We know that between their regular lives and their IRB responsbilities, our reviewers stay busy. We do, however, ask that you take the time to look over the entire agenda, even if you have no specific review assignments, and, if you do, not just the studies you’re assigned to, for each meeting you attend.  Some […]

If you’re working on a study that’s primarily being carried out at a different site, you may wonder whether your participation requires IRB review. The best way to find that out is by submitting a human subject research determination form in CLARA. For that kind of submission, it would be up to the IRB to […]

Informed consent process are to be conducted in “language understandable to the subject.” How should this requirement be addressed for research that will, or unexpectedly might, include subjects who don’t speak English well? Investigators who expect their studies to enroll non-English speakers should develop a consent process for this population. This would include describing in […]

Prisoners, when involved in a research study, are considered a vulnerable population subject to additional protections. UAMS IRB Policy 17.9 covers the basics about prisoner research, and OHRP has additional resources and information available. Here’s a recap of some of the considerations related to prisoners in research. Anyone “involuntarily confined or detained in a penal […]

The plain language consent form on the IRB’s website includes language asking you to clarify whether the study team is able to take information or samples out of the study after the study has started, e.g. if the subject decides to end participation early. If the consent form you’re using doesn’t include this language, the […]

The first installment of our latest continuing education program for IRB reviewers. We’ll have a new topic each month that we’ll post about on the blog and discuss briefly at that month’s IRB meetings. We’re starting with research involving children. Our affiliation with Arkansas Children’s means we not infrequently review human subject research involving child […]

The IRB has updated its basic protocol template, and the new version is now available on the IRB website’s Templates and Training page.  In addition to addressing some issues we’ve noticed ourselves sending a lot of contingencies about, this revised template makes some important updates to the data and specimen handling language. The regulatory oversight […]

Technology advances quickly, and sometimes so fast that ethics and the law have trouble keeping up. Science recently posted an article about legal ramifications of DNA sequencing (“lawsuits” appears in the title). While the article focuses on the clinical side of DNA testing, the issues raised could also apply to research-related DNA sequencing. You may […]

Researchers and the IRB spend a lot of time thinking about appropriate compensation for study subjects. What’s appropriate? What might unduly influence a decision whether or not to join or continuing participation in a study? The compensation model we typically see involves paying all subjects the same amount for participating, prorated for whatever portion of […]

Do you have more than one active account at citiprogram.org? If so, consider merging them so all your training will be consolidated into a single account, and you’ll be able to quickly tell whether you’re current on required training. To merge accounts, please send an email to support@citiprogram.org with the following information: Your name Your […]