitourinary Cancer SPOREs: April 1, 2004 Breast Cancer SPOREs: August 1, 2004 Gynecological Cancer SPOREs: December 1, 2004 (per NOT-CA-04-023) APPLICATION RECEIPT DATE: Myeloma and Genitourinary Cancer SPOREs: June 1, 2004 Breast Cancer SPOREs: October 1, 2004 Gynecological Cancer SPOREs: February 1, 2005 (per NOT-CA-04-023) THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR 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 PAR The Organ Systems Branch of the Office of the Deputy Director for Extramural Science at the National Cancer Institute (NCI) invites grant applications (P50) for Specialized Programs of Research Excellence (SPORE) in organ- specific cancers. Applicant institutions must be able to conduct the highest quality, balanced, translational research on the prevention, etiology, screening, diagnosis, and treatment of a specific organ-site cancer. SPORE applicants are judged on their current and potential ability to move basic research findings into a clinical or population setting or, conversely, to take a finding from the clinic/population and expand upon it in the laboratory. A SPORE must develop and maintain human cancer tissue resources for the particular organ-site that will benefit translational research; foster extended collaborations in critical areas of research need with laboratory and clinical scientists within the institution, as well as in other institutions; and participate with other SPOREs on a regular basis in sharing positive and negative findings, assessing scientific progress in the field, identifying new research opportunities, and promoting Inter-SPORE collaborations. Each SPORE and the "network" of SPOREs are expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality of human cancer. A SPORE should support a mix of basic and clinical researchers whose formal interactive and collaborative research efforts will result in new approaches for early detection, diagnosis, therapy, prevention and control of human cancer. The SPORE mechanism is not intended to support basic research to the exclusion of clinical research or vice versa. This Program announcement (PAR) addresses only SPORE applications for organ sites specified to be received in the year 2004. See announcement PAR-02-126 which was released in the NIH Guide on July 10, 2002, (https://grants.nih.gov/grants/guide/pa-files/PAR-02-126.html) for the receipt dates for SPORE applications associated with specific organ sites to be received in the year 2003. RESEARCH OBJECTIVES A SPORE must provide focal points for sustaining and maintaining state-of- the-art research that will contribute to improved detection, diagnosis, treatment and prevention of an organ-specific cancer (or related group of cancers). SPOREs are expected not only to conduct a wide spectrum of research activities, but should also contribute significantly to the development of specialized research resources (or cores), improved research model systems, and collaborative research projects with other institutions. The research supported through this program must be translational in nature. Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer. Inherently, this process involves an interdependence between basic and applied investigators. It should be noted that clinical/ epidemiological research that does not include a laboratory component or capitalize upon a biological discovery relevant to human cancer is not considered translational for the purposes of this program. MECHANISM OF SUPPORT A SPORE is supported through the specialized center (P50) grant mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This mechanism provides funding for a broad range of research and developmental activities, from basic to human intervention studies. These grants are intended to promote multidisciplinary research focused upon a specific cancer (or related cancer) site(s). SPORE grants differ from traditional Program Project (P01) grants in that they also provide support for pilot research projects and a career development program, as well as enable investigators more flexibility to modify their research activities when new opportunities arise. Applicants are responsible for the planning, direction, and execution of their proposed SPORE. (Updated language in paragraph below per NOT-CA-04-031) NCI policy for SPORE grants establishes the following limits to the requested budgets: new or competing renewal P50 SPORE applications may request a maximum annual direct cost of up to $1.75 million and maximum annual total cost of $2.75 million. The facilities and administrative costs related to subcontracts to other institutions or organizations are included in the total cost cap of $2.75 million, but not the direct cost cap of $1.75 million. Applications can exceed these caps in subsequent years as a result of standard cost-of-living increases or special supplements approved by NCI. A SPORE grant application may be submitted for up to five years of funding. This PAR uses just-in-time concepts. It also uses the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm 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 Eligible institutions may include foreign components as full research projects, or shared resources, or as part of a research project. SPOREs may also use developmental funds to establish collaborative research efforts with foreign