When submitting protocol and consent form revisions, the IRB asks that you submit clean and tracked-changes versions of revised documents. Microsoft Word makes it easy to create clean and tracked changes versions of items created in Word. Please note that your clean and tracked changes versions should exactly match each other, except for the tracking. […]
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There’s usually still a consent process if you are waiving documentation of consent
When completing new submission forms, you’ll encounter a question that asks you to check the type of consent process(es) to be used in the research. The four response options are Assent; Parental Permission (Pediatric Consent); Informed Consent; and Requesting Waiver of Consent Process. We’ve seen some creative answers given to this question when PIs are […]
Hints for numbering study documents
All protocols, consent forms, HIPAA authorization forms, and other study documents subject to revision should include a version number and date on each page. Whenever you update a document, please remember to update the version number and date on each page to reflect the changes. Also, when submitting tracked changes versions of documents, please make […]
Subject Selection is Equitable — the third criterion for approval
The next installment in our review of the criteria for IRB approval of research … The third approval criterion reads, “Seletion of subjects is equitable.” This criterion is rooted in the Belmont Report’s principle of justice. Who ought to receive the benefits of research, and who should bear its burdens? In considering this criterion, IRB […]
Earn CRS credit for an upcoming data security webinar
An upcoming webinar on data security will offer CRS elective credit. The UAMS Office of Research Compliance is to host the PRIM&R webinar “Data Security Incidents – the Role of IRBs and Information Security” on Thursday, February 26, from 12:00-1:30 p.m. in the Walton Auditorium on the 10th floor of the Cancer Institute. An overview of […]
TRI services available for the research community
The TRI Translational Research Services Center offers the following free protocol development services: We also offer other fee-based services which includes IRB submission assistance and ongoing regulatory maintenance services, research coordinator support and participant recruitment. To request any of the services offered by TRI, please submit your request to TRIServices@uams.edu.
Criteria for Approval, Continued — Risks, Benefits and the Second Criterion
As we work our way through a review of the criteria for approval, please keep in mind that these criteria should guide our study reviews and the drafting of contingencies sent back to study teams. The second criterion for approval is “Risks to subjects are reasonable in relation to anticipated benefits, if any, and the […]
Study closure form options explained
The CLARA closure form has three options for the status of a study that you’re trying to close. The study must fit into one of these three categories to qualify for closure. “Study never initiated (sponsored studies only)” is appropriate for industry-sponsored trials that, for whatever reason, never got off the ground at this site. […]
The First Criterion for IRB Approval of Research — A Refresher
When participating in those lively, and sometimes lengthy, discussions at IRB meetings, it can be easy to forget that IRB approval is based on on just a handful of criteria. Upcoming IRB Members Blog items will provide a refresher of these criteria. These criteria should underpin all the contingencies the IRB sends back to investigators. […]
New submission form changes, plus some tips for completing the form
Those who pay close attention to these things (and we hope that’s all of you!) may have noticed some recent changes to the HIPAA section of the new submission form. The changes include rewording some queries to make it clearer that the form is asking you to indicate which specific PHI elements you are going […]