and Human Services (HHS)
EXPIRED
EXTRAMURAL ASSOCIATES RESEARCH DEVELOPMENT AWARD (EARDA): SPONSORED RESEARCH INFRASTRUCTURE PROGRAM (SRIP) RELEASE DATE: February 12, 2003 RFA NUMBER: HD-03-007 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) LETTER OF INTENT RECEIPT DATE: March 24, 2003 APPLICATION RECEIPT DATE: April 24, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Program Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Extramural Associates (EA) Program, National Institute of Child Health and Human Development (NICHD), NIH, announces two initiatives directed at scientific faculty and academic science administrators of women's colleges and of institutions with significant underrepresented minority (i.e., Black, Asian/Pacific Islander, Hispanic, or Native American) student populations. The two initiatives target two different types of institutions. The Faculty Research Enhancement Support Program (FRESP) is published in a companion (RFA HD-03-006). This RFA describes the Sponsored Research Infrastructure Program (SRIP) and is intended for eligible institutions that award the Master's or the Ph.D. degree in the biomedical and/or behavioral sciences and/or other health-related professional degrees. In addition, it is expected that these institutions already have a modest research base of health-related research. The goal of these initiatives is to increase the participation of these institutions in biomedical and behavioral research and research training through an integrated residency and institutional grant support program. The objective of the SRIP program, through its five-month residency experience at the NIH, is to enhance the research capacity of the awardee institution by providing the following resources: (1) administrative support for the development of grant applications and/or contract proposals; (2) updated information about the availability of funds to support biomedical and behavioral research and research training; (3) grantsmanship seminars for faculty; and (4) the resources to develop approaches to encourage faculty and students to participate in biomedical and behavioral research. It is anticipated that the individuals participating in the residency program will be responsible for establishing or enhancing an office that provides administrative support for research and research training projects receiving external funding, and for implementing pilot studies that encourage faculty and students to engage in research from a broader perspective. PROGRAM OBJECTIVES Background The EA Program was established in 1978 at the NIH to promote the entry and participation of women and underrepresented minority institutions into biomedical and behavioral research. Overall, the program accomplishes this mission by providing EAs from women's colleges and underrepresented minority institutions with the opportunity to come to the NIH to gain the necessary understanding of the processes utilized by the NIH as well as other Federal agencies to provide funding to support biomedical and behavioral research and research training. The five-month SRIP winter residency program is for institutions with an individual wishing to establish or augment an Office of Research Development for the purpose of enriching faculty and student participation in biomedical and behavioral research activities. Scope [The terms 'Principal Investigator' and 'Extramural Associate (EA)' are used interchangeably in this document.] Candidates (Principal Investigators) for the Extramural Associates Research Development Award (EARDA) must be full-time scientific faculty or academic science administrators at the applicant institution. If approved and invited to participate, they will be required to spend five months at the NIH in residency training. The program has the flexibility necessary to allow each EA to participate in activities that are consistent with the institution's concerns and interests in health-related research. Upon entering the program, EAs are assigned a preceptor and participate in the regular EA Program curriculum. The EA's preceptor, a senior NIH or Public Health Service (PHS) official, is available for guidance with respect to working assignments and related activities to assure consistency with the Institutional Plan presented in the EARDA application. EAs attend an initial series of orientation sessions as well as in-depth seminars that prepare them to use their time effectively at the NIH. Working assignments are intended to provide in-depth exposure to the administration of NIH and other Federal extramural research programs. EAs have the opportunity to learn about the Federal legislative and budgetary processes, to study administrative procedures, and to observe staff meetings and scientific review meetings. During the course of the residency program, they visit other Federal agencies, and a nearby university's office of sponsored research. Opportunities may also be provided to observe NIH site-visits to grantee institutions. Upon completion of the program, the EAs have: (1) a comprehensive working knowledge of the range of Federal support of biomedical and behavioral research; (2) skills in preparation of research grant applications; (3) a plan to establish or expand the institution's "Office of Research Development;" (4) knowledge of the composition of an Advisory Committee with membership capable of reviewing, recommending for funding, and monitoring faculty pilot research projects; (5) a network of contacts to the NIH and other Federal agencies, so they can serve as a liaison for faculty and students to access NIH opportunities as well as those of other Federal and private agencies; and (6) the embryonic stage of a meaningful partnership with a research intensive institution. The Residency Program It is anticipated that awards will be made after the completion of the five- month NIH residency, which begins the first week of January 2004 and ends the latter part of May. However, successful applicants will be notified following the September 2003 meeting of the National Advisory Child Health and Human Development Council, so that the identified EA will have time to arrange for participation in the residency program during 2004. