Icon Legend

This session is not in your schedule.

This session is in your schedule. Click again to remove it.

Presentation Icons

Pre-Reg Required

CSP Icon

Livestreaming Session Icon

On-Demand Session

CIP Accredited

Additional Fee

CPIA Icon

Human Subjects Research

IACUC/Animal Care and Use

Crossover

Institutional Leadership

Deep Dive Series

Networking Series

Workshop Series

Vendor Insight Series

Thought Leader Series

Pillars Icon

Poster Icons

Record Session Icon

Pre-Reg Required

New for 2020

Part I/II

CSP Icon

Livestreaming Session Icon

Prerecorded Session Icon

CIP Accredited

Pillars Icon

Browse by HSR Content

Conference recordings were available for 90 days after the conclusion of the conference (March 15, 2023). Recordings access is no longer available. PRIM&R members will have access to the PRIMR22 recordings one year after the meeting date (December 12, 2023). To purchase recordings, visit: https://www.pathlms.com/primr/courses/48273.

To access your transcript/certificate, click on the Evaluations tile below and evaluate the sessions you attended.

Browse by HSR Content

Type here to filter the list

Tuesday, Dec 6th
10:00 AM – 1:00 PM ET
Introduction to the IRB: Ethics and Regulation
Location: On-Demand
Presenter: Ada Sue Selwitz, MA – University of Kentucky
Presenter: David H. Strauss, MD – Columbia University
Tuesday, Dec 6th
10:00 AM – 1:00 PM ET
Quality Assurance/Quality Improvement (QA/QI) in Human Subjects Research
Location: Livestreamed
Speaker: Leslie M. Howes, MPH, CIP (she/her/hers) – Harvard T.H. Chan School of Public Health
Speaker: Neala J. Lane, MS, CCRC (she/her/hers) – Indiana University
Tuesday, Dec 6th
1:00 PM – 2:30 PM ET
CIP Office Hours
Location: Livestreamed
Tuesday, Dec 6th
2:30 PM – 5:30 PM ET
Applying the FDA Framework in Conducting IRB Review
Location: Livestreamed
Speaker: Ann Meeker-O'Connell, MS (she/her/hers) – FDA
Speaker: Ada Sue Selwitz, MA – University of Kentucky
Speaker: Belinda M. Smith, MS, RD, CCRC – University of Kentuckky
Thursday, Dec 8th
10:00 AM – 1:00 PM ET
Exploring Hot Topics in Social, Behavioral, and Educational Research (SBER)
Location: Livestreamed
Speaker: Beth Irwin, MA, CIP (she/her/hers) – Northwestern University
Speaker: Casey Mumaw, MA, CIP (he/him/his) – Indiana University
Thursday, Dec 8th
2:30 PM – 5:30 PM ET
The IRB and Diversity, Equity, Inclusion, and Justice (DEIJ): Lead? Follow? Or Get Out of the Way? Exploring the Role of the IRB in DEIJ Efforts
Location: Livestreamed
Speaker: Martha Jones, MA, CIP (she/her/hers) – Mass General Brigham
Speaker: Susan Z. Kornetsky, MPH – Boston Children's Hospital
Speaker: Tina Young Poussaint, MD, FACR (she/her/hers) – Boston Children's Hospital
Speaker: Ivy Tillman, MS, CCRC, CIP – Mayo Clinic
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A01 - Bringing the IRB to the People, and the People to the IRB
Location: Livestreamed
Resource Person: Zena Alhija – Department of Health and Human Services, Office for Human Research Protections
Speaker: Emily E. Anderson, PhD, MPH – Neiswanger Institute for Bioethics, Loyola University Chicago
Speaker: Stuart G. Nicholls, PhD (he/him/his) – Clinical Epidemiology Program, Ottawa Hospital Research Institute
Speaker: Ivy Tillman, MS, CCRC, CIP – Mayo Clinic
Advancing Equity and Justice in ResearchCommunication With the PublicFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessIRB Chairs
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A02 - Ethical Considerations in Studies Involving Usual Care Arms
Location: Livestreamed
Speaker: Neal W. Dickert, MD, PhD (he/him/his) – Emory University School of Medicine, Division of Cardiology
Speaker: Todd W. Rice, MD – Vanderbilt University Medical Center
Speaker: Robert Silbergleit, MD – University of Michigan
Resource Person: Ivor A. Pritchard, PhD – OHRP
Emerging Challenges and Breaking Issues
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A03 - Incorporating Investigator Education into Postapproval Compliance Activities
Location: Livestreamed
Speaker: Lindsey Byrd – University of Utah
Speaker: Sana Khoury-Shakour, PhD (she/her/hers) – University of Michigan
Speaker: Maggie Leathers, MS, CCRP – Johns Hopkins University School of Medicine
QA/QI and Postapproval MonitoringEducation, Qualifications, and TrainingFlexibility and Innovation in Research Oversight Processes
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A04 - Categorical Conundrum: What Is the Tipping Point for Non-Exempt SBER Needing Convened Review
Location: Livestreamed
Speaker: Andrea R. McDowell, PhD (she/her/hers) – Seattle University
Speaker: Casey Pellien, CIP (she/her/hers) – University of Wisconsin—Madison
