National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Reissue of PAR-17-051
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research
To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:
This funding opportunity announcement (FOA) provides support to eligible, domestic institutions to develop and implement effective, evidence-informed approaches to biomedical research education and mentoring that will keep pace with the rapid evolution of the research enterprise. NIGMS expects that the proposed research education programs will incorporate extensive research experiences and well-designed courses for skills development to prepare recent baccalaureates from diverse backgrounds to transition into and complete rigorous, research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields. This program is limited to applications from doctoral degree-granting institutions that are research-intensive (i.e., those with NIH research project grant (RPG) funding averaging greater than or equal to $7.5 million in total costs per year over the last three fiscal years).
This Funding Opportunity Announcement (FOA) does not allow appointed participants to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.
December 2, 2019
February 21, 2020; January 27, 2021; January 27, 2022, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The over-arching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.
The over-arching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.
To accomplish the stated overarching goal, this FOA will support creative educational activities with a primary focus on:
Applications are encouraged from doctoral degree granting research-intensive institutions that propose to develop recent baccalaureate science graduates from diverse backgrounds (e.g., see NIH's Notice of Interest in Diversity) so that they have the necessary knowledge, skills, and networks to transition into and complete rigorous research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields.
Purpose and Background Information
The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences (collectively termed "biomedical") research workforce. Diversity at all levels — from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it — contributes to excellence in research training environments and strengthens the research enterprise. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual interests to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of research, enhancing public trust, and increasing the likelihood that health disparities and the needs of underserved populations are addressed in biomedical research. NIH strives to ensure that future generations of researchers will be drawn from the entire pool of talented individuals, bringing different aptitudes, perspectives, interests, and experiences to address complex scientific problems. NIH seeks to enhance the diversity of the biomedical research workforce by supporting individuals from a variety of backgrounds at multiple training and career stages in a variety of institutions and educational settings across the country.
Need for the Program
Promoting diversity in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act. While scientific workforce diversity supports the NIH mission, expanding the pool of academic investigators from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal. NIH has a longstanding commitment to training the next generation of biomedical scientists and supporting training of students from diverse backgrounds, for example groups underrepresented in biomedical research, through a variety of fellowships, career development awards, and institutional training and student development programs. In spite of recent advances, individuals from certain groups and backgrounds are underrepresented in the biomedical sciences research workforce as described in the Notice of NIH's Interest in Diversity. The severity of the underrepresentation of these groups increases throughout the training stages. For example, students from certain racial and ethnic groups, including Blacks or African Americans, Hispanics or Latinos/Latinas, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders comprise ~39 percent of the college age population (Census Bureau data), but earn only ~17 percent of bachelor’s degrees and ~13 percent of Ph.D. degrees in the life sciences (National Center for Science and Engineering Statistics). Additionally, while the United States has seen a significant increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from historically underrepresented racial and ethnic groups in the biomedical research workforce, a corresponding increase in the ranks of the faculty in basic science departments has not occurred (Gibbs, et al., eLife 2016; Valantine, Lund & Gammie, CBE-Life Sciences Education, 2016). Similarly, women have earned a majority of biomedical Ph.Ds. since 2008 (NSF data), but only approximately 1/3 of NIH-funded principal investigators are women (NIH Databook).
Several reports (see for example, ACD Working Group on Diversity in the Biomedical Workforce, 2012; PCAST Report, 2012; From College to Careers: Fostering Inclusion of Persons with Disabilities in STEM, 2014; and Increasing College Opportunity for Low Income Students, 2014) recommend supporting programs that strive to recruit, train, and mentor students from nationally underrepresented groups who have an interest in science, technology, engineering and math (STEM) as a means to effectively build a diverse and competitive scientific workforce.
The Postbaccalaureate Research Education Program (PREP) provides institutions the resources to support and provide research experiences and courses for skills development to research-oriented postbaccalaureate participants from diverse backgrounds who upon completion of a one-year research education program are likely to successfully transition into and complete rigorous research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields relevant to the NIGMS mission. This FOA is intended to enable the community to develop and implement evidence-informed approaches to biomedical research education and mentoring to enhance diversity in the biomedical research workforce. Funded programs are expected to provide activities that will build a strong cohort of research-oriented individuals while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members in the biomedical research community. Programmatic activities include, but are not limited to, providing authentic research experiences, courses for skills development, and additional mentoring -- activities proven to increase persistence in STEM fields (cited in PCAST Report, 2012, Graduate STEM Education for the 21st Century, 2018, and The Science of Effective Mentoring in STEMM, 2019). Program activities should build upon the strengths and assets of PREP participants and should not reflect deficit-models (i.e., those that focus primarily on remediation of perceived weaknesses) of career development.
