Back in 2005, UAMS was one of the first 25 organizations in the world to become accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and is in the middle of its third reaccreditation process. Part of each accreditation involves a site visit by AAHRPP staff. This year’s site visit is […]
Describing your test article in a consent form
If your study involves a test article (drug or device), then you’ll need to let subjects know during the consent process about the test article’s approval status. Please note that the IRB will want the approval status stated very clearly. We’ve seen, for example, long lists of all the countries in which a particular test article […]
Reviewing the entire renewal period when looking at Continuing Reviews
Ongoing studies are required to undergo continuing review by the IRB at least once per year. Please keep the entire timeframe in mind when looking at a continuing review submission. In addition to reviewing the CR form and any documents submitted with the form, take a look at everything that has been submitted on the study […]
Describing coded data in a consent form
The IRB may require you to put information in the consent form describing how subject data will be stored. If you are storing all data with only a code rather than direct identifiers, you should include consent language saying something like, “Your personal information will be identified only with a code and will not include anything […]
Sorting comments on agenda items
So, you’ve gotten your assignments for the week, you’re logged into CLARA, you open the first study you’ve been assigned, and what do you find? Sometimes what greets you is a jumbled mess of comments and suggested contingencies from the IRB consent reviewer, IRB prereview, and maybe the other IRB reviewer as well. Use the […]
Formatting, word choice, white space — they all matter in consent forms
Think back to your high school days, when you’d try to tackle a reading assignment from, say, your history textbook. Did you look forward to the prospect of reading page after page of small text, arranged in long paragraphs? Or were you hoping for some illustrations, bulleted lists, and white space to break up all […]
We’ll be so glad when the revised Common Rule is finally published…
…because then all the brouahaha about the revisions will finally settle down. Ha. We are such kidders. You may recall mention in this blog of the Notice of Proposed Rulemaking (NPRM), which the Office for Human Research Protections released to announce that it is considering revising the Common Rule. Proposed changes include requiring broad consent for future use […]
Simplify your consent form, part 4 (and maybe prevent yourself some hassle too)
The requirement to list the planned number of study subjects in a consent form is nothing new. It’s described in 45 CFR 46.116(b)(6) (applicable to all human subject research done at UAMS), 21 CFR 50.25(b)(6) (applicable to FDA-regulated studies), and UAMS IRB Policy 15.1. Even though this is not the most complicated consent form element, is […]
“Retrospective Chart Review” defined
When we see a study submission that describes a project as a retrospective chart review, the IRB needs to make sure the project is truly retrospective. A retrospective chart review involves looking at information that already exists at the time of IRB approval. We may ask that you specify an end date to document that all the […]
New blog quiz available — earn 0.5 CRS credits
The next IRB blog quiz is available at learnondemand.org. To find the quiz, go to the learnondemand.org home page and type “IRB” in the search box at upper right. Remember, these quizzes allow you to earn 0.5 Certified Research Specialist elective hours each – up to 2 hours per year – at the time and place […]