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Clinical Research Staff
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Monday, Nov 18
1:00 pmA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
Monday, Nov 18
1:00 pmA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of Health -
Monday, Nov 18
1:00 pmA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – Consultant -
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 pmA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug Administration -
Monday, Nov 18
1:00 pmA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health -
Monday, Nov 18
1:00 pmA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura Consulting -
Monday, Nov 18
1:00 pmA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting Group -
Monday, Nov 18
1:00 pmA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of Florida -
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 pmA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of Health -
Monday, Nov 18
1:00 pmA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric Institute -
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 pmA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical Center -
Monday, Nov 18
1:00 pmA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science Foundation -
Monday, Nov 18
1:00 pmA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico -
Monday, Nov 18
1:00 pmA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of Health -
Monday, Nov 18
1:00 pmA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New Hampshire -
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
2:45 pmB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – Advarra -
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 pmB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLP -
Monday, Nov 18
2:45 pmB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Michele Kennett, JD, MSN, CIP – University of Missouri -
Monday, Nov 18
2:45 pmB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309
Warren Capell, MD – University of Colorado Denver; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New Mexico -
Monday, Nov 18
2:45 pmB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital; Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia -
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 pmB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103
Lisa Denney, n/a – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical Center -
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 pmB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Joseph Crossno, MS, CPIA – Central Michigan University -
Monday, Nov 18
2:45 pmB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201
Melissa McGee, J.D. – University of New Hampshire; Heather H. Pierce, JD, MPH – Association of American Medical Colleges -
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 pmB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300
Jyoti Angal, MPH CIP – Avera Research Institute; Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe); Anita B. Frederick, MS Management – Tribal Nations Research Group -
Monday, Nov 18
2:45 pmB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104
Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention -
Monday, Nov 18
2:45 pmB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH -
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 amC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom A
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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 amC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLP -
Tuesday, Nov 19
10:15 amC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health San Antonio -
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 amC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; P. Pearl O'Rourke, MD – Harvard Medical School -
Tuesday, Nov 19
10:15 amC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202
Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh -
Tuesday, Nov 19
10:15 amC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of Medicine -
Tuesday, Nov 19
10:15 amC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services; David J. Hudson, PhD – University of Virginia -
Tuesday, Nov 19
10:15 amC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health -
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 amC19 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 104
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute; Matt D. Stafford, MPH – Boston Children's Hospital -
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 amC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health -
Tuesday, Nov 19
10:15 amC08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs
Location: Room 200
Luke Gelinas, PhD – Advarra; R. Peter Iafrate, PharmD – University of Florida; Brenda J. Klement – Morehouse School of Medicine -
Tuesday, Nov 19
10:15 amC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM -
Tuesday, Nov 19
10:15 amC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103
Kate Gallin Heffernan, JD – Verrill Dana LLP; Todd W. Rice, MD – Vanderbilt University Medical Center -
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 amC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIH -
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
11:45 amA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111
Jason Gerson, PhD – Patient-Centered Outcomes Research Institute -
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 pmD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital -
Tuesday, Nov 19
3:45 pmD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203
Julia G. Gorey, JD – OHRP; Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. -
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 pmD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting Group -
Tuesday, Nov 19
3:45 pmD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine -
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 pmD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Emily M.Q Schriver, JD – The Ohio State University; Michael J. Vernick, JD – Hogan Lovells US LLP -
Tuesday, Nov 19
3:45 pmD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout -
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 pmD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard -
Tuesday, Nov 19
3:45 pmD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom A
Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Laura Odwazny, JD, MA – US DHHS -
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 pmD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea R. McDowell, PhD – Seattle University; Rachel Zand, PhD – University of Toronto -
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 -
Tuesday, Nov 19
3:45 pmD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State University -
Tuesday, Nov 19
3:45 pmD20 - Staying Current and Keeping Pace—A Primer for IRB Chairs
Location: Room 104
J. Andrew Bertolatus, MD – University of Iowa; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Kerry A. Agnitsch, PhD – Iowa State University -
Tuesday, Nov 19
3:45 pmD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312
John A. Guidry, PhD – TRX Development Soutions; Matan Benyishay, MPP – AIDS Action Committee/Fenway Health; Dana J. Pardee, BS – The Fenway Institute -
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
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 amE07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309
