and Human Services (HHS)
EXPIRED
CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE) RELEASE DATE: August 19, 2003 RFA Number: RFA-RR-03-014 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.389 LETTER OF INTENT RECEIPT DATE: October 17, 2003 APPLICATION RECEIPT DATE: November 18, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) 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 Supplementary Instructions 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 purpose of the Institutional Development Award (IDeA) Program is to foster health-related research and increase the competitiveness of investigators at institutions located in states with historically low aggregate success rates for grant awards from the National Institutes of Health (NIH). The National Center for Research Resources (NCRR) of the National Institutes of Health invites applications for Centers of Biomedical Research Excellence (COBRE) from investigators at independent biomedical research institutes or biomedical research institutions that award doctoral degrees in the health sciences or sciences related to health within IDeA- eligible states. Collaboration with other non-doctoral degree-granting and research-performing institutes or institutions is encouraged. However, funds for research activities cannot be used at collaborative institutions in non- IDeA states. The purpose of this Request for Applications (RFA) is to augment and strengthen institutional biomedical research capacity through flexible support to expand and develop biomedical faculty research capability and to enhance research infrastructure through support of a thematic multi- disciplinary center, led by a peer-reviewed, funded investigator with expertise central to the research theme of the proposal. The application must have a thematic scientific focus in a specific research area, such as neuroscience, cancer, structural biology, immunology, or bioengineering, and may use basic, clinical or both research approaches to attain the goals of the proposed center. The scientific leadership provided by one or more established biomedical research faculty is critical to the success of this initiative, especially for the mentoring of promising junior investigators. The center is intended to support investigators from several complementary disciplines. It will enable the institution to develop a critical mass of investigators and enhance their competitiveness in a specific research area that accelerates the rate at which those investigators compete for other complementary NIH, Federal or non-Federal external peer-reviewed research grant support. It is also anticipated that, in some instances, the support through this initiative will facilitate the development of new disease- specific research centers or augment the capability of existing centers. RESEARCH OBJECTIVES This program seeks to promote the initiation and development or expansion of unique, innovative state-of-the-art biomedical and behavioral research at institutions in IDeA-eligible states. The research focus of this program encompasses the full spectrum of the basic and clinical sciences and also includes cellular and molecular biology, biophysics and biotechnology, genetics and developmental biology, pharmacology and other biomedical research areas. The NIH recognizes that the contributions from the institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this RFA is to assist these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art biomedical research. The objectives of this program are (1) to strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and (2) to enhance the ability of investigators to compete independently for complementary NIH individual research grant or other external peer-reviewed support. Although the individual career development of the junior investigators is an important and significant part of this program, the primary objective of the COBRE initiative is to build and develop thematic multi-disciplinary research centers. These centers are expected to engage in future growth through the promotion of collaborative interactive efforts among researchers with complementary backgrounds, skills and expertise and to compete independently for external peer-reviewed center or program project grant support. This goal is accomplished through the direction provided by a Principal Investigator (PI), who provides leadership to junior investigators (defined below) and has the primary responsibility for administering the program and for overseeing the development of the center and its associated core facilities. The PI of the COBRE application must be an established biomedical or behavioral research scientist who will ensure that high-quality research be performed and who has the experience to effectively administer and integrate all components of the program. The PI must have an active biomedical or behavioral research program that receives NIH, NSF or other peer-reviewed support in the scientific area of the center and have the requisite administrative experience to direct the program. A minimum time commitment of 25-percent is required for this individual; however, up to 50-percent effort will be supported for mentoring and administrative oversight of the COBRE. If the PI is not in place at the institution at the time of review or award, a plan to recruit such an individual must be included in the application. An award pursuant to this RFA will not be made until and unless the institution has appointed a permanent COBRE PI. OVERALL RESEARCH PLAN: Each application must describe an overall research plan to justify support of a thematic multi-disciplinary COBRE program for five years. Ideally, it is recommended that the research plan contain the descriptions of at least three