Social, Behavioral, and Educational Research
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A05 - A Case Study Exploring the Ethical Considerations for Pediatric Clinical Trials
Location: Livestreamed
Speaker: Albert J. Allen, MD, PhD (he/him/his) – Pediatric Drug Development, Safety and Bioethics
Speaker: Elizabeth L. Durmowicz, MD (she/her/hers) – Food and Drug Administration
Speaker: Susan Z. Kornetsky, MPH – Boston Children's Hospital
Speaker: Donna L. Snyder, MD, MBE – Food and Drug Administration
Populations Requiring Additional ProtectionsAdvancing Equity and Justice in Research
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A11 - A Dialogue With the Department of Veterans Affairs (VA): A Federal Agency’s Challenges and Solutions in Working with External IRBs to Facilitate Implementation of the Cooperative Research Provisions
Location: On-Demand
Presenter: Kristina C. Borror, PhD – Veterans Health Administration
Presenter: Elizabeth Clark A. Clark, RN (she/her/hers) – Department of Veterans Affairs
Presenter: Charlotte K. Jeans, PhD, CCRN, CIP – Department of Veterans Affairs
Presenter: Don Workman, PhD – Department of Veterans Affairs
A Dialogue With the Feds
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A12 - Navigating Data and Specimen Sharing for Transnational Research
Location: On-Demand
Presenter: David Curry
Presenter: Rita Lawlor – International Society for Biological and Environmental Repositories
Presenter: Carol Juliet Weil, JD (she/her/hers) – none
Transnational Research CollaborationsResearch Involving Data and Biospecimens
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A13 - When Employees Are Research Participants: Ethical Considerations and Perspectives of Academia, Government, and Private Industry
Location: On-Demand
Presenter: Tiffany Gommel, MS, CIP (she/her/hers) – National Institutes of Health
Presenter: Susan B. Watson, PhD – Eli Lilly and Company
Presenter: Megan Kasimatis Singleton, JD, MBE, CIP – Office of Human Subjects Research Johns Hopkins University School of Medicine
Emerging Challenges and Breaking IssuesPharma/Biotech PerspectivesPopulations Requiring Additional Protections
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A14 - FDA and the Center for Biologics Evaluation and Research's (CBER) Regulation of Biological Products, Including Regenerative Medicine Therapies
Location: On-Demand
Presenter: David G. Forster, JD, MA, CIP – WIRB-Copernicus Group
Presenter: Melissa Mendoza – US Food and Drug Administration
FDA Regulated Research
Monday, Dec 12th
11:45 AM – 12:45 PM ET
A15 - Inspiring Innovation: The Seven Habits of Highly Effective and Flexible HRPPs
Location: On-Demand
Presenter: Debra A. Dykhuis, CIP – University of Minnesota
Presenter: Kenia F. Viamonte, MA – University of Miami
Presenter: Nicole Vouvalis, J.D. (she/her/hers) – Utah State University
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
Monday, Dec 12th
12:45 PM – 1:15 PM ET
CIP Office Hours
Location: Livestreamed
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B01 - May I Borrow a Tissue? Secondary Use of Biological Samples
Location: Livestreamed
Speaker: Subahshini Chandrasekharan, PhD – National Institutes of Health
Speaker: Debra JH Mathews, PhD, MA – Johns Hopkins University Berman Institute of Bioethics
Speaker: Gretchen Parker, PhD, RAC, CIP (she/her/hers) – Pearl IRB
Pharma/Biotech PerspectivesResearch Involving Data and Biospecimens
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B02 - Recruiting, Training, and Retaining IRB Chairs
Location: Livestreamed
Speaker: Tracy Fawns, DNP, MSN.Ed, RN, CNE – Utah Tech University
Speaker: Lydia Furman, MD (she/her/hers) – UHCMC Rainbow Babies and Children's Hospital
IRB Chairs
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B03 - "Perfect" Study Submissions: Approaches to Improving IRB Submissions for a Better Review Process
Location: Livestreamed
Speaker: Rebecca M. Fasano, BS, CIP – Augusta University
Speaker: Ann Hardy, DrPH, CIP (she/her/hers) – Learn eCORE, LLC
Speaker: Petrice B. Longenecker, PhD, CIP – Uniformed Services University of the Health Sciences
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesEducation, Qualifications, and Training
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B04 - Beyond Subpart C: Understanding Prisoner Vulnerability, the Role of Prisoner Representatives, and Best Practices for Just and Comprehensive IRB Review
Location: Livestreamed
Speaker: Karen Reece, PhD – Nehemiah Community Development Corporation
Speaker: Marc Stern, MD, MPH – University of Washington