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Extramural Associates Research Development Award (G11) mechanism. The G11 mechanism is used to support institutional resources to improve the research infrastructure (including part-time professional and administrative staff, equipment, etc.). An award made to a successful FRESP applicant or to a successful SRIP applicant is termed an EARDA. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. FUNDS AVAILABLE The NICHD intends to commit approximately $190,000 in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2004 to fund three to five new grants in response to this RFA. Facilities and Administrative (F&A) costs for these awards are fixed at eight percent of total direct costs. Applicants may request a project period of five years and a budget for direct costs of up to $35,000 for the first 12-month budget period. In Years 02 through 05, budgets for direct costs of up to $50,000 may be requested for administration of an Office of Research Development. In addition, up to $35,000 may be requested in these four years to support faculty pilot research projects, seminars, and student participation in research projects. Thus, applicants may request up to $85,000 in direct costs per year in Years 02 through 05. Because the nature and scope of the effort proposed may vary, it is anticipated that the size of awards also will vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Transitional Awards Since a major goal of the program is to establish an Office of Research Development, applicants successful in receiving a five-year EARDA are expected to compete for a one-time, three-year "Transitional EARDA Award." The Transitional Award of $85,000 per year in direct costs will be based on a cost-sharing arrangement. The purpose of the Transitional Award is to allow the institutions sufficient time to assume full financial responsibility for the Office of Research Development after eight years of EARDA grant support. It is expected that during the first year of the Transitional Award (Year 06, overall), NICHD will contribute two-thirds of the total costs, and the institution one-third. During the second year, (07 year) NICHD and the institution will each contribute 50 percent, and in the third and final year, the institution will contribute two-thirds and NICHD will contribute one- third. Thereafter, the institution would assume full financial responsibility for maintaining the Office of Research Development. Applications for the Transitional EARDA award will be solicited from eligible institutions at the appropriate time. ELIGIBLE INSTITUTIONS Applications may be submitted by domestic, private and public women's colleges and educational institutions with significant underrepresented minority (i.e., Black, Asian/Pacific Islander, Hispanic, or Native American) student populations that offer programs in the biomedical or behavioral sciences. Preference will be given to those institutions that demonstrate the greatest need to establish or strengthen and develop research and research training infrastructure. The SRIP is intended for institutions that offer programs in the biomedical and/or behavioral sciences leading to a Master's degree or higher, including health-related professional degrees. These institutions are expected to have a modest research base already in place and to be interested in developing or enhancing a research infrastructure. In selected instances, institutions that award the baccalaureate as the highest science or health-related degree may seek to qualify for eligibility to apply for the SRIP. At a minimum, MARC or MBRS, preferably both, must have supported such institutions and they must have current or prior support from two other Federal agencies other than the Department of Education. For additional information, discuss eligibility with the EA Program Office contact, listed under WHERE TO SEND INQUIRIES, below. Institutions may nominate only one Principal Investigator per cycle for participation in the program. Eligible women's colleges and underrepresented minority institutions that have never had a faculty member participate in the EA Program are strongly encouraged to apply. Institutions that have received a Research Centers in Minority Institutions (RCMI) award, if successful in applying for this award, will have their budget requests reduced if there is significant overlap in funding for infrastructure components. Institutions that received an Extramural Associates Research Development Award (EARDA) in years 1994 through 2002 resulting from their response to RFAs OD-94-002, OD-94-003, OD-95-001, OD-96-001, OD-97-002, OD-98-004, OD-99-001, OD- 00-001, HD-01-003 or HD-02-007 are not eligible to apply under this announcement. Institutions that had EAs enrolled in the five-month NIH residency training program prior to 1994 and who have never received an EARDA grant are eligible to apply for this program. However, the proposed Principal Investigators from such institutions must agree to repeat the five-month NIH residency-training program. