Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions will not be reviewed

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The over-arching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs; (2) enhance the diversity of the biomedical, behavioral and clinical research workforce; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The 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 several 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 identified by a recent assessment of the program (JAMA 313, 5: 461-2, 2015), the requirements of the International Research Ethics Education and Curriculum Development Award (R25) funding opportunity were modified to enhance 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-16-082)was created for Ph.D. and postdoctoral training.

The overarching goal of this FIC 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. To accomplish the stated 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 components:

• Curriculum Development for a series of master's level didactic fundamental, ethics courses covering the ethical principles and theories relevant to research ethics; socio-culturally relevant 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; 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. These must include 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.
• 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.

It is anticipated that collaborating bioethics experts in LMICs, the U.S. and other high income countries (HICs) will begin to implement components of the master's level research ethics training at the LMIC institution within one year after award, with plans to implement the complete curriculum, skills courses, practicum experiences and mentoring activities proposed by the end of the five year grant period. Faculty and mentors from the U.S. or other 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. It is expected that subsequent renewal applications will be submitted by the collaborating LMIC institutions, with continued U.S. or other HIC involvement, as needed.

Research ethics education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support.

This FOA is relevant to FIC Strategic Plan Goal 1: Build research capacity through individuals, institutions and networks to meet future and evolving health challenges.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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)

Other

• 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) .

The collaborating institutions 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.

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

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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 have documented experience in international research ethics and be 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.

Designation of multiple PD/PIs representing the collaborating U.S., other HIC and LMIC institutions is encouraged.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• 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).

To the greatest extent possible, faculty and mentors from LMICs with research ethics expertise should be included in significant roles in the proposed education programs. Research ethics experts from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Faculty and mentors should have research ethics expertise and international 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.

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 training support or other training activities proposed. Applicants are encouraged to recruit participants from diverse backgrounds, persons with disabilities, and women.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• 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
Fax: 301-402-0779
Email: [email protected]

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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 of the collaborating institutions, 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, 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 ethics training and education following the format for Current and Pending Support.

Other Attachments. Programs should establish an Advisory Committee to monitor progress that includes a majority of members not affiliated with the program and equal representation from the collaborating LMIC. Describe the composition, roles, responsibilities, and expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will be involved in the approval and selection of participants. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of the proposed curriculum, the recruitment and retention of candidates, and the overall effectiveness of the program.

Please name your file "Advisory_Committee.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:

• 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.

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

The 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
• Diversity Recruitment Plan
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

Research Ethics Education Program Plan

Proposed Research Education Program. While the proposed research ethics education program may complement ongoing research ethics training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research ethics training and research education programs currently receiving U.S. support. When research ethics training programs are on-going in the same department, 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 ethical review of research at the research intensive LMIC institution where the proposed curriculum will be implemented as rationale for the specific program plan components proposed.

Program Components

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

Curriculum Development

It is expected that programs include a balance of didactic fundamental ethics courses and practicum research ethics education experiences innovatively designed to build sustainable masters level research ethics education at the LMIC institution. Plans for degree or non-degree master's level programs with international research ethics curriculum and practicum experiences for up to two years and no less than 12 months should be included. It is expected that the collaborators design and implement master's level research ethics training 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.

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 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 used.

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.

Ethics courses are expected to cover the ethical principles and theories relevant to research ethics; 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.

Applicants are also encouraged to design relevant special courses or program activities 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), and biobanks and biorepositories for genomic data and samples.

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. Skills development courses may be included in areas such as mediation, negotiation and communication; 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.

Mentorship Activities

Applicants may request support to train LMIC faculty in mentorship 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 curriculum created at the collaborating LMIC institution through the submission of a subsequent renewal application for a direct award to the collaborating LMIC institution with continued U.S. or other HIC collaboration, as needed.

Renewal Applications

Renewal applications are expected to 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; 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.

All renewal applications are expected to propose revisions to program approach and curriculum based on results of evaluation of previous program activities.

Renewal applications from current U.S. and other HIC-based research ethics education program grants are expected to 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.

