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IN THIS NEWSLETTER: A Word from Anita Balgopal, Executive Director New Form: AI Systems Used in Human Subjects Research Demystifying the IRB Review Process: Checklists Published Updates on Certificates of Confidentiality from NIH Upcoming Events and Training Featured Friend of the DHR: Dakota | |
A Word from Anita Balgopal, Executive Director I hope you are all having a great start to the fall semester! While summer often brings a slower pace for some, our research community—and the DHR team—remained very active. Between June and September, we received over 235 new protocol applications and processed more than 100 additional submissions, including modifications, renewals, and reliance agreements. These numbers reflect the tremendous level of human subjects research taking place across Northeastern—an inspiring testament to the engagement and innovation of our research community. I’m also thrilled to share that our review timelines remain well ahead of national averages. Published data show average review times of 24 days for expedited reviews and 13 days for exempt reviews. At Northeastern, the median turnaround time for protocols received and approved is 10 business days for new applications (exempt and expedited) and 3 business days for modifications. These metrics highlight the dedication, responsiveness, and strong work ethic of the entire DHR team—as well as the collaborative spirit of our research community. DHR remains committed to ensuring an efficient, thorough, and supportive review process for all researchers. I encourage you to join us during drop-in hours, at a Friday IRB 101 presentation, or at one of our topic-specific educational offerings. Details for all of these can be found in this newsletter. Finally, we always welcome your ideas for future educational programs and guidance topics. Thank you for your continued partnership in advancing ethical, high-quality research at Northeastern. Cheers, | |
New Form: AI Systems Use in Human Subjects Research We’ve created a new form to support research projects that use artificial intelligence (AI) systems or tools in human subjects research. The AI Systems Used in Human Subjects Research Form is designed to capture key details about AI use so the IRB can review research more efficiently and ensure compliance with federal regulations and ethical frameworks. The new form does not change any expectations related to review, but is rather designed to set researchers up for success by ensuring the IRB has the right information at initial submission. Find more information about the form here and find the AI Systems Used in HSR Form here. | |
Demystifying the IRB Review Process: Checklists Published We often hear from our research community that they wish they better understood what the IRB looks for when reviewing protocols. To support transparency, we’ve published our checklists on our website, alongside the reviewer guides that were previously published. These checklists complement our existing guidance and cover, for example, our scope of review for exempt review, DoD requirements, and the elements of informed consent. Although these checklists are tools for IRB reviewers, investigators may find them helpful when preparing submissions. We hope this added transparency supports a smoother and more informed submission experience. | |
Updates on Certificates of Confidentiality from NIH Over the summer, researchers were not able to apply for Certificates of Confidentiality (CoC) for non-NIH funded research. The NIH has an update that their CoC application process is operating again and researchers can apply for CoCs through NIH’s online application system again. A CoC is a legal protection issued by a federal agency that protects identifiable and sensitive information from forced disclosure (such as a subpoena or court order). | |
Upcoming Events and Training Our Fall 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. October
November
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Featured Friend of the DHR: Dakota Dakota, April’s dog, loves to help review study protocols and respond to investigators’ emails from the IRB Inbox. When not at work, she enjoys long walks on the beach, cuddling by a warm fire, and chasing her favorite ball and human boy, Austin.
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