We’ve found some more reports about the new NIH rules pertaining to clinical trials that we thought we’d share with the UAMS research community. One of the biggest changes is the expansion of NIH’s definition of “clinical trial,” which will apply to some UAMS and ACH researchers who are now conducting NIH-funded “clinical trials,” which […]
Assessing capacity to consent
Study teams and IRBs need to pay close attention to the consent process when preparing (or reviewing) a study that may enroll people whose capacity to consent is impaired. Study team members may also encounter potential subjects whose ability to provide consent is questionable, for whatever reason. What are some of the things IRBs and […]
A scholarly look at the subject reimbursement issue
Paying subjects for research participation can be a sticky issue, and it sometimes feels like we rely on gut feelings to decide what’s an appropriate amount of payment, how it should be disbursed, and whether payment unduly influences the decision to participate. Some human subject research ethics experts took a more scholarly approach. The New […]
IRB Questions of the Month
Our thanks once again to PRIM&R’s Ampersand blog and to First Clinical Research for sharing some thought-provoking Questions of the Month with the IRB community. February’s question addresses the exclusion from a phase 2 drug trial of a certain class of people, specifically people “Educated or employed as an attorney.” The drug in question is […]
Quick CLARA reminders
We review a whole lot of CLARA new submission forms in the IRB office, meaning we tend to notice patterns in the forms. Here are a few questions that tend to trip up study teams, and reminders for how to complete them. Subjects section: –How many subjects do you anticipate consenting to meet this goal? […]
Concerns about placebo use in a childhood asthma study leads to changes
Ethics reviewers wrestle with the issue of using placebos in research because of the fear that withholding a treatment from the controls may be denying controls access to a helpful treatment. And as our IRB members know, the IRB makes separate risk determinations for different groups in FDA-regulated investigational studies involving children, because different groups […]
Submissions that are complete get reviewed faster
When approving research, the IRB is required to make certain determinations, as spelled out in UAMS IRB Policy 7.1. The IRB therefore needs complete information about projects before it can review and approve a new submission. While we can very occasionally make exceptions, by doing things like issuing an approval letter saying we approve what […]
“Other” document types, that message you get when you “upload new document”
That “document type” drop-down box in CLARA is important – it helps classify study documents correctly, and allows CLARA users to sort documents by type. We’ve noticed a fair number of documents uploaded as document type “other,” which has struck us as odd, since these documents often fit into one of the other document type […]
Short, to-the-point, and hot off the presses: The FDA’s information sheet on subject payment
Paying subjects for their research participation engenders quite a lot of discussion, both among research teams and on the IRB. The Food and Drug Administration (FDA) recently released an information sheet regarding its current thinking on paying subjects. The FDA, like the UAMS IRB, feels that payment should accrue as the subject progresses through the […]
NIH will want more specifics about study subject populations
In an attempt to ensure that all populations that may benefit from research findings are included in clinical research, the NIH will soon require more discussions about including all age groups in NIH proposals. Specifically, says NIH’s Dr. Michael Lauer on his blog, “For application due dates on or after January 25, 2019 (yes, one year from […]