National Institutes of Health (NIH)
R25 Education Projects
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
May 6, 2022 - Notice of NICHD Participation in PAR-22-118. See Notice NOT-HD-22-021
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that foster a better understanding of the ethics of biomedical, behavioral and clinical research and its implications.
To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:
The Fogarty International Bioethics Training Program aims to increase the number of research intensive institutions in low- and middle-income countries (LMICs) that can provide advanced education in international research ethics. This FOA will support innovative LMIC master's level research ethics education programs proposing integrated activities to develop culturally appropriate foundational research ethics curriculum, research ethics career skills development courses, ethics research or practicum experiences, and effective mentoring approaches. Education programs supported by this initiative should equip scientists, health professionals and academics in these countries with in-depth knowledge of the ethical principles, processes and policies related to international research. Programs should be designed to strengthen the critical competencies needed to provide research ethics education, ethical review leadership and expert consultation to LMIC researchers, their academic or research institutions, governments and international health research organizations to enhance the application of research ethics principles.
May 7, 2022, May 6, 2023, May 6, 2024
|Application Due Dates||Review and Award Cycles|
|New||Renewal / Resubmission / Revision (as allowed)||AIDS||Scientific Merit Review||Advisory Council Review||Earliest Start Date|
|June 07, 2022||June 07, 2022||Not Applicable||November 2022||January 2023||April 2023|
|June 06, 2023||June 06, 2023||Not Applicable||November 2023||January 2024||April 2024|
|June 06, 2024||June 06, 2024||Not Applicable||November 2024||January 2025||April 2025|
All applications are due by 5:00 PM local time of applicant organization.
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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 overarching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications.
In response to the increasing amount of collaborative global health research and the unique scope of associated ethical concerns in low- and middle-income countries (LMICs), FIC and other NIH ICs supported International Research Ethics Education and Curriculum Development awards since FY2000. To address the continuing needs for in depth international research ethics education as well as evolving, complex ethical issues in research, this initiative will support the establishment and enhancement of sustainable master's level research ethics training at research intensive LMIC institutions. An additional funding opportunity, International Bioethics Research Training Program (D43) (PAR-22-116) supports LMIC Ph.D. and postdoctoral training programs.
This initiative will strengthen research ethics capacity in LMICs through increasing the number of LMIC research intensive institutions that can provide advanced (masters level) education in research ethics. Programs supported by this initiative will equip multiple participants such as scientists, health professionals and academics in these countries with in-depth knowledge of the ethical principles, processes and policies related to global health research. Programs will also strengthen the critical competencies needed to provide research ethics education, ethical review leadership and expert consultation to researchers, their institutions, governments, and international research organizations.
To accomplish this over-arching goal, this FOA will support LMIC, U.S. and other high income country (HIC) bioethics experts to collaborate in the development of innovative, comprehensive, master's level, socio-culturally relevant ethics education programs at research intensive institutions in LMICs which must include all of the following as integrated components:
Applicants must begin to implement components of the proposed master's level research ethics education program at the LMIC institution within one year after award.
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.
Not Allowed: Only accepting applications that do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Applications may request up to $230,000 direct costs per year.
The total project period may not exceed 5 years.
Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).
This R25 program is not intended as a substitute for an institutional research training program (e.g. D43). With sufficient justification, applicants may request costs to support either part-time or full time participants in the proposed education program.
Participants should be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.
Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.
While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray tuition and other education-related expenses.
Expenses for foreign travel must be exceptionally well justified.
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
Applicants may request support for bioethics education and curriculum development materials, practicum or research experience costs, publication costs for journal articles, and related costs.
Applicants may request support for participants to travel to relevant bioethics educational, career, and research conferences.
Applicants should plan to attend an annual networking meeting at NIH to share information, exchange best practices, and establish collaborations.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
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:
New applications may be submitted by U.S., HIC or LMIC research intensive institutions, however, all applications from U.S. or other HIC institutions must include a collaborating institution from a LMIC (defined by the World Bank classification system- also refer to NOT-TW-12-011"Notice of Change in Country Eligibility for Fogarty International Training Grants", for additional information).