Speaker: Elizabeth K. Victor, PhD, MSM (she/her/hers) – William Paterson University
Resource Person: Julia G. Gorey, JD (she/her/hers) – OHRP
Populations Requiring Additional ProtectionsAdvancing Equity and Justice in Research
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B11 - An Update From AAHRPP
Location: On-Demand
Presenter: Nichelle Cobb, PhD (she/her/hers) – AAHRPP
Presenter: Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.
Presenter: Robert Hood, PhD (he/him/his) – AAHRPP, Inc.
Presenter: Lori Kravchick, BA (she/her/hers) – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
Presenter: Elyse I. Summers, JD – Association for the Accreditation of Human Research Protection Programs, Inc.
Presenter: Jemelle Williams – AAHRPP
A Dialogue With the Feds
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B12 - International Data Privacy Regulations: An Overview of the Regulatory Landscape and Tools for Implementing a Review Process
Location: On-Demand
Presenter: Leslie M. Howes, MPH, CIP (she/her/hers) – Harvard T.H. Chan School of Public Health
Presenter: Emmelyn Kim, MA, MPH, MJ, CHRC (she/her/hers) – Northwell Health, The Feinstein Institutes for Medical Research
Presenter: Julie Moore, J.D., M.S. PA, CIP (she/her/hers) – Advarra, Institutional Research Center of Excellence
Legal Considerations in Research OversightResearch Involving Data and Biospecimens
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B13 - Apparently, Looks Do Matter: Visualizing IRB Data Differently
Location: On-Demand
Presenter: Marilyn Eshikena, MS, CIP (she/her/hers) – Icahn School of Medicine at Mount Sinai
Presenter: Lori Jennex, MA, CIP (she/her/hers) – Icahn School of Medicine at Mount Sinai
Presenter: Rachel Lally, MPH, CIP (she/her/hers) – The Pennsylvania State University
Presenter: Suzanne Caruso (she/her/hers) – WCG Clinical
HRPP/IRB Administration/Management and ProcessEducation, Qualifications, and Training
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B14 - How to Evaluate Terms of Service and Privacy Policies of Mobile Technologies
Location: On-Demand
Presenter: Luke Gelinas, PhD – Advarra
Presenter: David Peloquin, JD (he/him/his) – Ropes & Gray
Research Conducted in the Digital WorldLegal Considerations in Research Oversight
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B15 - Continuing Review as a QA/QI Opportunity
Location: On-Demand
Presenter: Jodi L. Mathieu, BS, CIP – The Pennsylvania State University
Presenter: Andrew Hedrick, MPA, CIP – The Ohio State University
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight Processes
Monday, Dec 12th
1:30 PM – 2:30 PM ET
B16 - Conducting Ethical Transnational Research in Times of Conflict
Location: On-Demand
Presenter: Dushyantha Jayaweera, MD, FACP – University of Miami
Transnational Research Collaborations
Monday, Dec 12th
2:30 PM – 3:30 PM ET
FDA Office Hours
Location: Livestreamed
Monday, Dec 12th
2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office Hours
Location: Livestreamed
Monday, Dec 12th
3:00 PM – 4:00 PM ET
CIP Office Hours
Location: Livestreamed
Monday, Dec 12th
3:30 PM – 4:30 PM ET
OHRP Office Hours
Location: Livestreamed
Monday, Dec 12th
3:00 PM – 4:00 PM ET
HRPP/IRB Management 101: Real-World Discussions Regarding How to Effectively Run a HRPP/IRB Office
Location: Livestreamed
Speaker: Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I (she/her/hers) – Yale University
Speaker: Nathalia Henry Whitely, MS, CHRC, CIP – Northwestern University
Speaker: Megan Kasimatis Singleton, JD, MBE, CIP – Office of Human Subjects Research Johns Hopkins University School of Medicine
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
Monday, Dec 12th
3:00 PM – 4:00 PM ET
A New Hope: IRB Jedi Unite—Exploring Regulations, Guidance, and Institutional Polices
Location: Livestreamed
Speaker: Tonya Ferraro, MEd (she/her/hers) – Boston Children's Hospital
Speaker: Andrew Hedrick, MPA, CIP – The Ohio State University
Speaker: Paul Lees – OHRP
Speaker: Kimberley Serpico, EdD, CIP – Harvard T.H. Chan School of Public Health
IRB BasicsFlexibility and Innovation in Research Oversight Processes
Tuesday, Dec 13th
10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary I: When Research Context Changes—Politics, Legislation, the Culture Wars impact on Independent Ethics Oversight
Location: Livestreamed
Moderator: Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University
Panelist: Sean Cahill, PhD (he/him/his) – The Fenway Institute
Panelist: Leslie Francis, PhD, JD (she/her/hers) – University of Utah
Panelist: Michelle C. Stickler, DEd, CIP – The University of Texas at Austin
Advancing Equity and Justice in ResearchLegal Considerations in Research OversightEmerging Challenges and Breaking Issues