Renewal applications from current LMIC master's level program grants must propose new approaches to strengthen participating faculty pedagogy and mentoring skills; curriculum rigor, effectiveness and sustainability; and post-participation engagement in research ethics related program activities.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research ethics and/or teaching 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. Research ethicists 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 pedagogy and mentorship, including the use of individual development plans with participants, can be proposed.

Faculty involved in distance learning approaches should have experience or be provided training in distance learning pedagogy.

Program Participants. Applications must describe the intended LMIC 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.

Applications should propose strategies to recruit LMIC participants with strong potential to provide research ethics leadership to their home institutions as well as result in the establishment of a critical mass of research ethics expertise necessary 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 in LMIC institutions where participants may be recruited.

Institutional Environment and Commitment. Describe the LMIC, U.S. and other HIC collaborating institutional environments, reiterating the availability of facilities and educational resources (described separately under "Facilities & Other Resources"), that can contribute to the planned Research Ethics Education Program. Evidence of institutional commitment to the research ethics educational program is required. A letter of LMIC, U.S. and other HIC collaborating 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 ethics 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. Also see NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal 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 ethics 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.

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 scientific 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, with the following Guide, with the following modification:

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 biomedical researchers bioethicists 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

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide .

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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.

Applicants are required to follow our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical, behavioral, and clinical research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance international 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.

Significance

Does the proposed program address a key LMIC audience and an important aspect or important need in international research ethics education? 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 accomplishedIf 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 mentorship? 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 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 intended audience? If distance learning education is proposed, is this approach likely to be more 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 comprehensive, master's level, 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 U.S., other HIC and LMIC 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 collaborating U.S., other HIC and LMIC institutional commitment? Is there evidence that the faculty at 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?

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

Not Applicable

Inclusion of Women, Minorities, and Children

Not Applicable

Vertebrate Animals

Not Applicable

Biohazards

Not Applicable

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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting and retaining LMIC individuals in research ethics career paths.

The quality of previous program activities related to participant success will be assessed as well as proposed revisions to the program approach and curriculum based on results of evaluation of previous program activities including practicum experiences, mentorship and post-participation ethics career enhancement activities.

The committee will evaluate the likelihood of success for plans for current U.S.-and other HIC-based research ethics education program grants to transfer a complete masters level curriculum to collaborating LMIC institutions by the end of the proposed grant period or plans from current LMIC masters level program grants to strengthen participating faculty pedagogy and mentoring skills, curriculum rigor, effectiveness and sustainability and post-participation engagement in research ethics related program activities.

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Recruitment Plan to Enhance Diversity

Not Applicable

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research ethics 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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

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 ethics education program .

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.

As part of the scientific peer review, all 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.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the FIC Advisory Board. The following will be considered in making funding decisions:

• 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

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of U.S. grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

If applicable, participants are encouraged to submit reports of their findings for publication to the journals of their choice. For each journal publication that results from a trainee's research, NIH support should be acknowledged in language similar to the following: "This investigation was supported by the Fogarty International Center, (add NIH co-sponsoring institutes, centers or offices for the grant) of the National Institutes of Health under the International Research Ethics Education and Curriculum Development program (grant number)." In addition, news releases and other documents about the project must acknowledge federal funding as provided in "Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding."

A final progress report 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 ethics education programs, employing the measures identified below. In assessing the effectiveness of its research ethics 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 ethics 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 ethics education program the Fogarty International Center expects to use the following evaluation measures:

For Courses for Skills Development:

• Aggregate number and demographic characteristics of participants
• Educational level of participants
• Content
• Participants' feedback on the program
• New knowledge or skills acquired

For Curriculum Development:

• Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
• General educational level of participants
• Effectiveness of the new curricula assessed by skills/competencies gained compared to existing curricula
• Dissemination and/or adoption of the new curricula

For Mentoring Involving Master Level Participants:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:

Successful completion of the graduate program

Subsequent participation in a formal research ethics training or career development program in research ethics.

Subsequent participation in research ethics activities

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

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Jean McEwen, J.D, PH.D
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: [email protected]

Liza Dawson, PH.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3210
Email: [email protected]

Karin Helmers
Center for Scientific Review (CSR)
Telephone: 301-254-9975
Email: [email protected]

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

Monika Christman
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7860
Email: [email protected]

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

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 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.