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: Completing the […]
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, […]
Who needs to be at an IRB meeting?
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 […]
Following up on an audit at continuing review time
If your study has been audited during the most recent review period, you may have to do some additional reporting at your next continuing review (CR). Audits frequently find protocol deviations that the IRB asks you to report at CR. Help us confirm that you are meeting this reporting requirement. To do so, in your […]
New requirements related to publishing study results
All of those research findings – what happens to them when the study is over? Not enough happens to them, according to federal regulators who recently issued new rules about publishing clinical trial results. Clinicaltrials.gov was created, in part, to make it easier for the public to find out about research and research results. However, the […]
Community Scientist Academy and our research mission
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 […]
Using social media in recruitment
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, […]