One definition of a human subject, per the Revised Common Rule, is a living individual about whom an investigator obtains, uses, studies, analyzes, or generates identifiable private information (emphasis added). Generally, data recorded without identifiers is not considered to be human subject data, because the identity of the subject cannot be “readily ascertained by the investigator or […]

It seems we hear each week of some new menace to our long-term health, whether it’s an emerging new condition or something that has been around for a while taking on new importance. Clinical research is one key to helping deal with these threats by developing effective treatments and bringing them to market. But what […]

As you prepare your continuing review submission, you may notice your study’s CLARA staff listing is out of date. While amendments are typically not allowed at continuing review, one exception is that you can, in fact, make changes to your staff listing, with some restrictions. Since the IRB will not approve revised documents at continuing […]

Ideally, new FDA-regulated products should be tested in populations that are similar to those that would eventually use the product after approval. However, ensuring the diversity of clinical trial populations has been an ongoing challenge. The FDA has released a draft guidance entitled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, […]

  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. […]

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 […]