One noticeable new aspect of the Revised Common Rule is the requirement to include a “concise and focused” presentation of key information that would help a subject decide whether or not to join a study in the consent process. Although guidance as to what form this summary should take is only trickling out, we have […]
The Revised Common Rule talk is still available
The Revised Common Rule (RCR), slated to be implemented Jan. 19, 2019, will be here before you know it. IRB staff recently gave a talk on the (RCR) changes most likely to affect research teams. For those who couldn’t attend, the talk was recorded, and will be rebroadcast in a webinar format at the following […]
Study progress details greatly appreciated on Continuing Review forms
Continuing review forms include a query asking you to summarize study progress in a free-text response. Please use this space to provide a complete summary of the study’s status, including describing how many subjects have completed the study, what part of the study any that haven’t completed yet are in, whether any notable positive or negative issues […]
Recording of the Revised Common Rule Overview presentation now available
If you couldn’t make it to the IRB’s October 30th talk about the changes coming with the Revised Common Rule, here are a few ways to catch up on what you missed. Feeling sociable? Attend one of the upcoming webinar replays: There will be two showings on Friday Nov. 9, Cancer Institute 10th floor, Room […]
Reminder about IRB confidentiality
Please remember discussions that happen inside the IRB’s meeting room need to stay inside the meeting room. IRB determinations and contingencies are considered group decisions. Those decisions are relayed to the research team via correspondence through CLARA. Reviewers – If someone on a research team asks you for specifics about their project’s IRB review, please […]
Data and sample handling and storage tips for protocol drafters
We’ve noticed a few things in new submissions regarding data and sample handling and storage that slow down approvals. Here are some reminders of things to keep in mind when drafting protocols and CLARA completing new submission forms: UAMS Administrative Guide Policy 3.2.01 requires research data, reports, and analyses to be kept for “7 years […]
Just how finished does a study need to be before you close it?
Determining the appropriate time to close a study can be trickier than you might think. If you’ve completed your study and all that’s left is writing manuscripts and disseminating your findings, can you close the study in CLARA? How about if you’ve completed all your subject interaction and data collection, but have not finished analyzing […]
Consent form formatting hint — don’t split signature blocks
When the IRB reviews written consent forms, we try to keep in mind formatting issues that make it easier for study teams to ensure the forms are completed correctly. If you send us a consent form that has signature components split across pages (e.g. the subject signature on one page, and the subject signature date […]
Data requests must match what your IRB submission indicated
The Arkansas Clinical Data Repository managed by TRI is a valuable resource, allowing you relatively straightforward access to vast stores of patient data. We encourage researchers across campus to use this resource whenever possible for their studies. (Hint: Patient data can often be provided without identifiers, which could mean your study is not subject to […]
Trial halted after infant deaths
A study involving pregnant women and fetuses was terminated early in The Netherlands after the deaths of 11 neonates. We post this here as a reminder of some of the things the IRB has in the back of its mind when reviewing studies, and that investigators think about when they develop and join studies.