Each program should provide high-quality research education experiences that equip participants with the technical (e.g., appropriate methods, technologies, and quantitative/computational approaches), operational (e.g., independent knowledge acquisition, rigorous experimental design, and interpretation of data) and professional (e.g., management, leadership, communication, and teamwork) skills required for careers in the biomedical research workforce. Funded programs are expected to promote inclusive research environments (i.e., institutional and departmental environments where researchers from all backgrounds are and feel integrated into and supported by the biomedical research community)
The Overarching Objective of PREP is to develop a diverse pool of well-trained postbaccalaureate participants who will transition into and complete rigorous biomedical, research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields relevant to the NIGMS mission. The long-term goal is to develop a diverse pool of well-trained biomedical scientists, who have the following technical, operational, and professional skills:
Diversity at all levels contributes to excellence in research environments and strengthens the research enterprise. This FOA is intended to support outstanding research education programs that will enhance diversity at all levels.
NIGMS intends to fund applications that propose feasible research education programs that will enhance diversity in the biomedical workforce. Programs are expected to have mentors from a broad range of biomedical disciplines relevant to the NIGMS mission to provide a breadth of research experiences to participants. Proposed programs focused in a single discipline (e.g., neuroscience, immunology, etc.) will be low priority for funding.
As postbaccalaureate scientists, the participants will be involved in independent research projects where they will learn to develop and answer scientific questions, allowing them to experience the fulfillment of discovery as scientists. The research environment should be inclusive, supportive and safe, and should include opportunities for the participants to interact with doctoral student peers, postdoctoral researchers, and other investigators who could contribute to their growth and will allow them to thrive in rigorous doctoral programs. PREP participants will be required to work as research postbaccalaureates at 9 person-months (75% full-time) effort, with the other 3 person-months (25% full-time effort) devoted to further skills development. The academic preparations may include courses, workshops, seminars, supplemental instruction, or lectures that will enhance the technical, operational and professional skills of the participants. The courses taken should be appropriate to the requirements for admission to, and successful completion of rigorous biomedical research-focused doctoral degree programs.
Funded programs should have training objectives (i.e., specific, measurable, and obtainable outcomes the program intends to achieve) and implement evidence-informed training and mentoring activities that are grounded in the literature and from evaluations of existing relevant programs. Program objectives must align with the overarching goal of PREP. Funded programs are expected to provide evidence of accomplishing the training objectives in progress reports and upon renewal, to make training and career outcomes publicly available, and are strongly encouraged to disseminate successful training practices to the broader community.
PREPs should generate carefully designed individual development plans (IDPs) that build upon the participant’s experience, combined with research projects mentored by faculty members with active extramurally funded research programs. The development plans will typically be designed within the context of a one-year research education program to provide the necessary skills to prepare the participants to transition into and complete rigorous research-focused higher degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields.
Participants should not be appointed for less than one year, and it is the expectation that most PREP participants will transition to a rigorous biomedical, research-focused doctoral degree program following a one-year postbaccalaureate experience. NIGMS also recognizes that each participant has individual strengths and areas of academic development, and that a one-year program may not be sufficient for some to fully prepare to be competitive for a rigorous biomedical, research-focused doctoral degree program. Therefore, a second year of support is allowable at the discretion of the PREP Program Director/Principal Investigator (PD/PI) if within the awarded costs of a particular program. This does not require NIGMS preapproval but should be used selectively for those participants who would benefit from a second year in the program. The second year experience must enhance participants' competitiveness to enter a rigorous doctoral program and not simply allow participants more time to decide if they wish to obtain a graduate degree or to explore other career options. This program will not support individuals earning master's degrees or individuals who have previously earned a graduate or professional degree. Applications may request up to ten postbaccalaureate positions for each year of the grant for individuals to engage in mentored research experiences and courses for skills development.