and up to five individual research projects. In addition, the establishment of core facilities necessary to carry out the objectives of a multi-disciplinary, collaborative program may be proposed. With respect to the overall COBRE program, the PI should describe the unique research opportunities that will be provided to the junior investigators and to the institution. If the proposed COBRE research is closely related to ongoing research or an existing center, an explanation how the research activities of the COBRE will complement but not overlap with existing research should be described. In addition, the PI should describe how the efforts of each junior investigator will assist in the establishment of a multi-disciplinary research center. The qualifications of the COBRE PI selected for this effort must be clearly described. The PI must demonstrate that he/she is an established biomedical or behavioral research scientist, that the he/she has an active research laboratory, that he/she has relevant peer-reviewed funding (either NIH, NSF or other Federal or non-Federal investigator-initiated support), and that he/she has demonstrated administrative leadership and mentoring experience. If that individual is not a member of the faculty at the time of review of the application, include a detailed plan that will result in having that individual on the full-time faculty within one year from the date of peer- review of the institution's application. Although no non-Federal matching funds are required for these applications, clear evidence of institutional commitment must be included with the application. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among institutions. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) should outline the commitment of resources and facilities to sustain and support the COBRE throughout the period of funding and to maintain these resources beyond the period of grant support. The institutional environment and resources that are available to investigators must be briefly described. Available resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources should be described. If core facilities are included for support, the relationship of each component research project to the core(s) should be described. INDIVIDUAL RESEARCH PROJECTS: Each COBRE program should ideally include three to five individual research projects that stand alone, but share a common thematic scientific focus. Each research project should be supervised by a single junior investigator who is responsible for insuring that the Specific Aims of that project are met. An initial minimum commitment of 50-percent effort is required for this individual. It is recognized that during the development of a junior investigator's career (for example, the acquisition of other research support) it may be necessary to reduce this effort. Investigators should consult with NCRR Program staff regarding appropriate reductions. Each individual research project should describe the Specific Aims in the selected area of research and the goals for the first year and for the long term. The design principles supporting the research or the hypotheses to be tested should be delineated. Preliminary studies are not required for COBRE applications, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should describe the rationale and scientific basis for the proposed research. Furthermore, each research project should describe the area of multi- disciplinary research that is the focus of the COBRE and critically assess the existing knowledge and approaches that have been or are being directed in the area with an emphasis on specifically how the multi-disciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research to the Specific Aims should be concisely stated. CRITERIA FOR ELIGIBILITY OF JUNIOR INVESTIGATORS: For the purpose of eligibility a junior investigator is defined either as (1) an individual who does not have or has not previously had an external, peer-reviewed Research Project Grant (RPG) or Program Project Grant (PPG) from either a Federal or non-Federal source that names that investigator as the PI or (2) an established investigator who is making a significant change to his/her career. With respect to item (1), grants that name an individual as a co- investigator, collaborator, consultant, or to a position other than Principal Investigator do not disqualify that investigator. Starter grants (such as NIH's FIRST award mechanism, R29), Academic Research Enhancement Award grants (AREA, R15), exploratory/pilot project grants (such as NIH R03 and R21 awards), career development awards (such as NIH K01 and K08 awards), or other Federal or non-Federal funding whose purpose is to provide preliminary support in anticipation of a RPG or PPG also do not disqualify the investigator. The intent of this initiative is not to disallow promising investigators whose early career support consists of awards geared toward initiating their intended area of research. However, investigators who have managed to obtain significant support in the form of a RPG or PPG (e.g., NIH R01 or P01, NSF, or other Federal or non-Federal agency awards) are not eligible. Investigators who propose to develop a new or alternate line of research, but whose intention is to maintain support through an active RPG or PPG in a different area of research are also not eligible. Investigators should indicate in the Biographical Sketch their current or previous history of peer-reviewed research support. A junior investigator must hold a faculty appointment at the time that the award is made. Moreover, a clear commitment to support this faculty appointment independent of the outcome of this application must be demonstrated from the institution by a letter(s) from