Renewal applications from U.S. or other HIC institutions are strongly encouraged to transfer grant leadership to the previous collaborating LMIC institution.
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
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 eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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 ethics education program 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.
The PD/PI should be an established expert in international bioethics and have extensive experience in the LMIC that is the focus of the proposed program and capable of providing both administrative and research ethics leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
U.S. or HIC applicants are encouraged to designate LMIC bioethicists as MPIs.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
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 per 22.214.171.124 Submission of Resubmission Application. This means that the NIH will not accept:
Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research ethics expertise and LMIC experience relevant to the proposed program, including but not limited to expertise in the philosophical foundations of bioethics, behavioral or social science or other empirical methods used for empirical bioethics investigation, global health policy or legal analysis and scholarship, and ethics of medical care. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.
Only individuals who are citizens of LMICs (defined by the World Bank classification system- also refer to NOT-TW-12-011 "Notice of Change in Country Eligibility for Fogarty International Training Grants", for additional information) are eligible for ethics education support or other educational activities proposed. Applicants are encouraged to recruit participants from diverse backgrounds, persons with disabilities, and women.
1. Requesting an Application Package
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.
2. Content and Form of Application Submission
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.
Letter of Intent
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:
Barbara Sina Ph.D.
Note: Effective for due dates on or after January 25, 2023 a Data Management and Sharing Plan is not applicable for this FOA.
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.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Include the applicant institution and all the collaborating institutions where training will occur, both U.S. and foreign, as performance sites.
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, 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 ethics training and education following the format for Current and Pending Support.
Project Summary/Abstract. Provide an abstract summarizing the entire application. Include the collaborators and overall design of the research ethics education program proposed, as well as key activities and components. Indicate the planned duration of master's level training provided, the projected number, LMIC institution and types of participants to be recruited and intended participant outcomes.
An Advisory Committee is a required component of a Research Ethics Education program. Proposed Advisory Committee members should be named in the application. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Members should not be affiliated with the program and a majority of members should be from the LMIC focus of the application. Describe how the Advisory Committee will contribute to the selection of participants as well as the development, implementation and evaluation of the overall effectiveness of the program. Please name your file “Advisory_Committee.pdf”.
Progress Report for Renewal Applications
Renewal applications must include progress reports with detailed information about all participants and activities supported during the previous grant period. This includes a comprehensive list of all participants and participant status after involvement in the program—including type and length of education provided and description of practicum projects; country of residence and institution of employment; and the participant's current position and responsibilities to provide research ethics training, review or consultation; research ethics publications; and other significant accomplishments related to the research ethics education provided. Include a list of research ethics publications arising from projects conducted by participants (mark participant author names in each citation) since the start of program participation. Please name your file “Progress_Report.pdf”.
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.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Follow all instructions provided in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:
Research Education Program Plan
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 U.S. government support. When research ethics training programs are on-going in the same institution, the applicant organization should clearly distinguish between the activities in the proposed research ethics education program and the research ethics training supported by the training program.
A detailed assessment of the needs and opportunities for research ethics education and the current status of the ethics review of research at the research intensive LMIC institution where the proposed curriculum will be implemented should be provided as rationale for the specific program plan proposed. The description of the research intensive LMIC institution should include a summary of the active human subject research and the current biomedical, behavioral and clinical research training conducted at this institution and its ethical review capabilities that may benefit from the proposed research ethics education program.
Bioethics experts in LMICs, the U.S. or other high-income countries (HICs) should collaborate to develop the proposed research ethics education program, however, LMICs faculty with research ethics expertise should play leading roles in the proposed activities to insure the relevance of the curriculum to the LMIC context and LMIC institutional sustainability. The designation of LMIC bioethicists as multiple PDs/PIs should be considered.
Applicants should describe the collaborative history of the LMIC, U.S. and other HIC institutions involved in the proposed program. Plans for each component of the proposed research education program should include a description of the collaborators involved.
