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NIDA Home > Recovery > Program to Enhance NIH-supported Global Health Research Involving Human Subjects

American Recovery and Reinvestment Act of 2009 (Recovery Act)

Recovery Act Limited Competition: Program to Enhance NIH-supported Global Health Research Involving Human Subjects (S07)
(RFA-OD-10-006)
National Institute on Drug Abuse

This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications from U.S. institutions for one year of support for resources and activities that will strengthen oversight of NIH supported human subjects research conducted collaboratively with institutions in low- to middle-income countries (LMIC).

This initiative is one of several being offered to help fulfill the goals of the American Recovery and Reinvestment Act (ARRA) to help stimulate the economy through support of biomedical and behavioral research. Additional information the Recovery Act and related NIH opportunities is available through the Office of Extramural Research (http://grants.nih.gov/recovery/ )

Additional Information:

The ARRA International Human Subjects Research Enhancement Program will provide short-term support for U.S. and developing country institutions already collaborating on NIH supported human subjects' research to jointly strengthen the ethical review and monitoring of such projects through enhanced collaboration and communication. This support is meant to improve the quality as well as enhance the efficiency of the ethical review and monitoring and accelerate global health research. It is expected that the enhancements supported will be sustained by the U.S. and foreign institutions after the award ends.

Objectives: Applications will be supported to develop collaborative processes and training as well as jointly used tools and systems to address the specific needs and capabilities for improved review and monitoring of protocols for NIH supported research conducted at a developing country institution. The grants will provide one year of support for an applicant U.S. Institutional Review Board (IRB) to collaborate with a developing country counterpart IRB which reviews some of the same NIH research protocols to do any of the following:

  • Develop sustainable electronic systems, procedures and communication methods to facilitate collaboration on review and monitoring of protocols sent to both IRBs;
  • Increase administrative, scientific, socio-cultural and ethical competencies of IRB members and staff related to research reviewed by both IRBs through joint workshops, short-term exchange and training activities;
  • Create sustainable international research ethics training resources for global health researchers at both institutions to improve research protocols and practices involving human subjects in the collaborating developing country.

Participation: Participants may include ethical review committee members, IRB administrators, NIH supported researchers and research trainees, research program administrators as well as others with expertise relevant to ethical review and monitoring of protocols from the proposed U.S. and developing country institutions.

Collaboration: Applicants are expected to demonstrate full partnership with the proposed developing country institution ethical review committee in the needs analysis to serve as the basis for the application and in proposed leadership, resource sharing and program activities. Applicants are strongly encouraged to designate multiple PIs on their application naming their primary developing country collaborator as a PI. Applications should include plans for sustaining proposed collaborative systems, processes, training components and resources after the end of the grant period at the U.S. and developing country institutions.

This funding opportunity announcement (FOA) solicits applications from applicant organizations that propose innovative IRB resource development and targeted IRB-related professional development programs related to the mission of FIC, NIAID, NIDA, NIMH and other NIH Institutes and Centers to strengthen capacity for the ethical review of NIH sponsored international human subjects research.

Funding and Budget Information:

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5. FIC has designated $650,000 in FY 2010 to fund 12-13 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications. FIC will fund only one application from any single U.S. institution. FIC will fund only one application involving a particular developing country institution.

Budget proposals are limited to $50,000 direct costs per year for one year.

F&A costs will not be provided.

This FOA will use the NIH Biomedical Research Support Grants (S07) mechanism which is a flexible and specialized mechanism designed to strengthen NIH supported research programs at grantee institutions by improving human and physical research resources such as those needed for ethical review of human subject research capacity.

Allowable Costs:

  • Personnel: Individuals (PD/PIs), faculty and staff designing, directing, and implementing the proposed research resource 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 U.S. or collaborating institution's policy for similar positions and may not exceed the congressionally mandated cap.
  • Resource Program-Related Expenses: Consultant costs, short-term fellowships, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research resource program and must not duplicate items generally available from other sources at the applicant or collaborating institution. Expenses for foreign travel must be exceptionally well justified. Applicants should include travel expenses to participate in a network meeting of all grantees supported as a result of this funding opportunity at NIH (or another venue identified by the program staff) at the end of grant period.
  • Participant Costs: Participant costs must be justified as specifically required for the proposed research resource program. Allowable participant costs depend on the educational level/career status of the individuals involved in the program. Amounts for all participants must conform to the established, consistently applied salary and wage policies of the U.S. or collaborating institution and reflect the percentage of time/effort devoted to the program.

The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Eligible Institutions: Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization.

Other Information:

  • The PD/PI should be capable of providing both administrative and research ethics leadership to the development and implementation of the proposed program. The PD/PI should have documented experience in international research ethics and an ethics review committee at the applicant organization. Due to the collaborative nature of the proposed program, applicants are strongly encouraged to designate a developing country collaborator as a PI (i.e multiple PDs/PIs).
  • More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application for projects that require a "team science" approach and therefore clearly do not fit the single-PD/PI model.
  • This is a one-time-only solicitation, resubmissions are not permitted.
  • Renewal applications are not permitted in response to this FOA.
  • Institutional Commitment: Applications are expected to include letters from the appropriate head research administrator at the U.S. and developing country institution substantiating the institutions commitment to the proposed research resource development and to sustaining the results of the proposed activities. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources that can contribute to the planned program.
  • Developing country collaboration: Applicants are expected to apply with a developing country collaborating institution 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)

Key Dates:

Opening Date: January 22, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: February 22, 2010
Application Due Date(s): March 22, 2010
Peer Review Date(s): June/July 2010
Earliest Anticipated Start Date(s): August 31, 2010

Application and Submission Information:

Letter of Intent:

Although the Letter of Intent (LOI) is not required, not binding and does not enter into the review of the subsequent application, an applicant may choose to submit one.

The information that the LOI contains allows IC staff to estimate and plan for the potential review workload.

Prospective applicants are asked to submit a LOI that includes the following information:

  • Descriptive title of proposed research resources program.
  • Name, address, and telephone number of the PD(s)/PI(s).
  • Names of other key personnel.
  • Participating institutions.
  • Number and title of this funding opportunity.

The letter of intent is due February 22, 2010.

The letter of intent should be sent to:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email: sinab@mail.nih.gov

Contact Information:

Program Contact(s):

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email: sinab@mail.nih.gov

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