Janet C. Donnelly, RAC – FDA; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of Kentucky -
Compliance, Regulatory, and QA/QI Professionals
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Monday, Nov 18
1:00 pmA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
Monday, Nov 18
1:00 pmA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of Health -
Monday, Nov 18
1:00 pmA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – Consultant -
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 pmA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug Administration -
Monday, Nov 18
1:00 pmA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health -
Monday, Nov 18
1:00 pmA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura Consulting -
Monday, Nov 18
1:00 pmA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting Group -
Monday, Nov 18
1:00 pmA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of Florida -
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 pmA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of Health -
Monday, Nov 18
1:00 pmA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric Institute -
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 pmA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical Center -
Monday, Nov 18
1:00 pmA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science Foundation -
Monday, Nov 18
1:00 pmA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico -
Monday, Nov 18
1:00 pmA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of Health -
Monday, Nov 18
1:00 pmA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New Hampshire -
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
2:45 pmB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – Advarra -
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 pmB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLP -
Monday, Nov 18
2:45 pmB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Michele Kennett, JD, MSN, CIP – University of Missouri -
Monday, Nov 18
2:45 pmB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309
Warren Capell, MD – University of Colorado Denver; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New Mexico -
Monday, Nov 18
2:45 pmB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital; Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia -
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 pmB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103
Lisa Denney, n/a – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical Center -
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 pmB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Joseph Crossno, MS, CPIA – Central Michigan University -
Monday, Nov 18
2:45 pmB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201
Melissa McGee, J.D. – University of New Hampshire; Heather H. Pierce, JD, MPH – Association of American Medical Colleges -
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 pmB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300
Jyoti Angal, MPH CIP – Avera Research Institute; Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe); Anita B. Frederick, MS Management – Tribal Nations Research Group -
Monday, Nov 18
2:45 pmB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104
Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention -
Monday, Nov 18
2:45 pmB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH -
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 amC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom A
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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 amC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLP -
Tuesday, Nov 19
10:15 amC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health San Antonio -
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 amC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; P. Pearl O'Rourke, MD – Harvard Medical School -
Tuesday, Nov 19
10:15 amC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202
Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh -
Tuesday, Nov 19
10:15 amC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of Medicine -
Tuesday, Nov 19
10:15 amC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services; David J. Hudson, PhD – University of Virginia -
Tuesday, Nov 19
10:15 amC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health -
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 amC19 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 104
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute; Matt D. Stafford, MPH – Boston Children's Hospital -
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 amC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health -
Tuesday, Nov 19
10:15 amC08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs
Location: Room 200
Luke Gelinas, PhD – Advarra; R. Peter Iafrate, PharmD – University of Florida; Brenda J. Klement – Morehouse School of Medicine -
Tuesday, Nov 19
10:15 amC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM -
Tuesday, Nov 19
10:15 amC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103
Kate Gallin Heffernan, JD – Verrill Dana LLP; Todd W. Rice, MD – Vanderbilt University Medical Center -
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 amC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIH -
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
11:45 amA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111
Jason Gerson, PhD – Patient-Centered Outcomes Research Institute -
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 pmD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital -
Tuesday, Nov 19
3:45 pmD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203
Julia G. Gorey, JD – OHRP; Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. -
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 pmD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting Group -
Tuesday, Nov 19
3:45 pmD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine -
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 pmD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Emily M.Q Schriver, JD – The Ohio State University; Michael J. Vernick, JD – Hogan Lovells US LLP -
Tuesday, Nov 19
3:45 pmD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout -
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 pmD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard -
Tuesday, Nov 19
3:45 pmD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom A
Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Laura Odwazny, JD, MA – US DHHS -
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 pmD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea R. McDowell, PhD – Seattle University; Rachel Zand, PhD – University of Toronto -
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 -
Tuesday, Nov 19
3:45 pmD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State University -
Tuesday, Nov 19
3:45 pmD20 - Staying Current and Keeping Pace—A Primer for IRB Chairs
Location: Room 104
J. Andrew Bertolatus, MD – University of Iowa; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Kerry A. Agnitsch, PhD – Iowa State University -
Tuesday, Nov 19
3:45 pmD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312
John A. Guidry, PhD – TRX Development Soutions; Matan Benyishay, MPP – AIDS Action Committee/Fenway Health; Dana J. Pardee, BS – The Fenway Institute -
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
