Ethics training for human studies?

All researchers conducting studies with human subjects and members of institutional review boards may soon have to undergo mandatory training in human research ethics. According to a linkurl:notice;http://edocket.access.gpo.gov/2008/E8-14917.htm in the Federal Register yesterday (July 1), the Office for Human Research Protections (OHRP) is seeking public comment on whether such training should be required. According to the notice, also reported in the linkurl:Chronicle of Higher Education,;http://chronicle.com/daily/2008/07/3642n.htm the call follows from a linkurl:report published a decade ago;http://www.the-scientist.com/article/display/11874/ that harshly criticized how institutions review human trials, and identified several problems with the protection subjects received, requiring seven institutions to suspend their research. In 2002, the NIH instituted requirements for investigators funded by NIH grants to receive education in the rules of human subject protection, and since 2002, OHRP has strongly recommended, but not required, universities to provide training more widely to those involved in trials. OHRP "has identified serious, systemic noncompliance" with such rules -- many of which, the agency believes, are due to "inadequate training and education," the notice states. A recommendation made last year suggested the OHRP mandate training for "IRB members and staff, investigators, and certain institutional officials, including the official that signed the institution's FWA." (FWAs are Federalwide Assurances -- OHRP-issued approvals for conducting human research studies.) If you do research on human subjects or have sat on institutional review boards, you may want to weigh in on the series of questions OHRP poses in the linkurl:notice;http://edocket.access.gpo.gov/2008/E8-14917.htm to gauge whether wider ethics training is needed, and how to implement it.

Ethics training for human studies?

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