and Human Services (HHS)
EXPIRED
RESEARCH SCIENTIST AWARD FOR MINORITY INSTITUTIONS RELEASE DATE: January 24, 2002 (see NOT-HL-04-118 and NOT-HL-03-015) RFA: RFA-HL-02-012 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) LETTER OF INTENT RECEIPT DATE: June 17, 2002 APPLICATION RECEIPT DATE: July 15, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research 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 National Heart, Lung, and Blood Institute (NHLBI) invites cooperative agreement grant applications from minority institutions that offer the M.S., Ph.D., or professional degree in the biomedical and/or behavioral sciences. The goals of the program are to augment and strengthen the research capabilities and resources of minority institutions for the conduct of biomedical and/or behavioral research by recruiting an established research scientist with expertise in areas related to cardiovascular, lung, or blood health and disease, transfusion medicine, or sleep disorders. For the purpose of this award, the recruited research scientist must have received competitive and independent NIH, or its equivalent, research support. The long-term objectives of this program are to ensure that traditionally minority institutions that have not had a strong research infrastructure will have an opportunity to strengthen their research capabilities, increase the number of minority individuals involved in biomedical and behavioral research, and reduce health disparities. RESEARCH OBJECTIVES Background The NHLBI is dedicated to eliminating the health disparities experienced by minority Americans. It is vitally important to this effort that the biomedical and behavioral research workforce have an adequate number of well- trained minority investigators. This goal is especially important to the elimination of health disparities because it has been demonstrated that participation of minority investigators in the biomedical and behavioral research enterprise: o Improves recruitment and retention rates in population-based research studies. o Encourages more minority students to pursue careers in the biomedical and behavioral sciences. o Improves access to health care in minority communities. o Adds to the body of knowledge about diseases that have a disproportionate impact on minorities. The contributions that minority institutions can make to fulfilling the promise of the NIH research agenda to reduce health disparities and increase the diversity of investigators are unique and essential. However, it is necessary to ensure that minority institutions can develop the infrastructure and obtain the resources required to conduct state-of-the-art biomedical and behavioral research and train the future cadre of scientists. In so doing, the pool of minority biomedical and behavioral investigators conducting research on cardiovascular, pulmonary, and hematologic health and disease, transfusion medicine, and sleep disorders can be increased and research on diseases with a disproportionate prevalence in minority populations can be benefited. Focused research programs, such as the Historically Black Colleges and Universities (HBCU) Research Scientist Award, have helped to achieve these objectives and foster the collaborative research affiliations needed to address heart, lung, blood, and sleep disorder research problems relevant to the communities and regions served by the minority institutions. Objectives and Scope The objectives of this new program are to assist such minority institutions to strengthen the science faculty at such institutions, to augment undergraduate and graduate science education, to improve the research infrastructure at minority institutions, and to augment and strengthen the research capabilities and resources for the conduct of biomedical and/or behavioral research in areas related to cardiovascular, lung, or blood health and disease, transfusion medicine, or sleep disorders. It is the intention of this award that an established scientist will be recruited to the minority institution. If the individual identified as the potential recruited research scientist is already at the minority institution and is likely to be considered for this award, the institution should contact the NHLBI staff listed in the Inquiries section of this RFA prior to preparation of the grant application. Program Characteristics Broad guidelines for this program are described below. This award is intended to encompass two phases. Phase I (24 months) would be a recruitment phase with the minority medical school having responsibility, with assistance from the NHLBI and an External Advisory Committee, to identify and recruit a research scientist who has competitive, independent research support to serve as Program Director and to develop and implement plans to begin research operations in Phase II (up to 5 years). The Principal Investigator during Phase I must be a senior institutional official of the Minority Medical School, e.g., the President or Dean and must devote a minimum of 5 percent effort to the program. While institutions may be at different stages in their readiness to recruit a research scientist and to make available resources to support a new research enterprise, Phase I must be completed within the 2 year (24 month) time period allotted. Only in rare circumstances, where a recruitment is in the final stages, but more time is required for the recruited scientist to relocate, will additional time be provided for Phase I activities. However, this additional time will not involve the commitment of additional funds beyond that awarded for Phase I. For the purpose of this award, the recruited research scientist must be an established investigator who has received competitive and independent research support in areas of interest to the NHLBI. Once Phase II is initiated, the recruited research scientist will assume the role of Principal Investigator and should devote a minimum of 50 percent effort. The transition to Phase II will occur when the following criteria has been met: a recruited scientist has been identified and has agreed to join the