The Association for the Accreditation of Human Research Protection Programs (AAHRPP) will require devicemakers and research institutions applying for accreditation to adopt stricter rules on conflicts of interest. The organization will base accreditation on an applicant’s ability to separate business interests from ethics review functions, according to draft standards released for public comment.
The standards split the problem into institutional conflicts of interest, investigators’ financial conflicts and other conflicts, Marjorie Speers, AAHRPP president and chief executive, said. Comments are due July 30, 2009.
“We expect to have reviewed all comments before October 1, 2009, when we will publish the Final Revised Standards, which will be used by accreditation applicants beginning March 1, 2010,” Speers said.
AAHRPP issued the first standards measuring the ethics and quality of research involving human participants in 2001. Since then, it has used them to accredit 175 research organizations including over 830 entities among the nation’s universities, medical schools, hospitals, and most recently the drug industry, when Pfizer earned accreditation for its clinical research units in the US, Belgium, and Singapore last March.
“While earning accreditation is still rigorous, we’ve reduced the workload on clients, by clarifying language, reducing the number of items, and streamlining the process,” according to AAHRPP vice president Peter Vasilenko, who led the revision process.
With input from AAHRPP’s clients, its Council on Accreditation, and board of directors, the Standards Revision Committee reduced the number of domains covered by the standards from five to three; the number of standards themselves, from 22 to 15; and the number of elements in the standards, from 77 to 65.