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 […]

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 […]

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 […]

Who, exactly, needs to be in attendance for us to be able to actually hold an IRB meeting? The regulation describing IRB membership, 45 CFR 46.107, is arguably somewhat non-specific. It requires an IRB to have at least 5 members. We have substantially more than 5 members on each committee roster, which is appropriate for a board that reviews […]

Community involvement has long been a concern in research. The Belmont Report mentions “justice” as one of its basic priniciples. Justice, in this context, refers to ensuring the burdens and benefits of research are equitably distributed. More recently, the issue of community based participatory research has come to the fore. This type of research brings community […]

A recent post on the PRIM&R blog Ampersand drew our attention to the issue of using social media to recruit research subjects. A Harvard-based working group recently published an open access guidance document titled, “The Use of Social Media in Recruitment to Research: A Guide for Investigators and IRBs.”  The guidance document, though fairly long, […]

Good news! Our most recent application to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was approved last week, so we are now fully reaccredited for another five years! According to the organization, “AAHRPP accreditation indicates that your organization follows rigorous standards for ethics, quality, and protections for human research.” UAMS was initially accredited […]

Making informed consent information understandable to participants has long been a challenge, as we at the IRB well know. Reading levels of many consent forms often exceed the recommended no-great-than-8th-grade guideline. The UAMS Center for Health Literacy has been working on coming up with ways to make working with some IRB staff, TRI, and others on […]

If you’ve ever been assigned an audit, you may have seen a form in CLARA called the assessment of noncompliance. IRB office staffers have been routinely completing that form as they prepare audits and audit responses for board review. Well, like so many other things, that form dates from the “BC” (Before CLARA) era, and we […]

Study staffers’ CITI training status is something that comes up a lot during IRB meetings. All study staffers listed in CLARA who interact with subjects or with identifiable data must be current on CITI training. A couple of things to keep in mind when evaluating whether someone’s CITI training is up to date: A study staffer […]