PAR-03-140: NIGMS' POST-BACCALAUREATE RESEARCH EDUCATION PROGRAM (PREP)

Department of Health
and Human Services (HHS)

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NIGMS' POST-BACCALAUREATE RESEARCH EDUCATION PROGRAM (PREP) RELEASE DATE: June 17, 2003 PA NUMBER: PAR-03-140 (Reissued as PAR-07-432) EXPIRATION DATE: August 14, 2006 (Expired August 14, 2006 per NOT-GM-06-114) (Also see NOT-OD-06-104) National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) APPLICATION RECEIPT DATE: October 20 This Program Announcement replaces PAR-00-139, which was published in the NIH Guide to Grants and Contracts on September 22, 2000. CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.375, 93.880, 93.960 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Program Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become PREP Scholars o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The Minority Access to Research Careers (MARC) Program Branch of the Division of Minority Opportunities in Research (MORE) of the National Institute of General Medical Sciences (NIGMS) provides research training opportunities for students from minority groups that are underrepresented in the biomedically relevant sciences, including mathematics. As part of the ongoing commitment to the development of prospective underrepresented minority researchers and the enhancement of their training, the MARC Program provides support to stimulate the interest of underrepresented minority students to consider biomedical research as a career. The MARC Branch is reissuing its institutional initiative, the Post- baccalaureate Research Education Program (PREP), to encourage underrepresented minorities who hold a recent baccalaureate degree in the biomedically relevant sciences to pursue a Ph.D. The purpose of this program is to heighten the interest of the post-baccalaureate participants in such areas of scientific research as cell biology, biophysics, biochemistry, genetics, neurobiology, physiology, computational biology and behavioral sciences. It is anticipated that participation in this program will facilitate the development of a cohort who will become the scientists who address the health problems that disproportionately affect minorities and the medically underserved people of this country. Participants in this program will acquire stronger research skills and improve the skills and competitiveness necessary for the successful pursuit of a graduate degree. Institutions with programs that have demonstrated significant experience in training Ph.D. candidates in the biomedical sciences and/or behavioral sciences may request from six to 12 post-baccalaureate positions, with a maximum of no more than 12 per year for each year of the grant (i.e., 60 participants for a five-year grant period), for individuals to engage in mentored research studies and student development activities under the direction of faculty preceptors. For this Program Announcement, underrepresented minority baccalaureates are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical research. Nationally, individuals who have been found to be underrepresented in biomedically relevant research include, but are not limited to, United States citizens who are African American, Hispanic American, Native American, and natives of the U.S. Pacific Islands. In this Program Announcement, the term "science" means the biological, chemical, computer, physical, and behavioral sciences, including mathematics, which have relevance to biomedical research. PROGRAM OBJECTIVES In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. In response to the Act, institutions with graduate programs and demonstrated experience in training Ph.D. candidates in the biomedical sciences and faculty involved in biomedical research would have an opportunity to target those talented and promising minority baccalaureate graduates who, for a variety of reasons, have decided to postpone application to Ph.D. programs. The overall goal of this initiative is to increase the number of competitively trained underrepresented minority students who enroll in and eventually complete biomedical sciences Ph.D. programs. In addition, we hope to develop a cohort who will eventually become the scientists who conduct research on cardiovascular disease, diabetes, cancer, arthritis, respiratory diseases, HIV, and other STDs, substance abuse, and other areas that address reducing health disparities. The applicant institution should define the goals and specific measurable objectives of its proposed program and how meeting those institutional goals and objectives will fulfill the objectives of this Program Announcement. The application should make clear how each of the proposed programmatic activities will contribute to meeting the PREP scholars' needs and the institution's stated goals and specific measurable objectives. The application should provide a plan to evaluate whether the specific measurable objectives, as stated in the application, have been met and how those data obtained will be analyzed. Applicant institutions are required to submit the following information: o Evidence of the applicant institution's commitment to the advancement of underrepresented minority students in the participating science departments. o Evidence of the applicant institution's efforts to recruit and retain underrepresented minority students in the participating science departments. o Evidence of previous involvement of faculty in providing meaningful research mentoring to underrepresented minority students in the proposed participating departments. o Description of a clear plan for the development of PREP scholars that includes courses and developmental activities that could provide them with the knowledge and skills needed to address any biomedical/behavioral scientific problem including those that pertain to health disparities, in addition to conducting mentored research. Applicant institutions are expected to provide detailed plans for the recruitment and selection criteria of PREP scholars and involvement of the scholars in any special developmental activities. For example, a program's curriculum or developmental activities might provide a broad overview of subjects as well as the skills and knowledge relevant to the national need of addressing health disparities, such as the human genome project or translational research. In addition, the overall curriculum should strengthen the mathematical and quantitative skills needed by the scholars to eventually complete the Ph.D. degree. Thus, the application should clearly describe how the PREP scholars would be better prepared for Ph.D. training and how the applicant institution will evaluate the quality and success of its PREP initiative. The application should also provide information on the credentials of the proposed faculty preceptors, including their experience as mentors, current research programs and publications, and current grant support. Only one application per institution may be submitted for this PA. MECHANISM OF SUPPORT This PA will use the NIH Institutional Educational Project (R25) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed program. The maximum initial grant period is five years with the opportunity to compete for renewal at the end of the period. This PA does not use the just-in-time concepts. It also does not use the modular budget format. 