Understanding Exception from Informed Consent - On Research Podcast

On Research - with CITI Program

On Research - with CITI Program

28:47

Tyler Summitt, son of legendary coach Pat Summitt, as well as the Co-Founder of Pat Summitt Leadership Group , shares the group’s mission, the story of Pat’s humble beginnings, the art of mastering full executive decision making in 90 second or less, the "secret sauce" to Pat’s leadership, what she definitely didn’t understand about, but learned from, a 5-year-old’s soccer game, how to visualize winning in a (very, very) highly detailed way, the key component that gets you to over a 90% success rate, and the answer to the mystery of just who is “Trish”? Mentioned in this episode: This episode is brought to you by Pat Summitt Leadership Group. Pat Summitt Leadership Group…

hace un año 35:28

MP3•Episodio en casa

FDA Guidance Document for EFIC studies - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research
NIH Resources about EFIC studies - https://www.ninds.nih.gov/current-research/trans-agency-activities/office-emergency-care-research/research-involving-exception-informed-consent
Learn more about CITI Program at about.citiprogram.org
Learn more about HRP Consulting at HRP Consulting Group (thehrpconsultinggroup.com).

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.

Capíttulos

1. Introduction to Research Ethics and Participant Care (00:00:00)

2. Welcome to 'On Research with CIT Program' Podcast (00:00:22)

3. Legal Disclaimer and Purpose of the Podcast (00:00:36)

4. Introducing Mike Link: A Veteran in Research and IRB Leadership (00:00:55)

5. Exploring the Concept of Exception from Informed Consent (EFIC) (00:01:06)

6. Mike's Journey: From Microbiologist to IRB Chair (00:01:47)

7. Mike's Current Projects and Contributions Post-Retirement (00:03:36)

8. Diving Deep into Exception from Informed Consent (EFIC) (00:05:08)

9. Community Consultation and Public Disclosure in EFIC Studies (00:09:41)

10. Adapting to Modern Communication Avenues for EFIC Studies (00:14:46)

11. Navigating the Complexities of EFIC Studies (00:18:16)

12. Public Perception and Acceptance of EFIC Studies (00:18:52)

13. Withdrawal and Data Retention in EFIC Studies (00:19:43)

14. Insights from the NIH Meeting on EFIC (00:20:25)

15. Evaluating EFIC Regulations and Future Directions (00:21:42)

16. Challenges and Considerations in EFIC Study Design (00:25:20)

17. The Importance of Community Involvement in EFIC (00:31:14)

18. Reflecting on a Career in Research and IRB (00:31:46)

28 episodios

#Science #CITI Program

Understanding Exception from Informed Consent - On Research Podcast

published hace un año

MP3•Episodio en casa

FDA Guidance Document for EFIC studies - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research
NIH Resources about EFIC studies - https://www.ninds.nih.gov/current-research/trans-agency-activities/office-emergency-care-research/research-involving-exception-informed-consent
Learn more about CITI Program at about.citiprogram.org
Learn more about HRP Consulting at HRP Consulting Group (thehrpconsultinggroup.com).

