Research data storage options have expanded far beyond keeping paper records secure in a locked filing cabinet in a locked room. The CLARA new submission form has now been updated to collect more specific information about study data storage. All study data should be carefully stored, whether it’s protected health information (PHI) or not. Study […]

Foreign involvement in US-based research studies is getting closer scrutiny of late. While some allegations related to foreign influence have led to well-publicized faculty firings, there have been more such cases that remained off the public’s radar, according the head of NIH’s extramural research program. Institutional have also had to repay “hundreds of thousands of […]

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 […]