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. ...
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for...
All of us in research are aware of the challenges with length and understandability of informed consent documents. In a new article found in the December issue of Anesthesiology News entitled “Uninformed Consent: Average Study Participant Likely Unaware of...
Health and Human Services announced in July a proposal to improve rules protecting human research. The proposed changes can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects...
“If it ain’t broke, don’t fix it,” that’s how the old saying goes. That’s not what what Kenneth Getz says about our current state of US human protection IRB system. Getz’ article published in Applied Clinical Trials Online titled...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?