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 amE07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309
Janet C. Donnelly, RAC – FDA; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of Kentucky -
Diversity
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Monday, Nov 18
1:00 pmA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
Monday, Nov 18
1:00 pmA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of Health -
Monday, Nov 18
1:00 pmA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – Consultant -
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 pmA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug Administration -
Monday, Nov 18
1:00 pmA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health -
Monday, Nov 18
1:00 pmA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura Consulting -
Monday, Nov 18
1:00 pmA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting Group -
Monday, Nov 18
1:00 pmA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of Florida -
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 pmA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of Health -
Monday, Nov 18
1:00 pmA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric Institute -
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 pmA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical Center -
Monday, Nov 18
1:00 pmA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science Foundation -
Monday, Nov 18
1:00 pmA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico -
Monday, Nov 18
1:00 pmA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of Health -
Monday, Nov 18
1:00 pmA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New Hampshire -
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
2:45 pmB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – Advarra -
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 pmB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLP -
Monday, Nov 18
2:45 pmB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Michele Kennett, JD, MSN, CIP – University of Missouri -
Monday, Nov 18
2:45 pmB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309
Warren Capell, MD – University of Colorado Denver; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New Mexico -
Monday, Nov 18
2:45 pmB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital; Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia -
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 pmB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103
Lisa Denney, n/a – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical Center -
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 pmB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Joseph Crossno, MS, CPIA – Central Michigan University -
Monday, Nov 18
2:45 pmB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201
Melissa McGee, J.D. – University of New Hampshire; Heather H. Pierce, JD, MPH – Association of American Medical Colleges -
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 pmB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300
Jyoti Angal, MPH CIP – Avera Research Institute; Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe); Anita B. Frederick, MS Management – Tribal Nations Research Group -
Monday, Nov 18
2:45 pmB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104
Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention -
Monday, Nov 18
2:45 pmB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH -
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 amC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom A
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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 amC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLP -
Tuesday, Nov 19
10:15 amC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health San Antonio -
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 amC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; P. Pearl O'Rourke, MD – Harvard Medical School -
Tuesday, Nov 19
10:15 amC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202
Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh -
Tuesday, Nov 19
10:15 amC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of Medicine -
Tuesday, Nov 19
10:15 amC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services; David J. Hudson, PhD – University of Virginia -
Tuesday, Nov 19
10:15 amC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health -
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 amC19 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 104
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute; Matt D. Stafford, MPH – Boston Children's Hospital -
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 amC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health -
Tuesday, Nov 19
10:15 amC08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs
Location: Room 200
Luke Gelinas, PhD – Advarra; R. Peter Iafrate, PharmD – University of Florida; Brenda J. Klement – Morehouse School of Medicine -
Tuesday, Nov 19
10:15 amC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM -
Tuesday, Nov 19
10:15 amC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103
Kate Gallin Heffernan, JD – Verrill Dana LLP; Todd W. Rice, MD – Vanderbilt University Medical Center -
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 amC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIH -
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
11:45 amA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111
Jason Gerson, PhD – Patient-Centered Outcomes Research Institute -
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 pmD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital -
Tuesday, Nov 19
3:45 pmD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203
Julia G. Gorey, JD – OHRP; Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. -
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 pmD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting Group -
Tuesday, Nov 19
3:45 pmD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine -
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 pmD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Emily M.Q Schriver, JD – The Ohio State University; Michael J. Vernick, JD – Hogan Lovells US LLP -
Tuesday, Nov 19
3:45 pmD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout -
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 pmD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard -
Tuesday, Nov 19
3:45 pmD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom A
Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Laura Odwazny, JD, MA – US DHHS -
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 pmD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea R. McDowell, PhD – Seattle University; Rachel Zand, PhD – University of Toronto -
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 -
Tuesday, Nov 19
3:45 pmD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State University -
Tuesday, Nov 19
3:45 pmD20 - Staying Current and Keeping Pace—A Primer for IRB Chairs
Location: Room 104
J. Andrew Bertolatus, MD – University of Iowa; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Kerry A. Agnitsch, PhD – Iowa State University -
Tuesday, Nov 19
3:45 pmD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312
John A. Guidry, PhD – TRX Development Soutions; Matan Benyishay, MPP – AIDS Action Committee/Fenway Health; Dana J. Pardee, BS – The Fenway Institute -
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
