If you’re wondering whether your project meets the definition of human subject research requiring review, you don’t need to go through the complete new submission form process to find out. Instead, you can complete the much shorter and simpler human subject research determination form in CLARA to find out. Not only is the form much simpler […]

We’ve revised the CLARA account request form so that it’s now fully online. That means there’s no more Word document for you to complete and email to the IRB office. To access the form, go to the CLARA home page, and click on the “Don’t have an account?” link. An electronic form will pop up […]

“When in doubt, disclose” relationships with foreign entities to the federal government, advise the authors of a recent recap of disclosure requirements that appeared in The Scientist. The federal government seems to be increasing its oversight of this kind of disclosure, leading to some criminal cases. In addition, different federal agencies have different policies regarding […]

The chair of Harvard’s chemistry and chemical biology department was arrested this week after prosecutors alleged he made a false statement to the federal government about a financial relationship with the Chinese government, according to this New York Times story. He was one of three scientists accused of foreign-influence-research-crimes this week, according to the story. […]

While we’re over here discussing whether the language in our HIPAA authorization forms meets regulatory requirements, Google is digging away at a trove of what’s been described as “tens of millions” of individuals’ health data, according to published reports. The Wall Street Journal first reported on this so-called “Project Nightingale.” (Please excuse the formatting of […]

We’re seeking your input as part of our continuing quality improvement at the IRB. Translation: We’d like some input on what we do well, and where we need to improve. To that end, everyone in CLARA who’s listed as being either a PI or has having “managing CLARA responsibilities” will receive an email with “IRB […]

Despite being the most specific individual identifier we currently know of, federal regulators still don’t consider DNA to be individually identifiable material. To be fair, the federal Office for Human Research Protections has said it will reconsider the notion of “identifiability” every 4 years, with whole genome sequencing likely to be one of the first […]

A recent Des Moines Register article describes a federal inquiry regarding human subject research conducted at a center for people with severe intellectual disabilities. The story includes links to previous reporting on the matter. We note the story indicates the request for information came from the Justice Department’s Civil Rights Division, and not from the […]

One new and one updated IRB policy were recently posted on the IRB’s website. The revised policy, 2.3, relates to the use of single or central IRBs (xIRBs). This policy describes the process changes implemented as xIRB use has become more common in recent years. The 2018 Common Rule will mandate the use of an […]

A recent New York Times column caught our eye, as it was about research. Columnist Frank Bruni writes about his experience participating in a randomized, placebo-controlled study testing a potential treatment for a rare disorder affecting vision. While there is no one typical subject experience, and not many research subjects have their own column in […]