International bioethics education and career development award. (Fellowships, Grants, & Awards.

The Fogarty International Center (FIC), in partnership with the National Center for Complementary and Alternative Medicine (NCCAM), the National Heart, Lung, and Blood Institute (NHLBI), the National Human Genome Research Institute (NHGRI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute on Drug Abuse (NIDA), the National Institute of General Medical Sciences (NIGMS), and the NIEHS, invites applications to develop or expand current graduate-level curricula and training opportunities in international bioethics related to performing research involving human subjects in low- and middle-income nations. As current programs provide training for participants from the Asian, African, and Latin American regions (for descriptions of current programs, see http://www.fic.nih.gov/programs/bioethics/bioethicsaward.html), new applications focusing on countries of the Middle East; North, East, and West Africa; Eastern Europe; and the former Soviet Union are encouraged.

Applicant institutions can request up to four years of support to create comprehensive curriculum development and training programs. Developing country institutions can request up to two years of support for program planning and curriculum development in preparation to apply for comprehensive training program support in the future. In addition, current International Bioethics Education and Career Development awardees may apply for competing supplements to their award to collaborate with other FIC programs (for descriptions of other programs, see the FIC web site: http://www.fic.nih.gov/programs.html).

Proposed curricula should provide a core set of advanced study courses that focus primarily on the internationally relevant aspects of the ethical, legal, and social principles guiding the responsible conduct of research in developing countries. Support will be provided for training developing-country health professionals working at institutions conducting biomedical, behavioral, or public health research involving human subjects, and for ethicists or philosophers from developing countries with an interest in biomedical/clinical research. Appropriate training may include advanced degree--and nondegree-associated course work and practicum experiences such as participation in ethical review committees, development of intensive short courses designed for members of human subjects research ethical review committees, analysis of ethical review guidelines or processes, and research on ethical practices in biomedical or behavioral research in the trainees' countries.

This request for applications (RFA) contributes to the FIC's initiative to strengthen research bioethics expertise in developing countries. This RFA is intended to stimulate the development of new instructional programs in international bioethics at institutions that do not currently offer such programs, and to expand existing instructional programs in international bioethics to include a major focus on issues relevant to developing countries. The goal of this initiative is to increase the cadre of biomedical and behavioral scientists, clinical investigators, nurses, and other health professionals and relevant academics in developing countries with state-of-the-art knowledge of ethical considerations, concepts, and methods in research involving human subjects. It is expected that such advanced training will enhance the career development of individuals from developing countries as well as strengthen bioethical expertise at the trainees' host institutions.

Few developing-country institutions provide formal training in bioethics, and few developed-country programs for advanced bioethics training focus in depth on the internationally relevant aspects of bioethics, particularly those related to clinical investigations and traditional medical interventions in developing countries. Therefore, few developing-country health professionals conducting laboratory or clinical investigations have received extensive training in the principles of bioethics, codes, and legal aspects of ethical research, ethical experimentation on vertebrate animals, informed consent, decision making related to collaborative agreements between hosts and sponsors of clinical research, elements of study design that affect the ethical conduct of clinical trials, or interventions that should be provided to study participants.

This initiative seeks to train academics, health professionals, and researchers from developing countries in culturally relevant bioethics related to research. Proposed training programs should equip them with the critical skills that are needed to provide bioethics expertise and leadership to their institutions, national governments, and international bodies, and potentially, to pursue studies on ethical practice in biomedical and behavioral research in developing countries. The specific objectives are as follows.

1) Curriculum development to improve the quality of international ethics training. This will be achieved by supporting the development of courses in fundamental areas needed to provide skills for teaching and research related to bioethics and the ethical review of research on acute and chronic diseases in developing countries. Curriculum should include topics most relevant to the bioethics issues widely experienced in conducting research involving human subjects in resource-poor settings in developing countries. These include voluntary informed consent, standards of medical care, sensitivity to cultural differences, research on vulnerable populations, benefits sharing, use of human biological materials, human rights, conflict of interest, equivalent protections, and harmonization of international guidelines. Applicants are encouraged to develop training modules including topics related to the specific research interests of the participating NIH institutes and centers listed above.

2) Training to support appropriate advanced training for a cadre of developing-country professionals who could assume the expert roles and leadership responsibilities when involved in ethics review, clinical trials, and epidemiological studies in their countries. Applications that provide training for participants from the Middle East; North, East, and West Africa; Eastern Europe; and the former Soviet Union are particularly encouraged.

This RFA will use the NIH R25 award mechanism that limits facilities and administrative (F&A) costs to 8% of direct costs (less equipment). Applicants that request funding for subcontracts to foreign organizations may also include F&A costs up to 8% of direct costs (less equipment). More information on the F&A costs allowed for foreign institutions and international organizations can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html. The anticipated award date is June 2004.

The participating institutes and centers intend to commit approximately $1.8 million in fiscal year 2004 to fund 7-8 new and/or competitive continuation awards and planning/curriculum development grants in response to this RFA.

For comprehensive curriculum development and training program awards, an applicant may request a project period of up to four years and a budget for total costs of up to $250,000 per year maximum (including 8% F&A costs).

For planning and curriculum development grants, developing-country applicants can request up to two years of support for a program for up to $25,000 total costs per year (including 8% F&A costs).

For competing supplements, principal investigators of active International Bioethics Education and Career Development awards may request a supplement of up to $25,000 total costs per year (including 8% F&A costs) for the number of years remaining in the project period of the parent award.

The NIDCR will provide supplements to grantee institutions to cover the training-related costs for oral health professionals or researchers per year, up to a total of $200,000 per year.

The deadline for receipt of letters of intent is 17 November 2004, with 16 December 2004 the deadline for receipt of applications. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398. html in an interactive format. Complete information on this RFA is located at http://grantsl.nih.gov/grants/guide/rfa-files/RFA-TW-04-001.html.

Contact: Barbara Sina, Division of International Training and Research, FIC, 31 Center Dr, Rm B2C39, MSC 2220, Bethesda, MD 20892-2220 USA, 301-402-9467, fax: [phone], e-mail: [e-mail]. Reference: RFA No. RFA-TW-04-001