Understanding Exception from Informed Consent - On Research Podcast

On Research - with CITI Program

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.

Chapters

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)