Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

International Research Ethics Education and Curriculum Development Award (R25)

Activity Code

R25 Education Projects

Announcement Type

Reissue of PAR-10-174

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-13-027

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.989, 93.865, 93.856, 93.398, 93.172

Funding Opportunity Purpose

The goal of this initiative is strengthen research ethics capacity in low- and middle-income countries (LMICs) through increasing the number of scientists, health professionals and relevant academics from these countries with in-depth knowledge of the ethical principles, processes and policies related to international clinical and public health research as well as the critical skills to develop research ethics education, ethical review leadership and expert consultation to researchers, their institutions, governments and international research organizations. 

 
Key Dates
Posted Date

November 26, 2012

Open Date (Earliest Submission Date)

March 22, 2013

Letter of Intent Due Date

April 22, 2013, April 22, 2014, April 22, 2015

Application Due Date(s)

May 22, 2013, May 22, 2014, May 22, 2015, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2013, October 2014, October 2015

Advisory Council Review

January 2014; January 2015; January 2016

Earliest Start Date(s)

March 2014; March 2015; March 2016

Expiration Date

May 23, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.


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Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Education Objectives

The Fogarty International Center and several ICs have supported International Research Ethics Education and Curriculum Development awards since FY2000 (see http://www.fic.nih.gov/Grants/Search/Pages/Awards-Program-Bioethics.aspx for list of current awards).  The goal of this initiative is to strengthen research ethics capacity in low- and middle-income countries (LMICs) through increasing the number of scientists, health professionals and relevant academics from these countries with in-depth knowledge of the ethical principles, processes and policies related to international clinical and public health research as well as the critical skills to develop research ethics education, ethical review leadership and expert consultation to researchers, their institutions, governments and international research organizations.   FIC and the participating ICs invite applications for International Research Ethics Education and Curriculum Development Program Award programs:

1. To develop a comprehensive ethics education program including master's level curricula and practicum opportunities for LMIC academics, researchers and health professionals in ethics related to performing research involving human subjects in their home countries or;

2. To revise and renew existing master's level international ethics education programs or;

It is expected that such master’s level research education will enhance the career development of participants from LMICs, as well as strengthen ethics scholarship and sustain their capacity to design and direct ethics activities related to clinical and public health research at their home institutions and countries.  Participant recruitment and selection strategies should be designed to identify the strongest potential LMIC leaders in research ethics as well as create institutional or regional networking and collaboration opportunities to sustain a critical mass of ethics leadership for maximum impact afterparticipation.   Faculty and mentors from LMICs with research ethics expertise should play significant roles in proposed programs to insure the relevance of the curriculum and sustainable impact of the participants afterward. Innovative approaches for continuing research ethics education and networking for participants that will sustain their development as research ethics leaders at their home institutions are encouraged.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

New education program applications may request a budget of up to $230,000 direct costs per year.

Renewal education  program applications may request a budget of up to $276,000 direct costs per year.

Award Project Period

The total project period for a new or renewal application submitted in response to this funding opportunity may not exceed 5 years.  

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the Congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).

Participant Costs

Participants may be paid if specifically required for the proposed research education program and sufficiently justified. Participant costs must be itemized in the proposed budget

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

While generally not an allowable cost, with strong justification, participants in the research education program may receive partial costs of meals unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, and other education-related expenses.

Expenses for foreign travel must be well justified.

Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Other

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date.

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.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Foreign Institutions

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.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research ethics education as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should  have documented experience in international research ethics and capable of providing both administrative and   ethics education leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Preceptors/Mentors

To the greatest extent possible, faculty and mentors from LMICs with research ethics expertise should be included in significant roles in proposed programs.  Research ethics experts from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as faculty or mentors. Faculty and mentors should have research ethics expertise and international experience relevant to the proposed program, including but not limited to expertise in the philosophical foundations of bioethics, behavioral or social science or other empirical methods in empirical bioethics investigation, health policy or legal analysis and scholarship and ethics of medical care. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Participants in proposed programs must be recruited from low- and middle-income countries as defined by the World Bank (according to Gross National Income (GNI) per capita as “low-income,” “lower-middle-income,” and “upper-middle-income” see:  http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS). Applications must describe the intended participants, and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels essential for participation in the planned program.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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:

The letter of intent should be sent to:

Barbara Sina Ph.D.
Fogarty International Center, NIH
31 Center Drive, B2C39
Bethesda, MD 20892-2222
Telephone: 301-402-9467
Email: sinab@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

SF424 (R&R) Other Project Information Component

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

Facilities & Other Resources

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

Advisory Committee (Uploaded via the Other Attachments section)

Programs should establish an Advisory Committee to monitor progress that includes a majority of members not affiliated with the program and representatives from potential participant LMIC countries. The responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the expertise of the proposed members. A plan for Advisory Committee approval and selection of participants should be included. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program.

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

R&R Budget Component

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

PHS 398 Research Plan Component

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

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below: Proposed Research Education Program, Institutional Environment and Commitment, Program Director/Principal Investigator, Program Faculty/Staff, Program Participants, Plan for Instruction in the Responsible Conduct of Research, Evaluation Plan, Dissemination Plan.

