Keynote Address by Michelle M. Mello, JD, PhD: Clinical Trial Data Sharing: Perspectives From Participants
8:30 AM – 9:30 AM East Coast USA Time
Keynote Address by Michelle M. Mello, JD, PhD: Clinical Trial Data Sharing: Perspectives From Participants
Location: Exhibit Hall H
9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With the Supporters and Exhibitors
9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With the Supporters and Exhibitors
Location: Exhibit Hall FG
10:00 AM – 11:00 AM East Coast USA Time
Explorations in… Panel Series
10:00 AM – 11:00 AM East Coast USA Time
Explorations A: Explorations in Optimizing Informed Consent and Assent
Location: Exhibit Hall H
10:00 AM – 11:00 AM East Coast USA Time
Explorations B: Explorations in Navigating the Single IRB Mandate
Location: Ballroom 20BC
10:00 AM – 11:00 AM East Coast USA Time
Explorations C: Explorations in Engaging Communities to Promote Ethical Research
Location: Ballroom 20D
11:15 AM – 1:30 PM East Coast USA Time
Breakout Session Series C
11:15 AM – 12:30 PM East Coast USA Time
C01 - A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
Location: Room 30C
A Dialogue With the Feds Track
11:15 AM – 12:30 PM East Coast USA Time
C02 - A Dialogue With the Secretary's Advisory Committee on Human Research Protections (SACHRP)
Location: Room 29C
A Dialogue With the Feds Track
11:15 AM – 12:30 PM East Coast USA Time
C03 - Standard of Care, Medical Innovation, or Research: How Should We Decide?
Location: Ballroom 20D
Boundaries and Balances Track
11:15 AM – 12:30 PM East Coast USA Time
C04 - Advancing Yourself as a Regulatory Professional: Education, Cooperation, and Self-Advocacy
Location: Room 30D
Educating and Training Track
11:15 AM – 12:30 PM East Coast USA Time
C05 - The Pressing Need for IRB Precedent
Location: Room 30E
Legal Track
11:15 AM – 12:30 PM East Coast USA Time
C06 - The Rise of the Patient Voice at FDA
Location: Room 23A
FDA Regulations Track
11:15 AM – 12:30 PM East Coast USA Time
C07 - Research Passport: Regulatory and Ethics Review Implications for International Participants in US-Based Clinical Trials
Location: Room 23C
Global Research Track
11:15 AM – 12:30 PM East Coast USA Time
C08 - Developments Regarding the Federal "Right-to-Try" Law and its Impact on the FDA's Expanded Access Program
Location: Room 30AB
Hot Topics Track
11:15 AM – 12:30 PM East Coast USA Time
C13 - Scientific and Ethical Considerations in Choosing a Study Control Group
Location: Room 23B
Pharma/Biotech Perspectives Track
11:15 AM – 12:30 PM East Coast USA Time
C20 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 31B
Responsible Conduct of Research Track
11:15 AM – 12:30 PM East Coast USA Time
C22 - Research in K-12 Settings
Location: Room 31A
SBER Track
11:15 AM – 12:30 PM East Coast USA Time
C23 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) Guidelines
Location: Room 29D
SBER Track
11:15 AM – 1:30 PM East Coast USA Time
C09 - Use It or Lose It: Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 33AB
Institutional Officials and HRPP Leadership Track
11:15 AM – 1:30 PM East Coast USA Time
C10 - Let's Review A Protocol: Reviewing Research that Requires Expedited or Full Board Review
Location: Room 28ABC
IRB 101 Track
11:15 AM – 1:30 PM East Coast USA Time
C11 - IRB Chairs Forum: A Structured Discussion for IRB Chairs
Location: Room 22
IRB Chairs Track
11:15 AM – 1:30 PM East Coast USA Time
C12 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 29B
IRB Operations Advanced Track
11:15 AM – 1:30 PM East Coast USA Time
C14 - Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996 (HIPAA): What’s New and What We Still Need to Worry About
Location: Ballroom 20A
Legal Track
11:15 AM – 1:30 PM East Coast USA Time
C15 - Scientific Aspects of Study Design: A Primer for Non-Scientists
Location: Room 21
Non-Scientist IRB Members Track
11:15 AM – 1:30 PM East Coast USA Time
C16 - Considerations for Return of Results Under the Revised Common Rule
Location: Room 28DE
Research Involving Data and Biospecimens Track
11:15 AM – 1:30 PM East Coast USA Time
C17 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