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 amE07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309
Janet C. Donnelly, RAC – FDA; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of Kentucky -
HRPP Educators
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Monday, Nov 18
1:00 pmA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
Monday, Nov 18
1:00 pmA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of Health -
Monday, Nov 18
1:00 pmA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – Consultant -
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 pmA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug Administration -
Monday, Nov 18
1:00 pmA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health -
Monday, Nov 18
1:00 pmA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura Consulting -
Monday, Nov 18
1:00 pmA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting Group -
Monday, Nov 18
1:00 pmA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of Florida -
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 pmA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of Health -
Monday, Nov 18
1:00 pmA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric Institute -
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 pmA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical Center -
Monday, Nov 18
1:00 pmA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science Foundation -
Monday, Nov 18
1:00 pmA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico -
Monday, Nov 18
1:00 pmA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of Health -
Monday, Nov 18
1:00 pmA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New Hampshire -
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
2:45 pmB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – Advarra -
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 pmB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLP -
Monday, Nov 18
2:45 pmB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Michele Kennett, JD, MSN, CIP – University of Missouri -
Monday, Nov 18
2:45 pmB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309
Warren Capell, MD – University of Colorado Denver; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New Mexico -
Monday, Nov 18
2:45 pmB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital; Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia -
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 pmB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103
Lisa Denney, n/a – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical Center -
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 pmB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Joseph Crossno, MS, CPIA – Central Michigan University -
Monday, Nov 18
2:45 pmB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201
Melissa McGee, J.D. – University of New Hampshire; Heather H. Pierce, JD, MPH – Association of American Medical Colleges -
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 pmB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300
Jyoti Angal, MPH CIP – Avera Research Institute; Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe); Anita B. Frederick, MS Management – Tribal Nations Research Group -
Monday, Nov 18
2:45 pmB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104
Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention -
Monday, Nov 18
2:45 pmB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH -
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 amC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom A
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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 amC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLP -
Tuesday, Nov 19
10:15 amC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health San Antonio -
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 amC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; P. Pearl O'Rourke, MD – Harvard Medical School -
Tuesday, Nov 19
10:15 amC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202
Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh -
Tuesday, Nov 19
10:15 amC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of Medicine -
Tuesday, Nov 19
10:15 amC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services; David J. Hudson, PhD – University of Virginia -
Tuesday, Nov 19
10:15 amC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health -
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 amC19 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 104
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute; Matt D. Stafford, MPH – Boston Children's Hospital -
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 amC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health -
Tuesday, Nov 19
10:15 amC08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs
Location: Room 200
Luke Gelinas, PhD – Advarra; R. Peter Iafrate, PharmD – University of Florida; Brenda J. Klement – Morehouse School of Medicine -
Tuesday, Nov 19
10:15 amC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM -
Tuesday, Nov 19
10:15 amC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103
Kate Gallin Heffernan, JD – Verrill Dana LLP; Todd W. Rice, MD – Vanderbilt University Medical Center -
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 amC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIH -
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
11:45 amA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111
Jason Gerson, PhD – Patient-Centered Outcomes Research Institute -
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 pmD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital -
Tuesday, Nov 19
3:45 pmD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203
Julia G. Gorey, JD – OHRP; Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. -
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 pmD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting Group -
Tuesday, Nov 19
3:45 pmD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine -
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 pmD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Emily M.Q Schriver, JD – The Ohio State University; Michael J. Vernick, JD – Hogan Lovells US LLP -
Tuesday, Nov 19
3:45 pmD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout -
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 pmD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard -
Tuesday, Nov 19
3:45 pmD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom A
Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Laura Odwazny, JD, MA – US DHHS -
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 pmD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea R. McDowell, PhD – Seattle University; Rachel Zand, PhD – University of Toronto -
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 -
Tuesday, Nov 19
3:45 pmD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State University -
Tuesday, Nov 19
3:45 pmD20 - Staying Current and Keeping Pace—A Primer for IRB Chairs
Location: Room 104
J. Andrew Bertolatus, MD – University of Iowa; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Kerry A. Agnitsch, PhD – Iowa State University -
Tuesday, Nov 19
3:45 pmD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312
John A. Guidry, PhD – TRX Development Soutions; Matan Benyishay, MPP – AIDS Action Committee/Fenway Health; Dana J. Pardee, BS – The Fenway Institute -
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
