EXPIRED
National Institutes of Health (NIH)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Institute of General Medical Sciences (NIGMS) (https://www.nigms.nih.gov/Pages/default.aspx) on behalf of the NIH.
National Research Mentoring Network: The Science of Mentoring, Networking, and Navigating Career Transition Points (U01 Clinical Trial Not Allowed)
U01 Research Project Cooperative Agreements
New
RFA-RM-18-004
RFA-RM-18-006, U54 Specialized Center- Cooperative Agreements
RFA-RM-18-002, U24 Resource-Related Research Projects Cooperative Agreements
RFA-RM-18-003, U24 Resource-Related Research Projects Cooperative Agreements
RFA-RM-18-005, U54 Cooperative Agreements
RFA-RM-19-003, U01 Research Project Cooperative Agreements
93.310
The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for the second phase of the NIH National Research Mentoring Network (NRMN) efforts. The NRMN is a nationwide consortium that was designed to enhance mentoring and career development of individuals from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce. This new cycle of NRMN will expand the scientific scope of the program to encourage grants with varied approaches aimed at the science of mentorship, networking, and navigating critical career transition points. The NRMN will be a set of cooperative agreements in which the Program Directors/Principal Investigators (PDs/PIs) will work through a NRMN Coordination Center and the NRMN Resource Center to disseminate effective resources. The NRMN research is expected to align with the hallmarks of success that have been defined by the Diversity Program Consortium and the Center for Evaluation and Coordination (CEC).
February 16, 2018
May 11, 2018
30 days prior to the application due date
June 11, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
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.
Not Applicable
October - November 2018
January 2019
July 2019
June 12, 2018
Not Applicable
It is critical that applicants follow 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 the 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The NIH recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from diverse backgrounds, including those from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences workforce because scientists and trainees from different backgrounds bring a variety of perspectives, creativity, and individual enterprise to address complex scientific problems. A diverse NIH-supported scientific workforce will also improve global competitiveness, contribute to robust learning environments, and enhance public trust.
The United States has seen an increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from groups and backgrounds traditionally underrepresented in the biomedical sciences (Gibbs, et al., 2016, eLife 2016;5:e21393); however, the attrition of scientists from underrepresented groups from biomedical research pathways continues to be an issue (Valantine, Lund & Gammie, CBE-Life Sciences Education, 2016, 15:fe4, 1-5).
With the recognized need to enhance diversity in the biomedical research workforce, the NIH Director requested input from the NIH Advisory Committee to the Director (ACD) regarding actions that the NIH should take to make transformative progress in this area. In 2012, the ACD Working Group on Diversity in the Biomedical Research Workforce explored ways to improve the recruitment of individuals from diverse backgrounds, including those underrepresented in biomedical research and methods to sustain their interest in and prepare them for successful biomedical research careers. The Working Group provided recommendations, endorsed by the ACD, about ways to develop and support individuals from diverse backgrounds, including those from groups underrepresented in the biomedical sciences, throughout their research career (from undergraduate study to acquisition of tenure in an academic position or the equivalent in a non-academic setting). In response to these recommendations, the NIH established the Common Fund Program "Enhancing the Diversity of the NIH-Funded Workforce," also known as the Diversity Program Consortium (DPC).
The first phase of the Enhancing the Diversity of the NIH-Funded Workforce Common Fund program allowed for the formation of a national consortium through which awardee institutions, in partnership with the NIH, began implementing and evaluating training and mentoring programs to engage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical sciences and help them prepare for and succeed in biomedical research careers. The DPC was developed in the context of existing programs through which NIH and other entities have made significant investments to engage scientists and institutions using a variety of training, mentoring, and research capacity-building approaches. Although these programs have shown positive outcomes for trainees and participants, data on the specific factors that contribute to successful outcomes is limited. The primary goal of the DPC is to provide robust evidence on effective ways to engage and sustain the interest of individuals from diverse backgrounds, including those from underrepresented groups in the biomedical research workforce and to encourage the dissemination of successful interventions to a wide variety of institutions across the United States.