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C01 - A Dialogue With OHRP
Location: Livestreamed
Speaker: Julie Kaneshiro, MA – Office for Human Research Protections
Speaker: Crystal Kelly, MPH (she/her/hers) – Office for Human Research Protections (OHRP)
Speaker: Natalie M. Klein, PhD, CIP (she/her/hers) – DHHS Office for Human Research Protections
Speaker: Yvonne Lau, MBBS, MBHL, PhD (she/her/hers) – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
A Dialogue With the Feds
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C02 - Building Your Toolbox: Strategies for Educating and Training Adult Learners
Location: Livestreamed
Presenter: Nichelle Cobb, PhD (she/her/hers) – AAHRPP
Presenter: Nancy A. Olson, JD – University of Nebraska Medical Center
Presenter: Scott Rule, MAT – PRIM&R
Education, Qualifications, and Training
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C03 - Investigational Device Exemptions (IDE) and Bioresearch Monitoring (BIMO) Inspection for Medical Device Clinical Investigations
Location: Livestreamed
Speaker: Cynthia E. Bushee, RN, BSN – US Food and Drug Administration
Speaker: Daniel Ramsey, M.S. – US Food and Drug Administration
FDA Regulated Research
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C04 - The Workplace Shift: New Realities, Future Uncertainty, and Meeting Staff Needs in a Post-Pandemic World
Location: Livestreamed
Speaker: Christine DeLussey, MS, CIP (she/her/hers) – Children's Hospital of Philadelphia
Speaker: Piper X. Hawkins-Green, MS, CIP (she/her/hers) – Northwestern University
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C05 - The Use of Social Media in Research: The Good, the Bad, and the Ugly
Location: Livestreamed
Speaker: Brenda L. Curtis, PhD, MSPH – National Institutes of Health
Speaker: Nalinee D. Patin, CIP (she/her/hers) – Clemson University
Social, Behavioral, and Educational ResearchResearch Conducted in the Digital WorldEmerging Challenges and Breaking Issues
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C12 - Enhancing Inclusion in a Time of Division
Location: On-Demand
Presenter: Amy Ben-Arieh, JD, MPH – The Fenway Institute
Presenter: Celia B. Fisher, PhD – Fordham University
Presenter: Meghan Blair – University of Pennsylvania, Abramson Cancer Center, Clinical Research Unit
Advancing Equity and Justice in ResearchEmerging Challenges and Breaking IssuesPopulations Requiring Additional Protections
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C13 - Bridging the Gap: Gene Therapy Research From the Perspectives of IRBs and Patient Advocates
Location: On-Demand
Presenter: Stephanie S. Cargill, PhD MSPH (she/her/hers) – Saint Louis University
Presenter: Mark E. Alexander, MD – Harvard Medical School
Presenter: Helaine Bader
Emerging Challenges and Breaking IssuesResearch Involving Data and Biospecimens
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C14 - IRB Guidance on Data-Sharing in the Social Sciences: Evidence of a Shift
Location: On-Demand
Presenter: Dessi Kirilova – Qualitative Data Repository www.qdr.org
Presenter: Diana Kapiszewski, PhD – Department of Government, Georgetown University
Presenter: Ying Zhang (she/her/hers) – Clarkson University
Social, Behavioral, and Educational ResearchHRPP/IRB Administration/Management and ProcessResearch Involving Data and Biospecimens
Tuesday, Dec 13th
11:45 AM – 12:45 PM ET
C15 - Innovations in the Oversight of Research Data
Location: On-Demand
Presenter: Jahn Barlow, MPA (he/him/his) – University of Utah
Presenter: Tamiko Eto, MS, CIP (she/her/hers) – Division of Research The Permanente Medical Group at Kaiser Permanente
Presenter: Valerie Smothers (she/her/hers) – Johns Hopkins Medicine
Flexibility and Innovation in Research Oversight ProcessesResearch Involving Data and Biospecimens
Tuesday, Dec 13th
12:45 PM – 1:15 PM ET
CIP Office Hours
Location: Livestreamed
Tuesday, Dec 13th
12:45 PM – 1:30 PM ET
Sponsored Presentation from Advarra: The Secret to Single IRB (sIRB) Reliance Success
Location: Livestreamed
Presenter: Frank Conte, MS (he/him/his) – Advarra
Presenter: Stacy West
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
Sponsored By
Tuesday, Dec 13th
1:30 PM – 2:45 PM ET
Plenary V: Progress in Defining and Evaluating HRPP/IRB Quality and Effectiveness
Location: Livestreamed
Moderator: Holly A. Taylor, PhD, MPH (she/her/hers) – National Institutes of Health
Panelist: Emily E. Anderson, PhD, MPH – Neiswanger Institute for Bioethics, Loyola University Chicago
Panelist: Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania
Panelist: Ann Johnson, PhD, MPH – University of Utah
