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The Evolution of IRBs: Navigating Ethical Considerations in Research - On Research Podcast
Manage episode 425582715 series 3435518
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.
Chương
1. The Evolution of IRBs: Navigating Ethical Considerations in Research - On Research Podcast (00:00:00)
2. Introduction to Julie Blasingim (00:01:02)
3. Julie's Journey into the Research Industry (00:01:42)
4. Evolution of Independent IRBs (00:03:02)
5. IRB Landscape Changes (00:07:09)
6. Managing Ethical Concerns in For-Profit (00:15:30)
7. Disconnect Between IRBs and Patients (00:19:54)
8. IRBs' Unique Position (00:23:45)
9. Patient-Centric Approach (00:24:46)
10. IRBs' Evolution (00:26:14)
11. Ethical Concerns in Research (00:28:29)
12. IT Security and IRB Boards (00:31:22)
13. AI Impact on IRBs (00:33:52)
14. Ethical Framework and Decision-Making (00:40:10)
15. Balancing Risk and Patient Empowerment (00:43:09)
16. Same Team: Impactful Research (00:46:37)
17. Closing Remarks (00:48:57)
25 tập
Manage episode 425582715 series 3435518
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.
Chương
1. The Evolution of IRBs: Navigating Ethical Considerations in Research - On Research Podcast (00:00:00)
2. Introduction to Julie Blasingim (00:01:02)
3. Julie's Journey into the Research Industry (00:01:42)
4. Evolution of Independent IRBs (00:03:02)
5. IRB Landscape Changes (00:07:09)
6. Managing Ethical Concerns in For-Profit (00:15:30)
7. Disconnect Between IRBs and Patients (00:19:54)
8. IRBs' Unique Position (00:23:45)
9. Patient-Centric Approach (00:24:46)
10. IRBs' Evolution (00:26:14)
11. Ethical Concerns in Research (00:28:29)
12. IT Security and IRB Boards (00:31:22)
13. AI Impact on IRBs (00:33:52)
14. Ethical Framework and Decision-Making (00:40:10)
15. Balancing Risk and Patient Empowerment (00:43:09)
16. Same Team: Impactful Research (00:46:37)
17. Closing Remarks (00:48:57)
25 tập
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