Full Agenda

7:00 AM - 8:00 AM East Coast USA Time

A Capella Musical Performance

Location: Pre-Function Hall C/ Veterans Memorial Auditorium

7:00 AM - 8:00 AM East Coast USA Time

Continental Breakfast to Welcome First-Time Attendees

Location: Ballroom A

7:00 AM - 5:00 PM East Coast USA Time

On-Site Check-In Open

Location: Pre-Function Hall C

8:00 AM - 8:15 AM East Coast USA Time

Welcome from the Conference Co-Chairs

Location: Veterans Memorial Auditorium

8:15 AM - 8:40 AM East Coast USA Time

Remarks from PRIM&R’s Executive Director, Elisa A. Hurley, PhD

Location: Veterans Memorial Auditorium

8:40 AM - 9:45 AM East Coast USA Time

Keynote Address by Janine Clayton MD, Associate Director for Research on Women’s Health; Director Office of Research on Women’s Health, NIH: It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women

Location: Veterans Memorial Auditorium

9:45 AM - 10:15 AM East Coast USA Time

Beverage Break With Supporters and Exhibitors

Location: Exhibit Hall C

10:15 AM - 11:30 AM East Coast USA Time

Panel I: Diverse Representation in Clinical Trials—Why Does It Matter and How Do We Move Forward?

Location: Ballroom B

10:15 AM - 11:30 AM East Coast USA Time

Panel II: Using Social Behavioral Data to Provide Insight into Health-Related Experiences

Location: Veterans Memorial Auditorium

10:15 AM - 11:30 AM East Coast USA Time

Panel III: What to Expect When We Sequence Expecting Moms

Location: Ballroom C

11:30 AM - 12:45 PM East Coast USA Time

Meet the Author Luncheon and Book Signing: The Perils of Partnership: Industry Influence, Institutional Integrity, and Public Health

Location: Ballroom A

11:30 AM - 12:45 PM East Coast USA Time

Networking Luncheon

Location: Exhibit Hall D

11:30 AM - 12:45 PM East Coast USA Time

SBER Network Luncheon

Location: Room 200

12:15 PM - 12:35 PM East Coast USA Time

Industry Expert Theater: Overview of the CIP® Exam

Location: Exhibit Hall C

12:15 PM - 12:45 PM East Coast USA Time

Federal Agency Office Hours

Location: Exhibit Hall C

12:15 PM - 12:45 PM East Coast USA Time

Meet and Greet With Supporters and Exhibitors

Location: Exhibit Hall C

1:00 PM - 2:15 PM East Coast USA Time

A01 - The Seven Habits of Highly Effective and Flexible IRBs

Location: Room 312

Flexibility and Innovation in IRB Processes Track

1:00 PM - 2:15 PM East Coast USA Time

A02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology

Location: Room 101

Educating and Training Track

1:00 PM - 2:15 PM East Coast USA Time

A03 - Ethics and Governance in Learning Healthcare Systems

Location: Room 102

Empirical Research Ethics Track

1:00 PM - 2:15 PM East Coast USA Time

A04 - FDA Clinical Holds and 21 CFR 50 Subpart D

Location: Room 206

FDA-Regulated Research Track

1:00 PM - 2:15 PM East Coast USA Time

A05 - Going Global for the First Time—Considerations for Reviewing International Research

Location: Room 103

Global Research Track

1:00 PM - 2:15 PM East Coast USA Time

A06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement

Location: Room 310

Institutional Officials and HRPP Leadership Track

1:00 PM - 2:15 PM East Coast USA Time

A07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)

Location: Room 309

IRB Basics Track

1:00 PM - 2:15 PM East Coast USA Time

A08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?

Location: Room 300

IRB Chairs Track

1:00 PM - 2:15 PM East Coast USA Time

A10 - Management of Incidental Findings (IFs) in Pragmatic Clinical Trials (PCTs)

Location: Room 201

Pharma/Biotech Perspectives Track

1:00 PM - 2:15 PM East Coast USA Time

A11 - Legal and Regulatory Changes: A Year in Review

Location: Room 302

Legal Considerations for HRPPs Track

1:00 PM - 2:15 PM East Coast USA Time

A12 - Operationalizing Data Sharing Policies—Challenges and Solutions

Location: Room 311

Research involving Data and Biospecimens Track

1:00 PM - 2:15 PM East Coast USA Time

A13 - Research With the Vulnerable—The Basics and Beyond

Location: Room 203

Populations Requiring Additional Protections Track

1:00 PM - 2:15 PM East Coast USA Time

A14 - Staying on Top of It All—Practical Strategies for Implementing Postapproval Monitoring (PAM)

Location: Room 202

SBER Track

1:00 PM - 2:15 PM East Coast USA Time

A15 - Privacy and Security Risks in Research With Wearable Technology

Location: Room 210

Research Conducted in the Digital World Track

1:00 PM - 2:15 PM East Coast USA Time

A16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections

Location: Room 204

Responsible Conduct of Research Track

1:00 PM - 2:15 PM East Coast USA Time

A17 - Challenges and Opportunities for Institutions With Small Research Programs

Location: Room 107

Small Research Programs Track

1:00 PM - 2:15 PM East Coast USA Time

A18 - Certificates of Confidentiality (CoCs)

Location: Room 111

SBER Track

1:00 PM - 2:15 PM East Coast USA Time

A19 - Fundamental Issues in Qualitative Research

Location: Room 306

SBER Track

1:00 PM - 2:15 PM East Coast USA Time

A20 - Two Hats, One Head—When IRB Members Are Also Investigators

Location: Room 109

Educating and Training Track

1:00 PM - 2:15 PM East Coast USA Time

A21 - An Introduction to the FDA and Their Regulations for the Non-Scientist IRB Member

Location: Room 108

FDA-Regulated Research Track

1:00 PM - 2:15 PM East Coast USA Time

A22 - From Non-Exempt to Exempt and Back Again—Navigating Exemption 2iii

Location: Room 104

IRB Operations Advanced Track

1:00 PM - 2:15 PM East Coast USA Time

A23 - Making Limited Review Work Without Reinventing the Wheel

Location: Room 313

IRB Operations Advanced Track

1:00 PM - 2:15 PM East Coast USA Time

A9 - The Etiquette and Necessity of Communication in the Single IRB World

Location: Room 304

IRB Operations Advanced Track

2:15 PM - 2:45 PM East Coast USA Time

Beverage Break With the Supporters and Exhibitors

Location: Exhibit Hall C