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Full time Science Faculty, i.e., faculty who have earned degrees in the life sciences (biomedical and or behavioral sciences) or in the physical sciences, mathematics or engineering are eligible to become Principal Investigators of the EARDA grant. Likewise, academic science administrators are also eligible as Principal Investigators. Mid-level and senior level faculty are preferable so long as they have the flexibility to participate in the residency training and carry out the expectations outlined in the RFA after completing the residency training. SPECIAL REQUIREMENTS Post-Award Monitoring To insure that the EA, upon returning to the home institution, is making satisfactory progress in achieving the goals and objectives of the EA Program and is receiving appropriate institutional support, two EARDA assessments will be conducted during the five-year grant period. The first assessment will take place at the institution approximately 18 months after the EARDA is awarded. NIH staff and consultants will be included. The second one, a grantee interview, will take place at the NIH during the latter part of the fourth year or early in the fifth year of the grant and will include the EA and one or two designated institutional officials. Applicants should include in their budget, funds necessary to participate in the grantee interview at NIH. Institutional Commitment In nominating the EA candidate, the sponsoring institution is expected to commit adequate resources to formulate and implement an Institutional Plan, which will build upon the EA's residency training experience. For the five- month residency program, this may include a commitment to provide the EA with support, in the form of designated authority, to develop or enhance an Office of Research Development upon his/her return to the institution. A sign of institutional commitment is a statement in the proposed plan describing how the institution plans to continue the developmental research activity once EARDA support expires. A contribution to the EA's residency training costs under the Intergovernmental Personnel Act (IPA) is also considered a demonstration of the institution's commitment to the goals of the program. The EA and the institution must be fully committed to the EA residency training. Specifically, because of the time and effort expended in scheduling and conducting the training, only in extreme cases will the EA be excused from any part of the training to engage in institutional responsibilities incurred prior to or during the residency training. Allowable Costs Funding for the program may be used to support the activities of the EA upon returning to the home institution. Such activities include equipping an office, support of small pilot research studies, conduct of student/teacher seminars and workshops to enhance research interest, and to establish consortia research arrangements. Other purposes for which funds may be used include, but are not limited to, the following: purchase of office supplies and equipment, administrative assistance, travel expenses for the EA to gain additional experience in carrying out the functions of the office, and membership dues in one professional organization whose function is related to the goals of the EA Program. Support for administrative assistance can be requested up to, but must not exceed, 50 percent. Any request for administrative assistance greater than 50 percent will be denied. Salary support for the EA during the five-month residency program will be provided through an IPA agreement mechanism described below, not through or from the EARDA grant itself. Therefore, salary should be requested for only seven months in the first 12-month budget period of the EARDA. The costs for the residency program are entirely separate from the EARDA award. Selected EAs will come to the NIH for the assignment under the IPA. The IPA enables temporary appointments to the Federal government by employees from academic institutions. Cost sharing is required. The IPA provides partial support for the EA while he/she is at NIH. Under the IPA arrangement, up to 67 percent of the cost of the EA's salary, while at the NIH, is reimbursed. Similarly, per diem (food and lodging) costs are reimbursed at 75 percent by NIH and the institution contributes 25 percent. The cost of relocating the EA from the home institution and any other costs incurred that are related to the residency program are reimbursed at 100 percent. Included in related costs are expenses to return to the home institution, for a one- week period, approximately mid-way through the five-month residency to meet with institution officials and faculty to discuss plans for implementing the institutional plan upon the EA's return. Although institutions with an existing Office of Research Development or similar office, or with funding through programs such as the RCMI may apply, adjustments in the final funding level for budgetary overlap will be made prior to the award. Change of Principal Investigator If a request to change the Principal Investigator of the EARDA is received at any time during the five-year grant, the EA Program Director may suspend support pending approval of a substitute Principal Investigator by the EA Program Director. Use of Human Subjects or Vertebrate Animals Should any of the planned pilot studies propose the use of human subjects or vertebrate animals, the grantee institution must obtain a Federal Wide Assurance (FWA) from the Office of Human Research Protection (OHRP) (for human subject) and/or negotiate an animal assurance from the Office of Laboratory Animal Welfare (for animals). In addition, the research protocols must be reviewed and approved by an Institutional Review Board (IRB) (for human subjects) or an Institutional Animal Care and Use Committee (IACUC) (for animals) prior to initiating the studies. Information about negotiating a FWA or establishing an IRB can be found at the OHRP website, http://www.hhs.gov/ohrp. Information about obtaining an animal assurance can be found at http://grants.nih.gov/grants/olaw/olaw.htm. WHERE TO SEND INQUIRIES We encourage inquiries concerning the RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research/programmatic, peer review, and financial or grants management issues. o Direct your questions about scientific/research/programmatic issues to: Matthew A. Kinnard, Ph.D. Director, Extramural Associates Program National Institute of Child Health and Human Development National Institutes of Health 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-2736 Fax: (301) 480-0393 Email: kinnardm@mail.nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 Fax: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Ms. Myrtle Coleman Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4572 Fax: (301) 480-4782 Email: colemama@exchange.