Applicants are encouraged to collaborate with FIC research and research training programs (http://www.fic.nih.gov/Programs/Pages/default.aspx) or other NIH grantees working at the LMIC institutions where participants will be recruited.
Applications should describe an integrated program including all four required components (curriculum development, research and/or practicum experiences, courses for skills development, and mentoring activities). Detailed plans for master's level programs for up to two years and no less than 12 months should be included. It is expected that the applicant and collaborators will design and implement a master's level research ethics education program at the LMIC institution within one year after award. If justified, plans may include a phased transfer of teaching and mentoring responsibilities to LMIC faculty to implement the complete curriculum proposed at the LMIC institution by the end of the five-year grant period, with continued U.S. or other HIC faculty involvement, as needed.
Programs should include a balance of a series of didactic foundational international research ethics courses cohesively designed to build a sustainable masters level research ethics education program at the LMIC institution. Applicants should describe a core set of master's level courses that focus on the relevant aspects of ethical, legal, and moral principles guiding international research involving human subjects. Proposed courses should reflect recent scholarship and employ innovative adult pedagogical approaches. Proposed ethics courses should cover the ethical principles and theories relevant to research ethics; LMIC socio-culturally relevant research ethics case studies; the concepts of informed consent, risk and benefits, vulnerability, privacy and confidentiality; international ethical issues in research; and responsible conduct of research. Curriculum imbued with culturally and scientifically relevant ethics topics to address likely LMIC participant needs and interests is strongly encouraged. Descriptions of courses and other proposed activities should include proposed faculty, learning objectives, specific knowledge and skills imparted to participants, duration, assessments, and resource materials provided.
Components of the curriculum may be delivered by distance learning technology. Include an explanation of why the proposed distance learning approach is appropriate for the curriculum topic and sustainable at the LMIC institution and for the LMIC participants involved. Applicants should provide evidence of the technical feasibility of the distance learning format proposed in the LMIC setting.
Special Interest Courses and Interests of Participating ICs
Applicants are also encouraged to design and integrate special courses or program activities into the core curriculum that focus on ethical issues of current interest to researchers working in LMICs (such as research with human specimens; design and conduct of clinical trials; research with pregnant women, children and other vulnerable populations; community engagement in research; public health practice; and decision-making) or topics related to research supported by the participating NIH ICs such as:
NHGRI: Ethical, legal, regulatory, policy, economic, cultural, and societal issues raised by the advancement and use of genomics. These issues may relate to the design and conduct of genetic and genomic research; the translation of genetic and genomic research into clinical medicine and health care; the interplay among a broad array of stakeholders in the field of genomics; and the value and meaning of genomics for the broader public. Examples of possible topics of interest are available on the ELSI Research Areas and Sample Topics website: https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program/research-areas
NIAID: Ethical issues relevant to international collaborative research on HIV/AIDS, TB, malaria, and other infectious diseases; ethics of clinical trials and implementation science; and other ethical issues relevant to NIAID's scientific mission.
Research or Practicum Experiences
Programs should include mentored ethics research or practicum experiences that build on the foundational bioethical knowledge provided by the proposed curriculum.
Each participant should be matched to a LMIC, U.S. or other HIC faculty expert in the bioethics area of the participant's practicum or research project to provide guidance and oversight.
Practicum and research project participants should receive mentored training on how to disseminate the results of these experiences through publication or other formats appropriate for the intended audiences.
Practicum experiences may include but are not limited to mentored participation in ethical review committees, development of research ethics courses/workshops for researchers and ethical review committee members or the creation or implementation of ethical review guidelines or processes.
Mentored research experiences focused on ethical practices or policies in biomedical, behavioral, or clinical research may be proposed. Consideration of team-based research approaches may also be warranted.
If ethics research experiences are proposed, applicants should include hands-on tutorials and expert guidance in research design and analysis methodology (including statistics, if needed) to participants who are not experienced in research as well as sufficient release time and support to complete a mentored ethics research project.
