Digital data collection tools, such as small wearable devices (think FitBits or Apple Watches) and apps downloaded onto a subject’s phone, are becoming increasingly common in human subject research. Some projects are testing the products themselves, while others use them merely to collect research data. You know that giant document that you never actually read […]
Consolidated single/central IRB review resource
The IRB’s website has been updated to make it easier to find information about single/central IRB review (we refer to that as “xIRB review). We’ve added a separate webpage consolidating an overview of the process and associated forms and information. The page also includes a link to a video of our most recent virtual class […]
HIPAA “Review Preparatory to Research” form to go online starting 12/14/20
Among the many blessings HIPAA has rained upon us (ahem) is a requirement pertaining to reviews preparatory to research. “Review preparatory to research” refers to accessing protected health information solely to prepare a research protocol before getting a signed HIPAA authorization or a HIPAA authorization waiver. A review preparatory to research can be done only […]
New policy for DoD-supported research
Additional agency-specific requirements apply to human subject research studies conducted or supported by the federal Department of Defense (DoD). Because we’re seeing a slight uptick in DoD funding applications, a trend we’re expecting to gain momentum, we’ve drafted a policy specific to DoD-supported research. Please note these policy requirements are in addition to all the […]
FDA has updated its “Clinical Trials during COVID-19” Policy
A December 4, 2020, update to the FDA’s policy on conducting clinical trials during the current public health emergency is now available. While we haven’t read all 38 single-spaced pages of it, we notice it contains information useful to our research community, such as guidance about informed consent options, and adapting study procedures to minimize […]
What do we owe our placebo group subjects?
In a randomized, blinded trial, when one group gets the test article and the other a placebo, what happens when the intervention turns out to be wildly effective? From an ethical standpoint, it would make sense to halt the study and offer the placebo group the intervention. But from a scientific perspective, that greatly complicates […]
More policy updates
We’re still cranking out the revised policies here at IRB Policy central. Newly posted are: IRB Policy 1.1, which describes the IRB’s principles and authority. We’ve added language about International Conference on Harmonization (ICH) guidelines. ICH guidelines are a standards many clinical trials involving investigational products follow. At UAMS, studies for which the institution holds […]
What reports are required with expedited studies’ continuing review?
Under the Revised Common Rule (RCR), expedited status studies initially approved after January 19, 2019, (and older expedited studies that switched to the RCR), are no longer required to undergo a complete continuing review. Those studies instead will get the two-question annual check-in form, which basically tells the IRB that the study is still a […]
Continuing our virtual world travels with Tagalog short forms
We continue to expand our collection of translated short form consent templates, with the addition of Tagalog (Filipino) adult and pediatric versions. A short form consent process can be used when you unexpectedly encounter a potential subject who doesn’t speak English well, and you don’t have your full consent form already translated into a language […]
The IRB’s protocol template has been revised — again
You know how we’re always harping on about always starting with fresh protocol and consent templates, and don’t try to adapt old documents to new studies, because we’re constantly updating template language to reflect new regulations, guidances, or best practices? Well, the updated protocol template we just now posted on the IRB’s website is an […]