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 […]
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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 […]
IRB calendar reminders
A few things to keep in mind, if you are facing any imminent IRB approval deadlines: There will be no IRB meeting on Tuesday, Nov. 29, or Tuesday, Jan. 31, as those are both fifth Tuesdays, and the board meets only on the first four Tuesdays of each month. As of now, our meeting for […]
Requirements for who must take Good Clinical Practice (GCP) training just changed
NIH clinical trials: NIH-funded investigators and clinical trial staff who are currently involved in the conduct, oversight, or management of clinical trials must complete Good Clinical Practice (GCP) training prior to the first of the year, per an NIH policy released in September. GCP training requirements can be met one of two ways: or GCP […]
Are pregnant partners research subjects?
Some new study submissions, in addition to all the usual material, include something called a pregnant partner consent form. These forms are intended to be used if the female partner of a study subject becomes pregnant during the subject’s participation in a clinical trial. They allow sponsors to collect information about the pregnancy and its […]
Study resources considered when approving research
When approving research, the IRB has to find that research risks are minimized by using procedures consistent with sound research design. One consideration in that determination is whether adequate resources are available to safely carry out research procedures and to protect data confidentiality. The resources of interest to the IRB can include adequate space and […]
Truth in (study recruitment) advertising
Many study teams use flyers, advertisements, and/or things like social media posts to recruit potential research subjects. If written materials, in whatever format, are a part of your recruitment strategy, please take a look at UAMS IRB Policy 14.3 for a refresher on advertisement content. Because the IRB must determine that subject selection is equitable, […]