We’re seeking your input as part of our continuing quality improvement at the IRB. Translation: We’d like some input on what we do well, and where we need to improve. To that end, everyone in CLARA who’s listed as being either a PI or has having “managing CLARA responsibilities” will receive an email with “IRB […]
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.
Predicting “future use” of research samples like DNA?
Despite being the most specific individual identifier we currently know of, federal regulators still don’t consider DNA to be individually identifiable material. To be fair, the federal Office for Human Research Protections has said it will reconsider the notion of “identifiability” every 4 years, with whole genome sequencing likely to be one of the first […]
Research involving residents with developmental disabilities scrutinized
A recent Des Moines Register article describes a federal inquiry regarding human subject research conducted at a center for people with severe intellectual disabilities. The story includes links to previous reporting on the matter. We note the story indicates the request for information came from the Justice Department’s Civil Rights Division, and not from the […]
IRB policies — one new, one updated
One new and one updated IRB policy were recently posted on the IRB’s website. The revised policy, 2.3, relates to the use of single or central IRBs (xIRBs). This policy describes the process changes implemented as xIRB use has become more common in recent years. The 2018 Common Rule will mandate the use of an […]
One subject’s perspective
A recent New York Times column caught our eye, as it was about research. Columnist Frank Bruni writes about his experience participating in a randomized, placebo-controlled study testing a potential treatment for a rare disorder affecting vision. While there is no one typical subject experience, and not many research subjects have their own column in […]
New clinical research health literacy resource now available
There’s a great new resource available for study teams interested in making research material more accessible to research participants. The Health Literacy in Clinical Research web site went live this week. This site contains a wealth of tips and resources intended to guide study teams to present information in an understandable way. Professor Christopher Trudeau, […]
A new look for the human subject research determination form
A revised human subject research determination form is slated to go live in CLARA beginning Monday, October 21. The form’s questions have been rewritten to use simpler language, and the CLARA pages have been redesigned slightly to make help text easier to find and read. We’ve also tried to word the questions to make them […]
New Blog Quiz available
Needing to earn the most convenient 0.5 hours of Certified Research Specialist elective credit ever? Look no further than the 3rd Quarter IRB Blog quiz, now live at learnondemand.org. You can find it by clicking the link and typing “IRB” into the search box at upper right. Take the test whenever it’s convenient for you. […]
October 2019 protocol template update
Hot off the presses – we’ve just posted an update to the IRB’s basic protocol template. The only change this time was to add some language in the “Dissemination of Data” section. We’ve noticed a few people using this protocol template to create a protocol to upload to a human subject research determination form. (Thank […]
The evolution of identifiability and privacy, part something (we stopped counting a while ago)
Per the Common Rule, data or specimens are considered “identifiable” if the identity of the subject “is or may readily be ascertained by the investigator” or associated with the information/sample (45 CFR 46.102(e)(5) and (6). The IRB, and just about everybody else really, struggles quite a bit with the notion of “identifiability” in general, and […]