On Research - with CITI Program

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 analysis process in place.     
 

Additional Resources: 

• Local Coverage Determinations CMS - https://www.cms.gov/medicare/coverage/determination-process/local
• National Coverage Determinations CMS - https://www.cms.gov/medicare-coverage-database/search-results.aspx?keyword=nat&areaId=all&docType=NCD
• Thorny Medicare Coverage Issues article by Andra Popa - https://compliancecosmos.org/thorny-medicare-coverage-issues
• Learn more about HRP Consulting here: https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org.  

Guest Bio: Andra Popa is responsible for healthcare content at CITI Programs and was part of the first group to conduct Medicare Coverage Analyses. She owned a consulting firm that worked with over 40 healthcare entities to create, assess, audit, and monitor compliance programs, as well as to create educational programs. A graduate of Boston College with degrees in English and economics, she also has JD and LLM (healthcare law) degrees from Loyola University Chicago School of Law. She has published over 100 articles, written book chapters, and conducted workshops in design and compliance.

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 Hart, Senior Vice President of IRB, IBC & QA at BRANY; Karen Christianson, Senior Vice President and Managing Director of the HRP Consulting Group; Walden Leverich, Senior Vice President and Managing Director of Tech Software; and Nate Ferguson, a consultant and IRB Analyst who collaborates with a variety of clients, including footwear and apparel companies conducting human subjects research.


Additional Resources: 

• PRIM&R’s 50th-anniversary blog post - https://blog.primr.org/the-history-of-primrs-conferences/
• Learn more about HRP Consulting here - https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org.  

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 Resources: 

• The Updated Final Rule on Research Misconduct - https://www.federalregister.gov/documents/2024/09/17/2024-20814/public-health-service-policies-on-research-misconduct
• Blog from ORI about the updated final rule - https://ori.hhs.gov/blog/ori-final-rule
• Learn more about HRP Consulting - https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org.  

Guest Bio: John R. Baumann, Ph.D., was the Associate Vice President for Research Compliance at Indiana University, including the Bloomington and Indianapolis campuses, as well as the five regional campuses and affiliated hospitals. Dr. Baumann has over 25 years of experience in research, research administration, responsible conduct of research, and research compliance. He has had direct-line responsibility for all aspects of research compliance with regulations and ethical standards related to research misconduct, human subjects research, research with animals, conflict of interest, radiation, and biological safety, as well as research development, coordination, and submission of grant and contract applications, and management of funded research.  

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 techs in future research.  

Additional Resources: 

• Learn more about clinical trials at Walgreens: https://go.walgreenshealth.com/clinicaltrials
• Article about the evolving role of pharmacists in research: https://pharmddegree.com/careers/research-pharmacist/
• Learn more about HRP Consulting here: https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org.  

Guest Bio: Adam Samson has 15 years of experience designing and executing clinical trials across multiple therapeutic areas, phases, and treatment modalities. Adam is a clinical research executive passionate about bringing clinical trials closer to patients through community pharmacies and other innovative models. Adam also serves as an Adjunct Faculty at George Washington University in the Regulatory Affairs and Clinical Research Leadership Graduate Program. He volunteers with several non-profit organizations that aim to improve the clinical research industry through pre-competitive collaborations.  

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 on productivity in general and sorting through the proper balance of efficiencies with compliance.    

Additional Resources: 

• The AI Risk Repository: A Comprehensive Meta-Review, Database and Taxonomy of Risks from AI - https://arxiv.org/abs/2408.12622
• Deloitte Report – How Generative AI can reshape the health frontier - https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-from-code-to-cure-1.pdf
• Learn more about HRP Consulting: https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org.  

Guest Bio: Charlie Fremont is an Epic EHR Application Analyst and independent consultant with extensive research and billing experience. With 15 years in the healthcare industry and 10 years in research, Charlie specializes in leveraging technologies such as ChatGPT, Python, and Excel Formulas/VBA. Charles has successfully implemented solutions that streamline workflows and improve operational efficiency, which he shares openly with colleagues in our research industry.  

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://ohiohouse.gov/members/rachel-b-baker
• Learn more about HRP Consulting: https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org.  

Guest Bio: Rachel Baker has earned a BSN, MSW, and PhD. She works as a Nurse Researcher and teaches Research and Biostatistics to graduate nursing students. She also serves as the State Representative for Ohio’s HD27. In her first year, she sponsored 13 bills addressing topics including adoption modernization, access to MAT for opioid use disorder, Adverse Childhood Experiences, healthcare workplace violence, & childhood exposure to lead. She serves on the Aviation & Aerospace Committee, Behavioral Health Committee, Health Provider Services Committee, Public Health Policy Committee, and Technology & Innovation Committee. She was appointed to the OneOhio Recovery Foundation Board and the Ohio Children’s Trust Fund Board. 

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&modificationDate=1645630780163&api=v2
• Example guidance of QI vs Research from Icahn School of Medicine - https://researchroadmap.mssm.edu/other-research/cnri/ebp-qi-research/
• Learn more about HRP Consulting here - https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org.  

Guest Bio: Tiffany Gommel, the Director of the Office of IRB Operations (IRBO) at the National Institutes of Health (NIH) for the Intramural Research Program, is responsible for the operation and support of the NIH IRB, which reviews and approves human subjects research from the 27 Institutes across the NIH. With over two decades of clinical research experience, Tiffany has valuable expertise running IRBs at multiple organizations.

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 and the impact of AI on the IRB process. 
 

Additional Resources: 

• Learn more about Univo IRB: https://www.univo-group.com/
• NIH article about research populations - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8889234/ 
• Learn more about HRP Consulting: https://thehrpconsultinggroup.com/
• Learn more about CITI Program at about.citiprogram.org
  
  

Guest Bio: Julie Blasingim, CEO of Univo IRB, is a seasoned IRB executive with 20 years of extensive regulatory, operational, and compliance experience in human research protection and site operations of clinical research. She has served in a dozen senior leadership roles across multiple central IRBs, has hosted countless FDA inspections at both the IRB and under-site operations, and has managed multiple accreditations and certifications through AAHRPP and ISO. Julie holds a master’s degree in business administration specializing in leadership.    

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 topic.   

Additional Resources: 

• Resources for increased access to research -  https://mrctcenter.org/
• Equitable Access to Clinical Trials: How Do We Achieve It? - https://ascopubs.org/doi/10.1200/EDBK_389838
• Learn more about the CITI Program at about.citiprogram.org.  

Guest Bio: Jessica Rowe is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office, where she oversees quality and education initiatives. Throughout her career, Jessica has held varying positions in the clinical research industry, focusing on quality, HRPP, and compliance. She is also the current President of the Society of Clinical Research Associates (SOCRA). 

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 Memorandum 33 document:
https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-united-states-government-supported-research-development-national-security-policy/
- National Institute of Standards and Technology – Research Security Framework:
https://nvlpubs.nist.gov/nistpubs/ir/2023/NIST.IR.8484.pdf
- Updated Policy Regarding Use of Common Disclosure Forms:
https://www.whitehouse.gov/wp-content/uploads/2024/02/OSTP-Common-Disclosure-Form-Policy.pdf
- CITI Program's Research Security Training Online Course: https://about.citiprogram.org/course/research-security-training/
- Learn more about CITI Program at: about.citiprogram.org.  

Guest Bio: Dr. Emily Bradford is the Assistant Director of Research Compliance at the University of Kentucky. Under the Office of Sponsored Projects, she oversees conflicts of interest, research security, export controls, and some aspects of clinical trial compliance. She was previously an assistant professor at the College of Medicine and has served on Animal Care and Use Committees as well as healthcare ethics committees.