RUTH L. KIRSCHSTEIN NRSA PROGRAM FOR NIGMS MARC PREDOCTORAL FELLOWSHIPS (F31) RELEASE DATE: April 29, 2003 PA NUMBER: PAR-03-114 (See Notice NOT-GM-08-124 Change in Review Contact) APPLICATION RECEIPT DATES: April 5 and December 5 EXPIRATION DATE: December 6, 2006, unless reissued National Institute of General Medical Sciences (NIGMS) ( This Program Announcement (PA) replaces PAR-99-142, which was published in the NIH Guide, August 16, 1999. CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.121, 93.172, 93.173, 93.233, 93.272,, 93.306, 93.361, 93.398, 93.821, 93.837-93.839, 93.846-93.849, 93.853-93.856, 93.859, 93.862-93.867, 93.880, 93.894, and 93.929. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Training Objectives o Mechanism of Support o Individuals Eligible to Apply o Specific Instructions to Applicants o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Additional Review Criteria o Award Criteria o Required Federal Citations PURPOSE In 2002, the National Research Service Award Program was renamed the Ruth L. Kirschstein National Research Service Award program as a tribute to Dr. Kirschstein's years of exceptional service to the country. Additional details related to this legislative change are available at training/news.htm. Under this congressional authority, the Minority Access to Research Careers (MARC) Program of NIGMS awards individual predoctoral fellowships (F31) to eligible applicants. The intent of the MARC Predoctoral Fellowship Program is to encourage students from minority groups underrepresented in the biomedical and behavioral sciences to seek graduate degrees, thus furthering the goal of the NIGMS MARC Branch of increasing the number of underrepresented minority scientists who are competitively trained to pursue careers in biomedical or behavioral research. It is expected that training will be conducted in graduate degree programs of the highest quality. MARC Predoctoral Fellowships will provide up to five years of support for research training leading to the Ph.D., M.D./Ph.D. or other combined professional degree/Ph.D. in the biomedical or behavioral sciences, including mathematics. These Fellowships are for selected students who are graduates of MARC undergraduate research training programs. Support is not available for individuals enrolled in medical or other professional degree schools unless they are enrolled in a combined professional degree/Ph.D. program in the biomedical or behavioral sciences. Support is also not available for study toward only the Master's degree. This NIGMS MARC Predoctoral Fellowship Program should not be confused with the Ruth L. Kirschstein Minority Predoctoral Fellowship Program, a trans-NIH supported program, which has different eligibility and program requirements, and different application receipt dates. TRAINING OBJECTIVES The goals of the MARC Branch are to increase the number of underrepresented minorities engaged in biomedical research and their potential for quality research, and to strengthen science course curricula and research training environments at minority/minority serving institutions. As part of its ongoing commitment to the development of research training capabilities at these institutions the MARC Branch will provide funds to eligible underrepresented minority students who, as undergraduates, were MARC trainees, and who have been accepted or enrolled in a program leading to a Ph.D. degree or equivalent in the biomedical/behavioral sciences. MECHANISM OF SUPPORT This PA will use the individual Predoctoral Fellowship (F31) award mechanism. It is issued under the auspices of the Ruth L. Kirschstein National Research Service Award Program (see AUTHORITY AND REGULATIONS). The proposed training under the F31 award must be within the fields related to biomedical or behavioral research and must be directed to obtain a research doctoral degree. Applicants are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program. Awards are not made for study leading to any of the professional degrees (M.D., D.O., D.D.S., etc.). The period of fellowship support requested in response to this PA may not exceed five years. (Note: the total period of predoctoral training support is limited to five years by statute, 42USC 288, except in unusual circumstances.) The recipient of MARC predoctoral fellowship support must submit a written request to waive this limit on the duration of support from the NIGMS. Continuation of the fellowship for each subsequent year beyond the first award period is based upon evidence of satisfactory progress in a graduate program. Fellowship awards are administered as described in the NIH Grants Policy Statement found at and the NRSA Guidelines for Individual Awards and Institutional Grants, available on the NIH Website at INDIVIDUALS ELIGIBLE TO BECOME FELLOWS CITIZENSHIP: At the time of application, individuals must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551 or other legal verification of such status). Non-citizen nationals are persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. MARC STATUS: Applicants must be graduates of either the MARC HURT or the MARC U*STAR Programs. In addition, applicants must be currently enrolled in a Ph.D. or equivalent research degree program, a combined