entities. Consortia agreements with foreign institutions must include provisions that ensure adequate representation of women, minorities, and children in all research components that involve clinical trials or any other type of human intervention and must be in compliance with NIH policies. To be considered, applications must have: (1) a statement of institutional commitment that addresses how the SPORE will be given high priority within the institution; (2) a minimum of four independent principal investigators who are successful in obtaining peer-reviewed research support (e.g., R01, P01, U01, U10, U19, ACS, DOD, or equivalent) directly related to the cancer being investigated, and who, as a group, have expertise in both laboratory and clinical research; (3) a minimum of four research projects, representing a balance and diversity of translational approaches. At least one research project must focus on early detection, screening, prevention, and/or population science. All proposed research projects must be led by co- investigators in basic and applied sciences who commit adequate percent efforts to the translational research endeavors; (4) a qualified principal investigator who is a scientific leader in the field; (5) a patient care facility that serves a substantial cancer patient population and, if the facility is not part of the parent institution, a consortium agreement with an associated institution that assures adequate access to cancer patients for clinical research; the statement must be signed by the responsible officials of the applicant institution and the consortia care facility; (6) a developmental research program; (7) a career development program; (8) a tissue resource, as well as (9) other shared resources designed to support the proposed translational objectives of the SPORE. Although an application can only be submitted by a single institution, subcontracted collaborative arrangements with scientists from other institutions may be included if these arrangements are clearly delineated and officially confirmed by signed statements from the responsible official at each institution. This circumstance, however, does not preclude the need for a full institutional commitment from the applicant organization. Support will not be provided for applications containing research projects focused exclusively on basic research, epidemiological research, or clinical interventions. Funding for the performance of a Phase I or II clinical trial can be requested in a SPORE application. NCI program staff listed under INQUIRIES should be consulted if there are questions regarding eligibility or the required components of a SPORE. 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 GUIDELINES OF THE SPORE PROGRAM: The general components and procedures for preparing a SPORE application are outlined in this program announcement under Eligible Institutions, Application Processing, and Peer Review Process. SPECIAL GUIDELINES that address programmatic, review and award concerns in more detail, however, must be followed when preparing a SPORE application. SPORE GUIDELINES CAN NOT BE SUPERSEDED BY THIS OR ANY OTHER ANNOUNCEMENT. Prospective applicants should request a copy of the SPORE GUIDELINES from the program staff listed under INQUIRIES above or can view a copy at http://spores.nci.nih.gov/guidelines/guidelines.html 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: Jorge Gomez, M.D., Ph.D. Chief, Organ Systems Branch Email: email@example.com Jane Fountain, Ph.D. Program Director (Gynecological SPOREs) Email: firstname.lastname@example.org Peter Ujhazy M.D., Ph.D. Program Director (Myeloma SPOREs) Email: email@example.com Andrew Hruszkewycz, Andrew M.D., Ph.D. Program Director (Genitourinary SPOREs) Email: firstname.lastname@example.org Rashmi Gopal-Srivastava, Ph.D. Program Director (Breast SPOREs) Email: email@example.com Organ Systems Branch Office of Centers, Training, and Resources Office of Deputy Director for Extramural Science National Cancer Institute 6116 Executive Boulevard, Suite 7013, MSC 8347 Rockville, MD 20852 (for express/courier service) Bethesda, MD 20892-7008 (for U.S. Postal Service) Telephone: (301) 496-8528 Fax: (301) 402-5319 Direct inquiries regarding review issues to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Email: firstname.lastname@example.org Direct inquiries regarding fiscal matters to: Ms. Kelli Oster Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard MSC 7150 Rockville, MD 20852-7150 (for express/courier service) Bethesda, MD 20892-7150 Telephone: (301) 496-8627 Email: email@example.com 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 PAR 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 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 the Program Director for the organ site (listed under Where to Send Inquiries) at the following address: Organ Systems Branch Office of Centers, Training, and Resources Office of Deputy Director for Extramural Science National Cancer Institute 6116 Executive Boulevard, Suite 7013, MSC 8347 Rockville, MD 20852 (for express/courier service) Bethesda, MD 20892-7008 (for U.S. Postal Service) SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001, updated 6/28/2002). The PHS 398 is available at https://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. The title "SPORE in (specific organ site) Cancer" and number of the PAR should be typed on line 2 of the face page of the application form and the YES box 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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 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 Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) It is important to send these copies at the same time that the original and three copies are sent to the Center for Scientific Review (CSR); otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received by the receipt date. 