Preconference Programs On-Site Check-In at the Manchester Grand Hyatt
8:30 AM – 4:30 PM East Coast USA Time
2018 AER Conference: Preconference Programs
8:30 AM – 12:30 PM East Coast USA Time
Ethical and Practical Issues in Global Human Research
Location: Old Town
8:30 AM – 12:30 PM East Coast USA Time
Tips and Tools for Effective Education and Training
Location: La Jolla
8:30 AM – 4:30 PM East Coast USA Time
Biobanking in an Era of Research Towards Precision Medicine: Approaches to the Ethical, Regulatory, and Practical Challenges
Location: Harbor Ballroom A
8:30 AM – 4:30 PM East Coast USA Time
Critical Topics in SBER
8:30 AM – 4:30 PM East Coast USA Time
Implementing the Revised Common Rule
Location: Grand Hall B
8:30 AM – 4:30 PM East Coast USA Time
IRB 101sm
Location: Harbor Ballroom H
8:30 AM – 4:30 PM East Coast USA Time
IRB Chairs Boot Camp: Tools for Successful IRB Leadership
Location: Harbor Ballroom G
8:30 AM – 4:30 PM East Coast USA Time
Single IRBs: From Idea to Implementation
Location: Harbor Ballroom C
1:00 PM – 4:30 PM East Coast USA Time
Ethical and Regulatory Review of Research: Case Studies
Location: Old Town
1:00 PM – 4:30 PM East Coast USA Time
Ethical Study Design Is Good Science
Location: La Jolla
4:30 PM – 5:30 PM East Coast USA Time
2018 AER Conference: Preconference Programs
4:30 PM – 5:30 PM East Coast USA Time
Preconference Programs Networking Reception
Location: Grand Hall A
Thursday, November 15, 2018
7:00 AM – 8:00 AM East Coast USA Time
Continental Breakfast to Welcome First-Time Attendees
7:00 AM – 8:00 AM East Coast USA Time
Breakfast to Welcome First-Time Attendees
Location: Ballroom 20A
7:00 AM – 5:30 PM East Coast USA Time
On-Site Check-In
7:00 AM – 5:30 PM East Coast USA Time
On-Site Check-In
Location: Exhibit Hall FG Foyer
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
Location: Exhibit Hall H
8:00 AM – 9:00 AM East Coast USA Time
Conference Welcome Remarks
8:00 AM – 9:00 AM East Coast USA Time
Morning Welcomes and Announcements
Location: Exhibit Hall H
9:00 AM – 10:00 AM East Coast USA Time
Keynote Address
9:00 AM – 10:00 AM East Coast USA Time
Keynote Address by Timothy Caulfield, LLB, LLM, FRSC, FCAHS: Celebrities, Science-y, and Pseudoscience: Tackling Misinformation in the Era of Health Noise
Location: Exhibit Hall H
10:00 AM – 10:30 AM East Coast USA Time
Beverage Break Supported by Kinetiq
10:00 AM – 10:30 AM East Coast USA Time
Beverage Break With the Supporters and Exhibitors
Location: Exhibit Hall FG
10:30 AM – 11:45 AM East Coast USA Time
Concurrent Plenary Sessions
10:30 AM – 11:45 AM East Coast USA Time
Panel I: Gun Violence and Public Health: Facts, Fiction, and the Future
Location: Ballroom 20D
10:30 AM – 11:45 AM East Coast USA Time
Panel II: At the Crossroads of Hope and Hype: Recruiting the Desperately Ill for Clinical Trials
Location: Ballroom 20 BC
10:30 AM – 11:45 AM East Coast USA Time
Panel III: The New Rule's Identity Crisis: Should Identifiability Be Changed?
