…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 […]
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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 […]
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 […]