and Human Services (HHS)
EXPIRED
SILVIO O. CONTE CENTERS FOR NEUROSCIENCE RESEARCH RELEASE DATE: July 1, 2002 PA NUMBER: PAR-02-121 (See Replacement PAR-07-430) (See Notice NOT-MH-06-120) (See Notice NOT-MH-06-118 Extending the expiration dates and change the cost limitations and application receipt dates) EXPIRATION DATE: October 26, 2006, unless reissued National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) LETTER OF INTENT RECEIPT DATE: August 1 2002, July 1 annually thereafter APPLICATION RECEIPT DATE: October 21, 2002, October 20 annually thereafter This program announcement (PA) replaces PAR-98-057, which was published in the April 17, 1998 issue of the NIH Guide. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this 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 Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Mental Health (NIMH) invites research center grant applications for Silvio O. Conte Centers for Neuroscience Research (CCNR). The purpose of this program is to provide a unifying framework for the pursuit of basic neuroscience research relevant to mental health and mental illness. A CCNR should conduct novel, integrative, and hypothesis driven research on a highly focused and well defined neuroscience question that is significant to the mission of NIMH. It is expected that these Centers will encourage investigators representing a variety of disciplines, approaches or perspectives to bring to the field of mental health research the full range of expertise and advanced technologies available in the basic sciences. In addition to the Silvio O. Conte Centers for Neuroscience Research, NIMH has a number of other center mechanisms with somewhat different programmatic goals. The purposes of these other mechanisms, and links to the relevant announcements, are summarized below: o Applicants who have all the elements expected of a Conte Center for Neuroscience Research or a Conte Center for the Neuroscience of Mental Disorders (see below) except for established collaborative research across participating laboratories, should consult (PAR-02-123) (http://grants.nih.gov/grants/guide/pa-files/PAR-02-123.html), Silvio O. Conte Centers to Develop Collaborative Neuroscience Research, o Applicants interested in funding for a Center for the bi-directional translation of research between basic and clinical neuroscience investigations relevant to severe mental disorders should consider (PAR-02-122), Silvio O. Conte Centers for the Neuroscience of Mental Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-02-122.html), o Applicants interested in funding for a Center for research at the interface between basic behavioral research and neuroscience should see PAR-00-130, Interdisciplinary Behavioral Science Centers for Mental Health (http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html), o Applicants interested in funding for a Center that would foster research projects on the translation of basic behavioral research to mental disorders and public health applications should consider PAR-01-027, Translational Research Centers in Behavioral Science (http://grants.nih.gov/grants/guide/pa-files/PAR-01-027.html), o Applicants seeking to establish core infrastructure support for mental health services and interventions research are referred to PAR-01-089, Advanced Centers for Interventions and Services Research (http://grants.nih.gov/grants/guide/pa-files/PAR-01-089.html) and PAR-01-090, Developing Centers for Interventions and Services Research (http://grants.nih.gov/grants/guide/pa-files/PAR-01-090.html), and o Those interested in a Center with a focus on HIV/AIDS should apply for funding through PAR-99-153, Core Support Program for Mental Health/AIDS Research (http://grants.nih.gov/grants/guide/pa-files/PAR-99-153.html). RESEARCH OBJECTIVES Background As research produces ever greater levels of detail in each of the fields that collectively constitute the neurosciences, the ability of individual investigators to integrate approaches and disciplines is diminished. Yet, the cutting edge of science is often defined across disciplinary boundaries and through the use of new technologies. The Conte Centers for Neuroscience Research (CCNR) support highly interactive research projects addressing different aspects of a common set of research issues at different levels of biological organization and from different disciplinary, methodological and technological perspectives. Such integrative approaches will provide unique opportunities to advance our understanding of factors that influence the development and function of the brain, offering new insights into brain-behavior relationships and mental illness. Objectives and Scope Each CCNR is designed to address a critical question of basic brain research through a multidisciplinary, well integrated, and highly focused research program. A CCNR is characterized as follows: o The purpose of a CCNR is to address one hypothesis (or a small number of closely related hypotheses) in neuroscience that is specific, well focused, and significant to the mission of NIMH. o A CCNR should clearly demonstrate a high interdependence of projects and investigators, and solid evidence of integration and synergy across projects. o It is expected that a Center will be organized specifically to address innovative, creative, and potentially high risk/high impact research questions. Centers must rigorously test the proposed hypothesis and generate new ones. It is expected that such research will advance neuroscience in fundamental and significant ways. o A CCNR should be based upon a highly integrated multidisciplinary approach which uses as many disciplines, perspectives, and approaches as are needed and appropriate to solve the research problem. The best neuroscience laboratories and investigators using the most advanced technologies should be enlisted toward this end. o The Center mechanism may not be used as a substitute for individual grant support. It is, therefore, expected that investigators participating in Centers will have independent, peer reviewed research support. A Center must be viewed as a unique scientific opportunity to investigate leading edge research questions not currently being addressed. o The CCNR Director should have a demonstrated capability to organize, administer and direct the Center. This individual should be the scientific leader of the Center, and thus must also head at least one of the projects, with a minimum total time commitment of 30 percent to the Center. o Investigators heading projects in a CCNR should be prominent scientists in basic neuroscience research who are at once leaders of their respective fields and actively involved in research. Investigators with the qualifications to contribute to a unique enterprise such as a CCNR may be located in different geographic areas. Therefore, collaborations among different