The COVID-19 has prompted a lot of rethinking of the conduct of clinical trials. The in-person contact many of these studies require may increase risk to both study staff and research participants. Institutions have taken a variety of approaches, everything from temporarily halting all research, to allowing only those essential to the subjects’ health or […]

Social media is pervasive (anyone else staying glued to social media during the coronavirus pandemic, while at the same time wishing they could stop looking at social media so much?), and its utility and application in human subject research should be considered, according to the authors of a recent editorial in JCO Cancer Clinical Informatics. The […]

Please continue to watch this space, as conditions related to the spread of coronavirus seem to change at least hourly. Last updated 6/3/20  4:45 pm with a link to updated TRI/institutional guidance about research during Covid-19.  Q. Will the IRB office remain open? A. Yes. However, we plan to work from home, so we ask […]

Study data and specimens aren’t always easy to come by, and once you’ve got them in hand, you may want to keep them for future use. If there’s any possibility at all that you will retain study data (including genetic data) or specimens for future use, please make sure your consent process/form (or requested consent-related waivers) address […]

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 […]