Have a few minutes/hours/days to fill? The Food and Drug Administration has released a compilation of all of its Good Clinical Practice questions and answers from 2017 through 2021. The good news: The Q&A is in a searchable Excel spreadsheet. The bad news: The spreadsheet contains close to 1,400 individual questions. Anyway, the resource might […]

This is our year to undergo the process to get reaccredited by the Association for the Accreditation of Human Research Protection Programs, or AAHRPP. We’ve already compiled and submitted the sizeable Step 1 application, and are now gearing up for our site visit, scheduled for May 16-18. The March 2021 IRB reviewer education gives a […]

Today’s blog post theme isn’t so much about the specific items mentioned in these articles as it is about the general availability of data. When we think about data protections, it’s helpful for us to remember the context in which to think about confidentiality. First, here’s an article about how the intelligence community uses smartphone […]

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 […]