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 […]
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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 […]
A quick HIPAA recap
HIPAA has been confusing for all of us as it applies to research. Even though we’ve been dealing with it for years, we still see scenarios that make us wonder whether HIPAA applies to a particular study and, if so, how to best meet HIPAA requirements. One thing to keep in mind is that HIPAA […]
A summation of what the Revised Final Rule delay means for us
Public Responsibility in Medicine and Research (PRIM&R), upon whom we rely for updates in the world of human subject protections, has come through again with a recap of how the delay in the implementation of the revised Common Rule affects us here on the ground. Some highlights worth mentioning: The above link will take you […]
Revised Common Rule Effective and Compliance Date Delayed 6 Months…for now
That sound you hear is a giant sigh of relief from a whole lot of institutions subject to OHRP oversight. Late this afternoon, we received word of the planned Federal Register Publication of an interim Final Rule, delaying the effective and compliance date of the Revised Common Rule until July 19, 2018, which is 6 […]
Another tool to help with the informed consent process
Some great ideas regarding language to use during the informed consent process has come to us via firstclinical.com. Basic Concepts for Informed Consent covers some of the foundational elements behind the concept of truly informed consent, and translates them into language subjects are likely to understand. It addresses some of the issues that can be […]
Still in a holding pattern regarding the revised Common Rule
Will we, or won’t we, have to comply with the revised Common Rule in a few short weeks? That’s the big question to which there’s still no solid answer as of this writing. January 19, 2018, has a big, red circle around it on our calendar. That’s the date the revised Common Rule is slated […]