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Sunday, Nov 17
9:15 amA01 - Academic Ethics—How Social Science Researchers Operationalize and Exercise Research Ethics
Location: Room 304
Alma Castro, MA, CIP – Harvard T.H. Chan School of Public Health; Jeremy T. Goldbach, PhD, LMSW – University of Southern California; Lara N. Sloboda, PhD – Dana Farber Cancer Insititute -
Sunday, Nov 17
9:15 amA04 - OHRP's Guidance on the Revised Common Rule—A Question and Answer Session
Location: Room 309
Lauren Hartsmith, JD – OHRP; Julie Kaneshiro, MA – Office for Human Research Protections; Ivor A. Pritchard, PhD – OHRP -
Sunday, Nov 17
9:15 amA05 - Optimizing Openness in Human Subjects Research—Balancing Transparency and Human Research Protections
Location: Room 313
Julie Goldman, MLIS – Harvard Medical School; Dessi Kirilova – Qualitative Data Repository www.qdr.org; Anna M. Mitchell, BA, CIP – Boston Children's Hospital; Diana Kapiszewski, PhD – Department of Government, Georgetown University -
Sunday, Nov 17
9:15 amA06 - Reviewing Exercise Science Research at Primarily SBER Institutions
Location: Room 310
Summer B. Cook, PhD – University of New Hampshire; Michael Leary, PhD CIP – Lindenwood University; Meghan Felicia Pronovost, MS – Harvard University -
Sunday, Nov 17
9:15 amA07 - Continuing Review or No Continuing Review, That Is the Question
Location: Room 302
Andrew Hedrick, MPA, CIP – The Ohio State University; Sharon L. Zack, MS – Westat -
Sunday, Nov 17
9:15 amA08 - May the Revised Common Rule Force Be With You: How to Become a Review Jedi
Location: Room 306
Tonya Ferraro, MEd – Boston Children's Hospital; Kimberley Serpico, MEd, CIP, EdD Candidate – Harvard School of Public Health -
Sunday, Nov 17
11:00 amB01 - From Flexible to More Flexibility—What's Left to Review?
Location: Room 311
Rebecca D. Armstrong, DVM, PhD – University of California, Berkeley; Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno -
Sunday, Nov 17
11:00 amB03 - Informed Consent in SBER
Location: Room 306
Jennifer B. Dier, CIP, CCRP, CHRC – UC San Diego; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New Mexico -
Sunday, Nov 17
11:00 amB05 - Exempt or Not? Don't Get Psyched Out By the Benign Behavioral Intervention Research Exemption
Location: Room 310
Sandra H. Berry – RAND Corporation; Nancy A. Olson, JD – Consultant; Michele Russell-Einhorn, JD – Advarra; Ivor A. Pritchard, PhD – OHRP -
Sunday, Nov 17
11:00 amB07 - Is This "Education Research" Research at All?
Location: Room 304
Jonathan M. Girard – Harvard University; Meghan Felicia Pronovost, MS – Harvard University -
Sunday, Nov 17
1:30 pmPlenary Session: Strategies and Solutions for Working With Challenging Principal Investigators (PIs)
Location: Ballroom B
Andrew Hedrick, MPA, CIP – The Ohio State University; RoseAnn Fleming, CIP – University of Southern California Institutional Review Board; Julie Slayton, JD, PhD – University of Southern California; Jessica R. Williams, MA, MS, CIP – University of Kentucky -
Sunday, Nov 17
3:15 pmC03 - The "Nuts and Bolts" of Running an IRB Meeting Virtually
Location: Room 309
Jaime A. Arango, EdD, CIP – CITI Program; Nicolaas Bodkin, CIP – Capella University; Angela L. Bruch, PhD – Capella University -
Sunday, Nov 17
3:15 pmC05 - Benign Behavioral Interventions (BBI) in Practice
Location: Room 302
Alma Castro, MA, CIP – Harvard T.H. Chan School of Public Health; Matt D. Stafford, MPH – Boston Children's Hospital; Ivor A. Pritchard, PhD – OHRP -
Sunday, Nov 17
3:15 pmC07 - Incentives and Compensation for Subjects in SBER
Location: Room 306
Colleen Kohashi, MA, CIP – UC Berkeley; Melissa McGee, J.D. – University of New Hampshire -
Sunday, Nov 17
3:15 pmC08 - Conflicted Cultures of Compliance—How the Revised Federal Regulations Change Conversations Between Ethnographers and IRBs
Location: Room 313
Montana Miller, PhD – Bowling Green State University; Laura Henderson, MA – Baystate Health -
Monday, Nov 18
10:15 amPanel I: Diverse Representation in Clinical Trials—Why Does It Matter and How Do We Move Forward?
