|
7-8 a.m.
|
Registration and continental breakfast
|
|
|
7:45-8 a.m.
|
Welcome
|
|
|
8-9 a.m.
|
In Pursuit of Harmonization: The SACHRP Subcommittee on Harmonization, Goals and Specific Issues
|
David Forster, JD
Western IRB
|
|
9-10:15 a.m.
|
Federal Panel including representatives from:
- Office for Human Research Protections (OHRP)
- Food and Drug Administration (FDA)
- National Institutes of Health (NIH)
- Veterans Affairs (VA)
|
Elyse Summers, JD
[Moderator]
Michael Carome, MD (OHRP)
Kevin Prohaska, DO (FDA)
Ann Hardy, DrPH (NIH)
Lynn Cates, MD (VA)
|
|
10:15-10:30 a.m.
|
Break
|
|
|
10:30-11:45 a.m.
|
Breakout session A
|
|
| |
Understanding the Complexities of Event Reporting (Advanced Track)
|
Michael Carome, MD
OHRP
Joseph Gibbons, MD
University Hospitals Case Medical Center
|
| |
Data Sharing and Security (Advanced Track; Regulatory Compliance Track)
|
Philip Cola, MA [Moderator]
University Hospitals Case Medical Center
Carolyn-Apperson Hansen, MStat
Case Western Reserve University
Ryan Terry
University Hospitals Case Medical Center
Anil Jain, MD
Cleveland Clinic
|
| |
Regulatory Requirements when Conducting Research Internationally (Advanced Track; SBER)
|
James Kazura, MD
University Hospitals Case Medical Center
Barbara DeCausey
Centers for Disease Control & Prevention
|
| |
How to be Relevant in the New Age of Human Research Protections (Hot Topics Track)
|
Hillard Lazarus, MD
University Hospitals Case Medical Center
Christian LaMantia, MBA
Research Compliance Counselor
|
| |
Fundamentals of Reviewing and Approving Human Research (Nuts and Bolts Track)
|
Freda Yoder, MA
OHRP
|
|
11:45 a.m.-1 p.m.
|
Lunch/Tour of Severance Hall
|
|
|
1-2:15 p.m.
|
Breakout session B
|
|
| |
FDA IRB Inspections and Common Findings (Advanced Track; Regulatory Compliance Track)
|
Kevin Prohaska, DO
FDA
|
| |
What's New in VA Human Subjects Protection? (Regulatory Compliance Track)
|
Lynn Cates, MD
VA
Joan Porter, DPA
VA
|
| |
Exempt and Expedited Determinations – Understanding the Flexibility Permitted by the HHS Regulations (Nuts and Bolts Track; SBER)
|
Elyse Summers, JD
OHRP
Catherine Anson, MA
John Carroll University
|
| |
Institutional Conflicts of Interest (Hot Topics Track)
|
Guy Chisolm, PhD
Cleveland Clinic
|
| |
Careers in Human Subject Research (Hot Topics Track; Nuts and Bolts Track)
|
Carol Fedor, ND
University Hospitals Case Medical Center
Edward Gabriele, DMin
Office of the Surgeon General of the Navy Bureau of Medicine and Surgery
|
|
2:15-2:30 p.m.
|
Break
|
|
|
2:30-3:45 p.m.
|
Breakout session C
|
|
| |
Lessons Learned: Implementing Electronic IRB Systems (Hot Topics Track)
|
Valerie Wiesbrock, MA
University Hospitals Case Medical Center
Daniel Beyer, MS
Cleveland Clinic
Kathleen Lawry, MSSA
MetroHealth Medical Center
Philip Cola, MA
University Hospitals Case Medical Center
|
| |
Department of Defense Research and the IRB (Hot Topics Track; Regulatory Compliance Track)
|
Laura Ruse Brosch, PhD
US Army Medical Research and Materiel Command
|
| |
Conducting Research on the Internet (Nuts and Bolts Track; SBER)
|
John Kennedy, PhD
Indiana University Bloomington
|
| |
New FDA Guidance: Investigator Responsibilities (Regulatory Compliance Track; Advanced Track)
|
Liz Wool, BSN
QD-Quality & Training Solutions, Inc.
|
| |
The Optimal Consent Process (Advanced Track)
|
Barbara Daly, PhD
University Hospitals Case Medical Center
Eric Kodish, MD
Cleveland Clinic
|
|
3:45-4 p.m.
|
Break
|
|
|
4-4:50 p.m.
|
Federal Panel Discussion/Q&A including representatives from:
- Office for Human Research Protections (OHRP)
- Food and Drug Administration (FDA)
- National Institutes of Health (NIH)
- Veterans Affairs (VA)
|
Michael Carome, MD (OHRP)
Kevin Prohaska, DO (FDA)
Ann Hardy, DrPH (NIH)
Lynn Cates, MD (VA)
Joan Porter, DPA (VA)
|
|
4:50-5 p.m.
|
Closing
|
|
|
5-6 p.m.
|
Reception/Tours of Severance Hall
|
|