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research development activity o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Matthew A. Kinnard, Ph.D. Director, Extramural Associates Program National Institute of Child Health and Human Development National Institutes of Health 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-2736 Fax: (301) 480-0393 Email: kinnardm@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: The instructions accompanying Form PHS 398 (rev. 5/2001) must be followed, with the exceptions noted below: Special Instructions for Research Plan For section I.C.9, Specific Instructions - Research Plan, use Continuation Pages to provide information on the three parts described below. The total length for these three parts combined should not exceed 15 pages. The Research Plan for a SRIP application consists of three parts. These parts are required and it is imperative that applicants fully address each point described in the outline below because they are reflected in the review criteria. Part I: The Nominee This part pertains to the nominee's background and potential as an EA. It should be prepared by the nominee and must include: o Evidence of rapport with faculty and students, ability to motivate and advise others, and commitment to serve the institution. o A description of the nominee's commitment to increasing and strengthening involvement of women and underrepresented minorities in biomedical and behavioral research at the institution. This description also should address his/her interest in and commitment to the objectives of the EA Program, the benefits that will accrue to the institution from his/her participation in the program, and the nominee's availability to participate in the five-month residency program at the NIH. o The names, titles, addresses, telephone and fax numbers, and e-mail addresses of three colleagues who have consented to submit letters of reference to the NIH attesting to the personal qualifications and potential effectiveness of the nominee. The reference letters must be included in the appendix. One of these letters should be from the President of the applicant institution. Reference letters should accompany the two applications sent to the NICHD (see SENDING AN APPLLICATION TO THE NIH, below). The reference letters must be received in the same package with the EARDA application. Otherwise, the application is considered incomplete and will be returned to the applicant without further consideration. In order to comply with this requirement, it is recommended that all reference letters be obtained from the referring individuals as far in advance of the application deadline as possible. o A detailed description of the current status of the sponsored programs office or similar office at the institution and the nominee's plan to take the institution forward with regard to developmental research activities. Part II: The Institution This part pertains to the institution's mission and goals related to the EA Program. It should be prepared by institutional officials and must include the following: o Statement of interest in and plans to improve the health-related research capabilities of the institution. o If applicable, a description of a current Office of Research Development or similar institutional unit. o If applicable, a description of a current Sponsored Programs Office or similar institutional unit. o A letter from the head of the Sponsored Programs Office or similar office signed and dated should be included in the Appendix. The letter should state explicitly that he or she is committed to working cooperatively with the Office of Research Development once established for the benefit of the entire institution. o Statement of the institution's demonstrated past and potential contributions to the advancement of minorities and/or women in biomedical and behavioral research and training. o Description of the current academic environment. This should include a history/accreditation, profile of the student population including a detailed categorization of the enrollment of minorities and women. o Description of the research environment. Include a description of the science faculty and the research capability as indicated by: (1) number of faculty members in biomedical and behavioral science disciplines; (2) number of faculty engaged in biomedical and behavioral science research; (3) number of faculty with external research support; (4) evidence of presentations at local, regional, and national meetings; (5) evidence of faculty research collaborations with investigators at other institutions; (6) faculty involved in peer review activities, as members of standing or ad hoc review committees; (7) current student population in the sciences and follow-up data (e.g., graduate and post-graduate career profiles); (8) current and planned facilities for scientific research and training; and (9) current and planned Federal and non-Federal research support. o Description of ongoing or planned cooperation and/or collaboration with other institutions or Federal or non-Federal organizations. o A copy of the institution's course catalogue should