ANNUAL BOARD MEMBER TRAINING

Transcription

1 ANNUAL BOARD MEMBER TRAINING Location: University of Utah Alumni House Date: Tuesday, November 13, 2018 AGENDA 7:30 AM Breakfast Ballroom 8:00 AM Welcome & State of the IRB Ballroom 8:15 AM 8:45 AM Intro to the Research Participant Advocate Sadie Gabler, Research Participant Advocate 8:45 AM 9:30 AM Data & Safety Monitoring 9:30 AM 9:45 AM Break, Head to Breakout Session 1 9:45 AM 10:30 AM BREAKOUT SESSION 1 (Choose 1) A. Latest Recommendations on Return of Individual Research Results to Participants from the National Academies of Sciences, Engineering, and Medicine Dr. Jeffery R. Botkin, Associate Vice President for Research Integrity B. FDA and the Right to Try Law: Expanded Access to Investigational Drugs & Devices, and What This Means for the IRB Brian Watts, Office of General Counsel 10:30 AM 10:40 AM Break, Head to Breakout Session 2

2 10:40 AM 11:30 AM BREAKOUT SESSION 2 (Choose 1) C. The $3 Million Research Breakdown: A Case Study in Research Misconduct Dr. Erin Rothwell, Assistant Vice President for Research Integrity D. The Risks and Benefits of VR: Using Virtual Reality Technology with Human Subjects Dr. Ashley Brown, Assistant Professor, Entertainment Arts & Engineering 11:30 AM 12:00 PM Lunch, Head to Breakout Session 3 12:00 PM 12:50 PM BREAKOUT SESSION 3 (Choose 1) E. DOUBLE TOPIC: Distinguishing Standard-of- Care from Research-Only Procedures in Research Involving Radiation; How to Review Research from the VA: Regulatory and Procedural Differences Lisa Bakhsheshy, Director of Clinical Services Radiology, IRB Staff F. IRB Determinations 101 Ammon Pate, IRB Operations Manager 12:50 PM 1:00 PM Break, Head to Breakout Session 4 1:00 PM 1:45 PM BREAKOUT SESSION 4 (Choose 1) G. Everything We Can Reasonably Tell You in 45 Minutes About FDA Regulations H. What Do I Need to Know About HIPAA Regulations? 2:00 PM 3:00 PM OPTIONAL SESSION (Choose 1) I. The Revised Common Rule Lisa Rigtrup, IRB Operations Manager

3 J. Single/Central IRB (SIRB/CIRB) Processes Annie Risenmay, IRB Operations Manager CONFERENCE MATERIALS Copies of presentation slides and conference materials will be made available to attendees on the IRB website after the last session has concluded. HELP US IMPROVE You may receive a brief evaluation survey following the training. We use your comments and suggestions from the survey to choose topics for next year s training! PHOTOS Some of the photos and videos taken at this year s training may be used on our website and/or for other promotional purposes. If you prefer to opt out of having your photograph taken and used by the University of Utah, please be sure to alert the photographer and/or videographer during the training. Thank you!

4 ANNUAL BOARD MEMBER TRAINING Location: University of Utah Alumni House Date: Monday, December 17, 2018 AGENDA 7:30 AM Breakfast Ballroom 8:00 AM Welcome & State of the IRB Ballroom 8:15 AM 8:45 AM Intro to the Research Participant Advocate Sadie Gabler, Research Participant Advocate 8:45 AM 9:30 AM Data & Safety Monitoring 9:30 AM 9:45 AM Break, Head to Breakout Session 1 9:45 AM 10:30 AM BREAKOUT SESSION 1 (Choose 1) A. Everything We Can Reasonably Tell You in 45 Minutes About FDA Regulations B. What Do I Need to Know About HIPAA Regulations? 10:30 AM 10:40 AM Break, Head to Breakout Session 2 10:40 AM 11:30 AM BREAKOUT SESSION 2 (Choose 1) C. The $3 Million Research Breakdown: A Case Study in Research Misconduct Dr. Erin Rothwell, Assistant Vice President for Research Integrity

5 D. The Risks and Benefits of VR: Using Virtual Reality Technology with Human Subjects Dr. Ashley Brown, Assistant Professor, Entertainment Arts & Engineering 11:30 AM 12:00 PM Lunch, Head to Breakout Session 3 12:00 PM 12:50 PM BREAKOUT SESSION 3 (Choose 1) E. DOUBLE TOPIC: Distinguishing Standard-of- Care from Research-Only Procedures in Research Involving Radiation; How to Review Research from the VA: Regulatory and Procedural Differences Lisa Bakhsheshy, Director of Clinical Services Radiology, IRB Staff F. IRB Determinations 101 Gary Henderson, IRB Operations Manager 12:50 PM 1:00 PM Break, Head to Breakout Session 4 1:00 PM 1:45 PM BREAKOUT SESSION 4 (Choose 1) G. Latest Recommendations on Return of Individual Research Results to Participants from the National Academies of Sciences, Engineering, and Medicine Dr. Jeffery R. Botkin, Associate Vice President for Research Integrity H. FDA and the Right to Try Law: Expanded Access to Investigational Drugs & Devices, and What This Means for the IRB Brian Watts, Office of General Counsel 2:00 PM 3:00 PM OPTIONAL SESSION (Choose 1) I. The Revised Common Rule Lisa Rigtrup, IRB Operations Manager

6 J. Single/Central IRB (SIRB/CIRB) Processes Annie Risenmay, IRB Operations Manager CONFERENCE MATERIALS Copies of presentation slides and conference materials will be made available to attendees on the IRB website after the last session has concluded. HELP US IMPROVE You may receive a brief evaluation survey following the training. We use your comments and suggestions from the survey to choose topics for next year s training! PHOTOS Some of the photos and videos taken at this year s training may be used on our website and/or for other promotional purposes. If you prefer to opt out of having your photograph taken and used by the University of Utah, please be sure to alert the photographer and/or videographer during the training. Thank you!