NINR MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY INVESTIGATORS RELEASE DATE: August 28, 2002 RFA: NR-03-001 National Institute of Nursing Research (NINR) (www.nih.gov/ninr) LETTER OF INTENT RECEIPT DATE: November 15, 2002 APPLICATION RECEIPT DATE: December 16, 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 Institute of Nursing Research (NINR) invites applications to support the research career development of doctorally prepared minority nurse investigators in tenure-earning positions at Traditionally Minority Based Institutions (TMBIs) and at majority academic institutions in the biomedical and behavioral scientific mission areas of the NINR. The purposes of this program initiative are to: (1) foster the development of independent investigators in nursing research on the faculties of TMBIs and majority academic institutions, (2) stimulate nursing research and nursing research training at these institutions, and (3) encourage the development of qualified minority nurse investigators in academic research settings who can become effective role models for minority students. RESEARCH OBJECTIVES Background The striking underrepresentation of racial/ethnic minority groups in biomedical and behavioral research in the United States has been underscored in many studies. There are existing programs at the NIH designed to improve this situation. These include: the Minority Biomedical Research Support Program, the Minority Access to Research Careers (MARC) Program, the Individual Predoctoral Fellowship for Minority Students Program, and the Research Supplements for Underrepresented Minorities Program. The NINR has been an active participant in these trans-NIH minority research training programs. NINR has had a long-standing interest in increasing the number of minority investigators in nursing research. Based on the recommendations from groups of minority health experts, NINR has developed a variety of outreach strategies that assist individuals at TMBIs and other majority institutions in obtaining support for research training, career development, and research funding from NINR. The NINR Mentored Research Scientist Development Award for Minority Investigators is one approach that NINR has taken to strengthen the participation of TMBIs, where there are few graduate schools of nursing, and majority academic institutions by addressing the needs of minority nurse investigators for additional research training with financial support. NINR also recognizes that the paucity of qualified minority nurse investigators in academic research settings has created a shortage of role models for minority students. This RFA seeks to address this problem by enhancing the research capabilities of minority nurse faculty members so these individuals may establish research laboratories and research programs in nursing at their institutions. In this fashion they will serve as role models for minority undergraduate and graduate students, stimulating them to consider research career opportunities in nursing research. The purposes of the present RFA are to: 1) foster the development of independent investigators in nursing research on the faculties of TMBIs and majority academic institutions, 2) stimulate nursing research and nursing research training at these institutions, and 3) encourage the development of qualified minority nurse investigators in academic research settings who can become effective role models for minority students. This is the sixth consecutive year NINR has issued this RFA. The NIH Office of Research on Minority health (ORMH), now the National Center on Minority Health and Health Disparities has been a co-sponsor of this initiative. Research Areas The research career development plan must address a research area consistent with the NINR mission. Descriptions of relevant research areas may be found on the NINR website at http://www.ninr.nih.gov/ResearchAndFunding/DEA/OEP/AreasofscienceFile.htm. Minority nurse investigators are encouraged to develop their innovative research career development plans in areas relevant to underserved minority populations and in priority areas of NINR"s scientific research mission, particularly research on health disparities. Applicants are encouraged to review NINR"s Strategic Plan on Reducing Health Disparities located at: http://www.ninr.nih.gov/research/diversity/mission.html. Environment The applicant TMBI or majority academic institution must demonstrate in the application a firm commitment to the development of the candidate as a productive, independent investigator in nursing research and to the pursuit of the research career development plan described in the application. The candidate should describe a career development program that will maximize the use of relevant research and educational resources available in the TMBI or the majority academic institution and in the mentor"s institution. Program The award provides three consecutive 12-month appointments to pursue a mentored research experience and specialized study in nursing research that are tailored to the individual needs of the candidate. At least 75 percent of the recipient"s full-time professional effort must be devoted to the program, and the remaining 25 percent devoted to other research-related and/or teaching or clinical pursuits consistent with the objectives of the award. The program must consist of both a research plan and a research career development plan that will develop knowledge and research skills relevant to his or her career goals. Mentor(s) The candidate must receive appropriate mentoring throughout the three- year program. Where feasible, women and minority mentors should be involved as role models. If the mentor (and/or a co-mentor, if desired) is geographically distant from the candidate, a detailed communication plan must be provided to document the mentor-candidate relationship and level of commitment for the successful implementation and completion of the proposed research and career development program. Allowable Costs: 1. Salary: The NINR will provide salary for the recipient of this award up to a maximum of $50,000 plus fringe benefits per year. The institution may supplement the NINR contribution up to a level that is consistent with the institution"s salary scale, however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose and provisions of this research career development award. Under expanded authorities, institutions may rebudget funds within the total costs awarded, but may not rebudget funds involving the salary component of the budget. The total salary requested must be based on a full-time, 12-month staff appointment. It 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. 