This proposal requests support for projects designed to enhance human subjects research protections at the Fred Hutchinson Cancer Research Center (FHCRC) and its research partners - local and international. Participation of community physicians and institutions in clinical trials and training of IRB members. The FHCRC will provide enhanced resources for physicians in the Puget Sound Region associated with the Puget Sound Oncology Consortium, and support a training program for IRB members in the Pacific Northwest. Key components of the project will include the development of web-based on-line forms and links to the FHCRC Institutional Review Office / Protocol database, training workshops, and the on-site piloting of assessment tools. Enhancing training opportunities at international sites HIV Vaccine Trials Network (HVTN) programs. The FHCRC serves as the coordinating center for the HIV Vaccine Trials Network and collaborates with Family Health International, the coordinating center for the HIV Prevention Trials Network. This project will focus on enhancing the protection of human research subjects in two regions with active HVTN programs at four international sites (Botswana, Dominican Republic, Republic of Haiti, and Malawi). At each site, after an assessment of IRB training needs and evaluation of site capacity to comply with U.S. Food & Drug Administration (FDA), International Conference on Harmonisation (ICH), and Office for Human Research Protections (OHRP) requirements, site-specific programs will be initiated. Representatives from each country will attend the December 2003 meeting of Applied Research Ethics National Association (ARENA)/ Public Responsibility in Medicine & Research (PRIM&R). Training workshops will be conducted on-site at two international regions, and pro-active compliance assessments will be offered to the four international sites. International Training Platform. FHCRC has pioneered the International Training Platform, a web-based resource for researchers who do not have English as a primary language. The platform provides training in the protection of human research subjects at no cost. Preliminary work in Chinese will be presented to the NIH this fall. FHCRC will continue to expand the site to include two additional languages (French and Portuguese) and will continue to develop the China module. Through a partnership with CITI (Collaborative IRB Training Initiative), administered at the University of Miami, these materials will be linked to their web site and the international site content will be maintained and upgraded by CITI beyond the period of this award.
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