All mentored research projects must be approved by an independent expert committee using scientific review procedures and an ethics review committee, if human subjects research is involved.
Courses for Skills Development
Plans for education in the skills necessary for participants to provide research ethics leadership in bioethics teaching, building institutional capacity for ethical conduct of research and review of research, ethics research and scholarship or policy in bioethics must be included. Skills development courses may be proposed in areas such as mediation, negotiation and communication; adult pedagogy; research design and analysis; case study, manuscript and grant writing; critical analysis of ethics literature, regulation and policy; and English as a second language.
Mentorship is considered critical to developing research ethics leadership and must be included in proposed ethics education programs. Applicants may request support to train LMIC faculty in mentoring skills and the use of individual development plans with participants. Support for participants to develop mentored research ethics activities upon return to their home institutions may be proposed such as practicum projects designed to meet participant ethics career goals. Applicants are also encouraged to propose innovative approaches for continuing research ethics education and networking for participants after completion of the proposed program to further enhance research ethics teaching, research review and leadership capabilities.
All applications from U.S. and other HIC collaborators must include a plan to sustain the proposed masters level research ethics program created at the collaborating LMIC institution. Applicants may propose activities that will result in the submission of a subsequent renewal application for a direct award or other sources of support to the collaborating LMIC institution with continued U.S. or other HIC collaboration.
All renewal applications are expected to propose new education activities and/or significant revisions to the previous program components (curriculum, research or practicum experiences, courses for skills development, mentorship activities) based on results of documented evaluation of previous program activities. Renewal applications may include activities to strengthen 1.) Pedagogy and mentorship 2.) Curriculum and other education components to increase rigor, effectiveness, and sustainability and 3.) Post-participation engagement in research ethics related program activities.
Renewal applications from current U.S. and other HIC-based research ethics education program grants should report on progress and propose additional plans to transfer previously developed master's level curricula, skills courses, practicum experiences and mentoring activities to collaborating LMIC institutions by the end of the proposed grant period, with U.S. or other HIC collaboration.
Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in international research ethics, and can organize, administer, monitor, and evaluate the research ethics education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.
Program Faculty. Faculty from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate in the proposed education program . Faculty should have research ethics expertise and LMIC experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.
To the greatest extent possible, faculty from LMICs with research ethics expertise should be designated for significant roles in proposed education programs.
LMIC faculty strengthening activities in ethics education, adult pedagogy and mentoring, including the use of individual development plans with participants, can be proposed.
Faculty involved in distance learning approaches should have experience in distance learning pedagogy. LMIC faculty can be provided training in distance learning methodology.
Program Participants. Applications must identify the career levels for which the proposed program is planned. 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 ethics education program.
Recruitment and Selection: Describe how the program will recruit participants with relevant academic degrees in biomedical, behavioral or social science or humanities and demonstrate a commitment to a career related to research ethics. Describe the design specific strategies the program will use to recruit and select LMIC participants with experience in research ethics related activities with strong potential to provide research ethics leadership as well as contribute to the establishment of research ethics capacity to meet the needs of research intensive LMIC institutions. Attention should be given to the recruitment and retention of participants from groups underrepresented in bioethics leadership in LMICs including racial and ethnic minorities, persons with disabilities and women.
Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under “Facilities & Other Resources” or the required “Institutional Commitment Letter of Support,” described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.
Evidence of institutional commitment to host and sustain the proposed research ethics educational program from the LMIC institution should be included in a letter of support from the appropriate LMIC institutional official.
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 culturally appropriate for LMIC participants 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. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.
For renewals, applicants should include an evaluation of sustainability for the master's curriculum at the LMIC institution and progress to transition of the program to LMIC faculty leadership.
Dissemination Plan. A specific plan must be provided to disseminate any findings resulting from and materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at research ethics meetings, workshops.
Letters of Support
A letter of institutional commitment must be attached as part of Letters of Support (see section above ”Institutional Environment and Commitment."
