Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the Training (T) 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 inSection IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

.

The International Bioethics Research Training program supports mentored doctoral and long-term postdoctoral research training for ethics experts from low and middle income countries (LMICs) that complements other global health research and research training programs in the mission areas of the NIH Institutes and Centers. The overall goal of this initiative is to support the training of a sustainable critical mass of bioethics scholars in LMIC research intensive institutions with the capabilities to conduct original empirical or conceptual ethics research that addresses challenging issues in health research and research policy in these countries. Collaborative programs should be designed to recruit, select and rigorously train LMIC individuals with the potential to become independent bioethics scholars, teach bioethics courses, and provide expert consultation to their institutions, governments and international research organizations. Awards will support innovative U.S. - LMIC collaborative institutional bioethics training programs that incorporate mentored research, advanced didactic theoretical and ethics career skill training elements to prepare a number of individuals for leadership positions in LMICs.

Note: This Funding Opportunity Announcement (FOA) allows support of trainees proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Purpose and Background Information:

Since 2000, the Fogarty International Center (FIC) and several NIH ICs have supported international bioethics education and research training awards in response to the increasing amount of collaborative global health research and scope of associated ethical concerns in LMICs. The initial International Research Ethics Education and Curriculum Development Award (R25) (companion funding opportunity PAR-22-118) supported the establishment of sustainable master's level research ethics programs at research intensive LMIC institutions (a list of currently funded awards can be found at https://www.fic.nih.gov/Grants/Search/Pages/search-grants.aspx?program=bioet70). The more recent International Bioethics Research Training Program (D43) described in this funding opportunity supports LMIC doctoral and long-term postdoctoral research training focused on the ethics of research in basic biomedical or clinical sciences, behavioral or social sciences, health services research, or any other discipline relevant to the NIH mission and the health research priorities of LMICs.

This announcement supports collaborations between U.S. and LMIC institutions to provide bioethics research training for multiple individuals with ethics expertise from LMIC research intensive institutions. The primary objective of proposed programs should be to provide LMIC trainees with advanced capabilities to conduct original empirical or conceptual research on critical ethical issues in health research in their countries. The proposed collaborative U.S.-LMIC institutional doctoral and/or long-term postdoctoral training program should:

-Provide a strong foundation in research design, methods, and analytic techniques appropriate for the trainee's proposed bioethics research area;

-Enhance trainees ability to conceptualize, analyze and resolve bioethics research problems with increasing independence;

-Support mentored bioethics research by trainees using state-of-the-art methods as well as presenting and publishing their research findings;

-Furnish trainee opportunities to interact with the international bioethics academic community at appropriate conferences and workshops; and

-Significantly expand trainees understanding of the bioethics theory and ethical practice related to global health research.

A secondary objective of proposed programs should be to provide training in the competencies necessary to sustain scholarly research careers in ethics leadership positions at their institutions in LMICs as well as teaching and mentoring bioethics students and providing expert research ethics consultation.

Program Considerations

Collaboration: Awards will support innovative U.S.-LMIC collaborative institutional bioethics training programs. 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 trainees will be recruited. The proposed institutional research training program should complement other ongoing FIC research training programs, including those supported by International Research Ethics Education and Curriculum Development awards, however, the proposed program must be clearly distinct from any current ethics related training programs.

Faculty Mentors: Proposed faculty from the U.S. or other high-income countries should have international bioethics research expertise and experience in LMICs. Faculty from LMICs with research ethics expertise should play significant roles in proposed programs to insure the relevance of the proposed research training and sustainable career development activities.

Each trainee should be matched to both a U.S. and LMIC mentor to provide research and career guidance. Mentorship training may be provided for faculty involved in the proposed program. It is expected that LMIC trainees will be mentored and supported to disseminate the results of their research at bioethics conferences and in peer reviewed publications.

Trainees: PDs/PIs should limit the selection of doctoral and postdoctoral trainees to individuals from LMICs who show documented evidence of research analytical skills as well as commitment to a bioethics career. Trainees with previous masters' or doctoral level training or equivalent bioethics related experience and bioethics related publications are preferred.

Trainee Research: In order to contribute to progress in both theory and practice in international bioethics, mentored research projects should focus on ethical issues faced in current research involving human subjects in LMICs and be conducted to the greatest extent possible in these countries. Trainee research is expected to lead to first author publications in leading international journals. Applicants may submit applications that focus on research training in any thematic bioethics area that is of high significance to the LMIC and/or specifically related to research supported by the participating NIH ICs such as:

NHGRI: Ethical, legal, regulatory, policy, economic, cultural, and societal issues raised by the advancement and use of genomics. These issues may relate to the design and conduct of genetic and genomic research; the translation of genetic and genomic research into clinical medicine and health care; the interplay among a broad array of stakeholders in the field of genomics; and the value and meaning of genomics for the broader public. Examples of possible topics of interest are available on the ELSI Research Areas and Sample Topics website: https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program/research-areas.

