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 a strong and high-quality 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 career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars 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 previous collaboration should be documented by 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) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 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 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 day to day administration of the program and is responsible for appointing members of the Advisory Committee, using their recommendations to determine the appropriate allotment of funds. 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 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 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.

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., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign 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.

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.

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]

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 training, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral,), and intended trainee outcomes. Include the name of the LMIC and US collaborating institutions and the bioethics focus of the proposed timing.

Other Attachments.

Training Advisory Committee

Provide a plan for a Training Advisory Committee (TAC) to monitor progress of the training program. The composition, roles, responsibilities, and expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the TAC will function to provide oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates and scientific review of trainees projects. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf

Progress Report

A Progress Report attachment is required if the type of application is a renewal.

Follow the Training (T) Instructions in the SF424 (R&R) Application Guide regarding the content for reporting accomplishments of the training program. Include a list of publications arising from work conducted by trainees (names marked in each citation) while supported by the training grant during the previous five-year grant period. Please name your file Progress_Report.pdf

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

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

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 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 mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

Training Program

Program Plan

Program Administration.

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.

In the event that a clinical trial is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of clinical trials, including any feasibility or ancillary study, proposed by trainees. .

Institutions with existing FIC research training programs must explain what distinguishes this program from the others, how the programs will synergize 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.

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 mentors, 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 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.

Proposed Training.

Applicants should include a description of an individual career development 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.

Describe how mentored trainee projects will be selected and monitored 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.

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

Trainee Candidates

Describe 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.

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.

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 clinical trials experience or the potential to organize, manage and implement clinical trials.

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.

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 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 the SF424 (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

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.

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 the awarding component 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. 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.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review. 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.

Applications submitted to the NIH in support of the NIH mission 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 facilities and bioethics research environment conducive to preparing LMIC trainees for successful careers as bioethics research scientists?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the courses, where relevant, 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 multidisciplinary research training opportunities?
• 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?
• Is it clear how the proposed training program is distinguished from other externally funded training programs at the collaborating institutions?
• Are the specific needs for bioethics capacity, scholarship and leadership in the LMIC adequately described and addressed by the proposed research training program?
• Will the mentored trainee research projects focus on ethical issues relevant to current research involving human subjects in LMICs?
• Is there 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 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?
• 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?

Preceptors/Mentors

• Are sufficient numbers of experienced LMIC, U.S. or other HIC preceptors/mentors with international bioethics expertise and funding available to support the number and level of trainees proposed in the application?
• Do the preceptors/mentors have strong records as bioethics researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?
• How successful is the history of institutional and individual collaborations among the U.S. and LMIC faculty of the participating institutions?
• 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 each of the proposed levels (predoctoral and/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 scientific careers as evidenced by successful competition for bioethics related positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to leadership positions; and/or other such measures of success?
• To what extent do trainees subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their bioethics research training and directly benefit the broader biomedical research enterprise?
• 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?

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

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

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

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

Recruitment Plan to Enhance Diversity

Not applicable

Training in the Responsible Conduct of Research

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.

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

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

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 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: Grantee 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 awardee 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, 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

A final RPPR, 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 RPPR.

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 ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, 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 instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

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

Seetha Bhagavan, Ph.D.
Center for Scientific Review
Telephone: 301-237-9838
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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.