2. Research Development Support: The NINR will provide up to $20,000 per year for the following expenses: (a) tuition, fees, and books related to career development, (b) research expenses, such as supplies, equipment, and technical personnel, (c) travel to research meetings or training, and (d) statistical services including personnel, research and computer time. These funds must be expended solely for the support of the candidate"s research career development plan. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed at eight percent of modified total direct costs. Evaluation In carrying out its stewardship of human resource related programs, the NINR or NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. MECHANISM OF SUPPORT This RFA will use the National Institute of Nursing (NINR) Mentored Research Scientist Development Award (K01) mechanism. This mechanism is described in program announcement PA-00-019 (NIH Guide, December 3, 1999). Although all general guidelines of PA-00-019 will apply, this RFA is written as a stand-alone document and contains provisions that are unique to this initiative. Planning, direction, and execution of the proposed career development program are the responsibility of the candidate and his/her mentor on behalf of the applicant institution. The total project period for grants awarded under this program may be up to three years. These grants are not eligible for renewal. The anticipated award date is July 1, 2003. This RFA uses just-in-time concepts. FUNDS AVAILABLE NINR intends to commit approximately $360,000 in FY 2003 to fund 3 to 4 new grants in response to this RFA. An applicant may request a project period of up to 3 years. Salary support for each recipient will be for a maximum of $50,000 plus fringe benefits with a minimum of 75% effort committed. Each year up to $20,000 may be requested for research development support. Although the financial plans of the NINR 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private domestic institutions, such as universities, colleges, hospitals, and laboratories o Traditionally Minority Based Institutions Applications from foreign institutions will not be accepted. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Awards will be limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. SPECIAL REQUIREMENTS Candidates must be from ethnic/racial groups determined by the applicant institution to be underrepresented in biomedical or behavioral nursing research. Candidates for this award must be full- time nursing faculty members in tenure-earning positions at Traditionally Minority Based Institutions or majority academic institutions who:(1) have a research or health-professional doctorate (e.g., PhD or DNSc), or its equivalent, (2) have demonstrated the capacity or potential for productive independent research career, (3) have a Registered Nurse license, and (4) have secured the commitment of an appropriate research mentor actively involved in research relevant to the mission of NINR. The candidate must identify an appropriate mentor or co-mentors with extensive research experience in the research area proposed in the application. The candidate must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and career development activities for the period of the award. The remaining 25 percent time should be devoted to other research-related and/or teaching or clinical pursuits consistent with the objectives of the award. Candidates who have served as principal investigators on PHS research grants or have been supported by a research career award in the past, are eligible to apply, provided the proposed research career development program is in a fundamentally new area of scientific endeavor for the candidate or there has been a significant hiatus in his/her research career because of family or other personal obligations. Current principal investigators on PHS research grants are not eligible. Applicants are encouraged to call the program director listed in the Inquiries section to discuss any aspects of this program that need clarification. 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: Janice Phillips, PhD, RN, FAAN Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6152 FAX: (301) 480-8260 Email: janice_phillips@nih.gov o Direct your questions about peer review issues to: John E. Richters, PhD Office of Review Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5971 FAX: (301) 451-5645 Email: jrichter@nih.gov o Direct your questions about financial or grants management matters to: Cindy McDermott Office of Grants and Contracts Management Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6869 FAX: (301) 451-5648 Email: cindy_mcdermott@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINR 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: Janice Phillips, PhD, RN, FAAN Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6152 FAX: (301) 480-8260 Email: janice_phillips@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 https://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. The application must address the following issues: Candidate o The candidate"s commitment to a nursing career in biomedical or behavioral research. o The candidate"s potential to develop into a successful independent nursing investigator. o The candidate"s immediate and long-term career objectives, and how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate"s potential for an independent nursing research career must be included as part of the application. Career Development Plan o The career development