PREP applications are institutional in nature and should reflect the plans and priorities of the applicant institution. Institutional commitment and support for the proposed training program are important elements of the application. The PREP program may complement and synergize with other ongoing federally-supported research training programs at the applicant institution (e.g., in the development of skills needed for careers in the biomedical research workforce); however, the PREP goals and activities to achieve those goals must be distinct from related programs currently receiving federal support at the same institution. In cases where an institution has multiple NIGMS training and diversity enhancing programs, it is expected that these programs will seek to create administrative efficiencies to reduce costs and improve participant services and outcomes. The research education grant should be well integrated within one or more department(s)/program(s) reflecting NIGMS mission areas. It is also anticipated that institutional PREP awards will help awardee institutions in achieving greater diversity in their doctoral programs, either through institutional change fostered by experience with the PREP program and/or through recruitment of successful PREP participants into those programs. PREP grants are usually awarded for five years.
It is expected that upon completion of the program, PREP participants transition into and complete rigorous research-focused higher degree doctoral programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields. Since PREP participants should have an interest in obtaining a research-focused higher doctoral degree as a condition of enrollment in the program, NIGMS expects that a successful PREP will provide the knowledge and skills such that the vast majority (e.g., greater than 75%) of its participants enter such programs within two years of completing PREP. Furthermore, with this expertise and experience, NIGMS expects that PREP participants who enter research-focused higher doctoral degree programs will complete the degree at rates comparable to or greater than students in similar disciplines at their institutions. Applicant institutions should design their program strategies within the context of the NIGMS's expectations and in line with their institutional settings and missions.
This Funding Opportunity Announcement (FOA) does not allow appointed participants to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is permitted.
Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Note: Appointed Participants are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The total direct costs for each award are limited to $400,000 annually.
The total project period may not exceed 5 years.
Salary support for the PD(s)/PI(s) [or combination of multiple PD(s)/PI(s)] is limited to up to a total of 1.2 person-months (10% full-time) effort per year depending on the number of participants in the program and the person-months devoted to administration of the program. Salary for a program coordinator to assist the PD(s)/PI(s) is limited to up to 6 person-months (50% full time) depending on the number of participants in the program and the person-months devoted to administration of the program. The duties and responsibilities of the program coordinator should be clearly defined in the application.
Remuneration for PREP participants is through salary and wages. The total compensation package for participants can include fringe benefits, and tuition remission and fees (if applicable and necessary for the program). PREP participants will be required to work as research postbaccalaureates devoting a minimum of 9 person-months (75% of full-time professional effort), and the remaining 3 person-months (25% effort) will be for further academic development. In order for the participant to receive this compensation, the following conditions must be met:
TRAVEL: Applicants may request support for travel of PREP participants to attend or present scientific papers at domestic scientific conferences. Requests for travel support must be carefully justified in the application.
Limited program evaluation costs are allowed up to a maximum of $3,000 for the 5 year project period. This includes salaries for evaluation consultants, if any.
A single consolidated budget for PREP is required, with each item clearly justified. The following items are unallowable costs for the PREP:
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For research education and training programs to enhance diversity, NIGMS recognizes separate institutional eligibility tracks: research-intensive, i.e., those with NIH research project grant (RPG) funding averaging greater than or equal to $7.5 million in total costs (direct and F&A/indirect) per year over the last three fiscal years; and research-active, i.e., those with NIH research project grant (RPG) funding averaging less than $7.5 million in total costs per year over the last three fiscal years (RPG data are available through NIH RePORT). For example, FY 2017, FY 2018 and FY 2019 for applications submitted in January 2020.
Institutional eligibility for this FOA is limited to research-intensive institutions (as defined above) that have strong biomedical Ph.D. degree programs in NIGMS mission areas. That is, institutions that are eligible for MARC or IMSD are eligible to apply, but those that are eligible for U-RISE or G-RISE are not eligible. Further, NIGMS encourages applications from highly research-intensive institutions (i.e., those with an average of NIH funding greater than or equal to $20 million total costs per year over the last three fiscal years) that have a significant number of faculty mentors with active and extramurally funded research programs (e.g., R01, R35 or equivalent awards) and robust research education environments.
An institution (normally identified by having a unique DUNS number or NIH IPF number) can have no more than one PREP award.
The sponsoring institution must assure support for the proposed program through an “Institutional Support Letter” within the “Letters of Support” attachment. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. Additionally, a signed letter is required from the Authorized Organization Representative/Business Official or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission according to the eligibility criteria indicated above. See the application instructions for the required “Letters of Support” attachment in Section IV.2.
Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
As described in the instructions for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in Section IV.2 below, NIGMS encourages multiple PD(s)/PI(s), particularly when each brings a unique perspective and skill set that will enhance the research education program. The PD(s)/PI(s) must be able to provide both administrative and scientific leadership to the development and implementation of the proposed program. At least one of the PD(s)/PI(s) should be an established investigator in the biomedical sciences. Additional PD(s)/PI(s), including individuals with experience in the science of education, relevant social science disciplines, program evaluation, mentoring, and university administration may be included to achieve the program goals. Any of the PD(s)/PI(s) may serve as the contact PD/PI. The contact PD/PI is expected to have a full-time appointment at the applicant institution unless extremely well-justified. If the full-time status of the contact PD/PI changes after the award, the institution must obtain prior program approval to appoint a new PD/PI or request a deviation from the full-time rule. The PD(s)/PI(s) will be responsible for the selection and appointment of participants to the approved research education program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) have responsibility for the day-to-day administration of the program and are responsible for appointing members of the Advisory Committee (when applicable) and using their recommendations to determine the appropriate allotment of funds.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The selected faculty should be trained researchers in the biomedical sciences as demonstrated by recent publications and research support. When building a team of mentors, programs should include faculty who are committed to training, mentoring, and providing supportive and inclusive research environments. Programs are encouraged to build a diverse team of preceptors/mentors that includes, for example, faculty from underrepresented groups (NIH's Interest in Diversity), women, and faculty at different career stages (i.e., early stage as well as senior faculty). Faculty should come from a wide variety of disciplines relevant to the NIGMS mission. Mentors must be committed to continue their involvement throughout the total period of the mentee's participation in this award.
The applicant institution will select the PREP participants who will receive salary support. It is the responsibility of the institution to establish the qualifications of the participants before they are supported by the program.
In order to receive salary support, the participant must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additionally, participants must have a baccalaureate degree in a biomedically relevant science from an accredited college or university awarded no more than 36 months prior to applying to a PREP, and must not be currently enrolled in a degree program. Parental, medical, or other well-justified leave for personal or family situations is not included in the 3-year eligibility limit, nor is national service (e.g., Peace Corps, or service in the National Guard or Armed Forces Reserves). All individuals selected as participants should intend to apply to research-focused biomedical doctoral degree programs (e.g., Ph.D. or M.D.-Ph.D.) during or immediately following completion of the research education program.
The overarching goal of this program is to develop a diverse pool of well-trained postbaccalaureate participants who will transition into and complete rigorous biomedical, research-focused higher degree doctoral programs. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, postdoctorate and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical sciences (e.g., see the Notice of NIH's of Interest in Diversity). For the purpose of this announcement, institutions are strongly encouraged to identify candidates who will enhance diversity on a national basis. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
Provide a brief description of the mission of the institution and its academic components. The application should describe how the level of institutional (and as appropriate departmental) commitment to excellence in research education will promote the success of the participants and program. A letter providing assurances of the institutional commitment must be included in the Letters of Support section of the application. Detailed instructions on the types of support are found below in the Letters of Support section of the FOA.
Advisory Committee Plan. An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application only if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file “Advisory_Committee.pdf”.
Outcomes Data Collection and Storage Plan (2-page maximum). Funded programs are expected to track participants for a minimum of 15 years beyond participation in the program. The applicant must provide a plan to track the outcomes for all supported participants. Programs are encouraged to make the aggregate outcome data available on the institution's website. If the applicant intends to make the data available, describe how the aggregate data will be deidentified before public posting. The applicant must include a strategy to ensure the secure storage and preservation of program data and outcomes. Describe how the data will be centralized, safeguarded, and retrievable during leadership changes. Please name the file “Data_Collection_Storage_Plan.pdf”.
Applications lacking an "Outcomes Data Collection and Storage Plan" attachment will be considered incomplete and will not be reviewed.
Training Data Table 4, Research Support of Participating Faculty Members, is a required attachment. Please follow the Instructions for the Data Tables [All Training Tables (Undergraduate Programs)]. Please name your file "Table 4 Research Support.pdf".
Applications lacking the "Training Data Table 4"attachment will be considered incomplete and will not be reviewed.
Training Data Table 8D (parts I and II, as applicable), Program Outcomes: Undergrad,
For renewal applicants. This is a required attachment to provide data on PREP postbaccalaureate participant outcomes. Please follow the Instructions for the Data Tables [All Training Tables (Undergraduate Programs)]. Please name your file "Table 8D Participant Outcomes.pdf". Renewal applications lacking this attachment will be considered incomplete and will not be reviewed.