institutions are encouraged, if scientifically appropriate. o A CCNR should provide opportunities for young investigators who have the potential for independent research careers to become skilled in the experimental strategies, approaches, and techniques of modern neuroscience research. In addition, there should be close coordination between the Center and relevant predoctoral and/or postdoctoral research training programs of the participating institutions. Special attention should also be given to the recruitment and training of minority students. o Each CCNR should provide outreach that makes the public aware of the importance and implications of the CCNR research for addressing basic neuroscience issues and their relationship to mental illness and mental health. Research Topics Silvio O. Conte Centers for Neuroscience Research are intended to support research in basic neuroscience relevant to the mission of NIMH. Since appropriate research covers a wide swath of neuroscience, prospective applicants are referred to the website that describes research programs of the Division of Neuroscience and Basic Behavioral Science, which funds Conte Centers for Neuroscience Research. The URL is http://www.nimh.nih.gov/diva/index.htm. Please note that although program staff are listed on the website, program inquires about CCNRs should be directed to the program staff listed under INQUIRIES. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) center award mechanism (P50), which provides funding for multidisciplinary and multi-investigator approaches to the investigation of specific and complex research problems requiring the application of diverse expertise and methodologies. As an applicant, you will be solely responsible for planning, directing, and executing the proposed center. Applicants may request support for a period of up to five years, followed by a competitive renewal application for a second five year period. The NIMH will not support individual Centers for longer than two consecutive funding periods. Direct costs are limited to $1.5 million in any one year, this limit applies to new grants, their non-competitive continuations, and any subsequent competitive renewals. Since the best scientific talent and resources are expected to be brought to bear on questions posed in each Center, and since these are often not all available at any single institution, projects constituting a given center may be based at multiple institutions. In an effort to allow for such multi- institutional involvement, for the purposes of this program announcement, Facility and Administrative (F&A) costs for consortium activity at collaborating institutions will not be counted against the $1.5 million limit to direct costs (but these costs should be delineated as instructed in form PHS 398 [rev. 5/2001]). Competitive supplements will not be considered for these Center grants. It is anticipated that individual projects, which are developed as outgrowths of a Center grant, will seek independent funding through mechanisms such as the research project grant (R01) mechanism. 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 Foreign institutions are not eligible for Center grants. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as CCNR Directors and heads of projects or cores. SPECIAL REQUIREMENTS Sharing Data, Biological Material Resources, and Tools Public Health Service (PHS) policy requires that investigators make unique research resources readily available to qualified individuals within the scientific community for research purposes following publication (the current NIH Grants Policy statement is dated March 1, 2001 and may be found at http://grants.nih.gov/grants/policy/nihgps_2001/). The intent of this policy, however, is not to discourage, impede, or prohibit the organization that develops unique research resources or intellectual property from commercializing the products. CCNRs marshal the very best researchers and resources for investigating neuroscience, and novel data, materials and tools, which can be difficult to develop under smaller mechanisms, are often the result. Therefore, the NIMH requires applicants to develop detailed plans for the dissemination of data and materials generated through the Center through commercial or non-commercial means. (It should be noted that even with non-commercial paradigms, the cost of developing such resources for distribution and the cost of distributing them may be charged to those requesting them.) The plan should be described in the Operational Plan for the CCNR, and the adequacy of the plan will be considered by NIMH staff in determining whether the grant should be awarded. The initial review group will comment on the proposed plan for sharing and the adequacy of the plan is among the review criteria. The sharing plan, as approved, after negotiation with the applicant when necessary, will be a condition of the award. 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, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues and address the letter of intent to: Laurie S. Nadler, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7194, MSC 9645 Bethesda, MD 20892-9645 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: [email protected] o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: [email protected] o Direct your questions about financial or grants management matters to: Ms. Carol J. Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: [email protected] LETTER OF INTENT Prospective applicants are strongly encouraged to contact the program staff member listed under INQUIRIES as early as possible in the conceptualization of a possible application for a CCNR. 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, 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 not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and to 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: Laurie S. Nadler, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7194, MSC 9645 Bethesda, MD 20892-9645 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: [email protected] 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: [email protected]. Application Format Guidelines A major requirement for each Center is the conduct of multidisciplinary, integrative research on a single, highly focused research question (or a small number of closely related questions). The application must describe the hypothesis to be tested, the goals of, and the approaches used in the Center. In addition, the application should clearly articulate the reasons a Center approach is needed for the proposed work as well as the unique benefits that will accrue from a Center. It should be emphasized that this center mechanism is not meant to be a substitute for individual grant support. Therefore, the reasons that constituent projects require center support should be fully justified. The application