News Briefs

Register now for Duke OHRP conference

Registration is now open for the Office of Human Research Protections' national conference: "Crossing the Line: What is Acceptable Risk?" The event is scheduled for Sept. 25-26 in Durham, NC, and is sponsored by the Duke University School of Medicine.

Topics to be discussed include the use of deception in research with children, understanding risk and autonomy in overseas AIDS research and community recruitment of vulnerable groups. There also will be regulatory updates from representatives from OHRP, the FDA, NIH, and other federal agencies. For more information visit http://dukeohrp2006.org/.

AAHRPP accredits its first international site

The Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) of Washington, DC, now has awarded full accreditation to its first international organization, Samsung Medical Center in Seoul, Republic of Korea.

"Samsung Medical Center is a full-service hospital, and it has expertise in cancer treatment," says Marjorie Speers, PhD, AAHRPP executive director. "Samsung conducts clinical trials primarily, both for Korea and also for United States-sponsored research," Speers adds.

AAHRPP is working on accreditation with three other countries at present, and at the beginning of July there were a total of 39 organizations that had received accreditation. These organizations represented 106 hospitals and other entities, Speers says.

"Now, we're working with 380 additional organizations, so accreditation absolutely is something people want to do," Speers says. "Also, a number of sponsors of research are asking about accreditation — I think it has become a symbol of excellence and something that organizations want to achieve."

Over time, increasing numbers of international organizations will become accredited as they seek to attract U.S. sponsors, Speers predicts.

"I think there is significant incentive for foreign institutions to seek accreditation because they want to have a mechanism to demonstrate they can meet the U.S. regulations as well as their own countries' ethical codes," Speers says. "And just as it does for U.S. institutions, it will give them a competitive advantage."

The accreditation process begins with a self assessment, which typically take six to 12 months to complete. An application is submitted and a site visit is scheduled. The Council on Accreditation will make a determination regarding accreditation status, typically within three to six months of the site visit, Speers says.