Let’s get the bad news out of the way: We have cancelled our webinar “After the Compliance Date: Revised Common Rule FAQs,” which was originally scheduled for February 28.
Now for the good news: We cancelled it because we haven’t been able to gather enough new issues to report to the research community.
Based on our conversations with others in the IRB world, it seems most IRBs were fairly well prepared for implementation of the revised Common Rule and the transition has been relatively smooth. That’s really good news. While there still is limited guidance available from OHRP, it seems that the implementation delays provided the research community with the opportunity to hash out how systems, operations, policies, and forms would need to be revised to address the changes.
After evaluating the issues that have been in the forefront since the go-live date for the revised Common Rule, we decided that a better approach right now is to address concerns and questions by way of a blog instead of a webinar.
In the following list, we discuss some areas that seem to have lingering questions and implementation issues. We’ve also included some reminders about hot topics on the transition.
We think the most important thing to remember about the new regulations is that we’re all in this together. If you’re still having trouble with something, don’t suffer in silence—reach out to a colleague, or post your question to a message board, or search online for answers. As a community we’ve made it this far, and we think we’re going to make it through this implementation period just fine.
Looking for more information on the revised Common Rule? Read our blogs Do I Need to Comply With the Revised Common Rule? and Informed Consent Changes in the Revised Common Rule.
Need specific guidance about a new study submission? Contact Business Development.