Sticklers for neatness that we are (as anyone who has ever stopped by IRB Blog Headquarters can attest – heh), we have added a query to CLARA’s “modification” and “site addition” forms. These forms now have a free-text box labeled “Notes for the IRB reviewer(s).” Please use this area to add any information the IRB […]

The IRB’s website has been updated to make it easier to find information about single/central IRB review (we refer to that as “xIRB review). We’ve added a separate webpage consolidating an overview of the process and associated forms and information. The page also includes a link to a video of our most recent virtual class […]

The IRB office has updated its policy on meeting minutes, IRB Policy 6.3. This policy recaps the regulatory requirements and best practices for what has to be documented when the IRB reviews a study. While the changes are minimal from the previous iteration of this policy, it’s important to note the IRB takes these policy […]

The questions of whether risks and potential benefits are in balance, and whether subject selection is equitable, are critical to the IRB’s review of proposed research. We’ve updated our policies that discuss Risk/Benefit Analysis, IRB Policy 7.1, and Subject Selection, IRB Policy 14.1, to give researchers and IRB members clearer guidance about concepts that guide […]

The IRB has updated its policy 7.11, Risk/Benefit Analysis. Like many of the policy changes we’ve posted about recently, many of the updates relate to formatting and editing to improve readability. This policy, in particular, we think really benefited from this update, given the importance of the material it addresses (and the fact that the […]

An updated version of IRB Policy 17.1, Children in Research, is now available on the IRB’s website. The changes are limited to formatting changes and the occasional language clarification, as the regulations and requirements related to human subject research involving children have not changed. However, we in the IRB office find ourselves having to refer […]

A revised IRB Policy 1.7, IRB Advisory Committee, (IAC) is now available on the IRB’s website, replacing the previous iteration of the policy, which was titled “IRB Executive Committee.” The name change is significant, as it denotes a change in the committee’s focus and membership. The IAC includes members from departments all over campus, with […]

The New York Times had a recent article about the so-called survivors of thalidomide, who are the people who experienced birth defects associated with use of the drug during pregnancy. The article is interesting on several levels. It tells the stories of thalidomide survivors, their use of social media to find each other, and their […]

We’ve noticed a few things in new submissions regarding data and sample handling and storage that slow down approvals. Here are some reminders of things to keep in mind when drafting protocols and CLARA completing new submission forms:

Determining the appropriate time to close a study can be trickier than you might think. If you’ve completed your study and all that’s left is writing manuscripts and disseminating your findings, can you close the study in CLARA? How about if you’ve completed all your subject interaction and data collection, but have not finished analyzing […]