the appropriate senior institutional official(s). Postdoctoral fellows or other positions that do not carry independent faculty status will disqualify that individual and his/her research project from further consideration. With respect to item (2), support may be provided to an established investigator who is making a significant change to his/her career goals by initiating a new line of research that is distinctly and significantly different than his/her current investigative program. The current or previous history of independent peer-reviewed research support, which may be indicated in the Biographical Sketch, in a different investigative area than that proposed in this application does not disqualify the investigator. Furthermore, this individual can be of any faculty rank. Please note that the intent of this initiative is to allow established investigators the opportunity to initiate and develop a new line or research. However, investigators whose current research is already supported by a RPG or PPG and who do not intend to change their current research program are not eligible. This initiative is not intended to replace support for ongoing investigator- initiated research programs of established investigators. Instead, established investigators should serve as mentors to advance the junior investigators' careers. DEVELOPMENT AND MENTORING PLAN FOR JUNIOR INVESTIGATORS: A clear plan for the development of junior investigators and for their transition to and attainment of independent status must be included. This plan should detail the long-term goals as to how the institution intends to make the transition from the research support of multi-disciplinary COBRE projects to competitive grant support through applications submitted by its faculty members to relevant NIH Institutes and Centers or to other appropriate Federal or non- Federal agencies or organizations. Each junior investigator must submit an investigator-initiated RPG application by the end of three years of support to maintain continued funding through the COBRE award. The development plan must include both formative and summative evaluation strategies with specific milestones. Faculty development should include a mentoring plan that involves oversight by established senior faculty members assigned as mentors, constructive evaluations by members of the External Advisory Committee (EAC) (see below under Special Requirements), and coordinated management of all of these individuals by the PI of the COBRE program. Additional oversight may be augmented through the use of an internal advisory committee, but this committee should not act as a substitute for the EAC. Each junior investigator should have at least one mentor. The mentor must be an established investigator who has demonstrated the ability to advise others through the acquisition of external support and the maintenance of an independent research laboratory. In some instances a suitable mentor may not be available within the applicant's institution and it is therefore acceptable to enlist appropriate mentors from outside institutions. Mentors may be provided 10 to 15-percent effort and should be listed in the Administrative Core's budget section of the application and not in the individual projects' budget sections. The junior investigators should clearly designate in the text the identity of their mentors and describe their qualifications, both scientific and advisory, that make them appropriate to assist in the oversight of the project. The award of a Research Project Grant (RPG) to a junior investigator should be viewed as a milestone and a criterion for changing the status of an investigator either from mentored to transitional support within the COBRE program (described below) or from mentored support to independent status where continued COBRE support would no longer be necessary. A junior investigator may also be considered for a status change if independence is indicated by the acquisition of sufficient skills and knowledge. However, it must be stressed that the intent of the COBRE program is to foster the development of a center and to encourage the continued participation of junior investigators in center activities. For example, investigators who have acquired independence can mentor newly appointed junior investigators or can direct one of the COBRE's core facilities. In any case, newly independent investigators should continue to contribute to COBRE activities and be allowed to use the center's facilities. It must be emphasized that COBRE support cannot be provided in instances where a junior investigator's new award overlaps or is significantly similar to that described in the COBRE program. In such cases a status change for the junior investigator must be invoked (see CHANGE IN STATUS OF JUNIOR INVESTIGATORS FROM MENTORED TO TRANSITIONAL SUPPORT). However, if the specific aims of the junior investigator's RPG are significantly different from the project described in the COBRE, then the junior investigator has an obligation to remain in the program to complete his/her COBRE project. In this latter case, continued support for personnel (e.g., postdoctoral associates, graduate students, technicians, etc.) associated with the COBRE project but also listed on the other award can be provided. However, the percent efforts of these individuals must be appropriately adjusted. Following the status change of a junior investigator, another junior investigator may be added following review of the replacement project by the PI and the EAC. The PI must communicate the EAC's recommendation to NCRR Program staff for review and approval of the appointment of the replacement investigator (and possibly new mentors) to the program. In some instances a junior investigator may