IRB Written Procedures Draft Guidance released

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs draft was released recently by the FDA and the Office for Human Research Protections (OHRP). This new draft guidance includes an IRB Written Procedures Checklist developed with the...

Article from Pearl IRB staff featured in SCRS InSite magazine

Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. ...

OHRP panel to update rules that guide online research protocol

Researchers are increasingly using the Internet as a means of conducting research. However, the question arises, how accurate and safe is this forum for collecting data? According to an article on Post-Gazette.com, author Tracie Mauriello notes that this is a topic of...