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight ProcessesIRB ChairsQA/QI and Postapproval MonitoringResearch Oversight Leaders and Institutional Officials
Tuesday, Dec 13th
2:30 PM – 3:30 PM ET
FDA Office Hours
Location: Livestreamed
Tuesday, Dec 13th
2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office Hours
Location: Livestreamed
Tuesday, Dec 13th
3:00 PM – 4:00 PM ET
CIP Office Hours
Location: Livestreamed
Tuesday, Dec 13th
3:30 PM – 4:30 PM ET
OHRP Office Hours
Location: Livestreamed
Tuesday, Dec 13th
4:00 PM – 5:00 PM ET
Department of Energy Office Hours
Location: Livestreamed
Tuesday, Dec 13th
3:00 PM – 4:00 PM ET
Insights into Key Recommendations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP)
Location: Livestreamed
Speaker: Mark Barnes, JD, LLM – Ropes & Gray Law Firm
Speaker: David A. Borasky, Jr., MPH, CIP – WCG
Speaker: Douglas Diekema, MD, MPH (he/him/his) – University of Washington School of Medicine
A Dialogue With the Feds
Tuesday, Dec 13th
3:00 PM – 4:00 PM ET
PRIMR22 Poster Presentation Program: Outstanding Work in Human Subjects Protections
Location: Livestreamed
Moderator: Lindsay McNair, MD, MPH, MSB – WCG
Speaker: Karah Y. Greene, MSW (she/her/hers) – University of South Florida School of Social Work
Speaker: Brian S. Mittman, PhD (he/him/his) – Kaiser Permanente Department of Research and Evaluation
Speaker: Deborah Mittman, MPS – Cedars-Sinai Medical Center
Speaker: Katherine W. Todman, MSW LCSW-C (she/her/hers) – National Institute of Mental Health
Informed ConsentEducation, Qualifications, and TrainingFlexibility and Innovation in Research Oversight Processes
Sponsored By
Tuesday, Dec 13th
3:00 PM – 4:00 PM ET
SBER Network Discussion: Faculty Mentorship in Human Research Protections
Location: Livestreamed
Speaker: Cecilia Brooke Cholka, PhD, CIP (she/her/hers) – Weill Cornell Medicine
Speaker: Marc Guilford – University of South Dakota
Speaker: Darcy L. Hammar – Rocky Mountain University of Health Professions
Speaker: Christina Lehmann – Michigan Technological University
Speaker: Linda E. Mayo, BA, CIP – The University of New Mexico
Speaker: Andrea Nash, CIP – Virginia Tech
Speaker: Julie F. Simpson, PhD – University of New Hampshire
Social, Behavioral, and Educational Research
Tuesday, Dec 13th
3:00 PM – 4:00 PM ET
When You're the New Kid in Town: Taking Over as an HRPP/IRB Leader
Location: Livestreamed
Speaker: Margie Brackeen, CIP (she/her/hers) – Nationwide Children's Hospital
Speaker: Sanjur (Sandy) Brooks, DPS – Virginia Commonwealth University
Speaker: Edith Paal, MSJourn MPH CIP CHRC – UAMS Institutional Review Board
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
Presenter: Minerva Hughes, JD, PhD (she/her/hers) – Center for Devices and Radiological Health, FDA
Presenter: Diane M. Maloney, JD – Food and Drug Administration
Presenter: Ann Meeker-O'Connell, MS (she/her/hers) – FDA
Presenter: Laurie Muldowney, MD (she/her/hers) – FDA
Presenter: Kevin A. Prohaska, DO, MPH (he/him/his) – Food and Drug Administration
A Dialogue With the Feds
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D02 - Equitable Inclusion and Local Community Context in Multi-Site Research
Location: Livestreamed
Speaker: Amy Ben-Arieh, JD, MPH – The Fenway Institute
Speaker: Nadia Johnson, MS, CIP – NYU Langone Health
Advancing Equity and Justice in ResearchEmerging Challenges and Breaking IssuesHRPP/IRB Administration/Management and Process
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D03 - Communication in Minimal Risk Research Using Waiver of Consent
Location: Livestreamed
Speaker: Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Speaker: Stephanie Morain, PhD, MPH – Johns Hopkins University
Speaker: Annie Risenmay, BA, CIP, MPA (she/her/hers) – University of Utah IRB
Emerging Challenges and Breaking IssuesInformed ConsentCommunication With the Public
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D04 - When Institutional Research and Corporate Worlds Collide: The Impact of Corporate Collaborations in Data Research
Location: Livestreamed
Presenter: Jahn Barlow, MPA (he/him/his) – University of Utah
Presenter: Mary L. Gray, PhD (she/her/hers) – Microsoft Research
Presenter: Dianne Henderson, PhD (she/her/hers) – ACT, Inc.
Research Involving Data and BiospecimensEmerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesResearch Conducted in the Digital World
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D12 - Small Research Program and Your First Clinical Trial: Now What?!
Location: On-Demand
Presenter: Jyoti Angal – Avera Research Institute
Presenter: Ross A. Hickey, JD, CIP, CPIA – University of Southern Maine