should utilize PHS Form 398 and include the following components in the specified order: Information for the Entire Center: o Face Page (noting this program announcement in Item 2) - Information provided here should pertain to the entire Center. o Description, Performance Sites, and Key Personnel (Form Page 2) - Information provided here should pertain to the entire Center. o Table of Contents (Form Page 3) o Budget Information (Form Pages 4 and 5) - Categorical figures should be provided to reflect the budget of the overall Center. Since detailed budget justification will be provided separately for each project and core (as described below), only items for which justification is not provided elsewhere should be presented in narrative here. o Biographical Sketches of Key Personnel - Biographical sketches should be provided for key personnel of the entire Center, and should be arranged alphabetically based on the individual"s surname. o Resources - Resources described here should be restricted to those not described separately for the individual projects and cores (as described below). o General Description of the Overall Center (Not to exceed 10 pages, for revised and resubmitted applications, a one-page introduction is allowed to describe changes from the previously submitted version): Provide an overview of the entire proposed Center describing the central hypothesis to be tested and goals to be achieved. Describe how the overall Center will achieve its major objectives. Explain the proposed contribution of each of the projects and cores in achieving the objectives of the Center and how these components, especially the projects, relate to each other scientifically. o Evidence of Feasibility and Preliminary Findings (for new, Type 1, applications and amended Type 1 applications only, not to exceed 10 pages, for revised and resubmitted applications, a one-page introduction is allowed to describe changes from the previously submitted version) Present evidence that the research team will be able to work together to accomplish the research proposed in the projects, present preliminary results, present evidence of competence in the areas proposed, etc. If previously supported by an NIMH Silvio O. Conte Feasibility Center for Neuroscience Research, indicate the outcome of that specific activity as it relates to the application for the proposed Center support. o Progress Report (for competing renewal, Type 2, applications and amended Type 2 applications only, not to exceed 3 pages for each project supported in the antecedent Center grant, for revised and resubmitted applications, a one-page introduction for the entire Progress Report is allowed to describe changes from the previously submitted version) Describe the results of each of the projects supported in the previous CCNR grant and the manner in which those results and projects relate to the currently proposed Center application. Describe the manner in which the Center mechanism provided synergy to the previously funded Center. o Operational Plan for Overall Center (not to exceed 11 pages, for revised and resubmitted applications, an extra one-page introduction is allowed to describe changes from the previously submitted version) The working administrative and logistical arrangements, as well as the resource support necessary to implement the research, should be fully elaborated in the application. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (documentation of these arrangements should be included in the "Letters of Support" section). Also included in this section is the manner in which an external advisory board will advise the Center. Prospective board members should not be chosen or contacted prior to a funding decision and therefore should not be named. The plan for sharing data, biological material resources, and tools generated by the Center should also be included in this section. o Research Career Development and Outreach Plans (not to exceed 2 pages) A description of the manner in which Center activities will provide opportunities for young investigators and how the proposed CCNR relates to existing training programs of participating institutions should be given. Also, plans for disseminating information to the public regarding the activities of the Center should be given. Information for Each Project or Core: For each project or core, the information should be arranged in the following order: o Cover Page - Information provided here should pertain specifically to the project or core. o Description, Performance Sites, and Key Personnel (Form Page 2) - Information provided here should pertain specifically to the project or core. o Budget Information (Form Pages 4 and 5) - Detailed budget information should be provided for each project or core, with a narrative justification given for all budget items. o Resources - Resources should be described for each project or core. o Research Plan for Individual Projects (Not to exceed 10 pages for any one project, for revised and resubmitted applications, an additional one-page introduction for each project is allowed to describe changes from the previously submitted version.) The research plan for each project should describe the specific aims, background and significance. In these sections, the research question to be addressed and the hypothesis to be tested by the proposed research project should be highly focused and fully explained. Full discussion is required on: the status of current research efforts addressing the issue (both within the Center and elsewhere), the limitations of existing research strategies, why the particular research question lends itself to a multidisciplinary, integrative approach, and how the proposed project is to be linked and integrated with other proposed Center projects. The research plan for each project should also include a description of the research design and methods. This will not require extensive details for individual experiments. Description of the experimental design should outline the strategies proposed to accomplish the specific aims of the project and should include a discussion of the innovative aspects of the approach. Experimental procedures need not be spelled out in great detail if those procedures have already been extensively published and widely accepted by the scientific community, the methods to be used should be cited and referenced Any new methodology, however, and its advantage over existing methodologies, should be fully described. Further, the feasibility of the proposed experiments, potential pitfalls, alternative approaches, if necessary, and relevance to Center goals should be discussed, as should plans for data sharing. o Descriptions of Individual Cores (Not to exceed 8 pages for any one core, for revised and resubmitted applications, an extra one-page introduction is allowed to describe changes from the previously