be removed from the COBRE program if a review by the EAC indicates a failure by the junior investigator to make significant progress toward achieving the specific aims of his/her project or, as noted above, to submit an investigator-initiated RPG application by the end of three years of COBRE support. In these instances another junior investigator may replace the removed investigator after review of the replacement project by the PI and the EAC. The PI must communicate the EAC's recommendation to NCRR Program staff for review and approval of the appointment of the replacement investigator (and possibly new mentors) to the program. CHANGE IN STATUS OF JUNIOR INVESTIGATORS FROM MENTORED TO TRANSITIONAL SUPPORT: The PI and EAC can determine that a junior investigator has achieved independent status either by receipt of an RPG or PPG and/or through an indication that independence has been achieved through the acquisition of sufficient skills and knowledge. The PI and EAC have the discretion of either withdrawing additional COBRE support or supplying the junior investigator with transitional support. When considering a change in status, every effort should be made to continue to include investigators who have achieved independence in the activities of the center. The PI must notify NCRR Program staff of any change in junior investigator status and may be asked to provide a revised budget and other support information for those junior investigators, as appropriate. The purpose of transitional support is to provide protected time for the investigator to further develop his/her research program. During the transitional support period, salary for the investigator can be requested for levels of effort between 25 and 50-percent. The actual salary provided by the NIH is based on the investigator's full-time, 12-month institutional salary. The salary requested must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The award will also provide fringe benefits on the calculated base salary at the established institutional rate. The institution may supplement the NIH contribution to the salary up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the transitional support phase of the investigator's career. In addition, recipients of transitional support may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100-percent. No additional funds above those described in the FUNDS AVAILABLE section of this RFA will be provided for transitional support of junior investigators. No support will be provided to the mentor during the transitional support period. The progress of the transitioned investigator should be monitored by the PI and the EAC yearly to determine whether transitional support should be continued. BIOGRAPHICAL SKETCHES: The Principal Investigator, co-investigator(s), junior investigators, and mentors must provide biographical sketches as indicated in the PHS 398 document instructions. This section must not exceed four pages per person. RESOURCES: The application must describe the equipment and facilities available to the proposed COBRE. CORE FACILITIES: Funds may be requested to establish core facilities. The applicant must demonstrate that each proposed core will serve the scientific needs of the individual research projects and must show how each core will impact the development of the center. Although the COBRE award is not intended to replace support for ongoing investigator-initiated research projects of established investigators, both the mentors, as well as other investigators at the institution, may use these facilities. Additional justification may be offered by showing how a core facility will benefit these individuals and improve the research infrastructure of the institution. Each core description should indicate the qualifications of personnel selected to manage the facility and/or plans to recruit personnel to operate the core, if needed. Furthermore, the PI should indicate any institutional commitment to support and maintain the proposed facilities. ALTERATION AND RENOVATION: Alteration and Renovation (A&R) costs to improve existing research laboratories or animal facilities are allowed. This RFA will provide up to $500,000 in direct costs in year one only of the award as a one-time cost expenditure. Direct costs requested for A&R are not subject to facilities and administrative costs (F&A). Although this amount will be provided in year one only, the proposed A&R work does not have to be completed in year one. However, PIs are strongly encouraged to complete all A&R work in an expeditious manner and all A&R work must be completed before expiration of the award. Alteration and Renovation projects must be relevant to the scope of the proposed research. Sufficient detail must be provided to estimate the cost and suitability of the project. Failure to adequately justify an A&R request will likely result in its deletion from the requested budget. This RFA will not provide support for new construction, including the completion of shell space, or for movable research equipment/instrumentation or for equipment intended for teaching or other non-research related purposes. Please note that Alteration and Renovation costs will be approved only for facilities improvements at the applicant's organization. Proposed improvements at consortia sites are disallowed. The expenditure of funds for all A&R projects in excess of $500,000 is restricted until project documentation/architectural drawings have been reviewed and approved by NIH staff. A&R projects of less than $500,000 that support the installation of fixed equipment or other structural alterations should not be initiated until the project documentation/architectural drawings have been reviewed and approved by NIH staff. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following sample format is suggested: o NARRATIVE SUMMARY (1) Relate the proposed renovations to the research projects that will use the facility. If renovations to animal facilities are proposed, relate the proposed renovations to the projected animal populations (by species). If renovations to animal facilities are proposed, include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included. (2) List the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project. (3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam. (4) List appropriate architectural criteria (such as width of corridors and doors, surface finishes). (5) List and justify all fixed equipment items requested for the renovated area. o LINE DRAWINGS (1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS.) These drawings will not be counted against the 25-page limit. All floor plans must be legible, with the scale clearly indicated. (2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. (3) The plan should indicate the location of the proposed renovation area in the building. (4) Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished. (5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan. (6) Indicate the type(s) of new finishes to be applied to room surfaces. o COST ESTIMATES Detailed cost estimates must be included. Provide vendor quotes when available. Those individuals interested in seeking additional funds for facilities improvements are referred to the NCRR Research Facilities Improvement and Animal Facilities Improvement Programs, which accept applications for construction and for extensive renovation. Please refer to the NCRR Website: http://www.ncrr.nih.gov/. MECHANISM OF SUPPORT This RFA will use the NIH exploratory grant award mechanism (P20). The applicant is solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is June 2004. This RFA uses just-in-time concepts. It also uses the non-modular budget format. Please follow the instructions for non-modular budget research grant applications. Individual project and core facility budgets should be grouped together with justifications and prefaced by a summary or composite budget for the entire center. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NCRR intends to commit approximately $20 million in FY04 to fund 10 to 12 new grants in response to this RFA. An applicant must request a project period of five years and may request a budget for direct costs of up to and no more than $1.5 million per year, excluding facilities and administrative (F&A) costs on consortium arrangements. The applicant may also request additional direct costs in year one only of up to $500,000 as a one-time expenditure for Alteration and Renovation of laboratory or animal facilities. If Alteration and Renovation costs are requested, then the total budget request for year one must not exceed $2 million in direct costs, excluding F&A costs on consortium arrangements. Regardless whether Alteration and Renovation costs are requested, budget requests for years two through five cannot exceed $1.5 million per year, excluding F&A costs on consortium arrangements. Individual research projects and core facilities that are proposed to begin in the first year should have corresponding individual budgets. Although the applicant can propose research projects and/or core facilities to begin in later years, each year's budget should include costs for those projects or cores that will be active in that year only. Funds may be used to develop Offices of Sponsored Programs or to recruit additional faculty who complement the scope of the proposed program. Recruitment funds are limited to $100,000 per year for each position. These funds may be used for salary, supplies, and/or equipment costs. The expenditure of funds for recruitment purposes must be approved by NCRR Program staff. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NCRR 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. CONSORTIUM ARRANGEMENTS: When a grant application includes research activities that involve institutions other than the grantee institution, it is considered a consortium effort. Such activities may be included in the COBRE grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, the thematic scientific focus of the COBRE must be evident in applications that include consortia arrangements. Applicants for COBRE grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. For the purposes of this RFA, F&A costs for the consortium organization(s) are excluded from the limit on the amount of direct costs that can be requested for the entire application. Applicants are encouraged to review the NIH policy and procedures applicable to consortium agreements, which are published as part of the NIH Grants Policy Statement, Part III, available on the NIH homepage at http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Questions may be directed to the fiscal contact identified below under Inquiries. ELIGIBLE INSTITUTIONS o CRITERIA FOR ELIGIBILITY OF AN IDeA STATE In making its assessment for eligibility, NCRR included all states/commonwealths with a success rate for obtaining NIH grant awards (number of applications awarded vs. number of applications approved) of less than 20 percent over the period of 1997-2001. Also included are those states that had higher success rates, but received less than $75 million average NIH funding over the five-year period. Under these criteria, the following states/commonwealth are eligible IDeA states: Alaska Arkansas Delaware Hawaii Idaho Kansas Kentucky Louisiana Maine Mississippi Montana Nebraska Nevada New Hampshire New Mexico North Dakota Oklahoma Puerto Rico Rhode Island South Carolina South Dakota Vermont West Virginia Wyoming o CRITERIA FOR INSTITUTIONAL