By CITI Program
Discussing issues that impact scientific research monthly, from clinical research to ethical considerations. Hosted by Justin Osborne. New episode every month. Learn more at about.citiprogram.org</
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The podcast currently has 21 episodes available.
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.
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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.
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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.
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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.
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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.
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.
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Guest Bio: Mike Linke is a scientist, researcher, and IRB Chair. He has been in the research industry for 30 years and serves as the StrokeNet IRB Chair and the SMART IRB Program Director for Education. Mike has extensive experience working with Exception from Informed Consent (EFIC) studies.
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 out as a research coordinator, then manager. He moved into project management at a CRO, then operations director at a central IRB and currently serves as the Vice President, Research Site Services at a phase 1-4 multi-specialty clinical research site.
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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.
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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 Gomes, Senior Director of Information Technology; and Gina Sullivan, Director of Sales and Marketing. The panel shares their personal reflections and observations gained from the conference. Stay tuned to hear about emerging hot topics and key takeaways. We also cover tips for getting the most out of your conference attendance.
To learn more about CITI Program please visit: https://about.citiprogram.org/
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 those of Dr. Jans and not the Centers for Disease Control and Prevention or the National Center for Health Statistics.
Survey research is a dynamic method that transforms curiosity into actionable insights. Utilizing carefully crafted questionnaires, it navigates the intricate terrain of public opinion, illuminating trends and attitudes. A powerful tool in social sciences and business, surveys enable the systematic collection of data, providing a quantitative understanding of diverse subjects. From gauging customer satisfaction to unraveling societal trends, each survey is a snapshot capturing the nuances of human perspectives. Methodical and versatile, survey research is a compass, guiding decision-makers toward informed choices. With its ability to distill complex data into comprehensible patterns, survey research is a cornerstone in evidence-based decision-making.
If you found the survey research insights in this episode interesting and want to learn more about this topic, check out CITI Program’s online course, Survey Research: Design, Planning, Implementation, and Ethics, authored by Dr. Matt Jans and Zoe Padgett. This comprehensive resource offers an in-depth exploration of survey research design, implementation, analysis, and ethical considerations.
Learn more about CITI Program:
- https://about.citiprogram.org/
- https://about.citiprogram.org/course/survey-research-design-planning-implementation-and-ethics/
The podcast currently has 21 episodes available.
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