For new applicant institutions. Training Table 8D (parts I and II) is not required and must not be included. Any relevant data can be summarized in the Research Education Program Plan.
No other data tables are permitted in the Other Attachments Section of the application. Inclusion of additional Training Data Tables will result in application withdrawal before peer review.The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:
Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.
The plan should describe an integrated set of activities that will develop a diverse pool of well-trained postbaccalaureate scientists who have the technical, operational and professional skills required to conduct research in an ethically responsible and rigorous manner, and to transition into and succeed in rigorous biomedical doctoral degree programs as described in the Program Objective. It is anticipated that several departments representing multiple biomedical disciplines within the NIGMS mission will be involved in the institutional PREP. Hence, the Proposed Research Education Program section of the PREP application should be organized to reflect the institutional scope of the proposed program. Applicants are encouraged to summarize what they view as especially important results contained in the data tables within the Research Education Program Plan of the application. This summary does not replace the data tables, and applicants are urged to ensure consistency between the summary and the relevant table information.
Include the following items in this section:
Current Status of the Graduate Biomedical Science Academic Programs: Describe the size of the graduate student body (Ph.D. level) in biomedically relevant disciplines. Provide institutional data on Ph.D. student enrollment from the last five years and indicate the percentage of students from underrepresented groups. Provide the number of Ph.D. students (overall and underrepresented groups) from the participating departments or programs, and their graduation rates for the last 5 years. Present this data in table format within the text (not in the appendix or with the required data tables).
Program Rationale, Mission, Objectives, and Overall Research Education Plan: Applications must include the rationale for the proposed PREP program as well as the feasibility of success in the context of the institutional setting. Describe and summarize institutional and externally sponsored programs to enhance diversity in the biomedical sciences at the participating institution within the last 5 years. Specifically, the application should describe the following:
Career Development. The application should describe how the program participants will:
Program Oversight, Participating Faculty Selection, and Mentor Training. The application should include the planned strategy and administrative structure to oversee and monitor the program and to ensure appropriate participant progress. The application should describe how the participating faculty are trained to ensure the use of evidence-informed approaches to teaching, training, and mentoring practices that promote the development of participants from all backgrounds, including participants from underrepresented groups in the biomedical sciences (e.g., NIH's Interest in Diversity). The application should describe the following:
If a program coordinator or administrator position is planned to enhance oversight, a description of the person's administrative capabilities that are essential to coordinate the program must be included in the application.
Progress Report: For renewal applications, include a detailed Progress Report. State the original specific measurable objectives, anticipated milestones, and outcomes. Provide a summary of the accomplishments of the PREP during the previous project period, with reference to participant research and/or other PREP-supported development activities, e.g., workshops, scientific meetings, or lectures. Summarize program outcomes (e.g., number of participants who matriculated into and completed PREP, percentage of participants who complete in one-year, number who matriculated into a biomedical research-oriented doctoral degree program and the number of these students who progress in good standing in their degree programs). Applications must provide PREP postbaccalaureate participant outcomes for all previous funding cycles up to 15 years by submitting Training Table 8D as an Other Attachment on the SF424 (R&R) Other Project Information form. Describe what has been learned through program assessment and any changes made in the program because of the assessment.
Program Director/Principal Investigator. The application should describe how the Research Education Program PD(s)/PI(s) will promote the success of the participants and research education program. NIGMS encourages multiple PD(s)/PI(s) (MPI), particularly when each brings a unique perspective and skill set that will enhance the research education program as described in the Eligible Individuals section above. The application should expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has:
The application must also describe the administrative structure and leadership succession plan for critical positions (e.g., PD(s)/PI(s)).
Program Faculty. The application should describe how the participating faculty will promote the success of the participants and research education program. Describe how the program has or will build a diverse team of participating faculty (e.g., individuals from underrepresented backgrounds, women, and faculty at different career stages) to help participants gain access to potential role models within the research education program and to enhance the excellence of the research environment. Summarize and expand on the material presented in the Training Table 4 and biosketches. The application should address how the participating faculty:
Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Provide the criteria and strategy for PREP participant selection. Program candidates should have the potential to strongly benefit from, and with proper support, succeed in the program and transition into rigorous research-oriented doctoral degree programs. Applications should explain why participants will strongly benefit from being in the PREP program rather than going directly to doctoral-degree granting programs. Strategies for ensuring that participants have sufficient commitment to careers in biomedical research should be described.
