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IN THIS IRBrrrrr NEWSLETTER: After Dark Drop-in Hours Reflections on Risk during Shifting Paradigms Leveraging AI for Better IRB Submission New Guidance: FDA “General Wellness” Devices and Software & PI Change Infographic Changes to Our Team: Welcomes and Farewells Upcoming Events and Training Featured Friend of the DHR: Butterbean | |
After Dark Drop-in Hours Got IRB questions but can’t make it during the day? We’ve got you covered with “After Dark” drop-in hours most Thursdays from 6-7PM EST. Swing by Thursday evenings to get your questions answered, troubleshoot complex regulatory issues you have, or just ask questions you’re too embarrassed to ask in the daylight. Be sure to visit our Calendar of Events which lists all our events, including drop-in hours, for our scheduled hours and details of how to join. These evening hours were added in response to feedback from our DHR Satisfaction Survey. We want you to know that we’re listening and making changes where we are able. If you haven’t completed the survey yet and would like to share your input, it’s a great way to help shape our office. | |
Reflections on Risk during Shifting Paradigms Shifting cultural and legal landscapes are making research risk harder to define, evaluate, and mitigate. What may be considered a minimal risk study has the potential to not be as social normal, laws, and protections shift. In this reflection, Claire explores how IRB’s and researchers can think more deliberately about risk, participant protection, and informed consent when the ground beneath our assumptions is evolving. Read Claire’s full reflection here. | |
Leveraging AI for Better IRB Submission Our office has written a set of Claude AI prompts that research teams can use to make the IRB submission and review process easier. These prompts can be used to help draft consent language and recruitment materials, evaluate accessibility of participant facing materials, and conduct a basic “pre-review” check before your submit. We also discuss responsible AI use. These tools should always augment our own skills rather than replace us. Find our blog post with our thoughts and the prompts here. | |
New Guidance: FDA “General Wellness” Devices and Software & PI Change Infographic The FDA released new guidance on “General Wellness: Policy for Low Risk Devices guidance” (January 2026) which offers apt and much-needed clarity on how the agency interprets and applies its regulations to “general wellness” devices or software. The guidance can help researchers and IRBs better understand when FDA regulation does — and does not — apply. Find the new FDA guidance here. In addition, we’ve published a PI Change Infographic outlining when a Principal Investigator change is needed and the steps to take. Bookmark our Guidance page where the PI Change Infographic and our other guidance documents live. | |
Changes to Our Team: Welcomes and Farewells We’re pleased to welcome Finn Leon to our team. Finn brings a wealth of knowledge and experience to us from the Teacher’s College, Columbia University IRB. You can read more about Finn here. We also share bittersweet news that Clarke has departed our team to explore the biomedical side of review at a hospital IRB. Clarke’s studies have been reassigned to other coordinators. | |
Upcoming Events and Training Our Spring schedule of IRB 101 and IRB Topics has already kicked off. The remaining upcoming sessions are below. As always, please be sure to visit our Calendar of Events which lists all our events, including drop-in hours, for our scheduled hours and details of how to join. Janurary February
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Featured Friend of the DHR: Butterbean Butterbean is a 13-year-old sausage dog with a pacemaker-run heart of gold and her fair share of attitude. She enjoys snoring through IRB meetings, baby carrots, and barking at back yard critters against whom she would not stand a chance in a fight. Butterbean’s accolades include a PhD from Clown College with a specialty in getting under-foot.
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