It can be difficult to remember, when you’re deep into the review of a complicated new submission, that there are only eight regulatory criteria for the approval of human subject research. These criteria are listed in more detail in UAMS IRB Policy 7.1 and at 45 CFR 46.111. A summary follows: Risks to subjects are […]
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.
True or False? Federal Regulations Require Consent Forms to be Written at an 8th-Grade Reading Level
FALSE. You may have heard that consent forms should be written at a reading level that’s no higher than what an 8th-grader could understand. However, this bit of conventional wisdom is just that – conventional wisdom, and not a regulatory requirement. Instead, regulations at 21 CFR 50.20 and 45 CFR 46.116 require information given to […]
Problems or questions with your assignments? Please let the office know EARLY
If you are unable to review your agenda items for any reason, please let the office know well in advance of the IRB meeting so your studies can be reassigned. For example, if you have a conflict, or are out of pocket and won’t have computer access before the meeting, please let us know. Also […]
What’s in a Quorum?
You may have heard the word “quorum” used during IRB meetings. The dictionary definition of quorum is “the minimum number of members required to be present at an assembly or meeting before it can validly proceed to transact business.” While federal regulations describe the minimum requirements for IRB membership, they do not specifically define “quorum.” […]
Social Media Research and related ethical considerations
Imagine a research proposal involving deliberate manipulation of participants’ emotions. The investigator proposes to subtly influence the environment to see if these changes make people feel happier or sadder, and to see if participants alter their behavior as a result. Both the environment and behavior are arguably public, and when the participants initially entered this […]
A reminder to confirm your attendance at meetings
Please remember to respond to the email you receive asking whether you’ll be at your next scheduled IRB meeting. You’ll get an email from the office staff about 2 weeks before the meeting asking if you’ll be able to attend. A quick response to that first email is appreciated – that helps us plan assignments […]
Industry-sponsored study? Be careful about recommending changes to the consent’s injury and costs sections
New submissions may be reviewed by several other offices before they ever reach the IRB. One of these reviews is done by legal staff, who negotiate with industry sponsors about, among other items, who will cover which costs associated with the study. Part of this negotiation includes nailing down the injury and cost statements in […]
A reminder to check notes and draft contingencies in CLARA
When reviewing studies, please remember to take a look at the notes and draft contingencies already entered into CLARA by the office staff. We use these CLARA functions to indicate areas that we think need may need additional input by the IRB, and to note draft contingencies the IRB may want to consider. Please note […]
Notes and contingencies in CLARA – which options to use?
Here’s a quick recap of the options available to reviewers to note comments and contingencies when they’re reviewing CLARA submissions. The “contingencies” option is for items that require a response from the study team. The “note” option can be used when you want to make a suggestion to the study team, or to bring something […]
Please look at ALL agenda items — even the ones that aren’t assigned to you
Please take a quick look at all the items on your meeting agenda – even the ones assigned to other reviewers. You may have some expertise in a particular area that would be helpful to the IRB as it reviews a particular study that you’re not assigned to. Your contributions on *all* agenda items are […]