M.D./Ph.D. program or other combined professional degree/Ph.D. program in the biomedical or behavioral sciences, including mathematics, and must have a thesis mentor and thesis project acceptable to the institution's Ph.D. dissertation committee(s). SPECIFIC INSTRUCTIONS FOR APPLICANTS ALLOWABLE COSTS: The MARC Predoctoral Fellowship Award provides an annual stipend to help meet the fellow's living expenses and an annual institutional allowance. STIPEND: A MARC Predoctoral Fellowship provides an annual stipend of $19,968. The actual amount of stipend will be prorated by the length of the award if the award is less than 12 months. The stipend is not provided as a condition of employment with either the Federal Government or the institution. TUITION, FEES, AND HEALTH INSURANCE: The NIH will offset the combined cost of tuition, fees and health insurance (either self-only or family as appropriate) at the following rate: 100% of all costs up to $3,000 and 60% of all costs above $3,000. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the fellowship. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at INSTITUTIONAL ALLOWANCE: NIH will provide an institutional allowance of $2,750 per 12-month period to nonfederal, nonprofit, or foreign sponsoring institutions to be used for expenses directly related to the applicant's research training. Examples of such training related expenses might be research supplies, small equipment, and travel to scientific meetings. The allowance is not available until the fellow officially activates the award. OTHER TRAINING COSTS: Additional funds may be requested by the institution when the training of a fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution or accommodations for fellows who are disabled, as defined by the Americans with Disabilities Act. The funds requested for extraordinary costs must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the institution. FACILITIES AND ADMINISTRATIVE COSTS: F&A (indirect) costs are not allowed on individual fellowship awards. STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME: An institution is permitted to provide funds to a fellow in addition to the stipend paid by the NIH. Such additional amounts may be in the form of augmented stipends (supplementation) or compensation for services. SUPPLEMENTATION: Supplementation or additional support to offset the cost of living may be provided by the sponsoring institution, but must not require any additional effort from the fellow. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may PHS grant funds be used for supplementation. COMPENSATION: An institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services, such as teaching or research. Compensation for services is not considered stipend supplementation. A fellow may receive compensation for services as a research assistant or in some other capacity on a Federal research grant, including a PHS research grant. However, compensated services must occur on a limited, part-time basis apart from the normal training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that is part of the F31 research training experience. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved NRSA training program. Additionally, compensation must be in accordance with institutional policies applied consistently to both Federally and non-Federally supported activities and supported by acceptable accounting records determined by the employer-employee relationship agreement. EDUCATIONAL LOANS OR THE GI BILL: An individual may make use of Federal educational loan funds and assistance under the Veteran's Readjustment Benefits Act (GI Bill). Such funds are not considered supplementation or compensation. CONCURRENT AWARDS: An F31 may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. TAX LIABILITY: The Internal Revenue Code, Section 117, applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report gross income, all stipends and any monies paid on their behalf for course tuition and fees required for attendance. The taxability of stipends, however, in no way alters the relationship between NRSA fellows and institutions. NRSA stipends are not considered salaries. NRSA fellows are not considered to be in an employee-employer relationship with the NIH or with the institution at which they are receiving their training. The interpretation and implementation of the tax laws is the domain of the Internal Revenue Service (IRS) and the courts. The NIH takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on the proper steps to be taken regarding their tax obligations. LEAVE: Fellows may continue to receive stipends during periods of vacation and holidays available to individuals in comparable training positions at the training institution. Also, fellows may continue to receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Fellows may continue to receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee or sponsoring institution have access to paid leave for this purpose and the use of parental leave is approved by the sponsor. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring extended periods of time away from their research training experience must seek approval from NIGMS for an unpaid leave of absence. 