Proposed Research Education Program (Component of Research Education Program Plan)

While the proposed research ethics education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving  U.S. support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research ethics education program and the research training supported by the training program. The information should include a description of the education and/or career levels of the planned participants.  

Significance/Background:  All applicants should provide a detailed assessment of the current status of the ethical review of research and needs and opportunities for research ethics education in the LMICs where participants will be recruited as rationale for the specific program plan components proposed.

Curriculum: Proposed programs should contain a balance of master’s level didactic fundamental ethics courses and practicum research ethics education  experiences innovatively designed to build sustainable research ethics capacity at LMIC institutions.  All applicants should provide a detailed description of the curriculum planned including learning objectives, specific knowledge and skills imparted to participants, duration, teaching methods used, assessments and resource materials used for each component.

1. Proposed curricula should provide a core set of master's level courses that focus on the internationally relevant aspects of ethical, legal and moral principles guiding research involving human subjects that reflects recent scholarship and employs innovative pedagogical approaches.

2.  Development of innovative curriculum imbued with culturally or scientifically relevant ethics topics to address LMIC participant needs and interests is strongly encouraged.

3. Plans should include education in the skills necessary for participants to provide research ethics leadership in teaching of bioethics, institutional capacity development for the ethical conduct and review of research and scholarship or empirical research in bioethics.  Proposed educational activities should include practicum experiences, such as participation in ethical review committees, development of research ethics education/training courses for researchers and ethical review committee members at their home institutions, analysis of ethical review guidelines or processes, and research on ethical practices in biomedical or behavioral research in the participants’ countries. Education may also be provided in areas such as mediation, negotiation and communication; pedagogy; research design and statistics; case study, manuscript and grant writing; ethics literature, regulation and policy analysis, and English as a second language, if needed.  

4. Five year program applications should propose degree or non-degree master’s level programs with international research ethics curriculum and practicum experiences for up to two years and no less than 12 months for LMIC participants at the grantee, consortium or home country institutions. 

5. Proposed master's level curriculum may be delivered by interactive distance learning technology, if appropriate and sustainable for the LMIC participants and institutions involved.

6.  Applicants are also encouraged to design relevant special courses or program activities that focus on the cross-cutting ethical issues of current interest to researchers working in LMICs (research with human specimens; design and conduct of clinical trials; research with pregnant women, children and other vulnerable populations; community engagement in research; public health practice and decision-making) or topics related to research supported by the participating NIH ICs:

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

-NIAID: ethical issues relevant to research on HIV/AIDS, TB, malaria, and other infectious diseases.

-NICHD:  Ethics of research with children and adolescents and protection of young people’s confidentiality while respecting parental concerns as well as varying cultural and legal standards.

-NCI:  Issues of informed consent and privacy protection of human tissue sample collection and biorepositories (such as sample use for future research, sociocultural implications, and whether the participant is being seen as an altruistic donor or a subject of human research), vulnerability in end-of-life research and care (such as phase I and II clinical trials in terminally ill patients) and the ethics of standard of care in cancer research in LMICs.

Recruitment Plans:  Applications should propose strategies to recruit participants with strong potential to provide ethics leadership to their home institutions.   Applicants should also design recruitment strategies that are likely to result in the establishment of a critical mass of research ethics expertise in institutions, countries or the region of participants necessary to meet the needs described in the rationale for the program.  Applicants are encouraged to collaborate with FIC research and research training programs http://www.fic.nih.gov/Programs/Pages/default.aspx or other NIH grantees working in LMIC institutions where participants may be recruited.   

Sustainability Plans:  New and renewal program applications must contain a sustainability plan to support participants to develop and sustain research ethics activities on return to their home institutions. Mentored participant practicum projects should be designed to meet participant ethics career sustainability goals.  Applicants are also encouraged to propose innovative approaches for continuing research ethics education and networking (including the use of electronic information and communication technology) for participants to further enhance their research ethics teaching, research review and leadership capabilities.  Applications may include support for participants to travel to research ethics conferences to present their work, laptop computers and internet connectivity, research ethics journal subscriptions and materials to initiate research ethics training courses, research ethics pilot research projects or publication. 

New Program Applications: Applicants should provide plans for internationally relevant curriculum development which will be offered to participants within one year after receipt of grant.

Renewal Program Applications: Applicants should include progress reports with detailed information about participants and activities supported during the previous grant period (comprehensive list of all participants and participant status after involvement in the program—including type and length of education provided and description of practicum projects; country of residence and institution; and the participant’s current position and responsibilities to provide research ethics training, review or consultation, research ethics publications and other significant accomplishments related to the research ethics education provided) as well as plans to revise program approach and curriculum based on results of evaluation of previous program activities including practicum experiences, mentorship and post-participation ethics career enhancement.

Institutional Environment and Commitment (Component of Research Education Program Plan)

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

Program Director/Principal Investigator (Component of Research Education Program Plan)

Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research ethics and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.      

