Mark your calendar to attend one (or both) of these upcoming classes. You’ll get information that may help your research, and earn education credit too. A webinar titled “Cracking the Code for Clinical Trial Recruitment: A Sponsor’s Perspective” is scheduled for Wednesday, March 18, 2015 from 11:00 am – 12:30 pm in COPH/G230. The webinar will be […]
Remember — We don’t do “required changes”
Here in the office we’ve noticed the occasional “Required Change” created by an IRB reviewer creeping back into our reviews. Please note that the “Required Change” option is used by offices other than IRB. When writing contingencies or comments, please use the “contingency” option for information that you expect to be sent back to the PI for a […]
Informed Consent – The Fourth and Fifth Criteria for Approval
The IRB, when approving research, is required to assure that informed consent will be sought from each subject, or subject representative, as required by federal regulations (that’s the fourth criterion for approval), and that consent will be appropriately documented to the extent required by the regulations (the fifth criterion). We’ve said it before, and we’ll […]
March is a 5th Tuesday month
March has five Tuesdays, but the IRB, per its standard practice, will not meet on the 5th Tuesday, March 31st. Please keep this gap in meetings in mind when planning for the review of anything that is facing a review deadline. And for those planning ahead, June, September, and December will also have 5th Tuesdays […]
Track changes — use’em, and please make sure the clean and tracked-changes versions match!
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. All […]
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: Reviewing and editing protocols and supporting documents prior to submission to Institutional Review Board (IRB) and other regulatory oversight bodies Provision of custom templates for research protocols, informed consent forms and other study documents Coordinating efforts of multi-disciplinary project teams during protocol […]