International Bioethics Research Training Program (D43 Clinical Trial Optional)

International Bioethics Research Training Program (D43 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH), Fogarty International Center (FIC). FIC supports LMIC-U. S.

collaborative institutional bioethics doctoral and postdoctoral research training programs.

Expired PAR-18-716: International Bioethics Research Training Program (D43 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations Fogarty International Center ( FIC ) National Human Genome Research Institute ( NHGRI ) Funding Opportunity Title International Bioethics Research Training Program (D43 D43 International Research Training Grants April 09, 2019 - This PA has been reissued as PAR-19-243 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The overall goal of this initiative is to support the development of a sustainable critical mass of bioethics scholars in low and middle-income country (LMIC) research intensive institutions with the capabilities to conduct original empirical or conceptual ethics research that addresses challenging issues in health research and research policy in these countries as well as provide research ethics leadership to their institutions, governments and international research organizations.

FIC will support LMIC-U.S. collaborative institutional bioethics doctoral and postdoctoral research training programs that incorporate didactic, mentored research and training components to prepare a number of individuals with ethics expertise for positions of scholarship and leadership in health research institutions in the This Funding Opportunity Announcement (FOA) allows support of Trainees as the lead investigator of an independent clinical trial; or a separate ancillary study to an existing trial; or to gain research experience in a clinical trial led by another investigator, as part of their research Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date May 17, 2018, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) May 17, 2018 by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the Training (T) Instructions (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description The International Bioethics Research Training program supports mentored doctoral and long term postdoctoral research training for ethic experts from low and middle income countries (LMICs) that complements other global health research and research training programs in the mission areas of the NIH Institutes and Centers.

The overall goal of this initiative is to support the development of a sustainable critical mass of bioethics scholars in LMIC research intensive institutions with the capabilities to conduct original empirical or conceptual ethics research that addresses challenging issues in health research and research policy in these countries.

Collaborative programs should be designed to recruit, select and rigorously train LMIC individuals with the potential to become independent bioethics scholars, teach bioethics courses, lead the ethical review of research and provide expert consultation to their institutions, governments and international research organizations.

Awards will support innovative U.S. - LMIC collaborative institutional bioethics training programs that incorporate didactic, mentored research and training elements to prepare a number of individuals with ethics expertise for leadership positions in health research institutions in the LMIC.

and Background Information In response to the increasing amount of collaborative global health research and scope of associated ethical concerns in LMICs, the Fogarty International Center (FIC) and several NIH ICs supported International Research Ethics Education and Curriculum Development (R25) awards since FY2000.

To address the continuing needs for in depth international research ethics education identified by a recent assessment of the program (JAMA 313, 5: 461-2), the requirements of the FIC International Research Ethics Education and Curriculum Development Award (R25) funding opportunity ( PAR-16-081 ) were modified to enhance the establishment of sustainable masters level research ethics training at research intensive LMIC institutions and this International Bioethics Research Training Program funding opportunity was created for LMIC doctoral and long term postdoctoral training.

Bioethics research training activities can be focused on the ethics of research in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission and the health research priorities of the LMIC.

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

The proposed doctoral and/or long term postdoctoral training program should provide: A strong foundation in research design, methods, and analytic techniques appropriate for the proposed bioethics research area; The enhancement of the trainees ability to conceptualize, analyze and solve bioethics research problems with increasing independence; Experience conducting bioethics research using state-of-the-art methods as well as presenting and publishing their research findings; The opportunity to interact with members of the international bioethics academic community at appropriate conferences and workshops; and The enhancement of the trainees understanding of the bioethics theory and ethical practice related to global health research.

A secondary objective of proposed programs should be to provide training in the competencies necessary to sustain scholarly careers in leadership positions at institutions in the LMIC as well as teaching bioethics, leading ethical review of research and providing research ethics consultation.

The overall goal of this initiative is to contribute to the development of a sustainable critical mass of bioethics leaders at the LMIC research intensive institution to meet the needs for research ethics capacity in this country.

Applicants should describe the specific needs for research ethics capacity, scholarship and leadership in the LMIC and how the results of the proposed doctoral and postdoctoral training will meet these needs at the end of the proposed award period.

