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, […]
Little glitch in CITI training right now
Because of an administrative issue involving CITI (the people who run the human subject protection training we require to be taken at citiprogram.org), UAMS does not, for the time being, appear on the list of institutions with which one can affiliate. Ordinarily this problem could be resolved fairly quickly. these, however, are not ordinary time. […]
Ownership and research use of genetic material
Think back to 20 years ago – who, at that time, could have predicted what we’re able to do with genetic information now? In particular, who would have predicted that some private companies would own their own genetic databases? An interesting, or perhaps concerning, consideration with these private databases is that the use of these […]
A reminder to PIs: The Buck Stops Here
Principal investigators (PIs) are ultimately responsible for everything that occurs on research at their sites. Few things irk monitors and auditors (including those from agencies such as the Food and Drug Administration) than hearing, “Well, that’s not my fault. That’s the study coordinator’s responsibility,” from a PI, in response to a finding. The Duke Clinical Research […]
Full reaccreditation of our Human Research Protection Program
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 […]
Plain language consent form templates
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 […]