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 amE07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309
Janet C. Donnelly, RAC – FDA; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of Kentucky -
HRPP Leadership and Institutional Officials
-
Monday, Nov 18
1:00 pmA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
Monday, Nov 18
1:00 pmA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of Health -
Monday, Nov 18
1:00 pmA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – Consultant -
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 pmA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug Administration -
Monday, Nov 18
1:00 pmA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health -
Monday, Nov 18
1:00 pmA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura Consulting -
Monday, Nov 18
1:00 pmA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting Group -
Monday, Nov 18
1:00 pmA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of Florida -
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 pmA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of Health -
Monday, Nov 18
1:00 pmA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric Institute -
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 pmA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical Center -
Monday, Nov 18
1:00 pmA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science Foundation -
Monday, Nov 18
1:00 pmA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico -
Monday, Nov 18
1:00 pmA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of Health -
Monday, Nov 18
1:00 pmA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New Hampshire -
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
2:45 pmB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – Advarra -
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 pmB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLP -
Monday, Nov 18
2:45 pmB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Michele Kennett, JD, MSN, CIP – University of Missouri -
Monday, Nov 18
2:45 pmB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309
Warren Capell, MD – University of Colorado Denver; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New Mexico -
Monday, Nov 18
2:45 pmB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital; Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia -
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 pmB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103
Lisa Denney, n/a – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical Center -
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 pmB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Joseph Crossno, MS, CPIA – Central Michigan University -
Monday, Nov 18
2:45 pmB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201
Melissa McGee, J.D. – University of New Hampshire; Heather H. Pierce, JD, MPH – Association of American Medical Colleges -
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 pmB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300
Jyoti Angal, MPH CIP – Avera Research Institute; Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe); Anita B. Frederick, MS Management – Tribal Nations Research Group -
Monday, Nov 18
2:45 pmB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104
Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention -
Monday, Nov 18
2:45 pmB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH -
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 amC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom A
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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 amC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLP -
Tuesday, Nov 19
10:15 amC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health San Antonio -
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 amC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; P. Pearl O'Rourke, MD – Harvard Medical School -
Tuesday, Nov 19
10:15 amC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202
Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh -
Tuesday, Nov 19
10:15 amC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of Medicine -
Tuesday, Nov 19
10:15 amC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services; David J. Hudson, PhD – University of Virginia -
Tuesday, Nov 19
10:15 amC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health -
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 amC19 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 104
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute; Matt D. Stafford, MPH – Boston Children's Hospital -
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 amC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health -
Tuesday, Nov 19
10:15 amC08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs
Location: Room 200
Luke Gelinas, PhD – Advarra; R. Peter Iafrate, PharmD – University of Florida; Brenda J. Klement – Morehouse School of Medicine -
Tuesday, Nov 19
10:15 amC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM -
Tuesday, Nov 19
10:15 amC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103
Kate Gallin Heffernan, JD – Verrill Dana LLP; Todd W. Rice, MD – Vanderbilt University Medical Center -
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 amC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIH -
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
11:45 amA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111
Jason Gerson, PhD – Patient-Centered Outcomes Research Institute -
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 pmD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital -
Tuesday, Nov 19
3:45 pmD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203
Julia G. Gorey, JD – OHRP; Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. -
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 pmD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting Group -
Tuesday, Nov 19
3:45 pmD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine -
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 pmD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Emily M.Q Schriver, JD – The Ohio State University; Michael J. Vernick, JD – Hogan Lovells US LLP -
Tuesday, Nov 19
3:45 pmD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout -
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 pmD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard -
Tuesday, Nov 19
3:45 pmD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom A
Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Laura Odwazny, JD, MA – US DHHS -
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 pmD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea R. McDowell, PhD – Seattle University; Rachel Zand, PhD – University of Toronto -
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 -
Tuesday, Nov 19
3:45 pmD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State University -
Tuesday, Nov 19
3:45 pmD20 - Staying Current and Keeping Pace—A Primer for IRB Chairs
Location: Room 104
J. Andrew Bertolatus, MD – University of Iowa; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Kerry A. Agnitsch, PhD – Iowa State University -
Tuesday, Nov 19
3:45 pmD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312
John A. Guidry, PhD – TRX Development Soutions; Matan Benyishay, MPP – AIDS Action Committee/Fenway Health; Dana J. Pardee, BS – The Fenway Institute -
Tuesday, Nov 19