Applicants are encouraged to develop plans for post-training interaction and activities among the doctoral and postdoctoral trainees specifically to create a sustainable critical mass for bioethics leadership at LMIC institutions.

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

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

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

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

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

Faculty and mentors from the U.S. or other high income countries should have international bioethics research experience. Faculty and mentors from LMICs with research ethics expertise should play significant roles in proposed programs to insure the relevance of the proposed research training and sustainable career development. Original bioethics empirical and conceptual research is increasingly complex and multidisciplinary in nature.

PDs/PIs are encouraged to develop institutional training programs that will expose trainees to a diversity of bioethics scholarship, systems for study, empirical and conceptual research approaches, and tools and technologies. Consideration of team-based research approaches may also be warranted depending upon the goals of the proposed bioethics training program.

In order to contribute to progress in both theory and practice in international bioethics, mentored research projects should focus on ethical issues faced in current research involving human subjects in the LMIC and be conducted to the greatest extent possible in this country.

Trainee research is expected to lead to first author publications in leading international For applications proposing training in clinical trials research plans, for training in data management and statistics relevant to clinical trials, good clinical practice (GCP) and good laboratory practice (GLP) should Training programs should make available structured, career development mentorship and learning opportunities (e.g., workshops, mentorship, Individual Development Plans).

Through such opportunities, trainees would obtain a working knowledge of various potential career directions that make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen The proposed institutional research training program may complement other ongoing FIC research training and career development programs at the applicant or collaborating institution, including those supported by International Research Ethics Education and Curriculum Development awards, however, the proposed program must be clearly distinct from any related programs currently receiving U.S. government support.

Short-term training is not supported by these awards, or any undergraduate, clinical or masters-level training. Masters level training for LMIC participants can be supported by International Research Ethics Education and Curriculum Development Award (R25) ( PAR-16-081 ). "Build research capacity through individuals, institutions and networks to meet future and evolving health challenges."

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

Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

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. Applicants may request up to $230,000 direct costs per The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

Stipends, Tuition, and Fees Awards may provide stipends as a subsistence allowance to help defray living expenses during the research training experience. Awards can contribute to the cost of tuition and fees. Individuals designing, directing, and implementing the research training 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 research trainees are considered a regular part of an individual's academic duties, then mentoring and other interactions with research trainees in the proposed program are non-reimbursable from grant funds.

Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles. For institutions covered by OMB Circular A-21, this type of training program may qualify as a major project where administrative salaries are allowable as a direct cost.

When specifically identified Trainee travel between collaborating institutions and to attend bioethics meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for doctoral and postdoctoral Training Related Expenses and Other Program Related NIH will provide funds to help defray other research training expenses, such as health insurance, trainee research project costs, staff salaries, consultant costs, laptop computers and internet connectivity, research supplies, ethics journal subscriptions and publication costs, faculty/staff travel directly related to the research training program, and PI travel to annual network meeting at FIC in Bethesda MD.

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated 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: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions American Native American Pacific Islander Serving Institutions (AANAPISIs) Non-domestic (non-U.S.) Entities (Foreign Institutions) The sponsoring institution must assure support for the proposed program.

Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. The applicant institution must have robust and high-quality research ongoing in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to contribute to the envisioned research training program.

It is anticipated that participating training program faculty will have active, funded research projects in which potential trainees may gain relevant research training experiences consistent with their career interests An application may be submitted by an eligible foreign institution in a low- or middle-income country (LMIC) or by an eligible domestic (U.S.) institution that demonstrates collaborations with an LMIC institution named in the application by documented joint publications, grants or previous research training activities.

LMICs are defined by the World Bank classification system (according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income ( http://data. worldbank. org/about/country-classifications/country-and-lending-groups ( http://data.

worldbank. org/about/country-and-lending-groups )). See Notice of Change in Country Eligibility for Fogarty International Training 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 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 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 Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. 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.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the 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.

Eligible Individuals (Program Director/Principal the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The Training PD/PI should be an established investigator in international bioethics and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI should have bioethics research and research training experience in the LMIC country which is the focus of the application.

