Anyone who has done their basic human subject protection training is aware of some of the research-related abuses that led to the creation of ethics oversight boards. We recently came across a couple of publications about one fairly well-known study that involved feeding radioactive cereal to institutionalized children. While these publications aren’t new, they do […]

Well, we made it through another site visit from our accrediting agency, the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Our two site visitors spent 2.5 days at UAMS reviewing records and policies and interviewing people from several components of our human research protection program. We are to receive a draft report […]

Consent form formatting and word choice can go a long way in making written consent forms easy to understand. While it may be tempting to cram as many words as possible onto a single page, in an effort to reduce the overall page count, having a bunch of gray text on a page will likely […]

We’ve noticed that if we’re not very, very careful, CLARA has the tendency to pull minutes from the wrong meeting to add to the agenda. The reason for this relates to a CLARA quirk involving the timing of agenda creation and meeting finalization in the CLARA system. CLARA is supposed to pull the minutes from […]

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 […]

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 […]

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 […]

…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 […]

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 […]

A stolen laptop containing research subjects’ personal information will cost one medical research institute close to $4 million dollars to settle the resulting HIPAA case, according to the Office for Civil Rights (OCR), the federal agency that enforces HIPAA. The Feinstein Institute for Medical Research in New York has agreed to pay $3.9 million to settle potential […]