One new and one updated IRB policy were recently posted on the IRB’s website. The revised policy, 2.3, relates to the use of single or central IRBs (xIRBs). This policy describes the process changes implemented as xIRB use has become more common in recent years. The 2018 Common Rule will mandate the use of an […]

A recent New York Times column caught our eye, as it was about research. Columnist Frank Bruni writes about his experience participating in a randomized, placebo-controlled study testing a potential treatment for a rare disorder affecting vision. While there is no one typical subject experience, and not many research subjects have their own column in […]

There’s a great new resource available for study teams interested in making research material more accessible to research participants. The Health Literacy in Clinical Research web site went live this week. This site contains a wealth of tips and resources intended to guide study teams to present information in an understandable way. Professor Christopher Trudeau, […]

A revised human subject research determination form is slated to go live in CLARA beginning Monday, October 21. The form’s questions have been rewritten to use simpler language, and the CLARA pages have been redesigned slightly to make help text easier to find and read. We’ve also tried to word the questions to make them […]

Needing to earn the most convenient 0.5 hours of Certified Research Specialist elective credit ever? Look no further than the 3rd Quarter IRB Blog quiz, now live at learnondemand.org. You can find it by clicking the link and typing “IRB” into the search box at upper right. Take the test whenever it’s convenient for you. […]

Hot off the presses – we’ve just posted an update to the IRB’s basic protocol template. The only change this time was to add some language in the “Dissemination of Data” section. We’ve noticed a few people using this protocol template to create a protocol to upload to a human subject research determination form. (Thank […]

Per the Common Rule, data or specimens are considered “identifiable” if the identity of the subject “is or may readily be ascertained by the investigator” or associated with the information/sample (45 CFR 46.102(e)(5) and (6). The IRB, and just about everybody else really, struggles quite a bit with the notion of “identifiability” in general, and […]

We’d tell you exactly how many days there between now and Thanksgiving, but knowing the exact figure might throw us into a panic. So we’ll just stick with the facts – the holiday season is just about upon us, which means feasts, presents, parties, and keeping any pressing research deadlines in mind. Both Christmas and New […]

Questions about the findings of earlier research (from the New York Times) have led to the pause of an NIH-funded trial testing stem cell therapy in heart failure patients, the Washington Post reported Oct. 29. These reports are significant for several reasons. As the Post’s article notes, subject safety is of primary importance, and a research […]

Can’t wait until the IRB’s Oct. 30th presentation to get familiar with the Revised Common Rule, slated to take effect in January? An online 10-module course on the Revised Common Rule is now available through citiprogram.org. Even better – you can earn Certified Research Specialist credit for successfully completing it. The exact credit amount is […]