NINDS/NIMH MENTORED RESEARCH CAREER DEVELOPMENT AWARDS IN AIDS RESEARCH RELEASE DATE: March 25, 2003 PA NUMBER: PA-03-086 EXPIRATION DATE: 1 November 2005, unless reissued National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853 (NINDS), 93.242 (NIMH) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 PA The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH) invite applications for Mentored Clinical Scientist Development Awards (K08s), or Mentored Patient-Oriented Research Career Development Awards (K23s) from physicians and basic scientists interested in pursuing research related to HIV infection of the nervous system. The intent of this Program Announcement (PA) is to encourage research and career development for individuals with a strong commitment to a research career in the area of NeuroAIDS, either in one of the basic sciences relevant to NeuroAIDS or in clinically-oriented research. Research related to the neuropathogenesis, the role of viral or host genetic factors, inflammatory mechanisms, peripheral neuropathy, or neurological dysfunction in the setting of anti-retroviral therapy is of particular interest. RESEARCH OBJECTIVES The objectives of this program announcement are to encourage individuals to pursue research careers in the area of NeuroAIDS and to increase the number of trained physicians and basic scientists interested in pursuing research related to the elucidation of the pathogenesis, progression, and treatment of cognitive or motor dysfunction, or peripheral neuropathy, associated with HIV infection in the nervous system. It has become clear that neurological and neuropsychiatric dysfunction associated with HIV infection may be caused by ongoing chronic inflammatory processes in the nervous system. Training in basic science areas of virology, immunology, glial cell biology, or genetics, as they relate to NeuroAIDS, or in clinical areas of the diagnosis and treatment for HIV associated dementia or peripheral neuropathy are encouraged. MECHANISMS OF SUPPORT This PA will use the Mentored Clinical Scientist Development Award (K08) and Mentored Patient-Oriented Research Career Development Award (K23) mechanisms. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. Salary, related fringe benefits, and research allowance will be provided as described (http://grants.nih.gov/grants/guide/notice-files/NOT-NS-03-001.html, http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html). The project period may be 3, 4, or 5 years and will depend upon the number of years of prior research experience, and the need for additional experiences to achieve independence. Awards are not renewable. This PA uses just-in-time concepts and the streamlined budgeting format described in Section IV "Research Career Award" of the PHS 398 application instructions available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. 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 o Faith-based or community-based organizations Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Candidates for this award must have earned a doctoral degree (Ph.D., M.D., D.Sc., etc.) by the time the award is made. The applicant institution must agree that the candidate can commit a minimum of 75 percent professional effort (of a full-time position) to the career development plan. Candidates must be U.S. citizens or non- citizen nationals, or must have been lawfully admitted for permanent residence by the time of award. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (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 are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible for this award. A person who has been principal investigator on a Public Health Service (PHS) research grant or who has had equivalent research support is not eligible for this award. The only exceptions to this rule are R03 and R21 grants. In addition, individuals who are in training status and are being supported by National Research Service Awards (NRSA) are eligible to apply, however, they may not activate the K08 or K23 award until the NRSA research training program has been completed or terminated. This award is intended for persons who plan to pursue careers in the neurological sciences and applies to all areas of research supported by NINDS. NIMH will support persons who plan to pursue careers in research relating to neurological and neuropsychiatric consequences of HIV-1 infection. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Note: Recipients of K08 and K23 awards are eligible for the NIH loan repayment program, if they are engaged in clinical and/or Health Disparities research (see http://www.lrp.nih.gov). SPECIAL REQUIREMENTS (1) Mentor Candidates must name a primary sponsor (or mentor), who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. The mentor's role involves a substantial commitment of time on behalf of the candidate; therefore, persons with extensive administrative responsibilities (e.g., chairpersons, deans) should not be selected as mentors without adequate justification. Candidates may choose more than one mentor; additional mentors may be at the candidate's institution or elsewhere within the United States, if a strong case is made for their contribution to the research career development of the candidate. The principal mentor should be in the candidate's home institution or be available locally. The typed name and signature of the principal mentor should appear at the end of the mentor's statement. "Per" signatures are not acceptable. Mentors are not funded for their role on the award. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models. (2) Duration of Award The award provides three to five consecutive 12-month awards. Because of the focus on progression to independence as a researcher, candidates for the K08 and K23 awards should propose a period of study and career development consistent with their previous research experience. For example, a candidate with limited experience in the proposed field of research may find a phased developmental program lasting five years the most efficient means of attaining independence. This period could include a designated period of didactic training followed by a period of closely supervised research. A candidate with previous research experience in a related field may not require extensive additional didactic preparation and a program that focuses on an intensive, supervised research experience may be appropriate. All programs must be tailored to meet the individual needs of the candidate ensuring that he/she will gain the skills and knowledge necessary to carry out high quality health-related research. Awardees may not apply for another mentored award at the conclusion of their support. (3) Time and Effort Recipients of this award must devote full time (at least 75 percent of a full time 12 month position) to career development activities, research, or other research-related activates relevant to their career goals. Activities such as participation in workshops, scientific meetings, or academic activities are encouraged if they contribute to the purpose of the award. Providing health care is acceptable only when it is necessary to maintain and enhance skills required for the conduct of research. (4) Salary Support The NINDS and NIMH will provide salary support as described, respectively (http://grants.nih.gov/grants/guide/notice-files/NOT-NS-03-001.html, http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html). The grantee institution may supplement the NINDS or NIMH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be provided from Federal funds unless specifically authorized by the Federal program from which such funds would be derived. In no case may other funds from the National Institutes of Health (NIH) be used to supplement the salary. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award, i.e., full-time commitment to supervised research and related activities. Individuals receiving salary support under the K08 and K23 awards are employees of the grantee institution and are subject to its established personnel policies dealing with professional status, title, salary, and related staff privileges and obligations. The salary proposed must be consistent with the established salary structure for full-time, 12-month staff appointments at the grantee institution. (5) Fringe Benefits Fringe Benefits are paid out of grant funds in proportion to the salary contribution. Practices related to payments of fringe benefits shall be consistent with grantee institution policies and not be altered for these awards. (6) Allowance for Research and Career Development Costs In addition to salary support, funds may be requested for each year to support research and/or career development activities (see (http://grants.nih.gov/grants/guide/notice-files/NOT-NS-03-001.html, http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html). The support for research activities is intended to enable the awardee to conduct research until regular research support can be obtained. Research costs include equipment, laboratory supplies, research assistants, and travel to scientific meetings and research workshops. Career development costs may include travel, per diem, tuition, or fees for study at centers other than the grantee institution. Funds requested must be carefully justified for each year and must be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Salary for mentors, secretaries and administrative assistants is not allowed. (7) Facilities and Administrative Costs Applicants may request up to 8% of direct costs for Facilities and Administrative Costs (F&A). F&A costs are not provided on tuition and related fees or on equipment expenditures. (8) Professional Income Other Than Salary Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research- related activities of this career development award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: (1) The funds may be used to supplement the NINDS or NIMH contribution up to a level that is consistent with the institution's salary scale; (2) the funds may be used for other health-related research purposes; or (3) the funds may be paid to the miscellaneous receipts of the U.S. treasury. Thorough records of disposition of such income must be maintained and summarized as requested in progress reports. Awardees may retain royalties and fees for activities, such as scholarly writing, or honoraria from other institutions, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. (9) Concurrent Application A candidate for the K08 or K23 award may not concurrently apply for or have an award pending for any other NIH career development award. It is expected that K08 and K23 recipients will apply for independent research grant support during the period of this award. (10) Special Leave and Reduction in Percent Effort Subject to institutional policy applicable to all employees regardless of the source of funds, a leave of absence may be arranged (with continued salary support from the award) for purposes of engaging in research or career enhancement activities related to the award. Prior written approval of the NINDS or NIMH awarding component is required for leave in excess of three months. Leave without award salary support may be taken for a period not to exceed 12 months, subject to prior approval by the NINDS or NIMH awarding component and the awardee's institution. The award termination date will be adjusted to allow a full period of recommended support. Under unusual and pressing personal circumstances, an awardee may submit a written request to the NINDS or NIMH requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or to adapt to any assigned duties associated with the employment role at the grantee institution. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. Further, the awardee must submit assurance of his or her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. (11) Termination or Change of Institution When a grantee institution plans to terminate an award, the appropriate NINDS or NIMH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. NINDS or NIMH K08 and K23 awards are not transferable to another individual but may be transferred to another institution. In the latter case, the awardee must contact the appropriate NINDS or NIMH Program Director to fully discuss the circumstances of the transfer, and must subsequently provide a written justification and rationale for the transfer. The period of support requested can be no more than the time remaining within the existing original award project period. Further, no transfer will be allowed for awards with less than six months remaining in the project period. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Michael Nunn, Ph.D. Program Director Neural Environment Cluster National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2118 Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 480-2424 Email: mn52e@nih.gov OR Jeymohan Joseph, Ph.D. Chief, HIV Neurovirology, Genetics and Molecular Therapeutics Program Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Blvd., Room 6202 Bethesda, MD 20892 Telephone: (301) 443-3012 FAX: (301) 443-9719 Email: jjeymoha@mail.nih.gov o Direct your questions about financial or grants management matters to: Mr. Ken Bond Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 3254 Bethesda, MD 20892 Telephone: (301) 496-9231 Fax: (301) 402-0219 Email: bondk@ninds.nih.gov OR Mr. Brian Albertini Grants Management Branch National Institute of Mental Health 6001 Executive Blvd., Room 6115 Bethesda, MD 20892 Telephone: (301) 443-0004 Fax: (301) 443-0219 Email: albertib2@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using Section IV of 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. Reference special K instructions. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. The essential elements of the K08 and K23 awards are an individualized, well-thought-out career development and research plan, a committed, capable mentor, and a commitment on the part of the applicant institution to the development of the candidate. Documentation concerning each of these essential elements must be included along with the other requirements listed in Section IV-D "Specialized Information" of the application instructions. Use the information provided in the PHS 398 application instructions and the supplemental information provided below to address the following elements: o The Candidate (Prepared by Candidate) The candidate should provide an overview of his or her prior research and clinical (if any) training experience. Detailed justification must be provided of the need for a mentor and for a 3-5 year award. In addition, this section should contain a statement of short-term and long-term research and career goals relevant to the neurological sciences, and how this award will contribute to their attainment. Three letters of recommendation are required of each candidate. Letters from