and Human Services (HHS)
EXPIRED
MENTAL HEALTH DISSERTATION RESEARCH GRANTS TO INCREASE DIVERSITY IN THE MENTAL HEALTH RESEARCH ARENA RELEASE DATE: April 21, 2003 (see clarification NOT-MH-03-008) PA NUMBER: PAR-03-110 (Replaced by PAR-06-217) EXPIRATION DATE: March 3, 2006 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) 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 APPLICATION RECEIPT DATES: April 22, August 22, December 22 PURPOSE OF THIS PA This Program Announcement (PA) replaces PAR-99-139, "Minority Dissertation Research Grants in Mental Health." The purpose of this PA is to increase the diversity of the Mental Health Research workforce. The Mental Health Dissertation Research Grant will enable doctoral candidates from racial and ethnic groups underrepresented in biomedical and behavioral science to pursue research careers in any area relevant to the research mission of the National Institute of Mental Health (NIMH). Eligible doctoral candidates will receive support through the NIH Dissertation Award (R36) mechanism to facilitate completion of their doctoral research and dissertation. This research support is for students who are not currently receiving support from a National Research Service Award (NRSA) individual fellowship or training grant or NIH research project grant. This program will be of particular interest to eligible students where support from NRSA institutional training awards, NIH research project grants, or other Federal research support is not available at their home institutions. RESEARCH OBJECTIVES A primary objective of the dissertation research grant is to increase the numbers of students from underrepresented racial and ethnic populations who will become successful investigators in areas of biomedical or behavioral science relevant to the mission of the NIMH. The usual mechanisms used for the support of doctoral dissertation research have attracted only limited numbers of students from underrepresented racial and ethnic populations to mental health research. A dissertation represents the most extensive research experience formulated and carried out by doctoral candidates, with the advice and guidance of mentors. Dissertation research involves a major investment of the doctoral student's time, energy, and interest and its substance is often the basis for launching a research career. The Mental Health Dissertation Research grant will provide full-time salary support and research funds for eligible students to facilitate completion of their doctoral research project and dissertation. The Dissertation Research Grant is designed to encourage and stimulate applications from students for whom support from the current NIH training and research mechanisms is not or may no longer be available. The Dissertation Research Grant mechanism includes an expedited submission, review and award process. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Dissertation Award (R36) mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. Grants to support dissertation research will provide up to $30,000 per year in direct costs for a maximum period of two years. This PA uses just-in-time concepts and the non-modular budgeting format. 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 http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS The applicant may submit an application if the student's institution is a domestic public or private non-profit university, college or professional school with an accredited doctoral degree granting program. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The student applying for a Mental Health Dissertation Research Grant must be enrolled in an accredited doctoral degree program in an area or discipline relevant to the mission of the NIMH, and must be conducting dissertation research relevant to that mission. The student applicant must be a doctoral candidate (advanced to candidacy) for whom all requirements for the doctoral degree (excluding the clinical internship requirement) other than the dissertation have been completed by the time of the award. Documentation of the applicant's advancement to candidacy for the doctorate degree and an approved dissertation project must be provided at the time of application (see SUBMITTING AN APPLICATION). For the purpose of this PA, eligible students are those individuals from an ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. The doctoral candidate must be a citizen or non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. Individuals on student or temporary visas are not eligible, nor is anyone already receiving predoctoral support under a National Research Service Award (NRSA) unless such support is terminated prior to acceptance of the dissertation award. Academic institutions are encouraged to facilitate submission of applications from qualified doctoral candidates. Applicants for the Mental Health Dissertation Research Grant are expected to pursue full-time research and career development activities directly relevant to the mission of the NIMH. Applications with marginal or no mental health relevance will be considered unresponsive to these programs. Such applications will not be considered further and will be returned to the applicant. Therefore, prior to preparing and submitting an application, it is suggested that prospective applicants contact the NIMH staff listed under INQUIRES to discuss any aspects of this program that need clarification. 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: For overall NIMH policy with regard to this initiative, direct your questions to: Michael A. Sesma, Ph.D. Chief, Research Scientist Development Program Office for Special Populations National Institute of Mental Health 6001 Executive Boulevard, Room 8125, MSC 9659 Bethesda, MD 20892 Telephone: (301) 443-2847 FAX: (301) 443-8022 Email: [email protected] Direct your questions about scientific/research issues to the following training staff: Mark Chavez, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6207, MSC 9623 Bethesda, MD 20892 Telephone: (301) 443-3563 FAX: (301) 443-6000 Email: [email protected] Debra Wynne, MSW Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7195, MSC 9645 Bethesda, MD 20892 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: [email protected] Enid Light, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892 Telephone: (301) 443-1185 FAX: (301) 443-4045 Email: [email protected] 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 6139, MSC 9608 Bethesda, MD 20892-9608 Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: [email protected] Direct your questions about financial or grants management matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892 Telephone: (301) 443-2805 FAX: (301) 443-6885 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. Further, an application that does not conform to the instructions, including the special instructions provided below, will be returned without review. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications must be submitted by the application receipt dates listed in the heading of the program announcement. Applications received late will be returned to the applicant. SPECIAL INSTRUCTIONS FOR THIS MENTAL HEALTH DISSERTATION RESEARCH GRANT APPLICATION: In addition to the above instructions the following specific instructions must be followed. The narrative portion of the application that describes the research plan (Sections A-D) of the dissertation may not exceed 10 pages. This does not include material on human subjects, vertebrate animals, consultants/collaborators, consortium/contractual arrangements, or literature cited. The information in the required narrative project description must be presented in a form suitable for detailed scientific and technical review. Appendices may not be used to exceed the page limitation. The Modular Application concept is not applicable to this dissertation research grant program. A detailed budget will be required. Scope of Awards: A Mental Health Dissertation Research Grant will be awarded for a period of up to 24 months. Within this time frame the applicant may request support for the amount of time necessary to complete the dissertation. Expenses usually allowed under PHS research grants will be covered by the NIMH dissertation research grant but may not exceed $30,000 per year in direct costs for the project for a maximum period of two years. An application that exceeds this period and cost will be returned. Details on allowable costs are described below. Letter of Certification: A letter from the faculty advisor, dissertation committee or university official directly responsible for supervising the dissertation research must be submitted with the application. The letter must (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIMH support; and (d) certify that the institution's facilities and general environment are adequate to conduct the proposed research. Additional Material: A transcript of the applicant's graduate school record should be included with the application as an appendix. The Biographical Sketch Section of the Form PHS 398 must contain a scientific autobiography. This autobiography must provide a statement of career goals, including reference to their interest in the specific area of mental health/mental disorders research, and a description of their intended career trajectory. A biographical sketch of the mentor or dissertation supervisor must also be provided. The mentor's biographical data should not exceed two pages and should also include information in the Other Support pages according to the instructions in the PHS 398. APPLICATION FORMAT AND ORGANIZATION: See PHS 398, rev. 5/01 - C. Specific Instructions (starting on page 6). However, note that not all of the Sections and Items are covered here. For those Sections and Items not covered below, follow the instructions in the PHS 398). Section 1 (Pages 6-10). Face Page: Item 2. Response to Specific Program Announcement: Check "YES" and enter the number and the title of this program announcement. Item 3a. Name of Principal Investigator: The doctoral candidate must be listed as principal investigator. Designate by name the doctoral candidate who is to be directly involved in carrying out the proposed research. Item 3d. Position Title: Enter "Doctoral Candidate." Item 3f. Department, Service, Laboratory or Equivalent: Enter the name of the department or program in which the principal investigator is candidate for a doctoral degree. Item 6. Dates of Proposed Period of Support: Applicants may propose a total project period of 24 months for the research project and its support. Items 7 and 8. Costs Requested for Initial Budget Period; and Costs Requested for the Proposed Period of Support: Dissertation research grant applications may request no more than $30,000 in direct costs per year, and $60,000 for two years. Item 9. Applicant Organization: Indicate where the project will be conducted. If there is more than one performance site, list all of them. Note that no additional costs will be provided when more than one performance site is involved. Item 15. Principal Investigator/Program Director Assurance: The applicant must sign here. Item 16. Applicant Organization Certification and Acceptance: The official signing for the applicant organization must sign here. Sections 4 and 5 (Pages 11-13). Detailed Budget for Initial Budget Period; and Budget for Entire Proposed Period of Support: Follow the PHS 398 (rev. 5/01) instructions for the budget pages. Expenses usually allowed under PHS research grants will be covered by the NIMH dissertation research grant but may not exceed $30,000 per year in direct costs for the project, for a maximum period of two years. An application that exceeds this amount will be returned. Allowable costs include the candidate's salary for 12 months full-time effort. This salary must not exceed the current NRSA stipend level for predoctoral students ($19,968 in 2003; http://grants.nih. gov/grants/guide/notice-files/NOT-OD-03-033.html); fringe benefits may be added to this amount. Additionally, up to $5,000 may be requested for research project expenses, such as data processing, supplies, payments to subjects, and dissertation costs (e.g., printing and binding). Such budgets must be justified in specific detail. The candidate may request up to $1,000 travel to one scientific meeting; any additional travel costs in connection with research at a remote performance site must be fully justified and included in the research project expenses. Specific costs not allowed on dissertation research grants are permanent equipment items, tuition, alterations/renovations, space rental, contracting or consortium costs, dissertation defense or deposit fees, membership fees and faculty/advisor mentor supervision. This listing is not exclusive, and the applicant institutions should contact the NIMH staff regarding any other cost item being considered. The applicant must provide detailed justification for each budget item requested on the detailed budget page for the total period of support being requested. Level of Effort: It is expected that students will devote 100 percent time and effort (based on 40 hours per week) on the dissertation. Any level of effort that is less than full time must be fully justified, and the student's salary must be prorated accordingly. Facilities and Administrative costs are limited to eight percent of approved direct costs, less any equipment costs. Section 9 (Page 14). Research Plan: The principal investigator must provide a narrative project description that contains a detailed scientific and technical discussion of the following specific points. This must not exceed 10 pages (Items addressing human subjects and/or regarding vertebrate animals must be provided if human subjects and/or vertebrate animals are to be involved). ADDRESS THE FOLLOWING POINTS RATHER THAN THOSE SHOWN IN THE PHS 398 INSTRUCTIONS: a. A description of the research project and what it is intended to accomplish; the relevance of the project to mental health/mental disorders b. A summary of related published research that addresses the identified problem(s) c. The questions to be answered or the hypotheses to be tested by the project d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be made, and steps that will be taken to protect human subjects or research animals as appropriate e. The management of the project, including a schedule or time-line of the main steps of the proposed investigation f. The facilities and resources that will be available in the project. AMENDED APPLICATIONS: If not awarded the applicant may submit one amended application. The amended application must include an Introduction (limited to 1 page) that addresses the issues and problems raised in the reviews contained within the summary statement. Refer to specific instructions on the preparation of an Introduction to a revised application in the PHS Form 398 (Rev 5/01). The Introduction page is not included in the 10-page limit for the research plan narrative for the Dissertation Research Grant Application. The submission dates for amended applications are the same as for new applications. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist and supporting documentation, 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 APPLICATION PROCESSING: Applications must be postmarked on or before the receipt dates listed on the first page. Applications will be reviewed for completeness by the Center for Scientific Review (CSR). Incomplete applications will be returned to the applicant without further consideration. 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 an 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 that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with standard NIH review procedures. Reviewers will take into account the applicant's stage of development and the importance of the dissertation as a learning experience that is part of the applicant's graduate education. Emphasis will be given to the scientific merit, feasibility, and relevance of the project to mental health research areas. The qualifications of the candidate will also be emphasized in the review. 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. It is the intent to provide review results and announce funding decisions within four months after the receipt date. Review criteria, award criteria, and continuation of support are described below. REVIEW CRITERIA FOR DISSERTATION RESEARCH GRANT APPLICATIONS: The overall goal of NIH-supported research is to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. For dissertation research grants, using the five criteria below reviewers will assess the significance of problem; scientific quality of the proposal; relationship of proposed research to expanding the knowledge base in mental health research areas; research design and research methods; personal qualifications of the candidate; supervision of the candidate; institutional facilities and support structure; and appropriateness of budget. Each of these criteria will be addressed and considered in the assignment of the overall score: (1) Significance. Does the proposed project address an important problem in mental health/mental disorders? If the aims of the application are achieved, how will scientific knowledge be advanced? Will the results have heuristic value? (2) Approach. Are the conceptual framework, hypothesis to be tested, research design, methodology, and analyses adequately developed, clearly defined, and appropriate to the aims of the project? Does the proposal describe the main steps of the investigation within the project period, acknowledge potential problem areas and consider alternative approaches? Does the proposal reflect a grasp of scientific principles and adequate knowledge of other research related to the problem? (3) Innovation. Within the context of dissertation research and training experience, does the proposed project employ novel concepts, approaches or methods? Within the same context, are the aims original and innovative? (4) Investigator. Is the student applicant appropriately trained and well suited to carry out the dissertation research? Does the student show promise as a research investigator in areas relevant to the proposal? Is the experience and training of the student sufficient to carry out the research, and is the proposed research project consistent with the long-term research interests of the applicant? Is the work proposed appropriate to the experience level of the student? (5) Environment. Does the scientific and training environment in which the work will be done contribute to the probability of success? Does the proposed project take advantage of unique features of the scientific and training environment? Will the faculty advisor provide the necessary supervision and mentoring to the student? Is there evidence of institutional support including available facilities appropriate to the research? 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: BUDGET: The appropriateness of the proposed budget in relation to the proposed research will be evaluated. The allocation of time and money reflects an understanding of the research tasks to be accomplished and of the problems likely to arise. 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. 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 NIMH program priorities In addition, there are Terms and Conditions Specific To Mental Health Dissertation Research Grants: o Continuation of support without additional funds: under expanded authorities, the grantee institution may extend this grant up to one year without additional funds. However, notification of an extension to the NIMH staff must include information documenting the progress of the awardees during the first two years of support and the circumstances leading to the extension. The grantee institution may provide a one-year extension of the grant, without additional funds, only if there is evidence of acceptable progress and the need for additional time. o Since this is a dissertation grant, the NIMH Program staff must be immediately informed if there is a change of mentor. A biographical sketch and material on the new mentor's research support should be provided to NIMH for approval. o Dissertation Research Grants may not be transferred to another institution, unless under unusual and compelling circumstances. One example is if the mentor moves to a new institution and both the mentor and the student wish to move together. o The dissertation constitutes the final report of the grant. As a part of the closeout process, two copies of the dissertation must be submitted to the NIMH within 90 days of the termination of the grant. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation, and it must be signed by the responsible official. o Concurrent Support: An applicant who receives support for dissertation research under a grant from the NIMH may not at the same time receive support under a predoctoral training grant or fellowship grant awarded by any Federal agency, nor be supported under any other research project grant. 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 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 "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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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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