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

Networking Breakfast

Location: Exhibit Halls C and D

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

On-Site Check-In Open

Location: Pre-Function Hall C

7:15 AM - 7:35 AM East Coast USA Time

Industry Expert Theater: AER19 Poster Presentation—Accelerating Clinical Coordinator Excellence (ACCE): Building for Excellence, Success and Empowerment

Location: Exhibit Hall C

7:40 AM - 8:00 AM East Coast USA Time

Industry Expert Theater: SkyiRIS Research Network for the NIH Single IRB of Use

Location: Exhibit Hall C

8:00 AM - 8:05 AM East Coast USA Time

Welcome from the Conference Co-Chairs

Location: Veterans Memorial Auditorium

8:05 AM - 8:10 AM East Coast USA Time

Presentation of PRIM&R’s Distinguished Service Award to Robert S. Bienkowski, PhD, Central Michigan University

Location: Veterans Memorial Auditorium

8:10 AM - 8:15 AM East Coast USA Time

Presentation of PRIM&R’s Applied Research Ethics National Association Legacy Award to Susan Z. Kornetsky, MPH, Boston Children's Hospital

Location: Veterans Memorial Auditorium

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

Remarks from PRIM&R’s Board of Directors Chair, Heather H. Pierce, JD, MPH

Location: Veterans Memorial Auditorium

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

Keynote Address by Scott D. Halpern, MD, PhD, Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy, University of Pennsylvania: Financial Incentives and Nudges for Research Participation—Undue, Unjust, or Uncertain?

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

C03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule

Location: Ballroom A

Research involving Data and Biospecimens Track

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

C04 - Bioresearch Monitoring (BIMO) Inspections—Regulatory Violations Observed in IRB and Clinical Investigator Inspections

Location: Room 101

FDA-Regulated Research Track

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

C05 - European Union (EU) General Data Protection Regulation (GDPR)

Location: Room 302

Global Research Track

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

C06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review

Location: Room 210

Institutional Officials and HRPP Leadership Track

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

C10 - A Case-Based Assessment of Post-Trial Access to Investigational Medicines

Location: Room 107

Pharma/Biotech Perspectives Track

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

C12 - Considerations for Return of Results and Incidental Findings

Location: Room 102

Research involving Data and Biospecimens Track

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

C14 - Nuts and Bolts of Investigator Site Audits

Location: Room 202

QA/QI and Postapproval Monitoring Track

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

C15 - Social Media in Research—Recruitment, Subject Communication, and Data Source

Location: Ballroom C

Research Conducted in the Digital World Track

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

C16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices

Location: Room 300

Responsible Conduct of Research Track

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

C17 - How to Maintain Institutional Memory at a Small Research Program

Location: Room 201

Small Research Programs Track

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

C18 - Reaching the Masses—Ideas for Researcher Education

Location: Room 204

SBER Track

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

C19 - Risk Mitigation in Mixed SBER and Biomedical Research

Location: Room 104

Advanced Track (SBER)

10:15 AM - 12:45 PM East Coast USA Time

C01 - HRPP Innovation Showcase—Creative Approaches to IRB Challenges

Location: Room 203

Flexibility and Innovation in IRB Processes Track

10:15 AM - 12:45 PM East Coast USA Time

C02 - I Love My Job!? Perspectives Throughout a Career in Human Research Protections

Location: Room 312

Educating and Training Track

10:15 AM - 12:45 PM East Coast USA Time

C07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review

Location: Room 304

IRB Basics Track

10:15 AM - 12:45 PM East Coast USA Time

C08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs

Location: Room 200

IRB Chairs Track

10:15 AM - 12:45 PM East Coast USA Time

C09 - Creative Solutions for Serving as a Reviewing IRB

Location: Room 306

IRB Operations Advanced Track

10:15 AM - 12:45 PM East Coast USA Time

C11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design

Location: Room 103

Legal Considerations for HRPPs Track

10:15 AM - 12:45 PM East Coast USA Time

C13 - IRB Review of Research With Children

Location: Room 309

Populations Requiring Additional Protections Track

10:15 AM - 12:45 PM East Coast USA Time

C20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches

Location: Room 311

IRB Operations Advanced Track

10:15 AM - 12:45 PM East Coast USA Time

C21 - A Look into the Crystal Ball—The HRPP of the Future

Location: Room 310

Institutional Officials and HRPP Leadership Track

10:15 AM - 12:45 PM East Coast USA Time

C22 - Scientific Aspects of Study Design—A Primer for Non-Scientists

Location: Room 108

Educating and Training Track

10:15 AM - 12:45 PM East Coast USA Time

C23 - Exempt Human Subjects Research Case Studies— Implementing Changes to the Exemption Categories Under the Revised Common Rule

Location: Room 206

IRB Operations Advanced Track

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

Break

11:45 AM - 12:05 PM East Coast USA Time

Industry Expert Theater: AER19 Poster Presentation—IRB Members' Assessment of Minimal Risk Procedures in Pregnancy

Location: Exhibit Hall C

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

A Dialogue With AAHRPP, Inc.

Location: Room 202

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

A Dialogue With DHHS Office for Civil Rights (OCR)

Location: Room 107

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

A Dialogue with DoD

Location: Room 313

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

A Dialogue With DOE

Location: Room 204

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

A Dialogue With FDA

Location: Ballroom C

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

A Dialogue with NIH

Location: Room 101

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

A Dialogue With OHRP

Location: Ballroom B

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

A Dialogue With ORI

Location: Room 109

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

A Dialogue With Patient Centered Outcomes Research Institute (PCORI)

Location: Room 111

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

A Dialogue With SACHRP

Location: Room 201

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

A Dialogue With the VA

Location: Room 302

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

Meet and Greet With the Supporters and Exhibitors, View the AER19 Posters

Location: Exhibit Hall C

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

PRIM&R’s Guide to Speaking at the AER Conference

Location: Room 300

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

The Certified IRB Professional (CIP®) Credential—How Do I Get Started?

Location: Room 102

12:10 PM - 12:30 PM East Coast USA Time

Industry Expert Theater: AER19 Poster Presentation—What Ethical Challenges Do Pragmatic Trials Pose for the Oversight of Human Subjects Research? An Interview Study With Key Stakeholders

Location: Exhibit Hall C

12:45 PM - 1:45 PM East Coast USA Time

Attendee Open Lunch Period

2:00 PM - 3:15 PM East Coast USA Time

Panel IV: Identifying and Avoiding the Conduct of Low Value Clinical Trials

Location: Ballroom B

2:00 PM - 3:15 PM East Coast USA Time

Panel V: Bioethics Turns 50—Reflections from The Hastings Center

Location: Ballroom C

2:00 PM - 3:15 PM East Coast USA Time

Panel VI: Studying Suicide and Subjects at Risk for Suicide—Identifying and Minimizing Risk to Promote Necessary Research

Location: Veterans Memorial Auditorium

3:15 PM - 3:45 PM East Coast USA Time

Beverage Break With the Supporters and Exhibitors

Location: Exhibit Hall C