Capíttulos

1. Introduction to Research Ethics and Participant Care (00:00:00)

2. Welcome to 'On Research with CIT Program' Podcast (00:00:22)

3. Legal Disclaimer and Purpose of the Podcast (00:00:36)

4. Introducing Mike Link: A Veteran in Research and IRB Leadership (00:00:55)

5. Exploring the Concept of Exception from Informed Consent (EFIC) (00:01:06)

6. Mike's Journey: From Microbiologist to IRB Chair (00:01:47)

7. Mike's Current Projects and Contributions Post-Retirement (00:03:36)

8. Diving Deep into Exception from Informed Consent (EFIC) (00:05:08)

9. Community Consultation and Public Disclosure in EFIC Studies (00:09:41)

10. Adapting to Modern Communication Avenues for EFIC Studies (00:14:46)

11. Navigating the Complexities of EFIC Studies (00:18:16)

12. Public Perception and Acceptance of EFIC Studies (00:18:52)

13. Withdrawal and Data Retention in EFIC Studies (00:19:43)

14. Insights from the NIH Meeting on EFIC (00:20:25)

15. Evaluating EFIC Regulations and Future Directions (00:21:42)

16. Challenges and Considerations in EFIC Study Design (00:25:20)

17. The Importance of Community Involvement in EFIC (00:31:14)

18. Reflecting on a Career in Research and IRB (00:31:46)

28 episodios

#Science #CITI Program

Todos los episodios

1
Community Engagement in Research - On Research Podcast 1:05:38

hace 10 días1:05:38

1:05:38

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 research, or the funding agency; it really takes all parties involved to work collaboratively towards improving research. A special thank you to Cynthia Bellas for helping produce this episode! Guest Bio: Dr. Jeremy Rossman is a virologist, President of the non-profit organization Research-Aid Networks, and an Honorary Senior Lecturer in Virology at the University of Kent. Dr. Rossman has conducted collaborative interdisciplinary research on the molecular biology of pandemic-causing viruses, international epidemic responses, evidence-based humanitarian aid and science education. Research-aid networks facilitate collaborative and evidence-based approaches for assessing need, delivering aid, evaluating effectiveness, and achieving equitable, long-term, sustainable community development worldwide. Additional Resources: Dr. Rossman’s Non-Profit Research-Aid Networks - https://researchaidnetworks.org/ NIH Community Engagement Alliance - https://ceal.nih.gov/ Long-COVID Patient-Led Research Collaborative - https://patientresearchcovid19.com/ Learn more about HRP Consulting here - https://thehrpconsultinggroup.com/ Learn more about CITI Program at about.citiprogram.org .…

1
Dual Use Research of Concern Policy - On Research Podcast 41:03

hace 5 weeks41:03

41:03

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 couple of weeks ago, in the midst of the many executive orders impacting research. Anne and Melissa do share their thoughts on how you should move forward in this gray area we’ve all found ourselves in, but we always encourage folks to stay up to date as much as possible on the evolving landscape. Additional Resources: DURC Policy released May 2024, effective May 2025 - https://bidenwhitehouse.archives.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and-PEPP.pdf Implementation Guidance for DURC policy - https://bidenwhitehouse.archives.gov/wp-content/uploads/2024/05/USG-DURC-PEPP-Implementation-Guidance.pdf Learn more about HRP Consulting: https://thehrpconsultinggroup.com/ Learn more about CITI Program at about.citiprogram.org . Guest Bios: Melissa James – Guest – Melissa is the BSL-3 Facility Manager for Yale University with 12+ years of high containment experience, including establishing and maintaining compliance with the Federal Select Agent Program. Her degrees in biology and Homeland Security and RBP credentials position her to share her vast knowledge and experience with others in the field. Anne Hawkinsbadge – Guest Host – Anne is the Assistant Director of EHS. She is a Certified Safety Professional, Certified Healthcare Safety Professional, Certified Healthcare Emergency Professional, and a Chemist with the American Society of Clinical Pathology. Her work experience includes healthcare, auto manufacturing, pharmaceutical, academia, worker compensation insurance, and chemical manufacturing.…

1
Coverage Analysis in Clinical Research - On Research Podcast 51:04

hace 9 weeks51:04

51:04

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.…

1
PRIM&R 2024 Conference Recap - On Research Podcast 56:31

hace 16 weeks56:31

56:31

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 .…

1
Updated Research Misconduct Final Rule - On Research Podcast 41:35

hace 16 weeks41:35

41:35

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.…

1
The Role of Pharmacy in Research - On Research Podcast 48:17

hace 22 weeks48:17

48:17

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.…

1
Practical Uses of AI in Research - On Research Podcast 47:18

hace 27 weeks47:18

47:18

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.…

1
Politics and Research: Transferrable Skills - On Research Podcast 43:41

hace 31 weeks43:41

43:41

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.…

1
Quality Improvement vs. Research: What's the Difference? - On Research Podcast 36:41

hace 35 weeks36:41

36:41

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.…

1
The Evolution of IRBs: Navigating Ethical Considerations in Research - On Research Podcast 49:31

hace 40 weeks49:31

49:31

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.…

1
Improving Access to Research Studies - On Research Podcast 35:31

hace 44 weeks35:31

35:31

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).…

1
Navigating the Complexities of Research Security - On Research Podcast 29:54

hace 49 weeks29:54

29:54

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.…

1
Understanding Exception from Informed Consent - On Research Podcast 35:28

hace 1 year35:28

35:28

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 NIH Resources about EFIC studies - https://www.ninds.nih.gov/current-research/trans-agency-activities/office-emergency-care-research/research-involving-exception-informed-consent Learn more about CITI Program at about.citiprogram.org Learn more about HRP Consulting at HRP Consulting Group ( thehrpconsultinggroup.com ). 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.…

1
Research Site Operations - On Research Podcast 41:59

hace 1 year41:59

41:59

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. Additional Resources: Interested in participating in a clinical research study? - Sign up with CTI: https://www.ctifacts.com/research-center/participate-in-a-clinical-research-study Developing Clinical Trial Budgets, Considerations, and Best Practices: pharmanewsintel.com Learn more about CITI Program at: about.citiprogram.org .…

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Research Compliance - On Research Podcast 31:47

hace 1 year31:47