minority institution, the individual has been reviewed by the External Advisory Committee, and the NHLBI staff has approved the appointment of the recruited research scientist as Principal Investigator of Phase II of the program. Phase II (5 years) program operations will be the responsibility of the newly recruited research scientist. That individual is expected to establish a research program at the minority institution that achieves the following: supports research related to cardiovascular, lung, or blood health and disease, transfusion medicine, or sleep disorders, provides intensive laboratory training experiences to selected undergraduate and/or graduate students with the capability and interest to pursue research careers, forges collaborative research and educational arrangements with the academic community (minority and nonminority institutions) and the private sector, attracts other biomedical and/or behavioral science faculty to the institution, strengthens the science curriculum at the minority institution, and arranges for science seminars and collaborative exchange activities related to cardiovascular, lung, or blood health and disease, transfusion medicine, or sleep disorders research. Although the primary interest of the NHLBI is in the areas identified, any research that is relevant to them will be accepted for consideration. If an acceptable candidate is not recruited, Phase II will not be awarded and the grant will be phased out. Pilot projects may be utilized during Phase II as a flexible means to develop investigators and/or explore new research activities or directions and unique scientific opportunities that could evolve into independently funded research projects. Pilot projects may provide faculty or junior investigators from the minority institution, who have not previously received independent research support, an opportunity to develop their research skills and/or to obtain preliminary research data needed for the submission of an independent research grant application. Pilot projects may also be utilized by new or recruited faculty to develop new research directions. In all cases, pilot projects will covered under the costs of the award and be of short duration (up to a maximum of 30 months) and limited cost (a maximum of $100,000 per year direct costs). In order to assess the success of the pilot projects and to provide for the implementation of new pilot projects, the program should include a provision for: o The External Advisory Committee to review the scientific merit of pilot projects. o Tracking the results of each pilot project (abstracts, publications, grant applications, etc.), ensuring that the results are made available to reviewers at program review meetings and including the results in non-competitive renewal applications. External Advisory Committee The External Advisory Committee will be composed of external scientists and will serve primarily as a review function. Expenses for the External Advisory Committee will be the responsibility of the awardee and should be budgeted for in the application. In Phase I, the External Advisory Committee is to assist in the recruitment process and review the qualifications and credentials of candidates for the position of recruited scientist. During Phase II, the External Advisory Committee, possibly with additional ad hoc expertise, would provide scientific and administrative review of the research program and any pilot projects proposed during Phase II of the program. It would also conduct a yearly program review once Phase II is initiated and advise the NHLBI and the minority medical institution as to program progress and direction and make recommendations concerning modifications, adjustments, or additions. This may include making recommendations, as appropriate, to the awardee institution and NHLBI with respect to: o the performance of the individual programs (including possible recommendations on actions to be taken), o the review of new pilot projects, o the recruitment of new scientific and technical staff to the program, including an assessment of qualifications to conduct high quality research, potential for collaborations, and reasonableness of the research to be conducted by recruited staff, o possible modifications in the scope and focus of the research program, o and, additional research endeavors within the approved research and negotiated budgets. Thus, the External Advisory Committee must provide a multidisciplinary and objective perspective, expert attention to the many factors during the course of the research program, and considerable judgement. Meetings of the External Advisory Committee will occur at least once a year, although meetings of the External Advisory Committee may occur more frequently, depending on program requirements and need. In some cases, it may be possible to conduct business of the External Advisory Committee through conference calls. The External Advisory Committee, to be established once an award is made, should consist of approximately six members. Most members of the External Advisory Committee are expected to be scientists, although a member of the External Advisory Committee may be an individual with experience in administering sponsored programs in an academic setting. The members of the External Advisory Committee must not be affiliated with the awardee institution or its collaborators and should have expertise in the area of science addressed by the program. Half of the members of the External Advisory Committee will be appointed by NHLBI staff, while the remaining members may be appointed by the awardee institution with approval of NHLBI. Additional members with specific scientific expertise may be added during Phase II to ensure an adequate review of the scientific program relative to the research projects proposed. The chair of the Committee will be elected by and from the members of the External Advisory Committee. A NHLBI staff member will participate in the External Advisory Committee meetings as an ex-officio member (see below). The External Advisory Committee will also be comprised of non-voting (ex- officio) members, including the NHLBI Program Scientist, who serves as the Executive Secretary. The Executive Secretary will be responsible for preparing the minutes for each meeting. Within 30 days after an External Advisory Committee meeting, the Executive Secretary will forward a copy of the final (signed/approved by both the Executive Secretary and the Chairperson) minutes to the other members of the External Advisory Committee. Other ex- officio members may include a representative of the investigators and other NHLBI representatives. The Executive Secretary, other ex-officio members, and ad hoc consultants and investigators may not vote. Allowable Costs The Research Scientist Award for Minority Institutions will provide support for: o Administrative Costs for managing the recruitment and planning effort such as: a. Salaries for key personnel b. Travel for key personnel c. Travel and per diem for outside advisors d. Supplies and materials to support an administrative structure o Developmental Funds for: a. Workshops, retreats, seminars and other forums to identify areas of greatest opportunity and highest priority and/or to merge existing programs and/or to create new minority institution programs. b. Pilot research projects or pilot programs (see above under Program Characteristics). c. Support for research assistants and research associates in various stages of their career development as independent scientists. d. Start-up packages for newly recruited investigators in areas of development. o Research Support Funds for: a. Research projects relevant to heart, lung, blood, and sleep disorders. b. Core facilities to be shared among investigators at the minority medical school. c. Administrative and infrastructure support for the program. Funds may NOT be used to purchase equipment unless included as part of a start-up package for a faculty recruitment. (In this case, the maximum allowable costs for such equipment items cannot exceed $25,000 for research purposes without prior approval by the NHLBI.) MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Research Scientist (UH1) award mechanism. The UH1 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Applications submitted in response to the RFA will consist of two phases. Phase I is a 24 month effort to identify and recruit a research scientist and to plan for the subsequent phase. Phase II consists of an additional 5 years of support for research activities and the operation of other program activities. Awardees are expected to continue support of the research programs after the initial seven years through regular competitive NIH research programs or from other sources. At this time, it is not known if this RFA will be reissued. In the event that an award is made, the project period may not exceed seven years and the anticipated start date of the award will be September 30, 2002 (changed to April 1, 2003 per NOT-HL-02-011). FUNDS AVAILABLE The NHLBI intends to commit approximately $300,000 in FY 2002 to fund up to four new grants in response to this RFA. An applicant may request a project period of up to seven years and a budget for direct costs of up to $50,000 per year for Phase I (first two years) and for direct costs of up to $500,000 per year for Phase II (up to five additional years). Although the financial plans of the NHLBI 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. Applicants for this program may request the full facilities and administrative (F & A) costs applicable to their institution. ELIGIBLE INSTITUTIONS You may submit an application if your institution is a minority institution that offers the M.S., Ph.D., or professional degree in the biomedical and/or behavioral sciences. Minority institutions are defined as domestic, public or private, non-profit, academic institutions at which more than 50 percent of the students enrolled are from minority, racial or ethnic groups, including those underrepresented in biomedical research (e.g., African Americans, Hispanics, American Indians, Alaskan Natives, Native Hawaiians, and Pacific Islanders). Applications will not be accepted from institutions that do not meet this criteria. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The individual submitting the application should be a senior institutional official, e.g., the President or Dean, as the Principal Investigator. In Phase II of the program, the recruited scientist is expected to become the Principal Investigator of the grant program. Only investigators who are U.S. citizens, permanent residents, or non-citizen nationals and have received competitive and independent research support may be recruited to serve as the Principal Investigator for Phase II. SPECIAL REQUIREMENTS Cooperative Agreement Terms and Conditions of Award These special Terms of Award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism). Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activities by involvement in and otherwise working jointly with the award recipient in a partner role. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee, although specific tasks and activities in carrying out the project will be shared between the awardee and the NHLBI Project Scientist. 1. Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of supported studies, as applicable to the scientific research and other program activities. Awardees retain custody of and have primary rights to data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Awardees have lead responsibilities for the project as a whole, and for all tasks and activities, with support from NIH for recruitment, identification of resources to support collaborative arrangement activities, and limited technical input into the research. The awardee with the assistance of the NHLBI will establish an External Advisory Committee composed of external scientists to assist in planning and identifying the recruited research scientist in Phase I, and in monitoring progress during Phase II. 2. NHLBI Staff Responsibilities The NHLBI Program Scientist will have substantial scientific/programmatic involvement in the award performance period through contributions to the planning and assessment activities, providing technical assistance, advice on future directions and ancillary support, and coordination beyond normal program stewardship for grants. The NHLBI Program Scientist will also provide assistance to recipients of the award in developing collaborative research and funding arrangements, the institutional environment, resources and other infrastructure and administrative areas. The NHLBI Program Scientist together with the External Advisory Committee will help the applicant institution and Principal Investigator establish reasonable time lines to achieve the developmental goals of the Research Scientist Award for Minority Institutions. The NHLBI Program Scientist will actively participate as Executive Secretary and non-voting member in all meetings of the External Advisory Committee during the performance period of the award. The NHLBI Program Director will have primary responsibility for stewardship of the award and overall responsibility for monitoring the conduct, progress, and fiscal management of the research program, and will reserve the authority to recommend reductions in budget, withhold support, suspend and/or terminate the award if technical performance falls below acceptable standards for quality and timeliness. The NHLBI Program Director may also be the designated NHLBI Program Scientist. The NHLBI reserves the right to terminate the award in the event of failure to recruit a research scientist within the two year Phase I period, failure of the grantee institution to provide the research resources or administrative and technical support required to sustain the program, departure of the Principal Investigator from the minority institution and if no suitable replacement is appointed within a reasonable time (90 days), substantive changes in scope of work with which the NHLBI does not concur, or unacceptable progress. 3. Arbitration Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NHLBI may be brought to arbitration. An arbitration panel will be composed of three members--one selected by the Principal Investigator, a second member selected by the NHLBI, and a third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: John Fakunding, Ph.D. Heart Research Program Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive., MSC 7940 Bethesda, MD 20892-7940 Telephone: 301-435-0544 FAX: 301-480-1336 E-mail: jf46f@nih.gov Direct your questions about peer review issues, send letter of intent and two copies of the application to: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Dr., Room 7178 (MSC 7924) Bethesda, MD 20892-7924 (20817 for Courier) Telephone: (301) 435-0270 Fax: (301) 480-0730 E-mail: clarka@nhlbi.nih.gov Direct your questions about financial or grants management matters to: Robert Vinson Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0175 FAX: (301) 480-3310 E-mail: vinsonr@nhlbi.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 program o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of the 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 NHLBI 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: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Dr., Room 7178 (MSC 7924) Bethesda, MD 20892-7924 (20817 for Courier) Telephone: (301) 435-0270 Fax: (301) 480-0730 E-mail: clarka@nhlbi.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 GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS The conventional format for research grant applications should be used to ensure that points identified in the section on Review Considerations are fulfilled. Page limitations described in the form PHS 398 are applicable to this RFA. THE FOLLOWING DETAILED MODIFICATIONS MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA: Budget Information Current and future year budgets or justifications (Form Pages 4 and 5) are required in the application. However, a detailed budget with justification must only be submitted for Phase I (the first 24 months). The budget for Phase II (Years 3-7) may be estimated with only general information as how the amount for the various budget categories were determined. The anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and all key personnel must be specifically stated at the beginning of the research plan. Research Plan Requirements The research plan must include the following: Institutional Environment and Resources. Features of the institutional environment that are relevant to effective implementation of the overall program must be described. As appropriate, available resources, e.g., clinical and laboratory facilities, patient populations, geographic distributions of space and personnel, and consultative resources, should be described. Infrastructure. Any institution submitting a grant application in response to this announcement must show evidence of an existing research infrastructure that can support some aspect of the research program. Research capabilities, i.e., previous (past 5 years) and current research support relevant to cardiovascular, lung, or blood health and disease, transfusion medicine, or sleep disorders, of the institution should be described in the application. The condition of the present research infrastructure and any changes needed to enhance support of the institution"s research program must also be delineated. Briefly describe how proposed activities will enhance the minority institution science faculty, improve the research infrastructure, and strengthen the science curriculum. Organizational and Administrative Structure. The chain of responsibility for decision making and administration, beginning at the level of the institution"s President and including all key staff should be described, in detail and by diagram, if appropriate. Individuals responsible for the day-to-day administrative details, program coordination, and planning and evaluation of the program should also be identified. Describe the relation between the proposed program and other existing research, academic, and administrative units of the institution and the means by which the