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 […]
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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 […]
Picking the right “document type” for your informed consent material in CLARA
When uploading documents in CLARA, you’ll encounter a dropdown list of different document types. Please be careful to choose the type that matches the document you’re trying to upload. We’ve noticed that, in particular, the seven informed consent-related options tend to get selected a bit randomly. They all begin with “Consent, Assent and HIPAA;” the […]
Remember to address both data AND specimen handling in your protocol, when applicable
If your study involves keeping data and specimens for possible future research use, please remember to address the security and storage of both the data and the specimens in your protocol. We very often see what we think of as protocols with good intentions – their storage and use sections start out by mentioning both […]