FICRS Support Center Site Solicitation & PA

Request for Application (RFA) to Serve as a Training Site for

International Clinical Research Scholars (ICRS) and Fellows (ICRF)

PURPOSE

The Fogarty International Center (FIC), through the ICRS Support Center at Vanderbilt University and the Association of American Medical Colleges (AAMC), seeks applicants from qualified institutions with eligible research programs based in developing countries supported by the U.S. government. These sites will provide opportunities and resources for advanced degree students in the health sciences to gain outstanding clinical research training experiences in an international setting.

Research programs must be located in a developing country (“host site”) that is not classified as “high income” as per this World Bank website: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS

ICRS seeks to support training for the next generation of clinical investigators to focus on international health issues. Programs based in developing countries that focus on chronic diseases (e.g., cardiovascular diseases, diabetes, cancer), infectious diseases (e.g,  HIV/AIDS, STIs, Malaria, TB, respiratory diseases, enteric infections, neglected tropical diseases) contraceptive research, nursing research, dental research, neuroscience, substance abuse, injury, environmental or occupational disorders, and complex emergencies are encouraged to apply.

To be eligible to host a scholar or fellow, a site must demonstrate US federal government supported research, e.g., the National Institutes of Health, the Centers for Disease Control and Prevention, the National Science Foundation, the Department of Defense, and the United States Agency for International Development. This funding support must be extant during the year that a fellow is on-site (i.e., for the 2009-2010 ICRF, US federal funding must extend through June 2010). Sites supported with the President’s Emergency Plan for AIDS Relief (PEPFAR) are eligible to compete, but they must demonstrate clearly their clinical research capacities. Only sites demonstrating strong ethical review processes and oversight of clinical research compatible with the guidelines of the Office of Human Research Protection (OHRP) of the U.S. Department of Health and Human Services (http://www.hhs.gov/ohrp/) may apply. Site investigators must have demonstrated their interest, commitment, and expertise in mentoring graduate-level health sciences students and/or fellows and post-doctoral trainees in clinical research.  Only research facilities with research funding will be considered.  

In coordination with program and review staff at the NIH, Vanderbilt University will convene a peer review committee of qualified clinical researchers, international health experts, and community advocates to review and advise on site selection. Final program selection will be based on criteria presented later in this RFA. Selected sites will be funded for 2 years, renewable for up to 4 years.   

As an “International Training Site” (ITS) for Scholars and Fellows, the site supporting a US and counterpart in-country scholar or fellow will receive the following benefits:

·         Stipend support for the US scholar or fellow (through Vanderbilt University).

·         Evacuation insurance for the US scholar or fellow (through Vanderbilt University).

·         Health insurance.

·         Two-week training orientation for both US and in-country scholars/fellows on the NIH Campus in Bethesda, Maryland. (through the AAMC).

·         For scholar (ICRS) applicants only, a required trip to Bethesda, MD in February/March for the International Training Site PI to interview and select scholars (through the AAMC).

·         For fellow (ICRF) applicants only, a required trip to Nashville, TN in November/December for the selection committee to interview and select fellows (through Vanderbilt University).

·         Funds to support the following (via a subcontract from Vanderbilt University to the recipient institutions that present this proposed budget in this RFA response and are selected for an ITS award):

o        An additional in-country scholar or fellow from the host country for each US counterpart (salary commensurate with comparable local positions)

o        $5K administrative support for the US or other co-sponsoring institution

o        $10K infrastructure support for host ITS in the developing country

o        $8K to support travel of the US scholar/fellow to the host ITS, to support travel clinic expenses such as vaccinations for US scholars/fellows, and an optional orientation for the scholars/fellows at the collaborating international institutions not located at the developing country site following the July training at the NIH, if applicable.  Any funds remaining may be used to travel the scholar/fellow to scientific meetings or to return to the overseas site in the 12 month period after completion of the training.

o        Laptop computers and basic software for use by all scholars/fellows will be provided to sites.

o        As per FIC-NIH regulations, Facilities and Administration (“indirects”) of 8% on eligible expenses for US Institutions (foreign sites cannot receive indirects).

