Credit hours for the Certified Research Specialist program will be available for several upcoming classes: Advanced Research Ethics, Tuesday, April 14th, from 8 am to 12 noon; IDW 114A/B Essentials of Quality Human Research, Wednesday, April 29th, from 9 am to 3:15pm; IDW 114A/B Genetic and Genomic Research, Wednesday, May 13th, from 11:30am to 12:30 […]
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Data monitoring, safety, and the 6th criterion for approval
The sixth criterion for approval of research reads, “When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects” [45 CFR 46.111(a)(6)]. This criterion is particularly applicable to studies looking at new treatments or other interventions that may have an impact on subjects’ health, safety, or well-being. […]
A thought about gift card reimbursements
Using gift cards to compensate study subjects for their participation is fairly common among studies that offer reimbursements for time and inconvenience. The IRB does not require too many specifics about what kind of gift card will be offered in submissions. The IRB will typically accept language along the lines of “a $25 gift card” as […]
Do you know where your reviewer handbook is?
Do you remember getting one of these books when you joined the IRB? (Older editions had a different cover – but those still count as the real item.) Haven’t seen your copy around lately? If so, please let Edith Paal in the IRB office know via email at paalediths@uams.edu. We like to keep enough of […]
Recruitment, expanded access, and education credits — upcoming educational offerings have it all
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 ensure 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. […]
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 […]