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.) (https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before the receipt date(s) for the respective organ sites listed on the first page of this program announcement. 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. Applications must meet all eligibility requirements summarized above and must address all programmatic requirements further described in the SPORE GUIDELINES (http://spores.nci.nih.gov/guidelines/guidelines.html). 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 CSR and for responsiveness to the guidelines of this PAR by the NCI program staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the 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: o Will receive a written critique o May undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score o That receive a priority score will receive a second level of review by the National Cancer Advisory Board REVIEW CRITERIA a. Research Projects Within the SPORE concept of translational research, reviewers will evaluate each research project using the five criteria listed below. Each of these criteria will be addressed and considered by the reviewers in assigning a merit score to the project. Note that the project does not need to be strong in all categories to be judged likely to have a major translational 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 (e.g., correlative or hypothesis generating studies) but is essential to assess the relevance of a research finding in a clinical/population setting. SIGNIFICANCE. The importance of the translational research objective to human cancer and its likelihood of completion within the project period. APPROACH. The adequacy of the experimental design and methods to achieve the research objectives; clear evidence of co-leadership by a basic and more applied scientist in the conception, design and proposed implementation of the project. INNOVATION. Originality and novelty of the experimental design as it relates to translational research. INVESTIGATORS. The qualifications of the basic and more applied co- investigators to conduct the proposed research and the appropriateness of the time commitments of each co-investigator to the conduct of the project. ENVIRONMENT. The scientific environment in which the translational research work will be done, and the unique features, if any, of the environment to support the proposed work. b. Shared Resources (Cores) 1. Tumor Bank/Tissue Resources o adequacy of the proposed plan and/or track record to develop and maintain a human cancer site-specific tissue resource, store the tissue and distribute the tissue with appropriate pathological and clinical data; o adequacy of the proposed plan and/or track record to prioritize the distribution of tissues within and outside the SPORE; o evidence of experienced and available personnel dedicated to the activities of tissue collection, quality control of tissue specimens, tissue storage, tissue distribution, collection of initial and follow-up clinical information, data entry, and maintenance of database and computer networks; o adequacy of proposed plan and/or track record to obtain informed written consent for all prospectively collected tissues; 2. Other Resources o degree to which plans and/or track record indicate that shared resources (will) effectively and efficiently support the research of the SPORE in a manner that can not be supported through available resources; o demonstration that the resource is essential to the success of the SPORE; o adequacy of qualifications and performance (if applicable) of resource directors; c. Developmental Research Program 1. adequacy of the process and/or track record for attracting new ideas for pilot studies within and outside of the SPORE institution. 2. adequacy of the proposed process and/or track record for continuously reviewing and funding a spectrum of pilot projects (e.g., research, technology development, resources) based on their potential relevance to translational research and impact on human cancer. 