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 […]

In a move that likely has all kinds of downstream implications, the genetic testing company 23andMe has announced it is working with a partner to improve clinical trial recruiting, according to a recent article in the online publication STAT. 23andMe already describes its research platform as “currently the world’s largest consented, recontactable database for genetic […]

If you’re planning a chart review study, before submitting, please give some thought to whether you could get your study data from the AR-CDR rather than directly from medical records. The AR-CDR (it stands for Arkansas Clinical Data Repository) is a vast collection of data extracted from EPIC and other, older, medical records systems. It […]

Ever wonder how the IRB office and board spend their time? We serve the research communities of UAMS and ACH, and we also pick up the occasional study from the Clinton School of Public Service and the Arkansas Department of Health. We have right around 1,000 open human subject research protocols in CLARA right now […]