submitted version.) Describe how the core will contribute to the overall goals of the Center as well as which projects will be supported by the core and the manner in which that support will be rendered by the core. The description of each core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed Center. o Human Subjects - For each individual project and core involving human subjects, describe the plans for protection of subjects from research risks, as well as plans for the inclusion of women, minorities, and children, as described in the PHS 398 application instructions (rev. 5/2001). o Vertebrate Animals - For each individual project and core involving vertebrate animals, provide a detailed description and justification for the use of animals as described in the PHS 398 application instructions (rev. 5/2001). Other Information: o Literature Cited - This section should include and compile literature cited throughout the application. o Letters of Support from Institutions and Collaborators - Also included in this section should be assurances from Institutional Animal Care and Use Committees and/or Institutional Review Boards (though the latter is not required for peer review). o Checklist o Personal Data on Center Director SENDING AN APPLICATION TO THE NIH: The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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: Jean Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (303) 443-4720 Email: [email protected] APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this PA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed by CSR for completeness and by NIMH program staff to determine if they satisfy the objectives and requirements of a CCNR as outlined in this program announcement (excluding scientific or technical merit). Applications that do not meet these objectives and requirements will not be accepted and will be returned to the applicant. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique and priority score o Receive a second level review by the National Advisory Mental Health Council 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 your 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 your application"s overall score, weighting them as appropriate for each application. Criteria for scientific/technical review of CCNR applications will include the following: o Intrinsic merit of the intellectual focus and research: the overall quality, scientific merit, and innovation of the research to be done, the likelihood that the work will lead to fundamental advances within the field, to new discoveries, and/or to new technological developments, in addition, the research conducted must center around a highly focused and well-defined question. o Integration across projects: the adequacy of the proposed Center to integrate across research projects so that activities in each project inform and advance the others o Appropriateness of the Center approach: the need for and suitability of the Center approach, whether a Center approach will add significantly to what could be done through other modes of research support, in this respect, the integration and synergy of the projects are of utmost importance and should be explicitly described. o Research competence: the capability and scientific credentials of the Center Director and constituent project directors and participating scientists, who are expected to be regarded by their peers as leaders in, and at the forefront of, their respective fields o Center Director credentials: ability of the Center Director to organize, administer, and direct the Center and, in addition, head at least one of the proposed projects, devoting a minimum of 30 percent of his/her time to the Center, the Director must, by necessity, be the scientific leader of the Center. o Institutional commitment: the nature and level of resource commitments from the home institution and from other participant institutions, and plans for interactions with the rest of the participating institutions o Appropriateness of management plans and arrangements: the feasibility and adequacy of the organizational and administrative plans, the appropriateness of the budget, and the mechanisms to evaluate the Center"s progress o Appropriateness of the proposed plan to share data, biological material resources, and tools (the plan may use commercial and/or non-commercial approaches) o Quality and appropriateness of the outreach and research career development components of the Center"s activities: the adequacy of approaches used to disseminate information regarding the Center"s activities as they relate to public understanding of science and mental health and illness, the likely effectiveness of approaches to attract and involve young investigators and students who show potential for significant future contributions and independent research careers in the work of the Center ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application o INCLUSION: 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, plans for the recruitment and retention of subjects will also be evaluated. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research The initial review group will make an overall recommendation for approval (and assign a priority score) or disapproval of the entire Center application. Under some circumstances, it may be appropriate for the initial review group to recommend disapproval of one or more project(s). RECEIPT AND REVIEW SCHEDULE To ensure a uniform review quality, all applications will be reviewed by a single review group, which will meet once per year. In accordance with this objective, there will be one receipt date each year. Applications received after this date will be returned to the applicant without review. Letter of Intent Receipt Date: August 1, 2002, July 1 annually thereafter Application Receipt Date: October 21, 2002, October 20 annually thereafter Administrative Review: November Scientific Review: April/May Advisory Council Review: May/June Earliest Starting Date: July AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the AMENDMENT "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 is 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. NIH GRANTS POLICY STATEMENT: The NIH Grants Policy Statement (NIHGPS) has been revised and reissued. The provisions of the revised NIHGPS are effective for all funded NIH grants and cooperative agreements with budget periods beginning on or after March 1, 2001. The revised NIHGPS is available at http://grants.nih.gov/grants/policy/nihgps_2001. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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. 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 http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract 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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