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:
No appendices are allowed in these applications.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined 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
DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.
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.
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must submit Delayed Onset Study information.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Unique Entity Identifier and System for Award Management (SAM)
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.
4. Submission Dates and Times
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.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
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.
7. Other Submission Requirements and Information
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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
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 foster a better understanding of biomedical, behavioral and clinical research and its implications by strengthening research ethics capacity in LMICs through increasing the number of LMIC research intensive institutions that can provide advanced education in research ethics. Programs supported by this initiative will equip scientists, health professionals and academics in these countries with in-depth knowledge of the ethical principles, processes and policies related to international clinical and public health research. Programs should be designed to strengthen the critical competencies needed to provide research ethics education, ethical review leadership and expert consultation to researchers, their institutions, governments and international research organizations.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research ethics education by fulfilling the goal of this R25 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.
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.
Does the proposed program address research ethics education in the LMIC for which it is designed? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?
Is the PD/PI capable of providing both administrative and international research ethics 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 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:
Faculty: Do the proposed faculty have research ethics expertise and international experience relevant to the proposed program?
Does the proposed faculty have experience in master's level ethics education and mentorship?
Is there a history of collaboration among the LMIC, U.S. and other HIC faculty from the participating institutions?
Do LMIC faculty with research ethics expertise play significant roles in the proposed program?
If applicable, does the faculty involved in distance learning have experience in this pedagogical approach or will appropriate training be provided in distance learning pedagogy?
Taking into consideration the nature of the proposed research ethics education program, does the applicant make a strong case for this program effectively educating LMIC participants with the most potential to provide research ethics leadership to their home institutions? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the participants?
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 research ethics 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?
Specifc to this FOA:
Does the proposed program include an integrated, socio-culturally relevant master's level curriculum appropriate for the LMIC context, research or practicum experiences, skills courses, and continuous mentoring activities?
Is the proposed education program likely to ensure that participants will be well prepared for bioethics leadership roles at LMIC institutions?
Is the proposed program likely to result in the establishment of sustainable master's level research ethics education at research intensive LMIC institutions? Are plans or progress for transfer of leadership of the proposed bioethics education program to the LMIC institution adequate?
If distance learning education is proposed, is this approach likely to be effective for the curriculum topics addressed, sustainable at the LMIC institution and accessible for the LMIC participants involved?
Is there an adequate description of the responsibilities of the advisory committee regarding the provision of input, guidance and oversight of the program?
Will the collaborating LMIC, US and other HIC research ethics, scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of these environments 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?
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.
Protections for Human Subjects
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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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 attracting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research.
Are feasible plans presented to sustain the proposed research ethics education program at the collaborating LMIC institution by the end of the award? Does the renewal application propose significant revisions or new educational components based on the results of evaluation of the previous program activities? Do renewal applications from US or other HIC institutions made progress in transferring leadership of the research ethics education program to the collaborating LMIC institution?
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review, and a Data Management and Sharing Plan is not applicable for this FOA.
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.
Recruitment Plan to Enhance Diversity
Training in the Responsible Conduct of Research
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.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research ethics programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Resource Sharing Plans
If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research ethics education program.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned to the Fogarty International Center. Following initial peer review, recommended applications will receive a second level of review by the Fogarty International Center Advisory Board. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
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.
1. Award Notices
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 recipient’s business official.
Recipients 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
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, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
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.
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.
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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
When multiple years are involved, recipients 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 in accordance with the RPPR Instruction Guide.
NIH FOAs outline intended research goals
and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.
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 recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
Failure by the recipient 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 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.
Other Reporting Requirements
Recipients are requested to annually update and maintain data regarding their participants in FIC CareerTrac (https://careertrac.fic.nih.gov/Welcome.vm).
A final RPPR 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.
In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Sujata Bardhan, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Center for Scientific Review (CSR)
Fogarty International Center (FIC)
National Institute of Allergy and Infectious Diseases (NIAID)
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 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
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