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 […]

There’s a great new resource available for study teams interested in making research material more accessible to research participants. The Health Literacy in Clinical Research web site went live this week. This site contains a wealth of tips and resources intended to guide study teams to present information in an understandable way. Professor Christopher Trudeau, […]

A revised human subject research determination form is slated to go live in CLARA beginning Monday, October 21. The form’s questions have been rewritten to use simpler language, and the CLARA pages have been redesigned slightly to make help text easier to find and read. We’ve also tried to word the questions to make them […]

Needing to earn the most convenient 0.5 hours of Certified Research Specialist elective credit ever? Look no further than the 3rd Quarter IRB Blog quiz, now live at learnondemand.org. You can find it by clicking the link and typing “IRB” into the search box at upper right. Take the test whenever it’s convenient for you. […]