Small Research ProgramsSocial, Behavioral, and Educational Research
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D13 - IRB Process Improvements: Collaborative Methods With Institutional Clinical Research Liaisons
Location: On-Demand
Presenter: Laura Pulido-Ramirez, MHA, BS, CCRC (she/her/hers) – UC Davis Health
Presenter: April M. Cuellar (she/her/hers) – University of California, Davis/Clinical and Translational Science Center (CTSC)/Clinical Trials Office
Presenter: Nicole Walters (she/her/hers) – UC Davis
Education, Qualifications, and TrainingFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D14 - When The @#&% Hits the Fan: When HRPP Noncompliance and Research Misconduct Occur Together
Location: On-Demand
Presenter: Sarah Archibald (she/her/hers) – University of Maryland, Baltimore
Presenter: Nichelle Cobb, PhD (she/her/hers) – AAHRPP
Presenter: Benjamin C. Silverman, MD (he/him/his) – Human Research Affairs, Mass General Brigham; Harvard Medical School
HRPP/IRB Administration/Management and ProcessLegal Considerations in Research Oversight
Wednesday, Dec 14th
11:45 AM – 12:45 PM ET
D15 - In the Eyes of the Consenter: The Informed Consent Process From the Perspective of People Who Obtain Consent
Location: On-Demand
Presenter: Lauren Blizzard, BS – Cincinnati Children's Hospital Medical Center
Presenter: Devan Vaughn, CIP, CCRP (she/her/hers) – Cincinnati Children's Hospital Medical Center
Presenter: Katie Hayes, MHA (she/her/hers) – Cincinnati Children's Hospital Medical Center
Informed Consent
Wednesday, Dec 14th
12:45 PM – 1:15 PM ET
CIP Office Hours
Location: Livestreamed
Wednesday, Dec 14th
12:45 PM – 1:30 PM ET
Sponsored Presentation from Huron: Improving Efficiency and Effectiveness for HRPPs and Beyond
Location: Livestreamed
Presenter: Maya Nikin – Huron Consulting Group
Presenter: Madeleine Williams, MA, CIP – Huron Consulting Group
Sponsored By
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E01 - Innovations in Recruiting Research Participants
Location: Livestreamed
Speaker: Neal W. Dickert, MD, PhD (he/him/his) – Emory University School of Medicine, Division of Cardiology
Speaker: David Magnus, PhD – Stanford University
Speaker: Kamora Wilson, MBA (she/her/hers) – Pharmaceutical Product Development (PPD)
Flexibility and Innovation in Research Oversight Processes
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E02 - Bottlenecks to Bridges: Defining and Implementing Your HRPP Vision and the Importance of HRPP Leadership
Location: Livestreamed
Speaker: Kristin J. Rochford, Ed.D,MPH, CIP – University of California Los Angeles
Speaker: Adam J. McClintock, MBA, CIP – University of Alabama at Birmingham
Speaker: Cheri M. Pettey, MA, CIP – Advarra, Inc.
HRPP/IRB Administration/Management and ProcessLeadership Skills Development
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E03 - “Do Not Take if You Are Pregnant”: Demystifying the Inclusion of Pregnant Participants in Research
Location: Livestreamed
Speaker: Anne D. Lyerly, MD, MA (she/her/hers) – University of North Carolina at Chapel Hill
Speaker: Miranda R. Waggoner, PhD (she/her/hers) – Florida State University
Populations Requiring Additional Protections
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E04 - Equity Beyond Selection: Applying Principles of Justice After Recruitment
Location: Livestreamed
Presenter: Hila F. Berger, MPH, CIP, CHC (she/her/hers) – Rutgers University
Presenter: Ivy Tillman, EdD, MS, CCRC, CIP (she/her/hers) – PRIM&R
Social, Behavioral, and Educational ResearchAdvancing Equity and Justice in Research
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E05 - Training IRBs for the Review of Transnational Research
Location: Livestreamed
Speaker: Jody L. Ference, MS, CIP, CCRA, CIM (she/her/hers) – Walter Reed Army Institue for Research
Speaker: Sharon C. Freitag, BSc – Unity Health Toronto
Speaker: Joan C. Pettit, JD, MA (she/her/hers) – Johns Hopkins Bloomberg School of Public Health
Transnational Research CollaborationsEducation, Qualifications, and Training
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E11 - An Update From DoD
Location: On-Demand
Presenter: Martha S. Alvarado, MPH, CIP (she/her/hers) – Army Human Research Protections Office (AHRPO)
Presenter: Laura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences
Presenter: Stephanie Bruce, CIP, CPIA – Department of Defense
Presenter: Jessica C. Candia, JD, CIP – Department of the Air Force
Presenter: Kimberly L. Odam, MS, CIP – US Army Medical Research and Development Command
A Dialogue With the Feds
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E12 - The Regulation and Ethics of the Return of Research Results to Human Subjects
