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 This new draft guidance includes an IRB Written Procedures Checklist developed with the...
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. ...
The Office for Human Research Protections discovered that a study involving premature babies did not disclose potential risks of the associated treatment with the involved families as indicated by a recent article published April 11, 2013 in the New York Times. The...
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...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?