Recruitment Plan to Enhance Diversity. Applicants are required to provide a Recruitment Plan to Enhance Diversity. The application should include outreach strategies and activities designed to recruit potential research education program participants who are from diverse backgrounds, e.g., recent baccalaureate graduates from underrepresented racial and ethnic groups, students from disadvantaged backgrounds, and individuals with disabilities (see NIH's Interest in Diversity). Applicants are encouraged to consult the NIGMS webpage for strategies to enhance diversity in training programs when designing their plans. Describe the specific efforts to be undertaken by the training program and how these might coordinate with recruitment efforts of the institution. Centralized institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups. Participating faculty are expected to be actively involved in recruitment efforts.
New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of participants from underrepresented backgrounds and may wish to include data in support of past accomplishments. Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.
Applications lacking a recruitment plan to enhance diversity will not be reviewed.
Plan for Instruction in Methods for Enhancing Reproducibility. Applicants are required to provide a Plan for Instruction in Methods for Enhancing Reproducibility. The plan must describe how participants will be instructed in principles important for enhancing research reproducibility including, at a minimum, critical evaluation of foundational research underlying a project, rigorous experimental design and data interpretation, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting. Applicants are encouraged to consult the NIGMS clearinghouse for training modules to enhance data reproducibility and other resources when developing the plans. Describe how instruction strategies are sufficiently well integrated into the overall curriculum, that is, how they are taught at multiple stages of participant development and in a variety of formats and contexts. Describe how all participating faculty will reiterate and augment key elements of methods for enhancing scientific rigor and reproducibility when program participants are performing research in their laboratories.
Applications lacking a plan for instruction in methods for enhancing reproducibility will not be reviewed.
Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.
Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.
Evaluation Plan. NIGMS funded research education programs must conduct ongoing evaluations to monitor the success of the programmatic and mentoring activities. The application should:
Applications lacking an evaluation plan will not be reviewed.
Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.
Applications lacking a dissemination plan will not be reviewed.Letters of Support
A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment.
Institutional Support Letter (10-page maximum). The application must include a signed letter on institutional letterhead from a President, Provost, Dean, or similar key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned research education program and its participants. As applicable, the letter should address how the institution: promotes a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct are advanced; provides opportunities for early stage faculty and those with a hiatus in research support to participate in training; supports core facilities and technology resources that can be used to enhance the research education program; provides adequate staff, facilities, and educational resources to the planned program; supports the PDs/PIs and other key staff associated with the planned research education program; ensures that faculty have protected time available to devote to mentoring, training and research; fosters and rewards excellence in research training and mentoring (for example, through institutional policies); provides support for remediation or removal of Participating Faculty who are poorly performing mentors; promotes diversity and inclusion at all levels of the research training environment (trainees, staff, faculty, and leadership); ensures that the research and clinical facilities as well as the laboratory and clinical practices promote the safety of the participants; ensures that the research and clinical facilities are accessible to participants with disabilities; promotes a positive, supportive and inclusive research, clinical and training environment for individuals from all backgrounds; ensures that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices and to appropriately respond to allegations of such discriminatory practices, including providing any required notifications to NIH (e.g., requesting a change of PD/PI status; see NOT-OD-19-029); ensures trainees and participants have access to appropriate support services, such as healthcare, counseling services, and housing; and provides resources and expertise for evaluating the outcomes of the program. For institutions that have multiple NIGMS training and research education programs, the letter should also explain how the programs will synergize and share resources when appropriate. All information related to institutional support, as defined above, must be included within the 10-page limit of this letter.
Applications lacking the Institutional Support Letter will be considered incomplete and will not be reviewed.
Institutional Eligibility Letter. (1-page maximum). The Authorized Organization Representative/Business Official or similar official with institution-wide responsibility must certify that all the components of the institution under the applicant DUNS number together have received support from the NIH greater than or equal to an average of $7.5 million per year (in both direct and F&A/indirect costs) in the past 3 fiscal years, as described in Section III, "Eligible Organizations". If this letter is not included, the application will be considered incomplete and will not be reviewed.
Applications lacking the Institutional Eligibility Letter will be considered incomplete and will not be reviewed.
Other Letters of Support. Additional letters of support (such as those from partner institutions or organizations) are permitted; however, these letters may not contain any information required in the Institutional Support Letter.