Location: On-Demand
Presenter: Jason Williams – Montclair State University
Advancing Equity and Justice in ResearchResearch Involving Data and BiospecimensCommunication With the Public
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E13 - Rigor Rules! How IRBs Assess Sound Research Design
Location: On-Demand
Presenter: Ilene F. Wilets, PhD – Program for the Protection of Human Subjects
Presenter: Stephanie C. Reed, PhD, CIP (she/her/hers) – New York State Psychiatric Institute/Columbia University Irving Medical Center
IRB BasicsFlexibility and Innovation in Research Oversight Processes
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E14 - The Protection of Non-Subjects From Research Harm
Location: On-Demand
Presenter: Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I (she/her/hers) – Yale University
Presenter: Nancy M.P King, JD – Wake Forest University School of Medicine
Presenter: David H. Strauss, MD – Columbia University
Legal Considerations in Research Oversight
Wednesday, Dec 14th
1:30 PM – 2:30 PM ET
E15 - The IRB Role and Practical Tools for IRB Review of Research Proposals Involving Artificial Intelligence (AI)
Location: On-Demand
Presenter: Challace Pahlevan-Ibrekic, MBE, CIP – Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health
Presenter: Francis P. Crawley – Good Clinical Practice Alliance
Research Conducted in the Digital WorldEmerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesResearch Involving Data and Biospecimens
Wednesday, Dec 14th
2:30 PM – 3:30 PM ET
FDA Office Hours
Location: Livestreamed
Wednesday, Dec 14th
2:30 PM – 3:30 PM ET
OHRP Office Hours
Location: Livestreamed
Wednesday, Dec 14th
2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office Hours
Location: Livestreamed
Wednesday, Dec 14th
3:00 PM – 4:00 PM ET
CIP Office Hours
Location: Livestreamed
Wednesday, Dec 14th
4:00 PM – 5:00 PM ET
Department of Energy Office Hours
Location: Livestreamed
Wednesday, Dec 14th
3:00 PM – 4:00 PM ET
Everyone Is Doing it, But Are We Doing it Well? Evaluating Your Role as a Single IRB (sIRB)
Location: Livestreamed
Speaker: Scott A. Hines, B.S., MLA – Johns Hopkins University school of Medicine
Speaker: Nadia Johnson, MS, CIP – NYU Langone Health
Speaker: Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
Wednesday, Dec 14th
3:00 PM – 4:00 PM ET
IRB Closet Clean-Out: Keep, Toss, TBD (to be determined)
Location: Livestreamed
Speaker: Cecilia Brooke Cholka, PhD, CIP (she/her/hers) – Weill Cornell Medicine
Speaker: Rachel Lally, MPH, CIP (she/her/hers) – The Pennsylvania State University
Speaker: Mikaela Myers (she/her/hers) – Cameo Consulting Group, LLC
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
Thursday, Dec 15th
10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary IX: Decentralized Clinical Trials (DCTs): Considerations of and for IRB review
Location: Livestreamed
Moderator: Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Panelist: Leanne Madre, JD – Medable, Inc.
Panelist: Robert H. Romanchuk, CCRC, CIP – Advarra, Inc.
Panelist: Megan Kasimatis Singleton, JD, MBE, CIP – Office of Human Subjects Research Johns Hopkins University School of Medicine
Emerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessPharma/Biotech Perspectives
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F01 - A Dialogue With NIH
Location: Livestreamed
Speaker: Lyric Jorgenson, PhD – NIH
A Dialogue With the Feds
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F02 - Developing a System of IRB Precedent: Value, Approaches, and Challenges
Location: Livestreamed
Speaker: Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania
Speaker: Sarah H. Kiskaddon, JD, MA – Dana-Farber Cancer Institute
Speaker: Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems
IRB ChairsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F03 - Compensation: How Much Inducement Is Due?
Location: Livestreamed
Speaker: Brandon Brown, MPH, PhD – School of Medicine, University of California, Riverside
Speaker: Neal W. Dickert, MD, PhD (he/him/his) – Emory University School of Medicine, Division of Cardiology
Speaker: Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania
Resource Person: Jerry A. Menikoff, MD, JD – Office for Human Research Protections
Pharma/Biotech PerspectivesPopulations Requiring Additional ProtectionsAdvancing Equity and Justice in Research
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F04 - Risky Business: The Basics of Evaluating Research Risk
Location: Livestreamed
Speaker: John D. Horigan, MA, CIP (he/him/his) – National Institutes of Health