3. general quality of the pilot projects provided by the SPORE to demonstrate the effectiveness of the process and/or track record of funding pilot projects; d. Career Development Program 1. adequacy of the plan, in general, to sustain significant activity for career development of translational research scientists; 2. adequacy of the process and/or track record for selecting candidates for independent careers in translational research; 3. adequacy of the process and/or track record to seek out and include qualified minorities, women, and persons with disabilities in the career development program; 4. current status and research activities of individuals who have been supported by the career development program, if applicable; e. Overall Program Organization and Capability 1. scientific qualifications and involvement of the SPORE principal investigator, as well as his/her demonstrated scientific and administrative leadership capabilities; adequacy of the time commitment of the principal investigator; 2. adequacy of the planning and evaluation process to include: determining translational research productivity of existing projects and resources; discontinuing activities of low productivity; initiating new activities in response to important translational research opportunities; establishing collaborations; and utilizing the advice of external advisors; 3. adequacy of access to patients and populations for conducting current and projected therapeutic, prevention, detection and control research; 4. a balance and diversity of research activities with a minimum of four scored projects of which at least one is devoted to early detection, screening, prevention, and/or population science; 5. effectiveness of and/or plans for promoting interdisciplinary scientific interaction; 6. effectiveness of and/or plans for integrating SPORE research and resources with existing Cancer Center programs (e.g., use of clinical data and safety management systems, biostatistical cores, etc.); 7. adequacy of tangible institutional commitments that will enable and facilitate the research objectives of the SPORE (e.g., special facilities, recruitments, discretionary resources such as dollars and space); 8. degree to which the organization and leadership of the SPORE promote and facilitate scientific interactions between projects, pilot projects, etc., and effective use of the SPORE infrastructure (e.g., tissue bank, other shared resources) in the conduct of research; 9. written assurance that SPORE interactions with commercial entities will uphold the principles of academic freedom, including the ability of SPORE investigators to collaborate freely, and to send and receive biomedical research materials without restriction to other scientific researchers; 10. facilitation of technology transfer; management of the intellectual property rights of the SPORE under the requirements of the Bayh-Dole Act and NIH funding agreements. f. Interactions with Other SPOREs 1. adequacy of plans (new application) or progress (competing renewal applications) to promote and maintain communication and integration of scientific projects of mutual interest with other SPOREs; 2. willingness to interact with other SPOREs and with the NCI in sharing information and in participating in committees to assess current scientific issues, research activities, and priorities. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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, shared resources, developmental research program and career development program. OVERALL EVALUATION AND SCORING OF APPLICATIONS Each component of the SPORE will be given a score. A single numerical priority score will then be assigned to the SPORE application as a whole. Although this score will be based primarily on scientific merit and progress where applicable (competing renewal applications), significant consideration will also be given to interdisciplinary interactions, potential for impacting on the disease, inter-SPORE collaborations and institutional commitment. The overall score will be weighted as follows: o 60% scientific merit of the translational research o 15% evidence of multidisciplinary/team approaches in the conduct of the research o 15% potential of the research to impact on the disease o 10% institutional commitment If a required component(s) of an otherwise meritorious SPORE application is of such low merit that it is not recommended for further consideration (NRFC) by the peer review committee, the entire application will also receive a NRFC. See Section I.E. of SPORE GUIDELINES (http://spores.nci.nih.gov/) for a more detailed description of each of the required components of a SPORE. 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 RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: Myeloma and Genitourinary Cancer SPOREs: April 1, 2004 Breast Cancer SPOREs: August 1, 2004 Gynecological Cancer SPOREs: December 1, 2004 Application Receipt Date: Myeloma and Genitourinary Cancer SPOREs: June 1, 2004 Breast Cancer SPOREs: October 1, 2004 Gynecological Cancer SPOREs: February 1, 2005 Peer Review Date: October/November 2004 and February/March 2005 Council Review: February 2005 and June 2005 Earliest Anticipated Start Date: April 2005 and July 2005 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: https://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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Guidance for investigators and institutional review boards regarding research involving human embryonic stem cells, germ cells, and stem cell-derived test articles can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.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, in the project description and elsewhere in the application as appropriate, 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 https://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 https://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 https://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.
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