Location: Ballroom B
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Denise Anne Dillard, PhD – Southcentral Foundation; Tesheia Johnson, MBA, MHS – Yale University; Paul Underwood, MD FACC – Boston Scientific Corporation -
Monday, Nov 18
10:15 amPanel II: Using Social Behavioral Data to Provide Insight into Health-Related Experiences
Location: Veterans Memorial Auditorium
Kimberly M. Nelson, PhD, MPH – Boston University School of Public Health; Teresa Doksum, PhD, MPH – Abt Associates Inc.; Luke Gelinas, PhD – Advarra; Julie Slayton, JD, PhD – University of Southern California -
Monday, Nov 18
10:15 amPanel III: What to Expect When We Sequence Expecting Moms
Location: Ballroom C
Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University; Josephine M. Johnston, LLB, MBHL – The Hastings Center; Haley K. Sullivan – Duke University; Ingrid A. Holm, MD, MPH – Boston Children's Hospital -
Monday, Nov 18
1:00 pmA03 - Ethics and Governance in Learning Healthcare Systems
Location: Room 102
Paul C. McLean – Center for Bioethics, Harvard Medical School; Nancy E. Kass, ScD – The Johns Hopkins University; Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine -
Monday, Nov 18
1:00 pmA10 - Management of Incidental Findings (IFs) in Pragmatic Clinical Trials (PCTs)
Location: Room 201
Juli Bollinger, M.S. – Johns Hopkins University; Debra JH Mathews, PhD, MA – Johns Hopkins University Berman Institute of Bioethics; Stephanie Morain, PhD, MPH – Baylor College of Medicine; Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University -
Monday, Nov 18
1:00 pmA11 - Legal and Regulatory Changes: A Year in Review
Location: Room 302
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Michele Russell-Einhorn, JD – Advarra; Laura Odwazny, JD, MA – US DHHS -
Monday, Nov 18
1:00 pmA14 - Staying on Top of It All—Practical Strategies for Implementing Postapproval Monitoring (PAM)
Location: Room 202
Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno; Andrea R. McDowell, PhD – Seattle University -
Monday, Nov 18
1:00 pmA20 - Two Hats, One Head—When IRB Members Are Also Investigators
Location: Room 109
Stephanie Collins Reed, PhD – New York State Psychiatric Institute; Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects -
Monday, Nov 18
1:00 pmA22 - From Non-Exempt to Exempt and Back Again—Navigating Exemption 2iii
Location: Room 104
Petrice B. Longenecker, PhD, CIP – Uniformed Services University of the Health Sciences; Laura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences -
Monday, Nov 18
2:45 pmB02 - Dear IRB, Please Tell Me What to Do and How to Avoid Mistakes
Location: Room 200
Ximena L. Levy, MD, MPH, CIP – Florida Atlantic University; Muhammad Waseem, MD, MS, CIP, CPI, CCRP – Lincoln Medical Center -
Monday, Nov 18
2:45 pmB03 - Why Informed Consent Doesn't Work and Why the Revised Common Rule Won't Fix It
Location: Room 210
Quincy J. Byrdsong, EdD, CIP, CCRP – WellStar Health System; Stephanie S. Cargill, PhD – Saint Louis University -
Monday, Nov 18
2:45 pmB04 - Investigational Device Exemptions (IDE) Mobile Medical Applications and IRB Review
Location: Room 311
Soma Kalb, PhD – US Food and Drug Administration; Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. -
Monday, Nov 18
2:45 pmB09 - Taking the Plunge—Transitioning Studies to the Revised Common Rule
Location: Room 306
Lauren Hartsmith, JD – OHRP; John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Nathalia Henry, MS, CHRC, CIP – Northwestern University -
Monday, Nov 18
2:45 pmB10 - Right to Try—Legal, Ethical, and Implementation Issues
Location: Room 203
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Richard Klein – GE2P2 Global; Christine MacCracken, BSN, MSHEd – Janssen, Pharmaceutical Companies of Johnson & Johnson -
Monday, Nov 18
2:45 pmB11 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review
Location: Room 202
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine -
Monday, Nov 18
2:45 pmB12 - Data and Biospecimens Across International Borders
Location: Room 102
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6; Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; Marianne K. Henderson, MS, CPC – National Cancer Institute, NIH, DHHS; Edward E. Bartlett, PhD – Office for Human Research Protections -
Monday, Nov 18
2:45 pmB13 - Engaging the Principal Investigators of Tomorrow With Research Ethics Today: Is It Possible?
