Full board meetings occur Monday afternoons at 4:30 PM Eastern. Complete study submissions received by the EOB Monday will be reviewed at the Monday meeting of the following week. To ensure a timely review of your study, please refer to the Example Timeline for Full...
When evaluating exempt protocols, we often get the comment, “Hey! This study is super simple, and obviously exempt. What’s the deal with the revisions?!”. While this is often very much the case, the IRB must evaluate what is presented against what is required by...
On October 8, 2020, Office for Human Research Protections (OHRP), on behalf of the Department of Health and Human Services (DHHS), issued an exception determination as permitted by 45 CFR 46.114(b)(2)(ii) stating that certain categories of cooperative research...
Full board meetings occur Monday afternoons at 4:30 PM Eastern. Complete study submissions received by the EOB Monday, will be reviewed at the Monday meeting of the following week. To ensure a timely review of your study, please refer to the Additional Information...
The 21st Century Cures Act mandated that the Department of Health and Human Services (“DHHS”) “revise the DHHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules to reduce regulatory duplication and unnecessary delays;...
This is the fourth of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Gretchen Parker, PhD, RAC, CIP, Pearl’s IRB Co-Chair, Senior Advisor, was interviewed for this piece. If you have...