All mentored research projects conducted with funding from this award must be approved by an independent committee using scientific review procedures established by the applicant institution (with documentation of education in the protection of human subjects for the trainee, compliance with legal requirements, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is being conducted if the projects include human subjects research).

Research Training Environment: Original bioethics empirical and conceptual research is increasingly complex and multidisciplinary in nature. PDs/PIs are encouraged to develop institutional training programs that will expose trainees to a diversity of bioethics scholarship, systems for study, empirical and conceptual research approaches, and tools and technologies.

Research training may be delivered by interactive distance learning technology, if appropriate and sustainable for the LMIC trainees and the institutions involved. If distance training is proposed, applicants should provide evidence of the technical feasibility of the chosen distance learning format in the LMIC trainee setting.

Career Development Skills: Training programs should make available structured, career mentorship and learning opportunities (e.g., workshops, networking activities, Individual Development Planning). Through such opportunities, trainees are expected to obtain a working knowledge of various potential career directions that make strong use of the knowledge and skills gained during ethics research training and the steps required to transition successfully to the next stage of their chosen research ethics career path and sustain research and scholarship.

For applications proposing training in clinical trials research, plans for training in data management and statistics relevant to clinical trials, good clinical practice (GCP) and good laboratory practice (GLP) should be included.

Short-term training or any undergraduate, clinical or masters-level training is not supported by these awards. Masters level training for LMIC participants can be supported by a International Research Ethics Education and Curriculum Development Award (R25) (please add link to companion FOA).

Renewal Applications: In addition to a progress report (see "Other Attachments" under SF424 (R&R) Other Project Information in Section IV. Application and Submission Information 2. Content and Form of Application Submission), applicants should explain how the training program has evolved in response to changes in relevant advances in global health research ethics knowledge, educational practices, and evaluation of the previous training program.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Other Award Budget Information

Section III. Eligibility Information

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)

Other

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

The sponsoring and 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.

The applicant and collaborating institutions must have a high quality bioethics research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs occurring at the applicant or collaborating institutions and that a substantial number of program faculty will have active ethics research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

An application may be submitted by an eligible foreign institution (in collaboration with a U.S. Institution) or by an eligible domestic (U.S.) institution that demonstrates collaborations with an LMIC institution named in the application.

All LMICs that are defined by the World Bank classification system according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income are eligible (https://datahelpdesk.worldbank.org/knowledgebase/articles/906519 ). With the exception of Sub-Saharan African countries, Fogarty will no longer accept research training or career development applications from or research training applications that involve training of individuals from "upper middle income countries" that are also members of the G20 (see Notice of Change in Country Eligibility for Fogarty International Training Grants and Country Eligibility (NOT-TW-12-011 https://grants.nih.gov/grants/guide/notice-files/NOT-TW-12-011.html ) for additional information. Other High-Income Country (HIC) Faculty and institutions may be named as collaborators.

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.

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.

• 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.
• Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
• Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
• eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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 training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 SF 424 (R&R) Application Guide.

The PD/PI should be an established researcher in international bioethics and capable of providing both administrative and ethics leadership to the development and implementation of the proposed program. The PD/PI should have bioethics research and training experience in the LMIC(s) that is the focus of the training proposed. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds. Non-U.S. applicants must be citizens of LMICs.

2. Cost Sharing

3. Additional Information on Eligibility

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Program faculty should have strong records as Bioethics researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of Bioethics research training, including successful, former trainees who have established productive careers in research ethics relevant to the NIH mission. Bioethics researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Trainees

Only individuals from LMICs that meet the Country Eligibility (http://www.fic.nih.gov/Grants/Pages/countryeligibility.aspx) are eligible for training under this FOA. Individuals who also have citizenship or permanent residency in the US, other high-income countries, or countries not eligible under the Country Eligibility (http://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx) are not eligible for support under this FOA.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.

• Predoctoral trainees must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program. Trainees with previous masters' level training or equivalent bioethics related experience and bioethics related publications are preferred.
• Postdoctoral trainees must have received a Ph.D. or comparable doctoral degree from an accredited domestic or foreign institution. Postdoctoral trainees should have faculty positions at an LMIC institution. Only long-term postdoctoral bioethics research training of at least one year can be supported.

Section IV. Application and Submission Information

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 Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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]

Page Limitations

All page limitations described in the SF424 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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees/scholars including their levels (i.e., predoctoral, postdoctoral), and intended trainee outcomes. Include the name of the LMIC and U.S. collaborating institutions and the bioethics focus of the proposed training.

Other Attachments:

An Advisory Committee is a required component of a training program. Provide a plan for an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Members should not be affiliated with the program and a majority of members should be from the LMIC focus of the application. Describe how the Advisory Committee will contribute to the selection of participants and their mentored research projects as well as the development, implementation and evaluation of the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application. 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.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R) Application Guide.

