Staff and Faculty Education
Would you like to know more about what we do at Regulatory Affairs? Outside Interest Disclosures and M-Inform? Conflict of Interest (COI) Management? How to answer COI questions in eResearch? ClinicalTrials.gov? Members of the Regulatory Affairs staff and the MEDCOI Board are available for appointments and presentations for faculty and/or staff.
- Email Regulatory Affairs for more information or to set up a meeting or presentation.
Also see our Policies and Guidance page for information.
The "Inside Scoop" on When the FDA Comes to Call by Nancy A. Bellamy, FDA Investigator, Bioresearch Specialist, Detroit Office, August 27, 2014
Nancy Bellamy kindly agreed to present the lecture she was unable to deliver in person at our FDA Research Symposium October 2013. She discusses issues of importance for human subject protection, how to run an FDA-compliant clinical trial, and what "observations" of concern are most commonly found during FDA inspections. Her presentation is available here: N. Bellamy Presentation.PDF
FULL VERSION OF THE INTERACTIVE MOVIE, THE LAB, NOW AVAILABLE ONLINE
The long awaited release of "The Lab: Avoiding Research Misconduct" is now available for viewing on the ORI web site. The video simulation allows users to assume the role of a graduate student, post-doc, research administrator, or PI and make decisions that affect the integrity of research.
2010 Clinical Conflict of Interest Symposia:
In early 2010, we held a series of three educational discussions on several clinical conflict of interest issues:
- “Academic / Industry Partnerships” (summary only)
- “Support for Academic Medical Education: Does Industry Have a Role?” (video and summary)
- “Industry Speakers Bureaus: Your Slides or Mine?” (video and summary)
- Background Reading: “Playing It Safe With Research Risk” by Karen Markin, The Chronicle of Higher Education, 8/12/2005.