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
The Appendix is meant to provide additional details to the following topics, but not meant to substitute for clear descriptions in the body of the application. Do not include items other than the allowable materials described below, as doing so will result in administrative withdrawal of the application. A summary sheet listing all the items included in the Appendix may be included in the first page of the Appendix attachment.
The following are required Appendix materials:
The following are allowable Appendix materials:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the NIH Center for Scientific Review and the NIGMS Office of Scientific Review. Applications that are incomplete or non-compliant will not be reviewed.
For the purpose of this FOA, follow the post-submission instructions for institutional training and training-related (e.g. T32 and T34) grants.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The goal of this R25 program is to support educational activities that prepare postbaccalaureates from diverse backgrounds to transition into and complete rigorous research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields.
Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?
Specific to this FOA: Is there convincing evidence that the proposed research education program will provide participants from diverse backgrounds with the experiences and skills that will allow them to transition into and complete rigorous biomedical, research-focused doctoral degree programs?
Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: Do the PD(s)/PI(s) have a demonstrated commitment to training the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments? Does at least one member of the PD/PI team have a demonstrated record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting in a biomedical field? Do the PD(s)/PI(s) have the time to commit sufficient effort to ensure the program’s success, given their other professional obligations? Have the PD(s)/PI(s) received training on how to effectively mentor participants, including those from underrepresented groups, and promote inclusive, safe, and supportive research training environments? Do participating faculty come from a broad range of biomedical disciplines within the NIGMS mission to provide a breadth of potential research experiences to participants? Do the participating faculty have a record of conducting ethically sound and responsible scientific research, and of rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results? Do the selected participating faculty come from diverse backgrounds (e.g., for individuals from groups underrepresented in the biomedical sciences, women, as well as faculty at different career stages)? If not, are there plans to recruit faculty to enhance the program faculty diversity? Do the participating faculty have the time to commit sufficient effort to ensure the participants' development and success, given their other professional obligations?
Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest effective practices to improve the knowledge and/or skills of the intended audience?
Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?
Specific to this FOA: Will the research experiences, courses for skills development, and structured activities achieve the stated mission and objectives of the research education program? Are the rationale and strategies for recruiting and selecting participants who strongly benefit from being in the PREP program rather than going directly to research-focused doctoral programs well conceived? Does the program provide research experiences in a broad range of biomedical disciplines within and relevant to the NIGMS mission? Does the program employ modern, evidence-informed approaches to training, mentorship, inclusion, and professional development? Are the activities likely to build a strong cohort of research-oriented individuals while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members? Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely progress for the participants? Is there a clear mechanism for matching the participants with appropriate participating faculty, and for monitoring mentoring, including oversight of the effectiveness of the participant/faculty match? Is there a plan for removing participating faculty displaying unacceptable mentorship qualities from the training program? If a program coordinator or administrator position is planned, is there a description of the person's administrative capabilities that are essential to coordinate the program?
Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
Specific to this FOA: Is there clear institutional commitment to develop and promote a culture in which the highest standards of scientific rigor, reproducibility, and responsible conduct of research are advanced? Are the core facilities and technology resources necessary for the success of the program well supported? Is there evidence that the research facilities and laboratory practices ensure the safety of program participants (and trainees generally)? Is there evidence that the institution fosters and rewards excellence in training and mentoring (for example, through institutional policies)? Are diversity and inclusion promoted at all levels of the research environment (participants/trainees, staff, faculty, and leadership)? Are appropriate policies and procedures in place to protect the participants from harassment and other prohibited practices? Are the research facilities accessible to participants/trainees with disabilities?
Training in Methods for Enhancing Reproducibility
Does the Instruction in Methods for Enhancing Reproducibility plan describe how participants will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of the rigor of the prior research that serves as the key support for a proposed project, rigorous experimental design, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency components sufficiently well integrated into the overall research education program? Are they taught at multiple stages of participant development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance participants' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when participants are performing mentored research their laboratories? The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in recruiting individuals from diverse populations, consistent with PREP’s Program Objective.
Recruitment Plan to Enhance Diversity
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.
If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIGMS Office of Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.
Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide. The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Other Reporting Requirements
Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.
In evaluating this research education program NIGMS expects to use the following evaluation measures:
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National Institute of General Medical Sciences (NIGMS)
National Institute of General Medical Sciences (NIGMS)
Stephanie Constant, Ph.D.
National Institute of General Medical Sciences
National Institute of General Medical Sciences
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