be attached to the application in the Appendix. Part III: Institutional Plan The EA selected to participate in the SRIP will submit a preliminary plan that describes the establishment or enhancement of the institution's Office of Research Development. This plan should describe an approach for enhancing the research capabilities of the institution using the skills to be gained by the nominee. The plan also should include details about steps to be taken for identifying, funding, and monitoring progress of scientifically meritorious pilot research studies, as well as the development of seminars and workshops, and plans to involve students in research activities. This section should be developed by both faculty and administrators and should include: o A statement of nominee's role, authority, and institution-wide accessibility upon return to the institution as well as a description of resources that will be made available to the nominee, including a detailed budget. o At least one advisory committee must be described and established. The purpose, function, and expectation of the committee should be described, but specific members should not be appointed until after an award is made. It is expected that at least one person external to the applicant institution will be on the Advisory Committee. This committee could serve as advisory to the EA in the establishment and maintenance of ongoing research development activities. This committee will also be responsible for the review, recommendation for funding, and monitoring of faculty pilot research studies. All other planned committees should be included in this section with a justification for the particular committee structure and function proposed and a description of the proposed membership. o A description of plans to initiate or expand local or regional cooperation/collaboration in research activities. Particular emphasis is placed on partnering with foundations and with private companies and businesses. o A preliminary plan, including the source of budgetary resources, for continuation of the program once NIH support expires. Special Instructions for Appendix The Appendix to the application should include the following items: o Reference letters from colleagues identified. o A copy of the institution's course catalogue should be attached to the application. o Letter from Director of Sponsored Programs Office. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of appendix materials including reference letters must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, Maryland 20892-7510 Rockville, Maryland 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness to this RFA by NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA CRITERIA TO BE USED IN EVALUATION OF THE NOMINEE: o Strength of personal qualifications as indicated by past training and experience. o Evidence of ability to enhance the institution's effectiveness in involving women and underrepresented minorities in health-related research. o Demonstrated interest and resourcefulness, and evidence that the nominee has the requisite experience and access to the science faculty and to the administration to accomplish the goals of the program. o Ability to commit himself or herself to function as the EA, preferably for the duration of the EARDA grant but at a minimum, for three full years. CRITERIA TO BE USED IN EVALUATION OF THE INSTITUTION: In the context of the institution's history and stage of development: o Quality of science education and potential for research and/or research training in biomedical and behavioral sciences. o Evidence of commitment to preparing women and/or underrepresented minorities for careers in science. o Evidence of potential for developing research and research training infrastructure. o Strength and quality of faculty and students in health-related science departments. o Potential for conducting collaborative sponsored research and research training projects. CRITERIA TO BE USED IN EVALUATION OF THE INSTITUTIONAL PLAN: o Evidence of a strong institutional commitment to implementing the plan. o Evidence, as reflected in institutional statements and the budget, that the nominee will be provided sufficient resources to carry out the plan. o Evidence that the nominee will have sufficient authority to carry out the plan. o Coherence of the plan and evidence that there is adequate coordination among key faculty and administrators (i.e., composition and functioning of committees) in its development. o Adequacy of the proposed committee membership to review, fund, and monitor pilot research studies. o The presence, strength, and viability of the proposed evaluation strategy. o The justification for establishing or expanding an Office of Research Development. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed institutional plan. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 24, 2003 Application Receipt Date: April 24, 2003 Peer Review Date: July 2003 Council Review: September 2003 Earliest Anticipated Start Date: February 1, 2003 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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 is available at http:// grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trails 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 PARTICIPATNTS 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 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 EMBRONIC STEM CELL (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 RFA 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 GRANTS 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.864 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization or Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 103-277, 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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