Researchers and IRB members are aware of the need to ensure study populations reflect the community. Careful attention to enrollment helps ensure study results are valid and generalizable, and allows the IRB to determine that subject selection is equitable (which is one of the criteria for approval). A recent New York Times article addressed the […]
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Change to the modification review process
Beginning January 3, 2017, ALL modifications submitted on studies with approved CLARA budgets will route through the Research Finance Team for review BEFORE they are sent to the IRB. What this means for investigators is that modification reviews and approvals may take a bit longer than they have in the past. This new procedure pertains […]
Can an investigator also be a research subject?
Can investigators also be research subjects in their own studies? Science Magazine recently published a piece discussing the regulatory and ethical issues about researchers doing their research on themselves. As the piece points out, self-experimentation can lead to results that are life changing, for better or worse – two scientists went on to win Nobel […]
Returning data to study participants — the pros and cons
Research subjects provide a tremendous service to subjects, at a sometimes not-negligible cost, in terms of time and inconvenience (and potentially needlesticks, radiation exposure, etc.) to them. Some research procedures may yield information important to the participant’s health, or that could minimize that person having to have the same procedures done as part of their regular […]
Remember: A contingency isn’t real until it shows up in a letter to you
We at the IRB have taken steps to increase the transparency of the review process. This change is typically a good thing, but can also create opportunities for miscommunication. IRB reviews of submissions can take hours or days to complete. The reviewer may start and stop working on it several times, drafting notes and contingencies […]
What to do when the person who needs to sign a consent form isn’t in the room with you?
Sometimes the person whose signature needs to be on a consent form isn’t able to meet face-to-face with an investigator during the consent process. Examples include the parent of a hospitalized infant who was transported here, the out-of-town legally authorized representative (LAR) of a hospitalized patient, or someone considering joining a telemedicine study. Fortunately, both […]
Consent process waivers and Consent documentation waivers are two different things
UAMS IRB Policy 15.3 describes the criteria that must be met when you either want to skip the consent process entirely (consent process waiver), or to not collect signed consent documents (consent documentation waiver). Please note that a consent process waiver and a consent documentation waiver are two different things. Different criteria apply to each, and the […]
Remember “Monday at noon before my Tuesday”
IRB members, we know you have that Tuesday afternoon meeting time noted on your calendars – in ink. Another important meeting-related time to keep in mind, however, is “noon Monday.” That’s the deadline we ask you to meet in reviewing your assignments and having your comments and contingencies entered into CLARA. Having them done relatively […]
No IRB Meeting December 27th
The IRB has cancelled its meeting scheduled for December 27th, due to a lack of available members that day. That’s the day after the UAMS Christmas holiday and, like many of the rest of us, our reviewers have other commitments that week. Our blog item of Nov. 22 mentioned the possibility of no IRB meeting […]
Clinicaltrials.gov rule change imminent
January 18, 2017, is the date the final rule for ClinicalTrials.gov and the new National Institutes of Health (NIH) policy regarding clinical trials registration are slated to take effect. The new ClinicalTrials.gov rule will make some previously optional elements required and will change some options available to choose from in the various drop-down boxes. Two significant […]