program will strengthen those activities and improve the research infrastructure. In addition, changes that will occur in the structure during Phase II should be identified and described. Research Program. The existing research program that is the basis for the grant application should be described along with future plans and how this award will enhance them. In addition, plans for the recruited research scientist should be delineated. Institution Commitment. The application must outline plans to create and sustain a supportive research environment after NHLBI funding has ended, describe opportunities for the individual recruited as the Phase II Principal Investigator to continue to grow and develop in research knowledge and skills, provide the position of the recruited research scientist in the organizational structure, including responsibilities, if applicable, beyond those associated with the grant, identify staff and other resources and support that will be made available to the recruited research scientist, outline research and publication responsibilities, and describe the institution"s commitment to ensure that administrators, faculty, staff, and students understand that the recruited research scientist"s primary responsibility to the institution is to increase its biomedical and/or behavioral research portfolio. The institution"s plan to obtain additional research support, e.g., private sector and/or NIH, should be described. Recruitment Plan. The skills of the individual to be recruited, the relative importance of those skills to the research program and the institution=s infrastructure needs, and the Institution"s plan for identifying, recruiting, and retaining such an individual must be described. The individuals to be involved in the recruitment activities, their specific responsibilities and a timetable outlining recruitment activities during Phase I should be included. Collaborative Arrangements. Plans for collaborative research arrangements should be submitted as part of the application. Letters of support by participating institutions and a commitment to finalize collaborative arrangements soon after the award is made should be included. Plans for obtaining additional research support from the private sector, NIH, and/or other sources should also be described. Face Page Currently, the Center for Scientific Review requires that requested costs be reflected on the face page for computer system tracking purposes. Since limited budgetary information is required, we are requesting that standard amounts be shown on the face page. IT IS UNDERSTOOD THAT THESE LEVELS ARE STRICTLY FOR ADMINISTRATIVE PURPOSES AND THAT ACTUAL AWARD LEVELS ARE SUBJECT TO NEGOTIATION, PRIOR TO AWARD. The following amounts should be reflected on the face page: 7a. Direct Costs for Initial Budget Period - $50,000, 7b. Total Costs for Initial Budget Period, 8a. Direct Costs for Proposed Period of Support - $2,600,000, 8b. Total Costs for Proposed Period of Support. The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The salary of the Principal Investigator must not exceed the actual institutional salary rates for the effort being devoted to the award. In addition, salary rates must not exceed an annual salary level of $161,200 plus fringe benefits (a maximum of $80,600 for 50 percent effort). In Phase I, the Principal Investigator must devote at least 5 percent effort to the award. In Phase II, the Principal Investigator must devote at least 50 percent effort to the award. A Principal Investigator may devote up to a total of 100 percent combined effort on this award and as an investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such sources accordingly. 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 as well as all five collated sets of Appendix material must be sent to Dr. Anne Clark at the address listed under Where to send Inquiries. 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. Principal investigators should not sent supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not received such a letter within three weeks after submitting the application, contact Dr. Anne Clark at the address listed under Where to send Inquiries. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. 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 NHLBI 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 NHLBI National Advisory Council. REVIEW CRITERIA All applications will be judged on the basis of the review criteria listed below: 1. Availability of resources to support the proposed research and other program activities. 2. Prior institutional research experience relevant to cardiovascular, lung, or blood health and disease, transfusion medicine, or sleep disorders. 3. Plans for identifying the recruited research scientist. 4. Plans to create and sustain a supportive research environment and to obtain additional funding. 5. Commitment of the minority institution to the success of the program and the recruited research scientist, including plans for recruitment of other faculty, and for training students, undergraduate and graduate) and postdoctoral individuals in biomedical and/or behavioral research. 6. Strength of and desired outcome of collaborative arrangements. 7. Qualifications and experience of the proposed staff. The scientific review group will address and consider each of these criteria in assigning your application=s overall score, weighting them as appropriate for each application. 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 research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 17, 2002 Application Receipt Date: July 15, 2002 Peer Review Date: October/November, 2002 Council Review: February 6-7, 2003 Earliest Anticipated Start Date: April 1, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: t is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA, Research Scientist Award Program for Minority Institutions, 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. 93.837, 93.838, and 93.839. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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