On Research - with CITI Program

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, whet...

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...

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 a...

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 Pres...

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 importan...

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 c...

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 pote...

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: 

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/dow...

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 topi...

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 Prof...

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 R...

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-guidan...

A discussion about research site operations. We talk about the different types of sites, different recruitment strategies, how DCTs impact dedicated research sites, and the financial impact technology brings to sites. Adam Roth, the Vice President of Site Services at CTI, shares his experience and insights into the site world.  

Guest Bio: Adam Roth has been in the clinical research industry for over 25 years. He started o...

Our guest this month is Kate Cohen, the Chief Compliance Officer at SIU Medicine in Illinois. Kate breaks down the concept of research compliance, sharing best practices and practical guidance. We dive into essential elements of a compliance research program, as well as how someone new to this side of the industry can take steps to break in and learn more. 

Additional Resources:  

• Updated OIG Guidance with 7 Elements https://oig...

This is a special edition of On Research with CITI Program. Guest hosted by Margaret Rankovic, Director of Content and Education at CITI Program, this podcast provides a recap, insights, and key takeaways from the recently concluded PRIM&R 2023 conference. The panel includes the following from CITI Program leadership team: Bharat Krishna, SVP & Managing Director; Jaime Arango, Vice President of Content and Education; Cid Go...

Dr. Matt Jans has been conducting and innovating surveys for almost 25 years. He is currently Lead Statistician for the National Health and Nutrition Examination Survey (NHANES) at the National Center for Health Statistics (NCHS).* His survey experience spans academic, government, and private sectors. He is an active member of the American Association for Public Opinion Research (AAPOR).
*The views and opinions expressed are t...

Dr. Matt Jans has been conducting and innovating surveys for almost 25 years. He is currently Lead Statistician for the National Health and Nutrition Examination Survey (NHANES) at the National Center for Health Statistics (NCHS).* His survey experience spans academic, government, and private sectors. He is an active member of the American Association for Public Opinion Research (AAPOR). 
*The views and opinions expressed are t...

Tanya Brown is the Senior Director, HR Consulting, Employee and Labor Relations at Vanderbilt University. She has 15 years of experience in Human Resources in many industries including the private sector, public sector, and higher education. Tanya currently leads a team of HR Consultants, who are the primary contact for leaders and employees across the university for matters related to human resources, and workers’ compensation and...