The first phase of the program provided an opportunity to establish the types of interventions and evaluative frameworks needed to begin understanding and addressing multi-dimensional factors that strongly influence success. The DPC implemented interventions and evaluative practices designed to understand effective approaches to mentoring, student engagement, research capacity building, faculty development, and infrastructure development. The interventions were designed around the following questions:
The second, and final, phase of this program, will allow the DPC to continue gathering data required to address the questions listed above and to assess the longer-term outcomes. During this phase, grantees are expected to refine their approaches and evaluations and to focus on sustainability and dissemination of successful interventions to enhance diversity in the biomedical research workforce. Additional relevant questions for the final phase include, but are not limited to:
The program consists of three highly integrated initiatives, in which awardees work together as the Diversity Program Consortium. The three components are described below.
The Building Infrastructure Leading to Diversity (BUILD) Initiative:
The BUILD initiative was designed to allow sites to implement and study innovative approaches to engaging and sustaining the interest of trainees from diverse backgrounds, including those from underrepresented groups, potentially helping them on the pathway to become future contributors to the NIH-funded research enterprise. BUILD sites were also funded to implement interventions at the faculty and institutional levels to maximize opportunities for faculty development and research capacity building. An integral component of the BUILD initiative is the long-term evaluation of the interventions. In the first phase, awardees were selected because they identified needs at their institutions and proposed robust approaches to understanding how certain interventions could enhance the diversity of the biomedical research workforce. In the second phase, awardees demonstrating rigorous preliminary results will continue to evaluate the interventions to understand the longer-term impact of the programs and will continue to focus on building research capacity to successfully compete for research and training grants. Awardee institutions are also expected to develop sustainability plans and dissemination methods, which will broaden the Diversity Program Consortium's impact to non-BUILD institutions, and provide more institutions with opportunities to increase the persistence of biomedical trainees from diverse backgrounds, including those from underrepresented groups and enhance the research capacity in biomedical research-related fields.
The National Research Mentoring Network (NRMN) Consortium:
Mentorship is crucial in the development of any scientist's career; however, the ACD Working Group on Diversity noted that the community lacks evidence on how to promote successful mentoring relationships for trainees from diverse backgrounds, including those from underrepresented backgrounds. The NRMN was developed to understand the elements that contribute to productive mentoring relationships for individuals from diverse backgrounds, including those from underrepresented groups, and to develop mentoring tools and resources across the national community of researchers in the biomedical research workforce.
During the first phase of the program, the NRMN was tasked with developing a highly networked set of motivated and skilled mentors from various disciplines linked to mentees across the country. In addition, the NRMN cores were selected to provide training opportunities for mentors, to facilitate networking and professional opportunities, and to collect data on effective practices for mentoring. As part of the Diversity Program Consortium, the NRMN contributed to the development of hallmarks of success and participated in data collection in collaboration with the Coordination and Evaluation Center (CEC).
In the second phase of the program, the NRMN initiative will continue to develop mentoring and networking opportunities for biomedical researchers from diverse backgrounds, including those from underrepresented groups, from undergraduates through early career faculty. To broaden the number of innovative strategies explored and increase the likelihood of impact, sustainability, and dissemination, the NRMN will be organized as a consortium of independent research projects, a Resource Center, and a Coordinating Center. The NRMN Coordinating and Resource Centers will work with the independent research projects to enhance dissemination and to promote synergies to provide evidence and resources for effective mentoring to enhance the diversity of the biomedical research workforce. The NRMN Coordination Center will coordinate data collection and storage with the CEC, and build upon and improve instruments and processes developed in the first funding period.
The Coordination and Evaluation Center (CEC):
The scale of the DPC's scientific approach necessitated a center to coordinate the consortium-wide evaluation and data collection efforts, and to store the vast amount of data collected. During the first phase, the CEC was responsible for coordinating consortium-wide activities and working with the BUILD and NRMN programs to develop site-specific and consortium-wide hallmarks of success, robust evaluation plans, and the data sharing agreement. These consortium-wide development activities were established through consensus in Executive Steering Committee meetings (See Section VI for details about the Executive Steering Committee). The CEC coordinated the clearance through the Office of Management and Budget to allow for the secure collection and reporting of data from BUILD and NRMN awardees. The CEC also facilitated consortium-wide working groups, meetings, discussions of approaches, progress, and lessons learned.