ELIGIBILITY CRITERIA

The competitive selection of the ITS will be based on these criteria:

1.       Substantial ongoing clinical research supported by recognized funders that extends through June 2010, at least.

2.       Evidence of compliance with OHRP-required Federal Assurances, including institutional review board (IRB) ethical review and, when indicated for clinical trials, data safety and monitoring boards. The clinical research projects of the ICRS/ICRF will be restricted to projects that are IRB-approved.

3.       A strong track record of clinical research and research training, including graduate-level training for both developing country students and U.S. students.

4.       An advantage, but not a requirement, is support from one or more Fogarty International Center training grants or PEPFAR training centers that enhance research capacity at the site.

5.       Strong mentoring capacity from home and host site investigators.

6.       Demonstration of effective mentoring, monitoring, follow-up, and educational capacities at the host site.

7.       Ability and willingness to recruit and support counterpart scholars/fellows from the host developing country.

8.       History of successful peer-level partnerships and collaborations between the U.S. and host country institutions.

9.       Suitable infrastructure arrangements for housing and transportation, including one month guaranteed housing support for incoming scholars/fellows to permit them time to find suitable housing for the rest of their stay.

10.   Awareness of and attention to health and safety issues, including a plan for evacuation in the face of civil strife.

11.   Ability to facilitate local language training, when appropriate.

12.   ITS location in an eligible nation, as per World Bank site referred to on page 1 of this RFA.

DEADLINE

Proposal Due Date: May 19, 2008

ITS Selection (Public Announcement) Date: July 21, 2008

APPLICATION SUBMISSION INSTRUCTIONS

Submit the original application via email to c.lem@vanderbilt.edu as an electronic copy (only RTF, DOC, WP, or PDF files accepted).

Use 11 to 12 point Arial fonts.

Please see the recommended outline for the application. We will solicit approval of your institutional grant official after the review rather than at this time.

REVIEW PROCEDURE AND CRITERIA

Applications will be reviewed for merit by a peer committee:

v      Eligibility of the applicant institution

v      Quality and feasibility of proposal

v      Interest and commitment as indicated by a well-thought-out plan and arrangements to support adequate funds to support scholars/fellows’ projects

v      Availability of appropriate mentors and supervisors

v      Evidence of institutional support

v      Benefit to the host country/institution

v      Contribution to health capacity building in host country/institution

v      Nature of the research base and opportunities

v      Past experience and success in research training in developing country settings.

No reviewer will attend reviews nor will they vote on proposals from their own sites or from sites where there may be a perceived conflict of interest. No single institution will have more than one member of the site selection peer review committee.  The Principal Investigator of the FICRS Support Center @ Vanderbilt-AAMC will convene the committee whose members will be listed on www.fogartyscholars.org after the review has taken place.  Dr. Aron Primack as the FIC-NIH program official will be consulted regarding all prospective reviewers.  Suggested reviewer names may be sent to him at primacka@mail.nih.gov.

TERMS & CONDITIONS FOR THE SUPPORT

Pre-approved site status will be granted for a 2-year period of time beginning July 1, 2008, renewable for up to four years. Subcontracts from the FICRS Support Center at Vanderbilt-AAMC will only be negotiated when a scholar or fellow is linked to the site after Fellow selection process in December and Scholar selection process in March each year.

APPLICATION

International Field Site Application

If you have any questions concerning this announcement, please contact:

Catherine Lem, MPH or Sten H. Vermund, MD, PhD

319 Light Hall, 2215 Garland Ave

Nashville, TN 37232-0242

Phone: (615) 343-3555

Email: c.lem@vanderbilt.edu

Phone: (615) 322-9374

Email: sten.vermund@vanderbilt.edu

Fax:     (615) 322-9400

Answers to all RFA queries will be posted to www.fogartyscholars.org.