Program Faculty/Staff (Component of Research Education Program Plan)

Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research ethics or other scholarly activities related to the mission of NIH.      

Program Participants (Component of Research Education Program Plan)

Where the proposed program involves participants, provide details about the pool of expected participants, their qualifications, recruitment strategies and sources of applicant pool, and any other information relevant to the selection process.     

Plan for Instruction in the Responsible Conduct of Research (Component of Research Education Program Plan)

Every participant supported by this Research Education grant must receive instruction in the responsible conduct of research. In addition to ethics education in research involving human subjects that is the primary focus of the proposed programs invited by this announcement, all applications must include plans to provide instruction in conflict of interest (personal, professional, and financial policies regarding human subjects), live vertebrate animal subjects in research, mentor/mentee responsibilities and relationships, collaborative research including collaborations with industry peer review, data acquisition (management, sharing and ownership), research misconduct and policies for handling misconduct, responsible authorship and publication, the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research.  Applicants should describe how these topics will be covered in the proposed curriculum (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Evaluation Plan (Component of Research Education Program Plan)

Applications must include a plan for evaluating the activities supported by the award.  The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Applicants should include specific plans to evaluate the effectiveness of the proposed curriculum, practicum experiences, mentorship and post-participation ethics career enhancement activities. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Dissemination Plan (Component of Research Education Program Plan)

A specific plan must be provided to disseminate internationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc.

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.  There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

Appendix

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

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 SF 424(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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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 education are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research education field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the proposed research education program address an important problem or critical question in research education or other critical issues?  How will implementation of the proposed program advance the objectives of the proposed program? Does the proposed international research ethics education and master's level curriculum development program address relevant international research ethics issues? How will implementation of the proposed program advance the objectives of both NIH and FIC in building research ethics capacity in low- and middle-income countries? Does the proposed program meet the needs for the international research ethics expertise of perspective LMIC participants, their institutions and national governments?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other faculty and mentors appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program?  If Early Stage Investigator or New Investigator, or in the early stages of an independent career, does the PD/PI have appropriate experience to lead the program?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Does the proposed advisory committee provide sufficient expertise and oversight in their described roles in the program?   

Innovation

Is the proposed research education program characterized by innovation and scholarship?  Does the proposed program challenge and seek to shift current research education paradigms or clinical practice, or address an innovative hypothesis or critical barrier to progress in the field?  Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area?  Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere?  Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.  If distance learning is proposed, is this approach appropriate for the curriculum delivered by this method to the proposed LMIC participants?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  If called for, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program?  Is there evidence that the program is based on sound research ethics concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? Does the proposed recruiting, application and selection process capture the most qualified LMIC individuals who could most benefit from the education and opportunities proposed, and immediately provide research ethics expertise and leadership to their institutions and countries after completing the program?  Do the proposed sustainability plans include appropriate practicum experiences, networking and other activities which will continue to enhance and sustain participant skills in ethical review of research, teaching research ethics, designing ethics research and consulting and publishing on research ethics issues and practices? 

Environment

Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success?  Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed?  Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is there evidence of appropriate collaboration among participating programs, departments, and institutions?  If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? 

Additional Review Criteria

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/priority 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, and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical and behavior research.

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 specific activities presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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/priority score.

Recruitment & Retention Plan to Enhance Diversity

Not Applicable.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the research education program, level of participant experience, and the particular circumstances of the participants, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Do the plans ensure participants will receive instruction (or in the case of more senior level participants, provide instruction) for an appropriate amount of time given the length of the research education experience?  Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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 Fogarty International Center Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the applications is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.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 the DUNS,  SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research, in accordance with the PHS 2590 Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards.

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. 

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.

Other Reporting Requirements

It is expected that participant data will be entered annually via the web-based CareerTrac System managed by FIC by the deadline for submission of progress reports.

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.

4. Evaluation

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

FIC:

Barbara Sina
Fogarty International Center (FIC)
Telephone: 301-402-9467
Email: sinab@mail.nih.gov

NCI:

Ming Lei
National Cancer Institute (NCI)
Telephone: 301-496-8580
Email: Ming.Lei@nih.gov

NHGRI:

Jean McEwen
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: Jean.McEwen@nih.gov

NIAID:

Liza Dawson
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3210
Email: Liza.Dawson@nih.gov

NICHD:

Susan Newcomer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6981
Email: Susan.Newcomer@nih.gov

Peer Review Contact(s)

Karin F. Helmers, PhD
Center for Scientific Review
Telephone: 301-254-9975
Email:  helmersk@csr.nih.gov

Financial/Grants Management Contact(s)

FIC:

Satabdi Raychowdhury
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: Satabdi.Raychowdhury@.nih.gov

NCI:

Shane Woodward
National Cancer Institute (NCI)
Telephone: 301 496-8791
Email: Shane.Woodward@nih.gov 

NHGRI:

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: chickc@mail.nih.gov

NIAID:

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5601
Email: Ann.Devine@nih.gov

NICHD:

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: Bryan.Clark@nih.gov

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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