The CEC's evaluation activities and coordination responsibilities will continue in the second phase of the program. The consortium-wide hallmarks and consortium-wide evaluation plans will be maintained during the second phase, and the CEC will work closely with BUILD and NRMN awardees to gather data and conduct program evaluations. In addition, the CEC will increase outreach and dissemination of successful interventions.
The long-term impact of this catalytic, trans-NIH program will be in the broad dissemination of effective, evidence-based training and mentoring strategies. The DPC's method of taking a scientific approach to understand training interventions is an innovative design that is likely to serve as a model for biomedical training programs across the Nation.
Effective mentoring and professional networking are associated with increased self-efficacy, educational and career satisfaction, career advancement, and research productivity for individuals pursuing biomedical research careers. It is the purpose of this FOA to support research to provide a strong scientific foundation for the effectiveness of mentoring and networking interventions for trainees from diverse backgrounds, including those from underrepresented groups.
The awards to be funded through this announcement are intended to build the knowledge base to allow the biomedical training community to use evidence-based mentoring and networking approaches to advance the careers of individuals from diverse backgrounds, including those from underrepresented groups in the biomedical research workforce. The grantees are expected to use robust experimental designs including randomized control trial approaches, case controls, matched pair design or other rigorous designs appropriate to the research questions. The mentoring and networking interventions are to be centered not only on psychosocial factors (e.g., engagement, belonging, science identity, self-efficacy, career satisfaction), but also outcomes (e.g., success in career transition, grant submissions, publications) so that the funded grants will inform the biomedical community on what factors influence and foster a sustained career in the biomedical research workforce and why those factors have an influence. The research questions are expected to move beyond participation satisfaction, self-reporting of perceived skills gained, or self-reporting of effectiveness.
As appropriate, the proposed studies should inform the field about the effectiveness of the duration, frequency, and intensity of the intervention and whether those effects can be enhanced by reinforcement sessions. The proposed projects should provide the scientific community with sound evidence of short, medium, and long-term effects of the intervention's efficacy. The interventions should be cost-effective, practical, realistic, and sustainable at a broad range of institutions.
The following research areas are possible areas for exploration; however, applications describing other aspects of interventions to enhance mentoring and networking are also encouraged.
The science of mentorship. Applications in this area will inform the community about which kinds of mentoring relationships, strategies and approaches have significant impacts on academic and professional successes of individuals from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce. Examples in this area include, but are not limited to, testing interventions that enhance:
Professional networks. The outcomes from these studies should inform the community how individuals from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce can build and sustain effective professional networks to promote their career advancement and network structure. Applications in this area may include, but are not limited to, determining effective strategies for:
Navigation of critical transition points (e.g., early career faculty-level to tenure; post-doctoral training to early career faculty-level; graduate student to post-doctoral training). Research in this area will inform the community about the kinds of interventions that aid in the timely transition and career progression of individuals from diverse backgrounds, including those underrepresented in the biomedical research workforce. The research should focus on institutional and organizational contexts. The results should be applicable to a broad range of institution types. Examples of studies in this area include, but are not limited to, determining effectiveness of the following:
Applications with the following will be deemed non-responsive and will be withdrawn without review:
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials
Need help determining whether you are doing a clinical trial?
NIH intends to commit $7.8M total costs per year to fund up to 15 awards.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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
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 underrepresented racial and ethnic groups as well as individuals with disabilities 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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms 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 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 may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Mercedes Rubio, Ph.D.
Telephone: 301-594-3900
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed. In addition, funds for the PD(s)/PI(s) to attend the annual grantees meetings should be budgeted.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Applicants should address the following areas:
The applicant should provide a detailed timeline with quantitative measures for achieving milestones integral to the success of the project. Applications should provide plans for identifying impediments and critical decision points that could require a revision in the work plan. NIGMS program staff will use the milestones to assess progress. Continued funding is dependent upon showing progress on an annual basis.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
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:
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Use only for applications with due dates on or after January 25, 2018. 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.