Research & Related (R&R) Budget

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

• Use the Other Personnel section to submit costs for salary support for administrative staff.
• Use the Travel section to submit costs for key personnel and faculty travel including the annual network meeting.
• Use the Participant/Trainee Support Costs section to submit costs for Trainees and training-related expenses. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). Do not use the Subsistence category. Provide details of trainees and training related expenses in the budget justification and identify by name any continuing trainees.
• Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification.

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix- .Do not submit any materials in appendices in the application.

Follow all instructions provided in the SF424 (R&R) Application Guide.

No additional modifications apply.

Particular attention must be given to the required Training Data Tables for International Programs. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

Training Program

Program Plan

Background

Rationale: The specific needs for research ethics capacity, scholarship and leadership in the LMIC that is the focus of the training program and how the results of the proposed doctoral or postdoctoral training will meet these needs at the end of the proposed award period should be provided as rationale for the specific program plan proposed. The description of the research intensive LMIC institution(s) involved should include a summary of the active human subject research and the current biomedical, behavioral and clinical research training conducted at this institution which may benefit from this program. Applicants are encouraged to develop plans for post-training interaction and activities among the doctoral and postdoctoral trainees specifically to create a sustainable critical mass for bioethics leadership at LMIC institutions.

Collaboration: Applicants should provide a description of previous collaboration and document joint accomplishments of the U.S. and LMIC faculty in the proposed program. Plans for each component of the proposed research education program should include a description of the collaborators involved.

Institutions with existing FIC research training programs must explain what distinguishes this program from the others, how the programs will collaborate with one another, if applicable, and make it clear that the pool of faculty, potential trainees and resources are robust enough to support additional training programs.

Program Administration.

PD/PI(s): Describe the acknowledged strengths, leadership and administrative skills, training experience, bioethics expertise, and active research of the PD/PI(s). Relate these strengths to the proposed management of the training program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize but not overlap with the Multiple PD/PI Leadership Plan section of the application.

If clinical trials training is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of clinical trials.

Program Administrator: When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate the program must be included in the application.

Proposed Faculty

For U.S. and other High-Income Country (HIC) faculty, describe the international bioethics research and bioethics research training experience in the LMIC country that is the focus of the application.

Describe in detail the roles faculty from LMICs with research ethics expertise will play in proposed programs to insure the LMIC relevance of the proposed research training.

For applications proposing clinical trials training, describe the expertise, experience and ability of the faculty to provide guidance on the organization, management and implementation of clinical trials.

Proposed Training

The program plan should include detailed descriptions of the didactic and methodological training components that will be supported. Include information about planned courses, mentored research experiences, and other activities designed to develop specific analytical or other skills essential for the proposed research training. Applicants are encouraged to include a timeline which includes all proposed training activities.

Describe how mentored trainee projects will be selected and monitored (in particular, for compliance with federal requirements for protection of human subjects in research and animal care and use in research, if relevant).

If trainee projects during the grant period include clinical trials, PD/PIs are required to provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed by trainee(s) before the project begins. Trainees participating in clinical trials and their mentors must be trained in Good Clinical Practice (GCP), data management and statistics relevant to clinical trials.

In addition, applicants should include a description of an individual career planning process for trainees and their mentors. Program activities intended to develop the working knowledge needed for trainees to prepare for the next step in varied bioethics career options available in their LMICs should be described. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in project management. Training may be proposed in other needed professional development areas for bioethicists such as mediation, negotiation and communication; adult pedagogy; ethics literature, regulation and policy analysis; and English as a second language, if needed.

Applicants are encouraged to include a timeline that illustrates the sequence of all proposed training activities.

Trainee Candidates

Applicants are encouraged to develop strategic plans for the recruitment, selection and training of a cohort of doctoral and postdoctoral trainees most likely to result in a sustainable critical mass for leadership in LMIC relevant bioethics research as well as teaching bioethics and providing research ethics consultation at the LMIC institution.

Trainee pool for recruitment: Describe the size and qualifications of the pool of trainee candidates including information about those with the types of prior bioethics educational background and applied experience, clinical and research training and career level required for the program. Do not name prospective Trainees.

Trainee selection: LMIC doctoral and postdoctoral trainees should be selected based on documented evidence (bioethics degrees or extensive bioethics related experience, bioethics related publications, fellowships or grants) of research analytical skills as well as commitment to a bioethics career and the long-term training necessary to achieve this goal.

Attention should be given to the recruitment and retention of participants from groups underrepresented in bioethics leadership in LMICs including racial and ethnic minorities, persons with disabilities and women.

For applications proposing training in clinical trials, the recruitment and selection plans should include specific strategies to identify trainees who have clinical trials experience or the potential to organize, manage and implement clinical trials.

