The U.S. Food and Drug Administration (FDA) says it is making available a free app to facilitate the obtaining of informed consent in situations where face-to-face consent processes are not practical. The app, now called COVID MyStudies, is designed to address situations where a potential participant with COVID-19 may be in an isolation room, or […]

An updated IRB Policy 3.3, Reviewer and Consultant Conflict of Interest, is now available on the IRB’s website. The revisions add another criterion to the definition of a financial conflict (the addition of a financial relationship for which a reviewer is on a management plan); highlights’ reviewers responsibilities to notify the IRB office or chair […]

The IRB has updated its policy 3.9, titled “Consultants.” The newly revised policy is now available on the IRB’s website. The policy describes the process to be used when the IRB determines it needs input from someone with a particular type of expertise to appropriately review research. For example, someone with experience in a particular […]

The IRB office has posted an updated IRB Policy 4.7, Participant Contact. Remember how the IRB typically requires IRB contact information to be included in consent documents? Well, this policy underscores why that contact information should be included, and how the IRB will process any contacts it receives from participants. We note that this is […]

The IRB has posted an updated version of IRB Policy 17.9, Prisoners in Research. Most of the changes from the previous version are cosmetic; the policy has been reorganized a bit in an attempt to improve readability. Please note that the prisoner requirements apply both to studies that target prisoners in their recruitment, and also […]

A revised IRB Policy 8.1, titled “Modifications to Previously Approved Research,” is hot off the presses and posted on the IRB’s website. The changes are mostly formatting related, although we did make a few minor content changes (e.g. we don’t, in fact, require a copy of the updated FDA Form 1572 with a PI change […]

The IRB has revised its human subject research determination form to make it easier to request HIPAA authorization waivers for research projects using material subject to HIPAA, but which aren’t really identifiable as far as the human subject research regulations are concerned. Let us explain. One thing that has long gotten our collective goat is […]

The IRB scribes have been hard at work updating the IRB policies to ensure they meet current regulatory and accrediting agency requirements, add references, and make them easier to read. New policies posted in recent days are: IRB Policy 2.3, Single/Central IRBs IRB Policy 3.2, Quorum IRB Policy 3.6, IRB Members and Alternates. Note that […]

Federal regulations and IRB policies require the IRB to make additional determinations when reviewing research involving minor subjects. In addition to determining which category of pediatric research a particular project fits into, the IRB must affirmatively determine how many parental signatures are required on the study’s informed consent/parental permission form. The three* categories are: Research […]

We’re feeling pretty darn proud of ourselves over here at IRB Blog Central. We got the second quarter IRB Blog quiz out and posted well before the second quarter was over. There are now two quizzes available at learnondemand.org. Access them both by going to the highlighted link and typing “IRB” into the search box […]