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.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
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. See Section III of this FOA for information on registration requirements.
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. 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 Center for Scientific Review and responsiveness by the National Institute of General Medical Sciences (NIGMS), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the application articulate how the findings could have a national impact to change the practices of mentoring, building and sustaining of robust networks, or navigating career transition points?
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: Does the application describe a robust scientific approach to understanding the factors that contribute to an effective mentoring or networking intervention designed to recruit and sustain the interest of individuals from diverse backgrounds, including those from underrepresented groups in the biomedical research workforce? Does the research move beyond participation satisfaction, self-reporting of perceived skills gained, or self-reporting of effectiveness?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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 PDs/PIs have the time to commit sufficient effort to ensure the success of the research effort, given their other professional obligations?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Does the application seek to shift current practices by providing evidence for and how to evaluate what are effective mentoring or networking interventions, and why they are effective?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA: Do the aims of the project align with the stated goals of the DPC and the NRMN? Will the investigators adhere to the evaluation practices of the DPC, including using the hallmarks of success?
Is there a stated commitment to working as part of a NRMN consortium with a NRMN Coordination Center and the NRMN Resource Center?
How likely is it that the proposed research will generate data that will lead to meaningful conclusions? Will the proposed project provide the scientific community sound evidence of immediate and long-term effects of the intervention's efficacy?
If applicable, will the proposed studies inform the field about the duration, frequency, and intensity of the intervention effects, and whether those effects can be enhanced by reinforcement sessions?
Is the intervention cost-effective, practical, realistic, and sustainable at a broad range of institutions?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the six 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 six 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 children 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.
Not Applicable
Not Applicable
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
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; (3) Genomic Data Sharing Plan (GDS); and (4) Software Dissemination Plan.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 NIGMS, 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:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
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.5. 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.
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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.
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.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH
grant administration policies.
The administrative and funding instrument used for this program will continue
as a cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated to continue during the performance
of the activities during the second phase of the project. Under the cooperative
agreement, the NIH purpose remains to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility has been and will remain
with the awardees for the project as a whole, although specific tasks and
activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff will continue to have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of joint responsibility include:
A Steering Committee will remain as the primary governing board for the cooperative agreement funded under this FOA. The Steering Committee membership will include the NIH Program Official(s), NIH Project Scientist(s), the PD(s)/PI(s) of the awarded cooperative agreement, who will serve as Steering Committee Chair(s), and two external members not involved in the project who are selected by the PD(s)/PI(s). Additional members of the Enhancing the Diversity of the NIH-Funded Workforce Working Group may be appointed to the Steering Committee by the co-chairs of the Working Group, but the total number of NIH votes may not exceed 1/3 of the Steering Committee voting membership. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions.
The Steering Committee will:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
Executive Steering Committee:
An Executive Steering Committee (ESC) remains responsible for providing general oversight and guidance to the Diversity Program Consortium awardees. The ESC membership will continue to include one non-NIH member from the Steering Committee of each of the BUILD, NRMN, and CEC awards, the NIH Program Official and/or Project Scientists for each program, and a member of the Enhancing the Diversity of the NIH-Funded Workforce Working Group, who will serve as ESC Chair. The co-chairs of the Enhancing the Diversity of the NIH-Funded Workforce Working Group may appoint additional members from the Working Group to serve as members on the ESC, but the total number of NIH votes may not exceed 1/3 of the Executive Committee voting membership. Awardee members of the DPC will be required to accept and implement policies approved by the ESC. The CEC will be responsible for communicating ESC feedback and guidance to the BUILD, NRMN, and CEC Steering Committees.
The ESC will meet through monthly conference calls and at least once annually in person.
Responsibilities of the ESC include the following:
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
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.
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system problems
that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]
GrantsInfo
(Questions regarding application instructions and process, finding NIH grant
resources)
Email: [email protected] (preferred method
of contact)
Telephone: 301-945-7573
Mercedes Rubio, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: [email protected]
Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]
Kaneisha Akinpelumi, M.S.W.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3915
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301, 402 and 405 of the Public Health Service Act as amended (42 USC 241, 282, and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.