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 in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The International Bioethics Research Training program supports mentored doctoral and long term postdoctoral research training for ethic 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 development 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, lead the ethical review of research 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 didactic, mentored research and training elements to prepare a number of individuals with ethics expertise for leadership positions in health research institutions in the LMIC.

Purpose and Background Information

In response to the increasing amount of collaborative global health research and scope of associated ethical concerns in LMICs, the Fogarty International Center (FIC) and several NIH ICs supported International Research Ethics Education and Curriculum Development (R25) 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), the requirements of the FIC International Research Ethics Education and Curriculum Development Award (R25) funding opportunity (PAR-16-081) were modified to enhance the establishment of sustainable masters level research ethics training at research intensive LMIC institutions and this International Bioethics Research Training Program funding opportunity was created for LMIC doctoral and long term postdoctoral training. Bioethics research training activities can be focused on the ethics of research in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission and the health research priorities of the LMIC.

The primary objective of proposed International Bioethics Research Training programs should be to support individuals with ethics expertise from a LMIC research intensive institution to develop the capabilities to conduct original empirical or conceptual research on critical ethical issues in health research in their countries. The proposed doctoral and/or long term postdoctoral training program should provide:

• A strong foundation in research design, methods, and analytic techniques appropriate for the proposed bioethics research area;
• The enhancement of the trainees ability to conceptualize, analyze and solve bioethics research problems with increasing independence;
• Experience conducting bioethics research using state-of-the-art methods as well as presenting and publishing their research findings;
• The opportunity to interact with members of the international bioethics academic community at appropriate conferences and workshops; and
• The enhancement of the 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 careers in leadership positions at institutions in the LMIC as well as teaching bioethics, leading ethical review of research and providing research ethics consultation.

The overall goal of this initiative is to contribute to the development of a sustainable critical mass of bioethics leaders at the LMIC research intensive institution to meet the needs for research ethics capacity in this country. Applicants should describe the specific needs for research ethics capacity, scholarship and leadership in the LMIC and how the results of the proposed doctoral and postdoctoral training will meet these needs at the end of the proposed award period. 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.

All mentored research projects under this award must be examined 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 the required federal citations, 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.

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.

Applicants may submit applications that focus on research training in a thematic bioethics area that is of high significance to the LMIC and specifically related to research supported by the participating NIH ICs. NHGRI supports applications that examine 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.

Trainee selection

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

Faculty

Faculty and mentors from the U.S. or other high income countries 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 proposed research training and sustainable career development.

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. Consideration of team-based research approaches may also be warranted depending upon the goals of the proposed bioethics training program.

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 the LMIC and be conducted to the greatest extent possible in this country. Trainee research is expected to lead to first author publications in leading international journals.

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.

Training programs should make available structured, career development mentorship and learning opportunities (e.g., workshops, mentorship, Individual Development Plans). Through such opportunities, trainees would obtain a working knowledge of various potential career directions that make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career path.

The proposed institutional research training program may complement other ongoing FIC research training and career development programs at the applicant or collaborating institution, including those supported by International Research Ethics Education and Curriculum Development awards, however, the proposed program must be clearly distinct from any related programs currently receiving U.S. government support.

Short-term training is not supported by these awards, or any undergraduate, clinical or masters-level training. Masters level training for LMIC participants can be supported by International Research Ethics Education and Curriculum Development Award (R25) (PAR-16-081).

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."

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

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

The applicant institution must have robust and high-quality research ongoing in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to contribute to the envisioned research training program. It is anticipated that participating training program faculty will have active, funded research projects in which potential trainees may gain relevant research training experiences consistent with their career interests and goals.

An application may be submitted by an eligible foreign institution in a low- or middle-income country (LMIC) or by an eligible domestic (U.S.) institution that demonstrates collaborations with an LMIC institution named in the application by documented joint publications, grants or previous research training activities. LMICs 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 (http://data.worldbank.org/about/country-classifications/country-and-lending-groups

(http://data.worldbank.org/about/country-and-lending-groups)). See Notice of Change in Country Eligibility for Fogarty International Training Grants and Country Eligibility 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.
Foreign components, as defined in the (NIH Grants Policy Statement), are allowed.