Location: Exhibit Hall H
11:45 AM – 1:00 PM East Coast USA Time
Lunch Sessions
11:45 AM – 1:00 PM East Coast USA Time
Lunch Session: A Dialogue With Patient-Centered Outcomes Research Institute (PCORI)
Location: Room 24A
11:45 AM – 1:00 PM East Coast USA Time
Lunch Session: A Dialogue With the Department of Energy (DOE)
Location: Room 24B
11:45 AM – 1:00 PM East Coast USA Time
Lunch Session: A Dialogue With the Office of Research Integrity (ORI)
Location: Room 24C
11:45 AM – 1:00 PM East Coast USA Time
Lunch Session: A Dialogue With the VA
Location: Room 25AB
11:45 AM – 1:00 PM East Coast USA Time
Meet the Author Lunch and Book Signing
11:45 AM – 1:00 PM East Coast USA Time
Research Ethics Discussion Luncheon : Fighting Health Myths with Stories, Art, and Fun
Location: Ballroom 20A
11:45 AM – 1:00 PM East Coast USA Time
Networking Lunch Supported by CITI Program, a division of BRANY
11:45 AM – 1:00 PM East Coast USA Time
Networking Lunch Supported by CITI Program, a division of BRANY
Location: Exhibit Hall FG
12:15 PM – 12:35 PM East Coast USA Time
Overview of the CIP Exam
12:15 PM – 12:35 PM East Coast USA Time
Overview of the CIP Exam
Location: Exhibit Hall FG
12:30 PM – 1:00 PM East Coast USA Time
Federal Agency/Accrediting Body Office Hours
12:30 PM – 1:00 PM East Coast USA Time
Federal Agency/Accrediting Body Office Hours
Location: Exhibit Hall FG
12:30 PM – 1:00 PM East Coast USA Time
Meet and Greet With the AER18 Supporters and Exhibitors
12:30 PM – 1:00 PM East Coast USA Time
Meet and Greet With the AER18 Supporters and Exhibitors
Location: Exhibit Hall FG
12:40 PM – 1:00 PM East Coast USA Time
eConsent: Modernize Your Consent Process—Don’t Change It
12:40 PM – 1:00 PM East Coast USA Time
eConsent: Modernize Your Consent Process—Don’t Change It
Location: Exhibit Hall FG
1:15 PM – 2:30 PM East Coast USA Time
Breakout Session Series A
1:15 PM – 2:30 PM East Coast USA Time
A01 - A Dialogue With OHRP
Location: Room 28ABC
A Dialogue With the Feds Track
1:15 PM – 2:30 PM East Coast USA Time
A02 - Does Diversity Matter in the Conduct of a Clinical Trial?
Location: Room 23C
Hot Topics Track
1:15 PM – 2:30 PM East Coast USA Time
A03 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 29B
Boundaries and Balances Track
1:15 PM – 2:30 PM East Coast USA Time
A04 - Stories Matter: The Use of Narrative in IRB Member Education
Location: Room 25C
Educating and Training Track
1:15 PM – 2:30 PM East Coast USA Time
A05 - Empirical Research on Ethical Issues in Patient Centered Outcomes Research (PCOR): New Data to Inform Deliberations
Location: Room 22
Empirical Research Ethics Track
1:15 PM – 2:30 PM East Coast USA Time
A06 - Demystifying FDA 21 CFR Part 11
Location: Room 31C
FDA Regulations Track
1:15 PM – 2:30 PM East Coast USA Time
A07 - Different Models of Review: A Global Comparison
Location: Room 23A
Global Research Track
1:15 PM – 2:30 PM East Coast USA Time
A08 - The Certified IRB Professional (CIP®) Credential: How Do I Get Started?
Location: Room 29C
Hot Topics Track
1:15 PM – 2:30 PM East Coast USA Time
A09 - Not Less Work, But Different: Re-Engineering for Single IRB Review
Location: Room 33AB
Institutional Officials and HRPP Leadership Track
1:15 PM – 2:30 PM East Coast USA Time
A10 - Back to Basics: Does My Project Fall Within the Scope of the Revised Common Rule?
