Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

The over-arching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications.

The International Research Ethics Education and Curriculum Development Award (R25) program supports research ethics educational activities that complement other global health research and research training programs in the mission areas of the NIH Institutes and Centers. In response to the increasing amount of collaborative global health research and the 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 and evolving, complex research ethics issues, this initiative will support the establishment of sustainable masters level research ethics training at research intensive LMIC institutions. An additional funding opportunity, International Bioethics Research Training Program (D43) (PAR-19-243) supports LMIC Ph.D. and postdoctoral training programs.

The overarching goal of this program is to support educational activities that foster a better understanding of the ethics of international biomedical, behavioral and clinical research and its implications. This initiative will strengthen 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 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, masters level, socio-culturally relevant ethics education programs at research intensive institutions in LMICs which must include all of the following integrated components:

• Curriculum Development of a series of master's level cohesive, didactic fundamental ethics courses covering the ethical principles and theories relevant to international research ethics; socio-culturally relevant LMIC based research ethics case studies; the concepts of informed consent, risk and benefits, vulnerability, and privacy and confidentiality; international ethical issues in research; and responsible conduct of research.
  
• Courses for Skills Development for participants to develop the necessary competencies to provide leadership in bioethics teaching, ethical review of research, research ethics consultation, scholarship and empirical research, in areas such as mediation, negotiation and communication; adult pedagogy; research design and statistics; case study, manuscript and grant writing; ethics literature, regulation and policy analysis, and English as a second language, if needed. Opportunities for practicum experiences such as participation in ethical review committees, development of research ethics education/training courses for researchers and ethical review committee members, analysis of ethical review guidelines or processes, and research on ethical practices in biomedical or behavioral research in the participants' countries must be included.
  
• Mentoring Activities to support participants to develop and sustain research ethics activities at their home institutions. Innovative approaches for continuing research ethics education and networking for graduates of the program that will enhance their development as research ethics leaders are encouraged.

Collaborating bioethics experts in LMICs, the U.S. and other high income countries (HICs) must begin to implement components of the master's level research ethics education at the LMIC institution within one year after award including new curriculum, skills courses, practicum experiences and mentoring activities. Faculty and mentors from the LMIC, U.S. or other HICs should have international bioethics research experience. Faculty and mentors from LMICs with research ethics expertise should play significant roles in proposed programs to insure the relevance of the curriculum and LMIC institutional sustainability.

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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) .

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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

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 investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific 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.

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. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have international 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 in 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.

Participants

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Barbara Sina Ph.D.
Telephone: 301-402-9467
Email:[email protected]

Include the applicant institution and all of the collaborating institutions where training will occur, both U.S. and foreign, as performance sites.

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments.

Advisory Committee

Applicants must propose an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .

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 (names marked in each citation) since the start of program participation. Please name your file Progress_Report.pdf .

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

Research Strategy

Research Strategy section must be used to upload the Research Ethics Education Program Plan, which must include the following components described below:

• Proposed Research Ethics Education Program
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

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 federal 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.

Significance/Background

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.

Collaboration

Applicants should describe the collaborative history of the LMIC, U.S. and other HIC institutions involved in the proposed program.

Program Components

Applications should describe an integrated program including all three required components (Curriculum development, courses for skills development, and mentoring activities).

Curriculum Development

Programs should include a balance of a series of didactic fundamental ethics courses and practicum research ethics education experiences cohesively designed to build a sustainable masters level research ethics education program at the LMIC institution.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 designated collaborators design and implement a master's level research ethics education program at the LMIC institution within one year after award. Plans may include a phased transfer of teaching 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.

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 that reflects recent scholarship and employs innovative adult pedagogical approaches. 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.

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.

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:

NHGRI: Ethical issues in genetics and genomics research, especially topics such as privacy, informed consent, return of genetic and genomic research results (including incidental findings), biobanks and biorepositories for genomic data and samples, and data and sample sharing.

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.

Courses for Skills Development

Plans for education in the skills necessary for participants to provide research ethics leadership in bioethics teaching, institutional capacity building for the ethical conduct and review of research, scholarship, and empirical research in bioethics must be included.Skills development courses may be proposed in areas such as mediation, negotiation and communication; adult pedagogy; research design and statistics; case study, manuscript and grant writing; critical analysis of ethics literature, regulation and policy; and English as a second language, if needed.