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. Facilities and administration costs will be provided at a rate of 8% minus exclusions. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Domestic private or public institutions, such as universities and colleges. o Research institutions or centers with graduate programs that have experience in training Ph.D. candidates and that offer a solid research environment. INDIVIDUALS ELIGIBLE TO BECOME PREP SCHOLARS To be eligible for participation in the program as a PREP scholar, individuals from underrepresented minority groups must have graduated with a baccalaureate degree in a biomedically relevant science from an accredited U.S. college or university no more than 36 months prior to applying to a PREP program. All individuals selected as scholars must intend to apply, within two years, for graduate education that will eventually lead to the research doctorate. In addition, PREP scholars must be U.S. citizens or permanent residents. The period of appointment for scholars participating in this post- baccalaureate program is for up to two years. During the period of appointment, the scholars will work as apprentice scientists in a preceptor's laboratory and participate in student development and/or educational activities at the applicant institution. The applicant institution should set as goals for its PREP scholars academic criteria that would allow for their admission to a Ph.D. program. It is expected that if the PREP scholar performs satisfactorily, he/she will be strongly encouraged to apply for admission to the Ph.D. program of the applicant institution, if it has one, as well as Ph.D. programs of other institutions. The PREP scholar's preceptor must be an active researcher with an extramurally funded research program. SPECIAL REQUIREMENTS Responsible Conduct of Research Applicant institutions must describe in detail plans for teaching responsible conduct in biomedical research to all PREP scholars and provide progress reports of the type of instruction given, who attended, and who taught. This is mandatory for all PREP grant applicants. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although NIH does not establish specific curricula or formal requirements, PREP programs are encouraged strongly to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Within the context of training in scientific integrity it is also beneficial to discuss the mutual responsibilities of the institution and the post-baccalaureate participants supported by this program. Plans must address the subject matter and format of the instruction, the degree of faculty participation, attendance of PREP scholars, and the frequency of instruction. In addition, the rationale for the proposed plan of instruction must be provided. During peer review the plans will be judged acceptable or unacceptable separately from the overall merit of the training program. The judgment will be based on the appropriateness of the topics, format, the nature of faculty participation, and the frequency and duration of instruction to the level and type of training being provided. The plan will be discussed after the overall determination of merit, so that the quality of the plan will not be a factor in the determination of the priority score. Regardless of the priority score, applications with unacceptable plans will not be funded. Reporting Requirements A progress report will be required two months before the end of each budget period. A final report will be required within 90 days after the termination date of the award. All progress reports must include information on each PREP scholar's progress and the benefits that the scholar derived from the program. In addition, the progress report should include information on the applicant institution's success in motivating these scholars to enroll in Ph.D. programs. Based on each year's progress report, the number of PREP slots may be modified depending on the rate of the PREP scholars enrolling in Ph.D. programs at the applicant institution or other institutions. In addition to the progress report, a Financial Status Report (FSR) will be required 90 days after the end of each budget period. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: programmatic, peer review, and financial or grants management issues, o Direct your questions about programmatic issues to: Adolphus P. Toliver, Ph.D. Division of Minority Opportunities in Research National Institute of General Medical Sciences 45 Center Drive, Room 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: tolivera@nigms.nih.gov o Direct your questions about peer review issues to: Richard I. Martinez, Ph.D. Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 3AN.12B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2849 FAX: (301) 480-8506 E-mail: rm63f@nih.gov o Direct questions about financial or grants management matters to: Ms. Antoinette Holland Grants Management Officer National Institute of General Medical Sciences 45 Center Drive, Room 2AN.50B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594 5132 FAX: (301) 480-2554 Email: hollanda@nigms.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, E-mail: GrantsInfo@nih.gov. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. ALLOWABLE COSTS: Costs for the overall administration of the PREP initiative, including coordination and evaluation of the program, are allowable. Such costs include salary support for the Program Director (up to 15% effort) for the portion of time devoted specifically to administering the program, salary support for secretarial or clerical help when directly related to the PREP initiative, and support for evaluation activities. PREP SCHOLARS SALARIES: Remuneration for PREP scholars is through salary and wages. Beginning PREP scholars will be paid a salary of $21,000/year. The maximum compensation package, which includes fringe benefits and tuition and fees (if applicable) a PREP scholar may be paid should not exceed $30,000/year. The following conditions must be met: o The PREP scholar must be performing necessary work relevant to the proposed training plan. o There must be an employer-employee relationship between the scholar and the university. o The total compensation must be reasonable for the work performed. o It is the institution's practice to provide compensation for all students in similar circumstances, regardless of the source of support for the activity. TUITION REMISSION: The applicant institution may request tuition remission for a course it deems necessary to enhance the preparedness of a PREP scholar for graduate studies and specifically justified. However, tuition remission may not exceed the in-state tuition cost at institutions that also have out- of-state tuition charges. TRAVEL: Applicants may request support for travel of PREP scholars to scientific meetings or to present scientific papers. Requests for PREP scholars travel to scientific meetings must be carefully and specifically justified. FACILITIES AND ADMINISTRATION ALLOWANCE: A facilities and administration (F&A) allowance based on 8 percent of total allowable direct costs (this excludes tuition, fees, health insurance, and equipment) will be paid. UNALLOWABLE COSTS: Housing, food, or recruitment expenses of any kind are not allowable costs under this program. Support for faculty research is not allowable, since faculty preceptors in competitive programs are expected to have their own research support and an active research program capable of supporting the mentored research experience of PREP scholars. APPLICATION RECEIPT DATE: Applications submitted in response to this program announcement will be accepted only for the receipt date listed in the heading of this PA. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist and three signed photocopies of application, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and appendix materials must be sent to: Richard I. Martinez, Ph.D. Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 3AN.12B, MSC 6200 Bethesda, MD 20892-6200 APPLICATION PROCESSING: Applications submitted in response to this program announcement must be received on or before the application receipt date listed in the heading of this PA. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned to NIGMS. Incomplete and/or unresponsive applications will be returned to the applicant without further consideration. An appropriate review group will be convened by the NIGMS in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm). Those applications that are complete and responsive will be evaluated for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique 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 second level of review by the National Advisory General Medical Sciences Council. REVIEW CRITERIA A suitable review group assembled by the NIGMS Office of Scientific Review will evaluate applications for technical and scientific merit based on the following criteria: o Appropriateness of the measurable specific objectives and the plan for the evaluation of the program; o Quality of the proposed research training and student development activities and probability they will provide a meaningful experience for the PREP scholars; o Qualifications and experience of the program director to carry out the proposed program; o Quality and experience of the proposed research faculty as investigators and research mentors; o Evidence of the institution's adequacy and availability of research resources and research training environment; o Evidence of the applicant institution's efforts to recruit and retain underrepresented minority students in the participating departments; o Evidence of previous involvement of faculty in providing meaningful research mentoring to underrepresented minority students in the proposed participating departments; o Description of a clear plan for the development of PREP scholars that includes courses and developmental activities that could provide them with the knowledge and skills needed to address any biomedical/behavioral scientific problem including those that pertain to health disparities, in addition to conducting mentored research; and o Appropriateness of the scope of the program and its potential benefit to the PREP scholars. 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 OR HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used by the PREP Scholars in their research experience, the five items described under Section F of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. INSTRUCTION IN THE RESPONSIBLE CONDUCT OF RESEARCH: The acceptability of the Responsible Conduct of Research Plan. Applications must include the applicant's plans for providing instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, duration and frequency of instruction. No award will be made if an application lacks this component. BUDGET: The reasonableness of the proposed budget. AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other recommended PREP applications. The following will be considered in making funding decisions: o Scientific and technical merit as determined by peer review. o Relevance to program priorities. o Availability of funds. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research Amended, October 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards: clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the inclusion of children as participants in research involving human subjects" that is available at 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 the official NIH identifier for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm . Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 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://www.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 a NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010", a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at 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 authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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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