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 […]

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 […]

The issue of whether genetic information or material can be considered identifiable prompts a great deal of discussion among researchers and IRBs. On the one side are those who believe that nothing is more uniquely identifiable than an individual’s genetic information. On the other are those who say that genetic information by itself cannot readily […]

Ensuring the right steps are taken to prevent pregnancy can be an important part of research subject safety, particularly for drug studies, as the effects of a research intervention on an embryo or fetus are often unknown. But what’s the best way to describe the requirement to avoid pregnancy in a consent form? Quorum Review […]

Research involving human  materials is again in the news at The New York Times. A recent news article about fetal tissue researchers highlights some of the nuances involved in this type of research, and not just the ethics of it. The article highlights issues related not just to sourcing of fetal material, but also to concerns relevant to the broader […]