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/programmatic, peer review, and financial or grant management issues. o Direct your questions about programmatic issues to: Adolphus P. Toliver, Ph.D. Chief, Minority Access to Research Careers Branch National Institute of General Medical Sciences 45 Center Drive, Room 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 E-mail: o Direct your questions about peer review issues to: Richard I. Martinez, Ph.D. Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 3AN.12B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2781 Email: o Direct your questions about financial or grants management matters to: Ms. Antoinette Holland Grants Management Officer National Institute of General Medical Sciences 45 Center Drive, Room 2AN.50B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-2554 E-mail: SUBMITTING AN APPLICATION Applications for a Ruth L. Kirschstein Individual National Research Service Award must be prepared using PHS 416-1 (6/02 rev.). The PHS 416-1 is available at in an interactive format. For further assistance, contact Grantsinfo, telephone (301) 710-0267, Email: Prospective student applicants are strongly advised to seek the assistance of their MARC Program Director, graduate program director, and/or research advisor in preparing his/her application. SUPPLEMENTAL INSTRUCTIONS: The applicant must follow all general instructions in the application kit (PHS Form 416-1, Revised 6/02) except for those which are modified by the supplemental instructions below. A. Information about the Student Applicant-Section 1/Part 1 Applicants are responsible for completing the following sections of the Fellowship Application Kit: Face Page: Items 1-8, 15 Form Page 2: Items 16-18; 22 (if appropriate) Form Page 3: Table of Contents Form Page 4: All Form Page 5: All Form Page 6: All Personal Data Page: All Form Page 9 (checklist): Section I only Clarifying Instructions for Selected Items 1. Face Page Item 2 (Face Page, Level of Fellowship): Type in the space provided "MARC Predoctoral Fellowship". Item 3 (Program Announcement/Request for Applications): Type "PAR-03-114". Item 6 (Prior and/or Current NRSA Support): Check "yes" and complete Item 24, Form Page 5. (Items 9 - 14 should be completed by the sponsor or research advisor.) 2. Form Page 2 Item 17 (Form Page 2, Employment): Your employment history during college should also be included if it involved a significant time commitment. Items 19, 20, and 21 should be completed by your sponsor or research advisor. Item 22 (Research Proposal Description): Complete this section following the instructions in the kit (instruction page 9). 3. Form Page 4 Item 23 (Form Page 4, Scholastic Performance): Be sure to include your scores from the GRE or MCAT at the bottom of the page. 4. Form Page 5 Item 24 (Form Page 5, Prior and/or Current NRSA Support): List the institution where you were a MARC trainee and give the dates. If you have received any other support from a National Research Service Award grant, such as a predoctoral training grant, list the grant number, institution, and dates. If you are not sure, check with the director of your graduate program. Generally, only students already enrolled in a graduate program will have had such support. Item 25b (Title of Thesis/Dissertation): If you have a Master's Degree, give the title of your thesis and indicate that it is your MS thesis; otherwise leave blank. Item 26 (Name of Thesis Advisor): Give the name, title, department, and institution of your thesis advisor. 5. Form Page 6 Item 28 (Form Page 6, Research Experience): Provide a thorough description of your relevant work and research experiences, including time, place, research director, the research projects, and your role in the research. Include a list of publications, abstracts, and poster presentations, if available. If you have them, submit three collated sets of copies of publications and abstracts as part of Section 3 (Appendix). Do not complete Item 28b. Item 29 (Revised Application) need not be completed unless THIS application is a revision of one submitted earlier. Item 30 (Research Training Plan) o Item 30a (Approximate Percentage ): Fill out the Table. o Item 30b and 30c (Research Proposal and Respective Contributions) o Complete these items according to the instructions in the application kit (instruction pages 11-21). You should work closely with your research advisor to complete this section. o Item 30d (Selection of a Sponsor and Institution): You should explain your reasons for selecting the degree program and school in which you have enrolled. o Provide a rationale for choosing that particular individual as your mentor. o Item 30e Give a description of the plan to provide formal and informal instruction on scientific integrity and ethical principles in research. B. Information about the Faculty Sponsor and Graduate Program-Section 2/Part II Your thesis research advisor should complete these items. Clarifying Instructions for Selected Items All of Section 2/Part II (Form Page 7) should be completed by the faculty sponsor. 1. Item 32 and Item 33 (Form Page 8) should be completed by the applicant's thesis research advisor. 