In this episode of On Research, we talk with Dr. Megan LaFollette, Executive Director of the 3Rs Collaborative, about the practical applications of Replacement, Reduction, and Refinement, emerging animal model alternatives, and how federal initiatives are shaping the future of science. Notes: The 3Rs Collaborative: https://3rc.org/ The 3Rs Certificate Course: https://about.citiprogram.org/course/3rs-certificate-course/ On Campus – A CITI Program Podca...

In this episode, we talk with Danielle Mitchell, CEO and founder of Black Women in Clinical Research (BWICR), a professional organization dedicated to empowering, supporting, and connecting Black women working in clinical research through mentorship, networking, and career development opportunities. Notes: Black Women in Clinical Research (BWICR) - https://bwicr.com/ On Campus – A CITI Program Podcast: https://www.buzzsprout.com/2120643 CITI Program’s course catal...

Guest host Dr. Anne Hawkinsbadge (CITI Program) and Dr. Regina Allen (Virginia Tech) discuss the NIH’s new requirement for Institutional Biosafety Committees (IBCs) to post approved meeting minutes online, effective June 1. They explore how institutions can comply, while also examining the role, membership, and importance of IBCs in research compliance and safety. Notes: National Institutes of Health (NIH) “NOT-OD-25-082: Implementation Update: Promoting Maximal Transparen...

They outnumber us by the quintillions. They’re used in research across genetics, behavior, ecology, neuroscience—even robotics. But when it comes to ethics and welfare, insects are often left out of the conversation. Can they feel pain? What responsibilities do researchers have to them? This episode of On Research explores big ethical questions about our smallest research subjects. Our guests are Dr. Meghan Barrett (Indiana University Indianapolis) and Dr. Bob Fischer (Texas State University)...

Today we’re stepping behind the scenes into a critical – but often invisible – part of the research world: maintaining integrity. Joining us is Dr. Courtney Karmelita, Executive Director of Ethical Research and Outreach at Penn State. In today's conversation, we'll talk about what really happens when concerns are raised, how institutions handle research misconduct investigations, the challenges of navigating gray areas, and why a culture of integrity matters now more than ever. ...

How do we responsibly study digital communities without violating their trust? Where do we draw the line between research and interference? Joining us today is Dr. Sarah Gilbert, a research associate at Cornell University and research director of the Citizens and Technology Lab. Her work focuses on supporting healthy online communities, including how online data can be reused ethically. Together, we'll unpack the CMV subreddit case, explore how current research norms are being tested in real ...

Today’s episode is a celebration of CITI Program’s 25th anniversary. We talk with a panel of long-time employees, including Jaime Arango, Vice President of Content and Education, Daniel Smith, Director of Content and Education, and Adiper Bello, Director of Operations and Support, about the history of CITI Program, key milestones in the company, and where CITI Program is headed. Additional resources: CITI Program timeline: https://about.citiprogram.org/get-to-know-c...

Join us for a fascinating discussion with Dr. Jeremy Rossman, a researcher of 25 years, virologist, and President of a non-profit aimed at creating lasting and sustainable community development in research worldwide. We take a deep dive into community engagement in research; what it means, the challenges and opportunities, and why it’s so important. Jeremy does a wonderful job of explaining community engagement from all sides, whether you’re the researcher, the community involved in the resea...

Join us for a fascinating discussion about the recently updated Dual Use Research of Concern policy. There was so much to cover that I brought in two experts – one as my co-host and the other as our guest. If you don’t know much about Dual Use Research of Concern, this conversation will be a fantastic primer. We discuss what Dual Use means, the policy updates, how these updates could impact your research institution, and why all of this matters. Also of note, we recorded this episode a...

Join us for episode 1 of season 3 as we explore an essential compliance topic: coverage analysis. It’s a complicated process, but lucky for us, we have Andra Popa. Andra is an expert with nearly two decades of experience in healthcare law, compliance, and coverage analysis. As one of the first in the industry to provide coverage analysis, Andra walks us through the intricate details of the process, including why it’s so important and the consequences if you don’t have a proper coverage analys...

Join us for an engaging recap of the recent PRIM&R conference, held on November 17-20 in Seattle. With an amazing panel of research professionals, we discuss the highlights, popular sessions, hot topics, and the benefits of attending this conference. Whether you attended or not, there is plenty of valuable information shared by the panel of experts in our field. Guest panel for this episode: Jaime Arango, Vice President of Content and Education at CITI Program; Rafaella ...

Join us for an in-depth discussion about the updated research misconduct final rule. John Baughman, a research compliance expert, gives an excellent overview of the updates, why they matter, and how to be prepared when the policy goes into effect on January 1, 2025. While we all wait for the templates and guidance documents from the Office of Research Integrity, John provides some excellent advice and breaks down the most important elements of the new final rule. Additional Resour...

Join us for a fascinating discussion about the evolution of pharmacy in clinical research. Adam Samson, Head of Clinical Delivery Operations at Walgreens, discusses how pharmacists and pharmacy techs have more opportunities to participate in clinical trials. Learn how Walgreens has developed its research program to include the pharmacy at the center of its operations. This program includes takeaways that any research organization can learn from, including how best to include pharmacists and t...

Join us for a deep dive into the world of AI and its practical applications in the world of research operations. Charlie Fremont, an EHR application analyst specializing in research operations and billing, discusses how AI technology has helped him create new workflows that have vastly improved processes. Not only does he share details around how he uses this technology, he also shares valuable insight into the limitations and potential risks of using these tools. We also discuss AI’s impact ...

Join us for a fascinating discussion about the intersection of Research and Politics. Rachel Baker, a research nurse and House Representative in the state of Ohio, discusses working in two very different fields and how they both inform each other. We focus on the similarities of the fields and the transferable skills that Rachel has learned from her political career that have helped in her research role. Additional Resources: Ohio House of Representatives website - https://oh...

Join us for a discussion about the always-interesting topic of Quality Improvement vs. Research. What is the difference between QI and Research, and how do researchers and IRBs determine the difference between the two? Tiffany Gommel shares her experience, some helpful insights, and practical advice on this topic. Additional Resources: Example of QI vs Research Checklist from NIH - https://irbo.nih.gov/confluence/download/attachments/70321066/QA-QI%20vs.%20Research.pdf?version=1&am...

Join us for a thoughtful, long-form discussion about the evolving IRB Industry. Julie Blasingim, the CEO of Univo IRB, sits down to talk about how we got to the current IRB landscape we have now, and the future of IRBs. She covers a lot of areas related to the IRB, including how for-profit IRBs balance ethical reviews with the economics of business, identifying the gap between patients and the IRB process, as well as some hot topics for the IRB, like growing privacy protection concerns ...

Access to research is a complicated but essential area of growing concern in the research industry. As technology advances, many smaller research sites and rural areas can’t compete or keep up. By narrowing the field of eligible research participants, we lose important patient populations. Jessica Rowe, the Director of Quality and Education at the Yale Cancer Center and the current President of the Society of Clinical Research Professionals (SOCRA), joins me in discussing this fascinating top...

Research security is about protecting the means, know-how, and products of U.S. research and development until they are ready to be shared. In 2021, the government issued a national presidential memorandum with updated requirements for institutions around research. Emily Bradford joins us to explain these new research security requirements and suggests how to grow or build a program to meet these updated requirements. Additional Resources: - The original National Security Presidential M...

A growing area of research involves exception from informed consent. In an emergency setting, participants can be enrolled in a trial without their consent. Mike Linke joins On Research to discuss the regulations and ethical considerations around this important area of research. Additional Resources: FDA Guidance Document for EFIC studies - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research...