plan, incorporating consideration of the candidate"s goals and prior experience. It should describe a systematic plan to obtain any necessary basic biomedical or behavioral science background and research experience to launch or reinitiate an independent nursing research career. o The candidate must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. No award will be made if an application lacks this component. Additional information is available at: http://ori.hhs.gov/policies/RCR_Policy.shtml#rcr Research Plan The candidate must describe the research plan and the use of a basic or clinical approach to a biomedical or behavioral problem. The candidate must describe the research plan as outlined in form PHS 398, including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Mentor"s Statement The application must include a biographical sketch and information on the mentor(s) including research qualifications and previous experience as a research supervisor. The application must also include information that describes the nature and extent of supervision that will occur during the award period. A letter of support from the mentor (and co-mentor, if appropriate) must be included in the application delineating the match with the candidate"s research and development plan and willingness to provide the necessary assistance. Environment and Institutional Commitment The sponsoring TMBI or majority academic institution must provide a statement of commitment to the candidate"s development into a productive, independent investigator in nursing research. This statement must indicate that the candidate will be provided with sufficient release time from other duties to accomplish the research and career development goals stated in the application. Budget Individuals applying for the K01 award must comply with the JUST-IN- TIME procedures announced in the NIH Guide on March 29, 1996 and May 17, 1996. 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: https://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 must be sent to: John E. Richters, PhD Office of Review Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 For express/courier service: Bethesda, MD 20817 ATTN: Minority Investigator MRSDA Telephone: (301) 594-5971 FAX: (301) 480-8260 APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NINR. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NINR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council for Nursing Research REVIEW CRITERIA The following criteria will be applied: Candidate o Commitment to an independent research career in nursing research, o Potential to develop (or evidence of the capacity to develop) as an independent nurse investigator, and o Quality and breadth of prior scientific training and experience, including, where appropriate, the record of previous research support, publications, and other scholarly activities. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of research independence, o Appropriateness of the research plan to the career goals of the candidate, o Appropriateness of the research plan to develop new nursing knowledge, o Consistency of the career development plan with the candidate"s prior research and academic experience and stated career goals, o Clarity of the goals and scope of the plan and the need for the proposed research experience, and o Quality of the proposed training in the responsible conduct of research. Research Plan A sound research plan that is consistent with the career development plan and the candidate"s level of research development must be provided: o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan, o Scientific and technical merit of the research question, design and methodology, judged in the context of the candidate"s previous training and experience, o Relevance of the proposed research to the candidate"s career objectives, and o When human subjects are involved, adequacy of plans to include both genders and minorities and children and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Mentor o Appropriateness of mentor"s(s") research qualifications in the specific areas of the application, o Quality and commitment of the mentor(s) to supervise and guide the candidate throughout the award period, o Previous experience in fostering the development of independent nurse investigators, and o History of research productivity and support. Institutional Environment and Commitment o Applicant institution"s commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program, o Adequacy of research facilities and training opportunities at the sponsoring institution, o Quality of environment for scientific and professional development, and o Applicant institution"s willingness to develop an appropriate balance of research, teaching and administrative responsibilities for the candidate. Budget Justification of budget requests in relation to career development goals and research aims and plans. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 15, 2002 Application Receipt Date: December 16, 2002 Peer Review Date: February 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 1, 2003 AWARD CRITERIA The NINR anticipates awarding up to four K01 grants in response to this RFA. The anticipated date of award is July 1, 2003. The following criteria will be considered in making funding decisions: o Responsiveness to the purpose of this request, o Quality of the proposed research career development program, as determined by peer review, and o Availability of funds. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at https://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 https://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 https://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 https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH 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 No. 93.361, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)(or other authorizations) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm (cite other relevant policies) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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