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 […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
My, what great big settlements you have, HIPAA regulation!
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 […]
Another risk to using genetic information?
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 […]
Simplifying consent forms, Chapter 3
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 […]
More research in the news
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 […]
The risks and benefits of research can be unpredictable
The decision to join a research study can have unpredictable long-term results. A man with autism who, at age 50, joined a study examining transcranial magnetic stimulation found the effects life-changing, in both positive and negative ways.
Simplifying consent forms, Part 2
Many research studies involve multiple visits, with specific procedures to be carried out at each visit. Consent forms often describe this kind of research in visit-by-visit lists that include each procedure at every visit. This format can lead to a long consent form that includes a lot of repetition, if procedures will be repeated. We encourage […]
Returning genetic testing results
Genetic testing poses all kinds of questions for IRBs. Are genetic testing results potentially identifiable? Are they meaningful? Should they be returned to patients? Our current ability to do genetic testing may have outpaced our ability to answer these questions, at least for now. When reviewing research, we sometimes are asked to put ourselves in […]
One way to simplify consent forms
Quorum Review IRB recently released an online resource recommending ways to shorten and simplify consent forms. Since overly long and convoluted consent forms are an ongoing headache for IRB members and researchers, we thought we’d share some of Quorum’s suggestions with you in a series of blog items. And we recognize that with industry sponsored […]
The IRB’s on the move
While we’re not exactly heading out to claim new territory, the weekly IRB meetings are set to move beginning Tuesday, June 7. We are returning to our old space in the Biomed 1 building, rooms 205/207 on the second floor. You can enter these rooms from the atrium at the top of the stairs. Those […]