Speaker: Michael Stidham, DPT – DHHS Office for Human Research Protections
Speaker: Christina Wright, MA, CIP – Virginia Commonwealth University
IRB Basics
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F05 - Big Data and Novel Technology: Considerations for Privacy and Participant Rights
Location: Livestreamed
Speaker: Danielle A. Griffin, CIP, Ed.D. (she/her/hers) – Encoura
Speaker: Dianna Reuter, Esq., CIPP/US – Children's Hospital of Philadelphia
Research Involving Data and BiospecimensEmerging Challenges and Breaking IssuesResearch Conducted in the Digital World
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F11 - A Dialogue With the Department of Energy (DOE): Addressing Implicit Bias in Human Subject Research—A Roundtable Style Discussion With Members of the DOE Implicit Bias Task Force
Location: On-Demand
Presenter: Susan Ehrlich – U.S. Department of Energy
Presenter: Cheri Hautala-Bateman, PhD (she/her/hers) – Department of Energy/National Nuclear Security Administration
Presenter: Timothy J. Ledbetter, DMin, BCC – PNNL & Central DOE
Presenter: James E. Morris (he/him/his) – Department of Energy
Presenter: Lindsay Motz, CIP (she/her/hers) – Oak Ridge Associated Universities
Presenter: Elizabeth P. White, MBA, MPH, CIP (she/her/hers) – United States Department of Energy
A Dialogue With the Feds
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F12 - The Return of Genetic Information
Location: On-Demand
Presenter: Lindsay McNair, MD, MPH, MSB – WCG
Presenter: Anastasia Wise
Presenter: Sandra Prucka
Pharma/Biotech PerspectivesResearch Involving Data and Biospecimens
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F13 - Creating a Quality HRPP Reliance Program
Location: On-Demand
Presenter: Tiffany M. Coleman, MS, MPH, CIP – Augusta University
Presenter: Hallie Kassan, MS,CIP – The University of Texas MD Anderson Cancer Center
Presenter: Janelle A. Maddox-Regis, MS, CIP – Johns Hopkins University School of Medicine
Small Research ProgramsHRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F14 - Reviewing Exercise Science Research at Primarily SBER Institutions
Location: On-Demand
Presenter: Kat DeMarco, MPH (she/they) – Montclair State University
Presenter: Brett R. Ely, PhD (she/her/hers) – Salem State University
Social, Behavioral, and Educational Research
Thursday, Dec 15th
11:45 AM – 12:45 PM ET
F15 - Research with Minors: Balancing Autonomy and Protection
Location: On-Demand
Presenter: Tiffany Chenneville, PhD (she/her/hers) – University of South Florida
Social, Behavioral, and Educational ResearchPopulations Requiring Additional Protections
Thursday, Dec 15th
12:45 PM – 1:15 PM ET
CIP Office Hours
Location: Livestreamed
Thursday, Dec 15th
1:30 PM – 2:45 PM ET
Plenary XIII: What Can We Learn From Participant Experiences of Informed Consent Processes?
Location: Livestreamed
Moderator: Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania
Panelist: Stephanie S. Cargill, PhD MSPH (she/her/hers) – Saint Louis University
Panelist: Stephanie A. Kraft, JD – Seattle Children's Research Institute
Panelist: Stephanie Morain, PhD, MPH – Johns Hopkins University
Informed ConsentEmerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesIRB Basics
Thursday, Dec 15th
2:30 PM – 3:30 PM ET
FDA Office Hours
Location: Livestreamed
Thursday, Dec 15th
2:30 PM – 3:30 PM ET
OHRP Office Hours
Location: Livestreamed
Thursday, Dec 15th
2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office Hours
Location: Livestreamed
Thursday, Dec 15th
3:00 PM – 4:00 PM ET
IRB Chairs Forum: A Structured Networking Event
Location: Livestreamed
Speaker: Donella S. Comeau, MD, PhD – Beth Israel Deaconess Medical Center
Speaker: Benjamin Henwood, PhD, LCSW – University of Southern California
Speaker: Aimee E. Huard, PhD – Great Bay Community College
Speaker: Dana H. Levitt, PhD, NCC – Montclair State University
Speaker: Benjamin C. Silverman, MD (he/him/his) – Human Research Affairs, Mass General Brigham; Harvard Medical School
Speaker: Julie Slayton, JD, PhD – University of Southern California
IRB Chairs
Thursday, Dec 15th
3:00 PM – 4:00 PM ET
Mad Science on Trial: The Real Ethical Problems With Fictional Scientists
Location: Livestreamed
Speaker: Ann Johnson, PhD, MPH – University of Utah
Speaker: Lisa Rigtrup, BS, CIP (she/her/hers) – University of Utah
Speaker: Amanda P. Sly, MS, CIP (she/her/hers) – OHRP
IRB Basics
Thursday, Dec 15th
3:00 PM – 4:00 PM ET
The Certified IRB Professional (CIP®) Credential Presentation
Location: Livestreamed
Speaker: Ross A. Hickey, JD, CIP, CPIA – University of Southern Maine
Speaker: Lori Roesch, CIP – Children's Wisconsin
HRPP/IRB Administration/Management and Process
Sponsored By