A revised IRB Policy 8.1, titled “Modifications to Previously Approved Research,” is hot off the presses and posted on the IRB’s website. The changes are mostly formatting related, although we did make a few minor content changes (e.g. we don’t, in fact, require a copy of the updated FDA Form 1572 with a PI change […]
HSR determination form changes to facilitate HIPAA authorization waivers
The IRB has revised its human subject research determination form to make it easier to request HIPAA authorization waivers for research projects using material subject to HIPAA, but which aren’t really identifiable as far as the human subject research regulations are concerned. Let us explain. One thing that has long gotten our collective goat is […]
Updated IRB Policies posted
The IRB scribes have been hard at work updating the IRB policies to ensure they meet current regulatory and accrediting agency requirements, add references, and make them easier to read. New policies posted in recent days are: IRB Policy 2.3, Single/Central IRBs IRB Policy 3.2, Quorum IRB Policy 3.6, IRB Members and Alternates. Note that […]
Parental signatures on pediatric studies informed consent/permission forms
Federal regulations and IRB policies require the IRB to make additional determinations when reviewing research involving minor subjects. In addition to determining which category of pediatric research a particular project fits into, the IRB must affirmatively determine how many parental signatures are required on the study’s informed consent/parental permission form. The three* categories are: Category […]
There’s a new blog quiz available
We’re feeling pretty darn proud of ourselves over here at IRB Blog Central. We got the second quarter IRB Blog quiz out and posted well before the second quarter was over. There are now two quizzes available at learnondemand.org. Access them both by going to the highlighted link and typing “IRB” into the search box […]
New review options from the Office of Research Compliance
The UAMS Office of Research Compliance announces some new review and feedback opportunities for the UAMS research community: Contact the ORC for more information or to request a review.
New IRB Policy 1.4 posted
The IRB has revised its policy 1.4, titled Studies Requiring Review and Human Research Determinations. This policy describes the UAMS IRB’s review and oversight responsibilities, its ability to cede those responsibilities when applicable, and the process for determining whether a project is human subject research requiring IRB review. The more notable changes include adding a definition […]
More updates to the FDA guidance on clinical trials during Covid-19
The FDA continue to set speed records in drafting and updating guidances as the Covid-19 pandemic continues. The agency has again updated its guidance titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The changes were made to the Q&A section at the end of the guidance. “The updated […]
Documenting atypical consent processes
All consent process that involve direct interaction with subjects should be documented with a separate note in the research record, according to IRB Policy 15.5. This extra documentation requirement takes on greater importance in situations like that presented by Covid-19. If your study is enrolling Covid-19 patients, you may not want to put study staff […]
OHRP Guidance on Covid-19
The federal Office for Human Research Protections has released guidance about research subject to the Common Rule under Covid-19. We took a quick look at it and are relieved to note it accords with what we’ve been telling people about current goings-on. Read it straight from the source here.