The Training PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The Training PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. Non-U.S. applicants must be citizens of LMICs.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission 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 ). faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program.

Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Only individuals from LMICs that meet the Country Eligibility ( http://www.

fic. nih. gov/Grants/Pages/countryeligibility.

aspx) are eligible for training under this FOA. Individuals who also have citizenship or permanent residency in the US, other high income countries, or countries not eligible under the Country Eligibility ( http://www. fic.

nih. gov/Grants/Pages/country-eligibility. aspx ) are not eligible for support under this FOA.

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

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

, M. D. , or comparable doctoral degree from an accredited institution.

Preferably, postdoctoral trainees should have faculty positions at the LMIC institution. Only long term postdoctoral bioethics research training of at least one year can be supported. Trainees with previous masters' level training or equivalent bioethics related experience and bioethics related publications are preferred.

and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the Training (T) Instructions (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant 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 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: All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an Follow all instructions provided in the SF424 (R&R) SF424(R&R) Project/Performance Site Locations Follow all instructions provided in the SF424 (R&R) SF424 (R&R) Other Project Information Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications: Summary/Abstract.

Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., doctoral, postdoctoral, ), and intended trainee outcomes.

Include the name of the LMIC institution from which trainees will be selected, if not the applicant institution, and the bioethics focus areas of the proposed and Other Resources : Include descriptions of facilities and other resources to be used Attachments. Provide the plan for a Training Advisory Committee (TAC). Responsibilities, frequency of meetings, and other relevant information should be included.

The composition of the TAC, the roles people should fill, and the desired expertise of the members should be described. The TAC should be composed of expert faculty and relevant professionals from the applicant country and from the United States as well as other countries, if appropriate.

TAC members should not be directly involved in the training program or in Describe how the TAC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, scientific review of trainees projects, and the evaluation of the overall effectiveness of the program. Please name your file Advisory_Committee.

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

SF424(R&R) Senior/Key Person Profile Expanded Follow all instructions provided in the SF424 (R&R) PHS 398 Cover Page Supplement Follow all instructions provided in the SF424 (R&R) PHS 398 Training Subaward Budget Attachment(s) Follow all instructions provided in the SF424 (R&R) Research & Related (R&R) Budget Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications: Personnel section to submit costs for salary support for section to submit costs for key personnel and faculty travel including the annual 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.

Direct Costs section to submit costs for other direct costs related to training activities.

Describe fully in the budget justification PHS 398 Research Training Program Plan The PHS 398 Research Training Program Plan Form is comprised of the following sections: Faculty, Trainees, and Training Record Other Training Program Sections Appendix Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications: Particular attention must be given to the required International Training Describe the acknowledged strengths, leadership and administrative skills, training experience, bioethics expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the training program.

If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize but not overlap with the Multiple PD/PI Leadership Plan section of the application. If clinical trial is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by trainee(s).

For U.S. and other High Income Country (HIC) faculty mentors, describe the international bioethics research and research training experience in the LMIC country that is the focus of the application. Describe in detail the roles faculty and mentors from LMICs with research ethics expertise will play in proposed programs to insure the LMIC relevance of the proposed research training.

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

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

Describe how trainees will be educated in the human health- and disease-related aspects of their bioethics research training. Describe the plans proposed for a scientific oversight committee to monitor the selection and performance of mentored research projects and their compliance with federal requirements for protection of human subjects in research and animal care and use in research.

Applicants should include a description of an individual career development planning process for trainees and their trainers (for example, workshops, mentorship, Individual Development Plans). Applicants are encouraged to include a timeline which includes all proposed training activities.

If clinical trial is proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed by trainee(s).

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

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

Applicants are encouraged to of doctoral and postdoctoral trainees most likely to result in a sustainable critical mass for leadership in LMIC relevant bioethics research as well as teaching bioethics, leading ethical review of research and providing research ethics consultation at the LMIC institution.

For applications proposing training in clinical trials, the recruitment and selection plans should include specific strategies to identify trainees who have the potential to organize, manage and implement clinical trials. If clinical trial is proposed, discuss the potential of prospective trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

Institutional Environment and Commitment to the Program The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for LMIC trainees selected for the program.

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