2. Item 34 (Training Plan, Environment, Research Facilities, Form Page 8): In addition to the information requested in the application kit (instruction page 27), provide a full description of the graduate or combined degree program in which the applicant is/is to be enrolled. This description should also outline the normal course of study (both didactic and laboratory) for students enrolled in the program. For example, the description of a degree program would commonly sketch the program's administrative organization and responsibilities. The following questions include the kind of information that the review group finds useful in assessing a graduate program. (The specific features described should be tailored to the local program being presented and need not necessarily include all, or be limited to, the suggested questions.) o How does a student become aware of the laboratories/mentors available for thesis research? o Who advises a student concerning course and research mentor selection? o What are the qualifications required of a faculty member if he/she is to be eligible to serve as a Ph.D. mentor? o Who is responsible for monitoring a student's overall progress? o Describe any special program features (courses, seminars, retreats, teaching requirements, etc.). o What is the current student enrollment of the program? How many students have entered and how many have completed the program in each of the last five years? o What have these graduates done since graduation? o What proportion of the program's entering students complete their Ph.D. or M.D./Ph.D. degree studies? o What has the program's experience been in recruiting and training underrepresented minorities? o In the case of M.D./Ph.D. programs, how are the medical and graduate portions of a student's program integrated, and how is the transition between the two assisted? Describe the applicant's course of study up to the time of submission of the application and plans for further study. C. Reference Reports/Letters-Section 3 At least three faculty reference reports must be submitted with your application. You should complete the top part of the reference form (Name of Applicant, Proposed Sponsoring Institution) and give one form to each person writing a reference letter for you. o One reference report must be from the MARC program director or a MARC faculty member who knows you well. o We strongly advise that at least one letter be from an individual who was your supervisor/advisor for one of your major research experiences, preferably a research experience outside of your home institution. APPLICATIONS SUBMITTED WITHOUT THE THREE REQUIRED REFERENCE REPORTS/LETTERS WILL BE RETURNED WITHOUT REVIEW. The reference letters must be in sealed envelopes and attached with a clip to the original copy of your applications. In addition to the three reference letters cited above, the following MUST be included with the application at the time of submission: o A copy of the results of either the Graduate Record Examination (GRE) or the Medical College Admission Tests (MCAT) for M.D./Ph.D. applicants must be included at the end of the application. o A clear and legible copy of the applicant's transcript(s) from all undergraduate and graduate institutions in which the applicant is/has been enrolled must be included at the end of the application. o A description of the graduate or combined degree program in which the applicant is either enrolled or has been admitted and agreed to enroll must be included as Item 33 of the application. D. TERMS AND CONDITIONS OF SUPPORT Fellowships must be administered in accordance with the current NRSA Policy Guidelines for Individual Awards and Institutional Grants (see the NIH Website, the current NIH Grants Policy Statement (see the NIH Website at grants/policy/policy.htm), and any terms and conditions specified on the Notice of Research Fellowship Award. ACTIVATION: No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5) has been submitted to the NIGMS. An awardee has up to six months from the issue date on the Notice of Research Fellowship Award to activate the award. Under unusual circumstances, NIGMS may grant an extension of the activation period upon receipt of a specific request from the fellow. CERTIFICATION AND REPORTING PROCEDURES: No application will be accepted without the applicant signing the certification block. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award. At completion of the training, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. These forms may also be found on the NIH Website at INVENTIONS AND DATA COLLECTION: Fellowships made primarily for educational purposes are exempted from the NIH invention requirements. F31 awards will not contain any provision giving PHS rights to inventions made by the award recipient. DATA SHARING: NIH policy is to make available to the public the results and accomplishments of the activities that it funds. Therefore, fellows are encouraged to publish the results and accomplishments of their F31 activities in the journals of their choice. Awarding unit support must be acknowledged in the publications. There are no restrictions on the publication of results in a timely manner. COPYRIGHTS: Except as otherwise provided in the terms and conditions of the award, when publications, data, or other copyrightable works are developed in the course of work under a NIH grant-supported project or activity the recipient is free to arrange for copyright without awarding unit approval. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce them, translate them, publish them, or otherwise use them, and to authorize others to do so for Federal Government purposes. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at only two of the standard application deadlines, i.e., April 5 and December 5. Standard application deadlines are available at Application deadlines are also indicated in the PHS 416-1 application kit. SENDING AN APPLICATION TO NIH: Submit a signed, typewritten (single-sided) original of the application (including the checklist, Personal Data form, at least three sealed reference letters, and all other required materials), and one signed photocopy 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 same time, one additional copy should be sent under separate cover to: Chief, Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 3AN.12, MSC 6200 Bethesda, MD 20892-6200 APPLICATION PROCESSING: Applications must be received by the receipt dates listed on the first page of this announcement. 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. 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 eight weeks. PEER REVIEW PROCESS Applications for this PA will be assigned to NIGMS. Applications will be evaluated for the merit of the overall research training by the MARC Review Committee, composed primarily of non-government scientists selected for their competence in research and research training, which is convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will: o Receive a written critique o Receive a second level review by the NIGMS Fellowship Oversight Group (FOG), comprised of NIGMS professional staff. REVIEW CRITERIA The MARC Review Committee will address and consider each of the criteria listed below in assigning the application's overall score, weighting them as appropriate for each application. The application need not be strong in all categories to be judged likely to have an important training impact and thus to deserve a high priority score. In the written comments, the reviewers will be asked to discuss the criteria listed below in order to judge the likelihood of successful completion of the proposed research training leading to a research doctoral (Ph.D. or equivalent) degree by the applicant and achievement of the goals of this PA. The review criteria focus on four main components: o Candidate o Sponsor and Training Environment o Research Proposal o Research Training Potential (1) CANDIDATE: An assessment of the applicant's qualifications and potential for a career as a researcher and teacher, based on past accomplishments, such as scholastic record and scholastic honors, career goals, scientific publications and/or presentations (if any), professional honors, and awards and letters of recommendation. (2) SPONSOR AND TRAINING ENVIRONMENT: An assessment of the qualifications of the sponsor as a mentor for the proposed research training program and of the quality of the training environment. (3) RESEARCH PROPOSAL: The quality and appropriateness of the proposed training, including the merit of the scientific proposal and its relationship to the candidate's career plans. (4) RESEARCH TRAINING POTENTIAL: An assessment of the value of the proposed research training in preparing the candidate for quality research and/or teaching. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTION OR 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 included in the section on Federal Citations, below.) ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. INSTRUCTION IN THE RESPONSIBLE CONDUCT OF RESEARCH: Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, duration and frequency of instruction. No award will be made if an application lacks this component. AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other recommended applications for Ruth L. Kirschstein NRSA MARC Predoctoral Fellowship Awards. The following will be considered in making funding decisions: o Scientific and technical merit of the application as determined by peer review. o Availability of funds. o Relevance to program 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 ( notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at _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: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide the official NIH identifier 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: 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 ( 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 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 a 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. NRSA awards are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288) and Title 42 of the Code of Federal Regulations, Part 66. Fellowships must be administered in accordance with the current NRSA Guidelines for Individual Awards and Institutional Grants, the current NIH Grants Policy Statement, and any terms and conditions specified on the Notice of Research Fellowship Award. 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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