The IRB office has updated its policy on meeting minutes, IRB Policy 6.3. This policy recaps the regulatory requirements and best practices for what has to be documented when the IRB reviews a study. While the changes are minimal from the previous iteration of this policy, it’s important to note the IRB takes these policy […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Policies on risk/benefit analysis and subject selection revised, posted
The questions of whether risks and potential benefits are in balance, and whether subject selection is equitable, are critical to the IRB’s review of proposed research. We’ve updated our policies that discuss Risk/Benefit Analysis, IRB Policy 7.1, and Subject Selection, IRB Policy 14.1, to give researchers and IRB members clearer guidance about concepts that guide […]
Updated policy on Risk/Benefit Analysis posted
The IRB has updated its policy 7.11, Risk/Benefit Analysis. Like many of the policy changes we’ve posted about recently, many of the updates relate to formatting and editing to improve readability. This policy, in particular, we think really benefited from this update, given the importance of the material it addresses (and the fact that the […]
Revised Policy 17.1, Children in Research, Now Posted
An updated version of IRB Policy 17.1, Children in Research, is now available on the IRB’s website. The changes are limited to formatting changes and the occasional language clarification, as the regulations and requirements related to human subject research involving children have not changed. However, we in the IRB office find ourselves having to refer […]
IRB Advisory Committee policy posted
A revised IRB Policy 1.7, IRB Advisory Committee, (IAC) is now available on the IRB’s website, replacing the previous iteration of the policy, which was titled “IRB Executive Committee.” The name change is significant, as it denotes a change in the committee’s focus and membership. The IAC includes members from departments all over campus, with […]
Thalidomide’s lasting legacy
The New York Times had a recent article about the so-called survivors of thalidomide, who are the people who experienced birth defects associated with use of the drug during pregnancy. The article is interesting on several levels. It tells the stories of thalidomide survivors, their use of social media to find each other, and their […]
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 […]