Applications from foreign institutions must be submitted by academic education or research institutions in LMICs (as defined by the World Bank (http://data.worldbank.org/about/country classifications/country-and-lending-groups (http://data.worldbank.org/about/country-classifications/country-and-lending-groups); low-income, lower-middle-income,and upper-middle-income countries are included). NOT-TW-12-011 (//grants.nih.gov/grants/guide/noticefiles/ NOT-TW-12-011.html) 'Notice of Change in Country Eligibility for Fogarty International Training Grants') applies to this FOA. With the exception of Sub-Saharan African countries FIC no longer accepts applications from upper-middle income countries that are also members of the G20 major economies (https://www.g20.org/ (https://www.g20.org/)).

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 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 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 SF 424 (R&R) Application Guide.

The Training PD/PI should be an established investigator in international bioethics and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI should have bioethics research and research training experience in the LMIC country which is the focus of the application. The Training PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The Training PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

Non-U.S. applicants must be citizens of LMICs.

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 programmatically distinct.

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

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

Program faculty should have strong records as 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 research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

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. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.

Postdoctoral trainees must have received a Ph.D., M.D., or comparable doctoral degree from an accredited institution. Preferably, postdoctoral trainees should have faculty positions at the LMIC institution. Only long term postdoctoral bioethics research training of at least one year can be supported. Trainees with previous masters' level training or equivalent bioethics related experience and bioethics related publications are preferred.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the 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.

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

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
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.

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

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 including their levels (i.e., doctoral, postdoctoral, ), and intended trainee outcomes. Include the name of the LMIC institution from which trainees will be selected, if not the applicant institution, and the bioethics focus areas of the proposed research training.

Facilities and Other Resources: Include descriptions of facilities and other resources to be used for research

Other Attachments. Provide the plan for a Training Advisory Committee (TAC). Responsibilities, frequency of meetings, and other relevant information should be included. The composition of the TAC, the roles people should fill, and the desired expertise of the members should be described. The TAC should be composed of expert faculty and relevant professionals from the applicant country and from the United States as well as other countries, if appropriate. TAC members should not be directly involved in the training program or in mentoring trainees.

Describe how the TAC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, scientific review of trainees projects, and the evaluation of 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.

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

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:

• 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

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 Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

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

Particular attention must be given to the required International Training Data Tables.

Training Program

Program Plan

a. Program Administration.

Describe the acknowledged strengths, leadership and administrative skills, training experience, bioethics expertise, and active research of the PD/PI. 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 trial is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by trainee(s).

b. Proposed Faculty

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

Describe in detail the roles faculty and mentors 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 mentors to provide guidance on the organization, management and implementation of clinical trials

If clinical trial is proposed, provide documentation of the faculty mentors expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by trainee(s).

C. Proposed Training.

The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied bioethics career options available. Training may be proposed in other professional development areas such as mediation, negotiation and communication; pedagogy; ethics literature, regulation and policy analysis; and English as a second language, if needed.

Describe how trainees will be educated in the human health- and disease-related aspects of their bioethics research training.

Describe the plans proposed for a scientific oversight committee to monitor the selection and performance of mentored research projects and their compliance with federal requirements for protection of human subjects in research and animal care and use in research.

Applicants should include a description of an individual career development planning process for trainees and their trainers (for example, workshops, mentorship, Individual Development Plans).

Applicants are encouraged to include a timeline which includes all proposed training activities.

If clinical trial is proposed, 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).

e. Trainee Candidates

Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about 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.

Doctoral and postdoctoral trainees should be selected from the LMIC who show documented evidence of research analytical skills as well as commitment to a bioethics career and long-term training necessary to achieve this goal. Trainees should have previous bioethics masters' level training or equivalent bioethics related experience and preferably, bioethics related publications.

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, leading ethical review of research and providing research ethics consultation at the LMIC institution.

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

If clinical trial is proposed, discuss the potential of prospective trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

f. Institutional Environment and Commitment to the Program

The sponsoring institution 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 that there will be protected time for LMIC trainees selected for the program.