Location: Room 101
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill; Leah R. Eisenberg, JD, MA – University of Arkansas for Medical Sciences -
Monday, Nov 18
2:45 pmB15 - The Secrets of Big Data—Public, Private, or Something Else?
Location: Room 304
Ivor A. Pritchard, PhD – OHRP -
Monday, Nov 18
2:45 pmB18 - A Comparison of Human Subjects Protections Auditing Between Biomedical and Social-Behavioral Human Subjects Research
Location: Room 313
Narayan A. Escolin, MBS, CCRP – Rutgers University; Kate Sasamoto, JD – Office of Research Compliance Review, University of Michigan -
Monday, Nov 18
2:45 pmB22 - Ethical Considerations in Vaccine Development and Use
Location: Room 108
Walter L. Straus, MD, MPH – Merck Co., Inc.; Jennifer E. Gerber, MSc – Johns Hopkins Bloomberg School of Public Health; Jason L. Schwartz, PhD, MBE – Yale School of Public Health -
Monday, Nov 18
2:45 pmB23 - Flexible Strategies to Manage Unregulated Research in the Era of the Revised Common Rule
Location: Room 111
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group -
Tuesday, Nov 19
10:15 amC04 - Bioresearch Monitoring (BIMO) Inspections—Regulatory Violations Observed in IRB and Clinical Investigator Inspections
Location: Room 101
Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration; Jan L. Hewett, BSN, JD – Food & Drug Administration -
Tuesday, Nov 19
10:15 amC10 - A Case-Based Assessment of Post-Trial Access to Investigational Medicines
Location: Room 107
Karla Childers, MSJ – Johnson & Johnson; Ariella Kelman, MD – Genentech, a member of the Roche Group -
Tuesday, Nov 19
10:15 amC18 - Reaching the Masses—Ideas for Researcher Education
Location: Room 204
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine; Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno -
Tuesday, Nov 19
10:15 amC01 - HRPP Innovation Showcase—Creative Approaches to IRB Challenges
Location: Room 203
Madelon V. Baranoski, PhD, CIP – Yale University; Jeri Burr, RN-BC, MS, CCRC, FACRP – University of Utah; Martha Jones, MA, CIP – Partners HealthCare System, Inc.; Christine Suver, PhD – Sage Bionetworks -
Tuesday, Nov 19
10:15 amC02 - I Love My Job!? Perspectives Throughout a Career in Human Research Protections
Location: Room 312
Tonya Ferraro, MEd – Boston Children's Hospital; Danielle A. Griffin, Ed.D., CIP – University of Houston; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention; Ada Sue Selwitz, MA – University of Kentucky -
Tuesday, Nov 19
10:15 amC13 - IRB Review of Research With Children
Location: Room 309
Ran Goldman, MD – University of British Columbia; Bethany Johnson, JD, CIP – Indiana University; Andrew Neel, CIP – Indiana University -
Tuesday, Nov 19
10:15 amC21 - A Look into the Crystal Ball—The HRPP of the Future
Location: Room 310
John R. Baumann, PhD – Indiana University; Nichelle Cobb, PhD – University of Wisconsin-Madison; Rachel A. Wenzl, MPH, CIP – Research Compliance Services, University of Nebraska - Lincoln -
Tuesday, Nov 19
10:15 amC23 - Exempt Human Subjects Research Case Studies— Implementing Changes to the Exemption Categories Under the Revised Common Rule
Location: Room 206
Christine DeLussey, MS, CIP – Children's Hospital of Philadelphia; Julie M. Eiserman, MA, CCRP – National Institutes of Health; Caitlin Alcorn, MPA, CIP – University of Oregon -
Tuesday, Nov 19
2:00 pmPanel IV: Identifying and Avoiding the Conduct of Low Value Clinical Trials
Location: Ballroom B
John R. Baumann, PhD – Indiana University; Laura Odwazny, JD, MA – US DHHS; Eileen M. O'Reilly, MD – Memorial Sloan Kettering Cancer Center; Deborah Zarin, MD – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Medical School; Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems -
Tuesday, Nov 19
2:00 pmPanel V: Bioethics Turns 50—Reflections from The Hastings Center
Location: Ballroom C
Mildred Z. Solomon, EdD – The Hastings Center; Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine; Nancy M.P King, JD – Wake Forest School of Medicine; Alex John London, PhD – Carnegie Mellon University; Karen J. Maschke, PhD – The Hastings Center -
Tuesday, Nov 19
2:00 pmPanel VI: Studying Suicide and Subjects at Risk for Suicide—Identifying and Minimizing Risk to Promote Necessary Research
Location: Veterans Memorial Auditorium
David H. Strauss, MD – Columbia University; Celia B. Fisher, PhD – Fordham University; Samantha Marquez McKetchnie, LCSW – Massachusetts General Hospital -
Tuesday, Nov 19
3:45 pmD01 - Lost in Transition? Flexible and Innovative Approaches to the Revised Common Rule
Location: Room 210
Charles Brightbill, CIM, CIP – Geisinger Health System; Cynthia S. Shindledecker, B.A., CIP – University of Michigan -
Tuesday, Nov 19
3:45 pmD04 - FDA’s Oversight of ClinicalTrials.gov Requirements
Location: Room 309
Anthony Keyes, MBA, PMP – Johns Hopkins University; Patrick J. McNeilly, PhD – Food and Drug Administration -
Tuesday, Nov 19
3:45 pmD05 - Export Controls
Location: Room 300
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Lisa A. Griffin, JD, MPH – Brigham and Women's Healthcare, Inc. -
Tuesday, Nov 19
3:45 pmD06 - Complex Institutional Relationships—Going Beyond the Multi-site Model
Location: Room 202
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Sara Chandros Hull, PhD – NIH; Mary M. Klote, MD, CIP – Veterans Health Administration; Theresa M. Straut, RAC, CIP – US Army, Combat Capabilities Development Command, Army Research Laboratory -
Tuesday, Nov 19
3:45 pmD09 - Ensuring IRB Compliance in a Hybrid World—Strategies for Operating in a World Where Multiple Regulatory Frameworks Apply
Location: Room 310
Martha Jones, MA, CIP – Partners HealthCare System, Inc.; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine -
Tuesday, Nov 19
3:45 pmD10 - Returning Research Results to Participants—Whose Job Is It?
Location: Room 201
Gianna McMillan, DBe – Loyola Marymount University; Carol Juliet Weil, JD – National Cancer Institute; Karla Childers, MSJ – Johnson & Johnson -
Tuesday, Nov 19
3:45 pmD13 - Inclusion of Pregnant Women in Clinical Trials
Location: Room 101
Kristine Shields, MSN, DRPH – Shields Medical Writing and Consulting; Leyla Sahin, MD – FDA -
Tuesday, Nov 19
3:45 pmD16 - Responsible Conduct of Research (RCR) for Research Leaders—Integrating Research Administration for a Successful Collaborative Framework
Location: Room 107
John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc.; Jane Strasser – University of Cincinnati -
Tuesday, Nov 19
3:45 pmD18 - Reviewing SBER—A Guide for the Non-Scientist, Unaffiliated IRB Member
Location: Room 108
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine; Amy Corneli, PhD, MPH – Duke University -
Wednesday, Nov 20
10:00 amPanel VII: From Fortnite to Facebook—Data Security and Breaches, Downstream Harms, and the (Precarious) Role of IRBs
Location: Ballroom B
Jacob Metcalf, PhD – Ethical Resolve, LLC; James R. Foulds, PhD – University of Maryland, Baltimore County; Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems -
Wednesday, Nov 20
10:00 amPanel VIII: The Challenges of Studying Marijuana Use in the United States
Location: Ballroom C
Albert J. Allen, MD, PhD – Eli Lilly and Company; Benjamin C. Silverman, MD – Partners HealthCare System, Inc.; Juliette Roddy, PhD – University of Michigan Dearborn; Beth Watters, JD – Partners HealthCare System, Inc. -
Wednesday, Nov 20
10:00 amRepeat Breakout Session (B15): The Secrets of Big Data—Public, Private, or Something Else?