previous research mentors or supervisors are especially helpful. These letters must be attached to the application in sealed envelopes. The candidate's statement must also contain a description of specific career development activities. It should include a statement of the knowledge and skills that the candidate proposes to acquire or enhance during the period of the award and the proposed activities and arrangements for accomplishing these goals. The career development plan should describe what will be learned, how and where this will take place, and why it is important for the candidate's development. The plan should contain a realistic time frame for achieving scientific independence, taking into account the research experiences and career goals of the candidate. o The Sponsor(s) (Mentor), Cosponsor, Consultant(s), and Collaborator(s) (Prepared by Sponsor) Dependence upon a mentor early in the award period will be related to the extent of the candidate's previous research experience; increased independence is expected during the course of the award. The mentor must document that he or she is prepared to personally supervise the candidate's research. The application must describe the specific role of the mentor and identify the proposed commitment of effort to assist the candidate in carrying out his or her career development plan. o Environment and Institutional Commitment to the Candidate (Prepared by Sponsoring Program or Department) Evidence must be provided that the candidate will have a full-time regular faculty appointment at the time an award is activated. The level (e.g., assistant professor) and effective date of this appointment must be provided. This appointment must not be contingent on the receipt of an award. Evidence also must be provided to insure the feasibility of the proposed research development plan, including the availability of office and laboratory space, equipment, and other resources, and access to clinical and/or other research populations. This section should contain a description of the candidate's teaching load, committee and administrative assignments, and clinical or other professional activities, if applicable, for the current academic year. These statements should bear the typed name and signature of the head of the department, program or comparable organizational unit in which the candidate will be working. "Per" signatures are not acceptable. In those instances in which a candidate will be working away from the home institution, the head of the host department, program, or laboratory should also attest, by signature, to the agreement to accept the candidate and provide the necessary resources for his or her development. o Research Plan (Prepared by the Candidate and the Sponsor) The Research Plan should contain a specific statement of research career interests in the area of neurological science. It must include a description of the research areas to be investigated, the research aims, a summary of current knowledge in the area, and methods to be employed. The candidate should use the format cited in the application form PHS 398 (rev. 5/2001) "Research Plan" in the presentation. Although it is understood that the K08 and K23 awards do not require the extensiveness or detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. In general, less detail will be expected with regard to research planned in the later years of the award, but the candidate should outline the general plans for these years. The candidate should make certain that the relationship between the career development plan and the research plan is clearly described. The proposed research should complement the career development plan and provide a vehicle for the applicant's development as a scientist. Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines for AIDS-related grant applications, 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, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) The number and title of this program announcement should be typed in item 2 on the face page of the application, and the "Yes" box should be checked. APPLICATION PROCESSING: Applications must be received by or 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 PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. 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 appropriate National Advisory Council. REVIEW CRITERIA Applications for this mentored research career development award will also be reviewed for the candidate's potential to develop into a productive neurological sciences researcher. Reviewers will consider: (1) the qualifications of the candidate, including the suitability of the candidate relative to the eligibility criteria and purposes of this program; (2) the soundness of the proposed career development plan; (3) training in responsible conduct of research; (4) the nature and scientific/technical merit of the research plan; (5) the mentor; and (6) the institutional environment, including the commitment of the institution to the candidate's career. The following review criteria apply to all applicants: (1) Qualifications of the Candidate o Quality of the candidate's research, academic and (if relevant) clinical record; o Potential to develop as an independent researcher; and o Commitment to a research career. (2) Career Development Plan o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence; o Consistency of the career development plan with the candidate's career goals; o Likelihood that the plan will contribute substantially to the achievement of scientific independence. (3) Training in the Responsible Conduct of Research o Quality of the proposed training in responsible conduct of research. (4) Research Plan o Scientific and technical merit of the research question, design and methodology o Relevance of the proposed research to the candidate's career objectives; o Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan o Adequacy of the plan's attention to children, gender and minority issues when human subjects are involved. (5) Qualifications and Appropriateness of Mentor/Co-Mentor o Appropriateness of mentor(s) research qualifications in the area of this application; o Quality and extent of mentor(s) proposed role in providing guidance and advice to the candidate; o Previous experience in fostering the development of researchers; o History of research productivity, and o Adequacy of support for the proposed research project. (6) Environment and Institutional Commitment o Adequacy of research facilities and training opportunities; o Quality and relevance of the environment for scientific and professional development of the candidate; o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; and o Applicant institution's commitment to an appropriate balance of research and clinical responsibilities including the level of 75 percent effort proposed by 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 and career development activities. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities 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. MONITORING PLAN AND DATA SAFETY AND 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 Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 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 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. 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 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.
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