This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed training program, or other commitments essential to a successful training program.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the 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 courses in the responsible conduct of research adapted to the locally relevant scientific context at the LMIC institution that include LMIC faculty.

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

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

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.

If you check the Anticipated Clinical Trial box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to FIC before any Trainee begins clinical trial research.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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 convened by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific 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. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. 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 training site(s) facilities and research environment conducive to preparing LMIC trainees for successful careers as bioethics researchers?
• Are the objectives, design and direction of the proposed bioethics research training program likely to ensure effective training?
• Do the research-related courses and bioethics research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
• Does the program provide appropriate inter- or multi-disciplinary research training opportunities?
• Are the proposed training program career development components likely to ensure LMIC trainees will be well prepared for bioethics leadership careers that include independent research and scholarship?
• Is the level of institutional commitment to the training program from all collaborating institutions, including administrative and research training support, sufficient to ensure the success of the program?
• Is it clear how the proposed training program is coordinated with and distinguished from other externally funded bioethics training programs at the institution?
• Are there plans for appropriate oversight of the selection and performance of mentored research projects in training related areas, including compliance with federal requirements for protection of human subjects in research and animal care and use in research?
• Are the specific needs for bioethics capacity, scholarship and leadership in the LMIC adequately described and addressed by the proposed program?
• Will the mentored trainee research projects focus on ethical issues relevant to current research involving human subjects in LMICs?
• If proposed by Trainee(s), are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
• Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

• Does the training PD/PI have the international bioethics research 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?
• With regard to the proposed leadership for the training program, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial?

Preceptors/Mentors

• Are sufficient numbers of experienced LMIC, U.S. or other HIC preceptors/mentors with International bioethics research expertise to support the number and level of trainees proposed in the application?
• Do the LMIC, U.S. or other HIC preceptors/mentors have strong records as international bioethics researchers, including recent publications and successful competition for bioethics research support in areas directly related to the proposed research training program?
• Do the preceptors/mentors have strong records of training the LMIC doctoral and postdoctoral trainees proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient international bioethics research training experience are likely to provide strong and successful mentoring?
• How successful is the history of institutional and individual collaborations among the faculty of the participating institutions?

For applications proposing clinical trials training:

• Do the preceptors/mentors who will supervise the Trainee(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

Trainees

• Does the recruitment plan contain strategies to attract high quality trainees? Is a competitive applicant pool in sufficient numbers to warrant the proposed size and levels of the training program in evidence?
• Are there well-defined and justified selection criteria as well as retention strategies?

For applications proposing clinical trials training:

• Do prospective Trainees have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective Trainees?

Training Record

• Is there evidence of a successful past international bioethics training record of the PD/PI and mentors, including the success of former LMIC scholars in seeking independent support and establishing productive bioethics leadership careers?
• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

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

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

Inclusion of Women, Minorities, and Children

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.

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

Not Applicable

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

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

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 LMIC trainee experience, and the particular circumstances of the LMIC 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 relevant to the LMIC context, 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 LMIC, U.S. or other HIC faculty will participate in the instruction? 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 (doctoral and postdoctoral) and at a frequency of no less than once every four years? Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

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

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research training, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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), 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. 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 balance

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

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

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

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

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

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

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 supports 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 of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/ (//grants.nih.gov/ClinicalTrials_fdaaa/).

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols for trainee research involving human subjects are reviewed by IRBs or IECs at the U.S. and LMIC institutions involved. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH information 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 https://humansubjects.nih.gov/data_safety and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, trainee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

Not Applicable

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.

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.

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 trainees in NIH's CareerTrac (https://careertrac.niehs.nih.gov/))
• Trainees 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 Bioethics Research Training 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, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement . Evaluation results should be included as part of the final Progress Report

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

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.

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

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

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

Barbara Sina Ph.D.
Fogarty International Center (FIC)
Telephone: 301-401-9467
Email: [email protected]

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

Karin Helmers Ph.D.
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]

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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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.