Location: Room 28DE
IRB 101 Track
1:15 PM – 2:30 PM East Coast USA Time
A11 - Meeting Management for IRB Chairs
Location: Room 29A
IRB Chairs Track
1:15 PM – 2:30 PM East Coast USA Time
A12 - It’s Not as New as You Think: Understanding How to Operationalize the Revised Common Rule
Location: Room 30AB
IRB Operations Advanced Track
1:15 PM – 2:30 PM East Coast USA Time
A13 - ClinicalTrials.gov: How Academic Institutions Can Respond to New Clinical Trial Disclosure Requirements
Location: Room 31A
Pharma/Biotech Perspectives Track
1:15 PM – 2:30 PM East Coast USA Time
A14 - Legal and regulatory changes: A Year in Review
Location: Room 30D
Legal Track
1:15 PM – 2:30 PM East Coast USA Time
A15 - Defining Roles & Expectations for the Non-Scientist and Non-Affiliated IRB Member: Deconstructing Regulatory and Research Terminology
Location: Room 27B
Non-Scientist IRB Members Track
1:15 PM – 2:30 PM East Coast USA Time
A16 - Implementing NIH’s Genomic Data Sharing Policy: Challenges and Solutions
Location: Room 25AB
Research Involving Data and Biospecimens Track
1:15 PM – 2:30 PM East Coast USA Time
A17 - Vulnerability Explored: Concepts and Applications
B18 - Ideas and Practices for Compliance and Auditing of Single IRB Studies
Location: Room 31A
QA/QI and Post-Approval Monitoring Track
3:00 PM – 4:15 PM East Coast USA Time
B19 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 28DE
Research Conducted in the Digital World Track
3:00 PM – 4:15 PM East Coast USA Time
B20 - Case Studies in Research Misconduct
Location: Room 29C
Responsible Conduct of Research Track
3:00 PM – 4:15 PM East Coast USA Time
B21 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 24C
Small Research Programs Track
3:00 PM – 4:15 PM East Coast USA Time
B22 - College Students and Research: Challenges and Issues for IRBs
Location: Room 29A
SBER Track
3:00 PM – 4:15 PM East Coast USA Time
B23 - Assessing and Mitigating Risk in SBER Research: A Case Study Approach
Location: Room 24B
SBER Track
4:15 PM – 5:30 PM East Coast USA Time
AER18 Welcome Reception
4:15 PM – 5:30 PM East Coast USA Time
AER18 Welcome Reception
Location: Exhibit Hall FG
4:45 PM – 5:05 PM East Coast USA Time
Forte eReg: Ensure Compliance and Streamline Your Regulatory Processes
4:45 PM – 5:05 PM East Coast USA Time
Forte eReg: Ensure Compliance and Streamline Your Regulatory Processes
5:45 PM – 7:15 PM East Coast USA Time
Young Professionals Networking Reception
5:45 PM – 7:15 PM East Coast USA Time
Young Professionals Networking Reception
Friday, November 16, 2018
7:00 AM – 5:00 PM East Coast USA Time
On-Site Check-In
7:00 AM – 5:00 PM East Coast USA Time
On-Site Check-In
Location: Exhibit Hall FG Foyer
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
Location: Exhibit Hall H
8:00 AM – 8:30 AM East Coast USA Time
Welcome and Award Presentations
8:00 AM – 8:30 AM East Coast USA Time
Welcome and Award Presentations
Location: Exhibit Hall H
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
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
D19 - Social Media in Research: Recruitment, Subject Communication, and Data Source
Location: Ballroom 20A
Research Conducted in the Digital World Track
3:30 PM – 4:45 PM East Coast USA Time
D20 - Agents and Rogues: The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 29C
Responsible Conduct of Research Track
3:30 PM – 4:45 PM East Coast USA Time
D21 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 23C
Small Research Programs Track
3:30 PM – 4:45 PM East Coast USA Time
D22 - Clinical Trials in the SBER Context
Location: Room 25C
SBER Track
3:30 PM – 4:45 PM East Coast USA Time
D23 - Navigating Uncertainty: Research With Undocumented/Unauthorized Immigrants
Location: Room 30E
SBER Track
4:45 PM – 6:00 PM East Coast USA Time
Federal Agency Office Hours
4:45 PM – 6:00 PM East Coast USA Time
Federal Agency/Accrediting Body Office Hours
Location: Exhibit Hall FG
4:45 PM – 6:00 PM East Coast USA Time
Meet the AER18 Poster Authors
4:45 PM – 6:00 PM East Coast USA Time
Meet the AER18 Poster Authors
Location: Exhibit Hall FG
4:45 PM – 6:00 PM East Coast USA Time
Networking Reception With the Supporters and Exhibiters
4:45 PM – 6:00 PM East Coast USA Time
Networking Reception With the Supporters and Exhibiters
Location: Exhibit Hall FG
4:50 PM – 5:15 PM East Coast USA Time
Simplifying Research Compliance With Cayuse IRB
4:50 PM – 5:15 PM East Coast USA Time
Simplifying Research Compliance With Cayuse IRB
Location: Exhibit Hall FG
Saturday, November 17, 2018
7:00 AM – 12:30 PM East Coast USA Time
On-Site Check-In
7:00 AM – 12:30 PM East Coast USA Time
On-Site Check-In
Location: Exhibit Hall FG Foyer
8:00 AM – 8:30 AM East Coast USA Time
Welcome and PRIM&R Membership and CIP Updates
8:00 AM – 8:30 AM East Coast USA Time
Welcome and PRIM&R Membership and CIP® Updates
Location: Exhibit Hall H
8:30 AM – 9:30 AM East Coast USA Time
Keynote Address by Vickie M. Mays, PhD, MSPH
8:30 AM – 9:30 AM East Coast USA Time
Keynote Address by Vickie M. Mays, PhD, MSPH
Location: Exhibit Hall H
9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With Supporters and Exhibitors
9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With Supporters and Exhibitors
Location: Exhibit Hall FG
10:00 AM – 11:15 AM East Coast USA Time
Concurrent Plenary Sessions
10:00 AM – 11:15 AM East Coast USA Time
Panel VIII: Big Data: Who's Minding the Store?