Practicum experiences may include but are not limited to participation in ethical review committees, development of research ethics courses/workshops for researchers and ethical review committee members, creation of ethical review guidelines or processes, and research on ethical practices in biomedical or behavioral research.

Mentoring Activities

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 and sustain mentored research ethics activities on return to their home institutions may be proposed such as practicum projects designed to meet participant ethics career sustainability 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 their research ethics teaching, research review and leadership capabilities.

Sustainability Plans

All applications from U.S. and other HIC collaborators should include a planning process to sustain the masters level research ethics program created at the collaborating LMIC institution through 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, as needed.

Renewal Applications

All renewal applications are expected to propose significant revisions to program approach and curriculum and new education components based on results of evaluation of previous program activities. Renewal prpslapplications should include activities to strengthen pedagogy and mentoring; curriculum rigor, effectiveness and sustainability; and 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 propose 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, as needed.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research 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. Describe how the program will encourage r esearchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have international research ethics expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for their intended roles.

To the greatest extent possible, faculty and mentors from LMICs with research ethics expertise should be included in 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 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. Identify the career levels for which the proposed program is planned.

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.

Applicants are encouraged to engage LMIC participants from diverse backgrounds, persons with disabilities, and women.

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.

Institutional Environment and Commitment. Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under Facilities & Other Resources ), that can contribute to the planned Research Education Program. Evidence of institutional commitment to host the research ethics educational program from the LMIC institution is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate for LMIC participants and reasonable for the nature and duration of the proposed program. Applicants should integrate RCR courses into research ethics curriculum developed for LMIC institutions. 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. 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 of masters curriculum at the LMIC institution and transition of the program to LMIC faculty leadership.

Dissemination Plan. A specific plan must be provided to disseminate any findings resulting from or materials developed under the auspices of the research ethics 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:

• Software source code should be freely available to bioethicists, biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

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.

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.

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.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

1. Criteria

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.

Significance

Does the proposed program address an important need for international 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?

Investigator(s)

Are the PD/PI(s) 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?

Faculty: Do the proposed faculty and mentors 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 mentoring? Do LMIC faculty and mentors 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 training be provided in distance learning pedagogy?

Innovation

Taking into consideration the nature of the proposed research ethics education program, does the applicant make a strong case that new curriculum, skills building courses and mentoring activities will effectively educate 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 intended audience?

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?

Approach

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?

Does the proposed program include an integrated, master's level, LMIC socio-culturally relevant, curriculum, skills courses with practicum experiences, and post-participation mentoring activities? Is the proposed program likely to result in the establishment of sustainable masters level research ethics training at research intensive LMIC institutions?

Environment

Will the collaborating LMIC, U.S. and other HIC research ethics, scientific and educational environments 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 LMIC institutional commitment? Is there evidence that the faculty from each collaborating institution 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?

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

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.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Recruitment Plan to Enhance Diversity

Not applicable.

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 education 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 reasonablein relation to the proposed ethics education program.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

• 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.

• Will receive a written critique.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic distribution

3. Anticipated Announcement and Award Dates

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Programs that involve participants should report on education in the responsible conduct of research in accordance with the RPPR Instruction Guide. Programs will also be required to submit Training Table 8I, Part 1 (International) annually.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Other Reporting Requirements

Recipients are requested to annually update and maintain data regarding their participants in FIC CareerTrac (https://careertrac.fic.nih.gov/Welcome.vm).

4. Evaluation

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.

In evaluating this research education program FIC expects to use the following evaluation measures:

• Aggregate number and demographic characteristics of participants

• Educational level of participants

• Participants feedback on the program

• New knowledge or skills acquired

• Dissemination and/or adoption of the new curricula or methods

Subsequent educational/career progress of participants, including:

• Successful completion of a graduate program
• Subsequent participation in a formal research training or career development program in research ethics
• Subsequent participation in research ethics
• Subsequent employment in a research ethics or research ethics-related field
• Subsequent authorship of scientific publications in research ethics
• Subsequent independent research ethics grant support from NIH or another source

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Ebony Madden, Ph.D
National Human Genome Research Institute (NHGRI)
Telephone: 301-503-5620
Email: [email protected]

Barbara Sina Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9467
Email (preferred): [email protected]

Joana Roe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3213
Email: [email protected]

Seetha Bhaguvan, PhD.
Center for Scientific Review
Telephone: 301-402-9467
Email: [email protected]

Mollie Shea
Fogarty International Center (FIC)
Telephone: 301-451-6830
Email: [email protected]

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]