Institutional Environment and Commitment to the Program.

The sponsoring and collaborating institutions must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program and protected time for LMIC trainees selected for the program to complete all proposed training activities. This commitment may also include PD/PI or faculty salary, stipend or tuition support for individuals involved in the proposed training program, or other resources essential to a successful training program.

?????Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Applicants are strongly encouraged to develop predoctoral and postdoctoral courses in the responsible conduct of research adapted to the locally relevant research context at the LMIC institution and include LMIC faculty

Appendix:

No appendices can be submitted in these applications.

PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional modifications:

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must complete a Delayed Onset Study.

PHS Assignment Request Form

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

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. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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 fieldof the Senior/Key Person Profile form.Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

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:
Reviewers should evaluate the international bioethics research program’s potential for developing a sustainable critical mass of bioethics scholars in low and middle-income country (LMIC) research intensive institutions with the capabilities to conduct original empirical or conceptual ethics research that address challenging issues in health research and research policy in these countries as well as provide research ethics leadership to their institutions, governments and international research organizations.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive bioethics research careers and thereby exert a sustained influence on the research field(s) involved, 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 the merit of the training program, 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.

Training Program and Environment

• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the courses and bioethics research experiences provide opportunities for trainees to acquire advanced ethics knowledge, analytical methods, and tools that are relevant to current research involving human subjects in LMICs?
• Is the proposed training program likely to ensure trainees will be well prepared for bioethics leadership careers in LMIC institutions that include independent research and scholarship?
• Is the level of commitment from all collaborating institutions to the training program, including administrative and research training support, sufficient to ensure the success of the program?
• Are the training facilities and bioethics research environment conducive to preparing LMIC trainees for successful careers as bioethics researchers?
• Are the specific needs for bioethics capacity, scholarship and leadership in the LMIC adequately described and addressed by the proposed research training program?
• How successful is the history of institutional and individual collaborations among the U.S. and LMIC faculty of the participating institutions?
• Is there an adequate description of the responsibilities of the advisory committee regarding the provision of input, guidance and oversight of the program?
• Are there plans for appropriate oversight of the selection and performance of mentored ethics research projects, including compliance with federal requirements for protection of human subjects in research?
• If clinical trials training is proposed, does the application adequately address the existing capabilities to conduct clinical trials at the proposed training site(s)?

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)

• Does the PD/PI have the international bioethics background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI plan to commit sufficient effort to ensure the program’s success?

For applications designating multiple PDs/PIs:

• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?
• If applicable, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of proposed clinical trials training?

• Are sufficient numbers of experienced LMIC, U.S. or other HIC faculty with international bioethics expertise to support the number and level of trainees proposed in the application?
• Do the faculty have strong records as bioethics researchers, including recent publications and successful competition for ethics research support?
• Do the faculty have strong records of training individuals at the level of trainees proposed in the program? Are appropriate plans in place to ensure that faculty lacking sufficient research training experience are likely to provide strong and successful mentoring?
• If the program will support clinical trial research experience for the trainees, do the mentor(s) who will supervise the trainee(s) have clinical trials expertise, experience, resources, and ability to provide appropriate guidance to them?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified LMIC trainees for the training program?
• Is there a competitive applicant pool of sufficient size and quality at the proposed levels (predoctoral or postdoctoral), to ensure a successful training program?
• Are there well-defined and justified selection criteria as well as retention strategies?
• If the proposed program provides training in clinical trials, are there specific strategies proposed to recruit and criteria to select trainees with the potential to organize, manage, and implement clinical trials, feasibility or ancillary studies?
• If the proposed program provides training in clinical trials, are there plans to provide instruction in Good Clinical Practice, data management and statistics relevant to clinical trials to trainees?

Training Record

For renewal applications, how successful are the trainees (or, for new applications, other past LMIC students/postdoctorates in similar training) in completing the program?

• For renewal applications, has the training program ensured that trainees are productive (or, for new applications, other past LMIC students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent fellowship or career development awards?
• For renewal applications, how successful are the trainees (or, for new applications, other past LMIC students/postdoctorates in similar training) in achieving productive careers as evidenced by attaining bioethics related positions in industry, academia, government or other research venues; grants; receipt of honors or awards; high-impact publications; promotion to leadership positions; and/or other such measures of success?
• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Training in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in ethical reasoning, rigorous research design, relevant research methods, consideration of relevant biological variables such as sex, quantitative or qualitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees?

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.. Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period ? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

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.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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 of awards

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

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

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

Recipients must comply with any funding restrictions described in Section IV.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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable.

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

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

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

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

A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. NIH FOAs outline intended research training goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

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

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

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

Rene Sterling
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301.435.1275
E-mail: [email protected]

Center for Scientific Review (CSR)
[email protected]

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

Section VIII. Other Information

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.