ELIGIBILITY An eligible institution must be within an IDeA state. An eligible institution must either be (1) a domestic, public or private, or non-profit research institution that awards doctoral degrees in health sciences or sciences related to health, or (2) an independent biomedical research institute. Applications will be accepted only from eligible institutions that hold fewer than three active COBRE awards. Eligible institutions that do not hold a current COBRE award are encouraged to apply. Please note that applications will NOT be accepted from institutions that hold three or more active COBRE awards; these institutions cannot submit applications. Applications are encouraged from veterinary and dental schools in IDeA states. For purposes of this RFA, veterinary and dental school components of institutions will be treated as separate eligible entities and will be allowed to submit applications in addition to the parent institution. Applications are also encouraged from eligible institutions in IDeA states that propose research that relates to the scope and mission of the National Institute on Deafness and Other Communication Disorders (NIDCD). o RESTRICTIONS FOR SUBMITTING AN APPLICATION No eligible institution, including veterinary and dental schools, can submit more than one application in response to this RFA. Multiple applications received from these institutions or applications received from ineligible institutions (those that hold three or more active COBRE awards) will not be reviewed. If an institution is writing more than one application, it is the responsibility of that institution to appoint a steering or selection committee to decide which single application to submit in response to this RFA. 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 his/her 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. The PI of the COBRE application must be an established biomedical or behavioral research scientist who has demonstrated the administrative abilities to effectively carry out the objectives of the COBRE program and meet its goals. The qualifications of the PI have been previously described. SPECIAL REQUIREMENTS The COBRE PI should budget for an annual two-day meeting in Bethesda, Maryland with NCRR staff. Each COBRE application must include an External Advisory Committee (EAC) comprised of scientists with national scientific reputations in their field; their expertise must be directly relevant to the scientific theme of the COBRE. The PI must select and name in the application at least three, but no more that five scientists who will serve as EAC members. Furthermore, the participation of each member in the EAC must be confirmed by inclusion in the application of a letter of acceptance and a current biographical sketch. The PI may recruit additional members to the EAC after an award is made. However, the selection of additional EAC members must be approved by NCRR staff. The EAC critiques the scientific progress of the COBRE and also offers advice on scientific matters to the COBRE PI. The EAC activities include concept development, program planning, encouraging and assisting faculty development and mentoring, identifying resources, evaluating the development of the center, critiquing the progress of the individual research projects, and evaluating the junior investigators' progress toward acquiring independent status. The PI will share the advice and critiques provided by the EAC with other investigators at the center. The EAC also will review and approve candidates for replacement/substitute projects and investigators, as required, before such requests are forwarded to NCRR for confirmation and approval. The EAC must meet at least twice per year on average. Minutes are to be recorded and made available for review by NCRR Program staff responsible for the COBRE. A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NCRR. 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: Dr. Lawrence N. Yager Division of Research Infrastructure National Center for Research Resources National Institutes of Health 6701 Democracy Boulevard, Room 930 Bethesda, MD 20892-4874 Telephone: (301) 435-0760 FAX: (301) 480-3770 E-mail: [email protected] o Direct your questions about peer-review issues to: Dr. Bo Hong Office of Review National Center for Research Resources National Institutes of Health 6701 Democracy Boulevard, Room 1078 Bethesda, MD 20892-4874 Telephone: (301) 435-0811 FAX: (301) 480-3660 E-mail: [email protected] o Direct your questions about financial or grants management matters to: Ms. Alice Chi Office of Grants Management National Center for Research Resources National Institutes of Health 6701 Democracy Boulevard, Room 1056 Bethesda, MD 20892-4874 Telephone: (301) 435-0844 FAX: (301) 480-3777 E-mail: [email protected] 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; o Name, address, and telephone number of the Principal Investigator; o Names of other key personnel; o Participating institutions; and 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 NCRR 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: Dr. Bo Hong Office of Review National Center for Research Resources National Institutes of Health 6701 Democracy Boulevard, Room 1078 Bethesda, MD 20892-4874 Bethesda, MD 20817-4874 (for express/courier service) Telephone: (301) 435-0811 FAX: (301) 480-3660 E-mail: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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, E-mail: [email protected]. SUPPLEMENTARY INSTRUCTIONS An application for a COBRE award must include the following: o A clear definition of the nature and extent of research collaboration, including a full explanation of the necessary administrative, fiscal, and scientific aspects of the proposed COBRE. o A research plan for five years that includes the proposed organization and component functions of the COBRE. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to developing a significant and productive research program. o A description of and justification for the proposed individual research projects and core service facilities that collectively will contribute to the center. Applicants should ideally propose at least three and up to five meritorious individual research projects and must describe the nature and scope of any scientific research collaborations. o A description of the research and research training or career development goals and capabilities of the proposed COBRE. The PI must establish a time line indicating the plans for each COBRE supported junior investigator to prepare and submit proposals for traditional research grant review during the performance period of the COBRE award. o A description of the infrastructure for conducting studies aimed at developing a nationally competitive biomedical research program. o A narrative summary, line drawings and cost estimates must be provided for any proposed Alteration and Renovation project. An itemized budget and justification of the impact that this Alteration and Renovation would have on the COBRE activities must also be provided. o The Research Plan section of the application describing the proposed center, but not including the individual junior investigators' research projects, core facilities, and Alteration and Renovation descriptions, is limited to no more than 25-pages, including all text, tables, graphs, figures, diagrams and charts. The Research Plans for the junior investigators' research projects and core descriptions are limited to no more than 10-pages each. These limitations do not include the sections describing Human Subject Research, Vertebrate Animals, Literature Cited, Consortium/Contractual Arrangements, Consultants, and/or supporting letters. The Alteration and Renovation section does not have a page limit, nor does this section count against the 25-page limit. Each Biographical Sketch is limited to no more than four pages. If not specifically cited in the PHS 398 document instructions, no page limit is in place for any other section. However, applicants are strongly urged to be succinct. o Applicants should follow the order of content described in the PHS 398 document instructions and indicated on the Table of Contents page. With respect to specific sections, the Budget section should begin with the summary or composite budget for the center, followed by the individual budgets for all projects, cores, consortia and contractual arrangements. Do not separate the individual project budgets into each project section. All Biographical Sketches should be grouped together with the PI's biographical sketch presented first followed by all other sketches in alphabetical order. Do not separate the biographical sketches into each project section. The Research Plan for the center should be followed with letters indicating institutional commitment, any letters of support for the proposed center (if applicable), and letters of acceptance from EAC members. Do not place these letters in the Appendix. The Research Plan for the center (including letters) should be followed with the Alteration and Renovation section. Core descriptions and individual junior investigator Research Plans should follow next. Although a PHS 398 face page for each individual research project is not required, a cover page should be included that indicates the project title, the name of the junior investigator supervising the project, the name of the mentor(s), whether human subject/human subject materials will be used in the project, and whether vertebrate animals will be used in the project. A Description page that provides an Abstract of the proposed project is required and should immediately precede each project's Research Plan. As necessary, each project section can be concluded with letters of commitment from mentors and, as needed, letters of commitment from collaborators and/or consultants. Do not place these letters in the Appendix. Consecutively number the pages throughout the application. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b, etc. o The main body of the application should be self contained and the Appendix must not be used to circumvent page limitations. Applicants must adhere to the guidelines described in the PHS 398 document instructions regarding the preparation and presentation of materials that can be included in the Appendix. 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 20817-7710 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Dr. Bo Hong Office of Review National Center for Research Resources National Institutes of Health 6701 Democracy Boulevard, Room 1078 Bethesda, MD 20892-4874 Bethesda, MD 20817-4874 (for express/courier service) Telephone: (301) 435-0811 FAX: (301) 480-3660 E-mail: [email protected] 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. 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. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCRR. Incomplete applications will not be reviewed. Applications that are not responsive to this RFA or that exceed the maximum allowable first-year direct cost limit of $1.5 million (or $2 million, if requesting first year Alteration and Renovation costs), excluding F&A costs for consortium budgets, will not be reviewed. 