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 […]

The federal Office for Human Research Protections (OHRP) requires institutions like ours to maintain a current Federalwide Assurance (FWA) for the Protection of Human Subjects. Outside IRBs that review research done here, industry sponsors, and others sometimes ask study teams for the current FWA number and expiration date. (Of course the federal government gives each […]

The thought of a 17,000-word-long consent form causes our eyes to glaze over – that’s more than 30 pages of single-spaced text. But apparently such a thing exists, according to a recent study about consent forms from IDE studies, accepted for publication in the journal Contemporary Clinical Trials and reported on at the Regulatory Affairs […]