Location: Room 306
Ivor A. Pritchard, PhD – OHRP -
Wednesday, Nov 20
10:00 amRepeat Breakout Session (D1): Lost in Transition? Flexible and Innovative Approaches to the Revised Common Rule
Location: Room 210
Cynthia S. Shindledecker, B.A., CIP – University of Michigan; Charles Brightbill, CIM, CIP – Geisinger Health System -
Wednesday, Nov 20
11:30 amE01 - Innovations in IRB Evaluation and Improvement
Location: Room 210
Holly A. Taylor, PhD, MPH – NIH; Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects -
Wednesday, Nov 20
11:30 amE02 - Strategies for IRB Member Education
Location: Room 304
Toby L. Schonfeld, PhD – Prime Review Board; Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine -
Wednesday, Nov 20
11:30 amE04 - Assessing the Prospect of Direct Benefit in Early-Phase Pediatric Studies
Location: Room 202
Melanie Bhatnagar, MD – Food & Drug Administration; Donna L. Snyder, MD – Food and Drug Administration; Albert J. Allen, MD, PhD – Eli Lilly and Company -
Wednesday, Nov 20
11:30 amE05 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures
Location: Room 302
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6; Derek Englis, MBA, EdS, CIP – Armed Forces Services Corp./Magellan Federal; Bussara Sukpanichnant, BS (Nursing), M.Ed., CIP – Armed Forces Research Institute of Medical Sciences (AFRIMS); Edward E. Bartlett, PhD – Office for Human Research Protections -
Wednesday, Nov 20
11:30 amE06 - Making Your HRPP Distinct and Organized in a Single IRB World
Location: Room 102
Ann Johnson, PhD, MPH, CIP – University of Utah; Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center -
Wednesday, Nov 20
11:30 amE11 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability
Location: Room 312
Theresa J. Colecchia – Johns Hopkins University; Valerie H. Bonham, JD – Ropes & Gray LLP -
Wednesday, Nov 20
11:30 amE13 - Under the Influence—Capacity and Consent
Location: Room 203
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Health; Lara N. Sloboda, PhD – Dana Farber Cancer Insititute -
Wednesday, Nov 20
11:30 amE15 - The Regulatory and Ethical Implications of Melding Consumer "Big Data" With Medical "Big Data"
Location: Room 310
Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. -
Wednesday, Nov 20
11:30 amE16 - IRBs and Conflict of Interest (COI) Oversight—Mind the Gaps
Location: Room 206
John R. Baumann, PhD – Indiana University; Scott J. Lipkin, DPM, CIP – Ankura Consulting; Shelby Moench, BA – Intermountain Healthcare -
Wednesday, Nov 20
11:30 amE17 - Building Models for Hospital and Practice-Based Research Programs—Agony and Ecstasy
Location: Room 107
Paul Papagni, JD, CIP – Holy Cross Hospital/Trinity Health; Patricia Seymour, CCRC, MA, CIP – WCG Clinical -
Wednesday, Nov 20
11:30 amE20 - Who's Minding the Store? Local Oversight of Research Without an IRB
Location: Room 201
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Hallie Kassan, MS, CIP – Northwell Health; Greg E. Manship, DBe, MDiv, CIP, CIM – OSF HealthCare -
Wednesday, Nov 20
11:30 amE22 - Implementation of a System to Promote Compliance With 45 CFR 46.116(h)—Posting Consent Forms
Location: Room 313
Matthew Ogrodnik, MS, CIP – Boston Medical Center and Boston University Medical Campus; Lauren Hartsmith, JD – OHRP -
Wednesday, Nov 20
11:30 amE23 - Implementing Key Information in Multi-Site Research
Location: Room 108
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Jeanne Velders, JD, CIP – Washington University in St. Louis; Joan Affleck, M.A., M.B.A. – Merck & Co., Inc. -
Wednesday, Nov 20
12:45 pmClosing General Session Luncheon—Designing Ethical Cars and Computing Clinicians: Research and the Ethics of Artificial Intelligence (AI) Programming
Location: Veterans Memorial Auditorium
Neal W. Dickert, MD, PhD – Emory University School of Medicine; Marshall Chin, MD, MPH – University of Chicago; David Magnus, PhD – Stanford University; Tamiko Eto, MS, CIP – Stanford Research Institute (SRI) International