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 Office of Review, NCRR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score; o receive a written critique; and o receive a second-level review by the National Advisory Research Resources Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers are asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, important work may be proposed that by its nature is not innovative but is essential to move a field forward. The review of the COBRE application is additionally based not only on these traditional review criteria, but also on the qualification and stature of the PI to provide both scientific and administrative leadership and on the feasibility and potential for investigators to become competitive for independent funding. Senior, funded investigators must not be proposed as leaders for individual research projects. The following criteria will be used to evaluate the 1) administrative leadership and overall potential for enriching the intellectual milieu for doing research, 2) scientific merit of the individual biomedical research projects, and 3) effectiveness in training and promoting junior investigators: ADMINISTRATIVE LEADERSHIP AND OVERALL POTENTIAL FOR ENRICHING THE INTELLECTUAL MILIEU FOR DOING RESEARCH: The scientific review group will be asked to consider the following criteria: o The qualifications of the Principal Investigator to provide scientific and administrative leadership in developing and directing the COBRE, and establishing thematic collaborative research efforts. The PI must demonstrate that he/she is an established biomedical or behavioral research scientist, that the he/she has an active research laboratory, that he/she has relevant peer-reviewed funding (either NIH, NSF or other Federal or non-Federal investigator-initiated support), and that he/she has demonstrated administrative leadership and mentoring experience. o The significance, approach, and innovation of the proposed research projects and of the COBRE as a whole. o The nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators. o The strengths of the applicant investigators and the collaborating researchers, if involved, particularly their academic qualifications, biomedical expertise and research productivity. o The level of institutional commitment with regard to assuring that the resources and facilities to sustain the COBRE program are present, including, but not restricted to, existing relevant equipment, animal, and/or computer resources, and departmental or interdepartmental cooperation. o The need for the proposed core facilities and the effectiveness of these facilities to enhance the research effort. The applicant must demonstrate that each proposed core will serve the scientific needs of the individual research projects and must show how each core will impact the development of the center. o The ability to augment and strengthen the institutional biomedical research capability. o The ability to provide support for the development of a thematic multidisciplinary center. o The means by which basic or clinical research is encouraged. o The establishment and maintenance of a scientific thematic focus. o The suitability of the External Advisory Committee. o The appropriateness and suitability of evaluation strategies and specific milestones necessary to measure progress toward attaining long-range goals. SCIENTIFIC MERIT OF THE INDIVIDUAL BIOMEDICAL RESEARCH PROJECTS: Although the scientific review group should evaluate the qualifications of each junior investigator using the traditional criteria and considerations indicated in this RFA, reviewers should also evaluate each junior investigator's qualifications in terms of his/her career development potential and ability to achieve independent status. o SIGNIFICANCE: Does the study address an important problem? If the aims of the application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? o APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Are potential problem areas acknowledged and alternative tactics considered? o INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the investigator and to that of other researchers (if any)? o ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? EFFECTIVENESS IN TRAINING AND PROMOTING JUNIOR INVESTIGATORS: The scientific review group will be asked to use the following criteria in evaluating this criterion: o The quality of the research training, career development and mentoring plan for junior investigators of the center. o The plan for development of junior investigators and for their transition to and attainment of independent status. o The suitability of the plan for recruiting new faculty. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS: SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. The NIH policy on data sharing, as well as guidance on this subject, can be found at http://grants.nih.gov/grants/policy/data_sharing. 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: October 17, 2003 Application Receipt Date: November 18, 2003 Peer Review Date: March 15, 2004 (subject to change) Council Review: May 20, 2004 Earliest Anticipated Start Date: June 1, 2004 AWARD CRITERIA Award decisions will be based on scientific and technical merit as determined by peer-review, the National Advisory Research Resources Council, geographic distribution, program balance, the enhancement of the research competitiveness of the institution, and the availability of funds. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA SAFETY AND MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (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). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant and contract 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 routing 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.is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant and contract 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 routing 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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