Location: Exhibit Hall H
10:00 AM – 11:15 AM East Coast USA Time
Panel IX: Is a Misconception Always a Misconception?
Location: Ballroom 20D
10:00 AM – 11:15 AM East Coast USA Time
Panel VII: IRB Decision-Making From a Behavioral Economics Perspective
Location: Ballroom 20BC
11:30 AM – 12:45 PM East Coast USA Time
Breakout Session Series E
11:30 AM – 12:45 PM East Coast USA Time
E01 - A Dialogue With AAHRPP, Inc.
Location: Room 29B
A Dialogue With the Feds Track
11:30 AM – 12:45 PM East Coast USA Time
E02 - Two Offices Divided by a Common Goal: Conflict of Interest (COI) and IRB
Location: Room 22
Institutional Officials and HRPP Leadership Track
11:30 AM – 12:45 PM East Coast USA Time
E03 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 30AB
Boundaries and Balances Track
11:30 AM – 12:45 PM East Coast USA Time
E04 - Building Bridges Through IRB Education Outreach
Location: Room 31A
Educating and Training Track
11:30 AM – 12:45 PM East Coast USA Time
E05 - Correcting and Avoiding Noncompliance: Examining Real-life Cases
Location: Room 32AB
QA/QI and Post-Approval Monitoring Track
11:30 AM – 12:45 PM East Coast USA Time
E06 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 29A
FDA Regulations Track
11:30 AM – 12:45 PM East Coast USA Time
E07 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures: Challenges, Cultural Considerations, Collaborations, and Experiences
Location: Room 30D
Global Research Track
11:30 AM – 12:45 PM East Coast USA Time
E08 - User Agreements in Human Subjects Research During the Burgeoning Technology Age
Location: Room 25AB
Research Conducted in the Digital World Track
11:30 AM – 12:45 PM East Coast USA Time
E09 - Ethical and Operational Issues Related to Clinical Trial Billing: What HRPPs and IRBs Should Consider
Location: Room 25C
Institutional Officials and HRPP Leadership Track
11:30 AM – 12:45 PM East Coast USA Time
E10 - IRB Review of Informed Consent: Moving Beyond the Form
Location: Room 33AB
IRB 101 Track
11:30 AM – 12:45 PM East Coast USA Time
E11 - The Role of the IRB Chair in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 28DE
IRB Chairs Track
11:30 AM – 12:45 PM East Coast USA Time
E12 - Overlapping Roles of Data Safety Monitoring Boards (DSMBs) and IRBs in the Protection of Human Subjects
Location: Room 30C
IRB Operations Advanced Track
11:30 AM – 12:45 PM East Coast USA Time
E13 - Designing and Implementing Expanded Access Programs
Location: Room 31C
Pharma/Biotech Perspectives Track
11:30 AM – 12:45 PM East Coast USA Time
E14 - From Shield to Sword? How the 21st Century Cures Act and NIH Policy Have Altered Certificates of Confidentiality (CoCs)
Location: Room 24AB
Legal Track
11:30 AM – 12:45 PM East Coast USA Time
E15 - Considerations and Strategies for Maximizing Contributions and Promoting Effective Communication for Non-Scientist and Unaffiliated IRB Members
Location: Room 24C
Non-Scientist IRB Members Track
11:30 AM – 12:45 PM East Coast USA Time
E16 - Building a Better Biobank: Promise and Challenges of the National Cancer Institute Cancer Moonshot Biobank
Location: Room 29C
Research Involving Data and Biospecimens Track
11:30 AM – 12:45 PM East Coast USA Time
E17 - Tribal Research Futures: Resources to Strengthen Governance, Trust, and Culture in Research Partnerships