3:45 pmD23 - Challenges and Lessons for Implementing New Exemption 4(iii)—Secondary Research Involving Only Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule-Protected Identifiable Health Information
Location: Room 102
Kim Fowler, CIP, CIM – University of Georgia; Megan McFarland, MS, CIP, CCRP – Army Human Research Protections Office (AHRPO) -
Wednesday, Nov 20
10:00 amRepeat Breakout Session (A9): The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 302
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
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 (C3): Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Room 312
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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
10:00 amRepeat Breakout Session (E2): Strategies for IRB Member Education
Location: Room 304
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine; Toby L. Schonfeld, PhD – Prime Review Board -
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 amE07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309
Janet C. Donnelly, RAC – FDA; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of Kentucky -
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. -
IRB Administrators, Managers, and Staff
-
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
1:00 pmA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
Monday, Nov 18
1:00 pmA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of Health -
Monday, Nov 18
1:00 pmA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – Consultant -
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 pmA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug Administration -
Monday, Nov 18
1:00 pmA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health -
Monday, Nov 18
1:00 pmA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura Consulting -
Monday, Nov 18
1:00 pmA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting Group -
Monday, Nov 18
1:00 pmA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of Florida -
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 pmA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of Health -
Monday, Nov 18
1:00 pmA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric Institute -
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 pmA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical Center -
Monday, Nov 18
1:00 pmA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science Foundation -
Monday, Nov 18
1:00 pmA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico -
Monday, Nov 18
1:00 pmA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of Health -
Monday, Nov 18
1:00 pmA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New Hampshire -
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 pmB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – Advarra -
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 pmB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLP -
Monday, Nov 18
2:45 pmB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Michele Kennett, JD, MSN, CIP – University of Missouri -
Monday, Nov 18
2:45 pmB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309
Warren Capell, MD – University of Colorado Denver; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New Mexico -
Monday, Nov 18
2:45 pmB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital; Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia -
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 pmB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103
Lisa Denney, n/a – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical Center -
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 pmB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Joseph Crossno, MS, CPIA – Central Michigan University -
Monday, Nov 18
2:45 pmB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201
Melissa McGee, J.D. – University of New Hampshire; Heather H. Pierce, JD, MPH – Association of American Medical Colleges -
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 pmB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300
Jyoti Angal, MPH CIP – Avera Research Institute; Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe); Anita B. Frederick, MS Management – Tribal Nations Research Group -
Monday, Nov 18
2:45 pmB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104
Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention -
Monday, Nov 18
2:45 pmB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH -
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 amC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom A
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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 amC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLP -
Tuesday, Nov 19
10:15 amC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health San Antonio -
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 amC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; P. Pearl O'Rourke, MD – Harvard Medical School -
Tuesday, Nov 19
10:15 amC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202
Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh -
Tuesday, Nov 19
10:15 amC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of Medicine -
Tuesday, Nov 19
10:15 amC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services; David J. Hudson, PhD – University of Virginia -
Tuesday, Nov 19
10:15 amC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health -
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 amC19 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 104
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute; Matt D. Stafford, MPH – Boston Children's Hospital -
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 amC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health -
Tuesday, Nov 19
10:15 amC08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs
Location: Room 200
Luke Gelinas, PhD – Advarra; R. Peter Iafrate, PharmD – University of Florida; Brenda J. Klement – Morehouse School of Medicine -
Tuesday, Nov 19
10:15 amC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM -
Tuesday, Nov 19
10:15 amC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103
Kate Gallin Heffernan, JD – Verrill Dana LLP; Todd W. Rice, MD – Vanderbilt University Medical Center -
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 amC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIH -
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
11:45 amA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111
Jason Gerson, PhD – Patient-Centered Outcomes Research Institute -
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 pmD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital -
Tuesday, Nov 19
3:45 pmD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203
Julia G. Gorey, JD – OHRP; Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. -
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 pmD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting Group -
Tuesday, Nov 19
3:45 pmD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine -
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 pmD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Emily M.Q Schriver, JD – The Ohio State University; Michael J. Vernick, JD – Hogan Lovells US LLP -
Tuesday, Nov 19
3:45 pmD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout -
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 pmD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard -
Tuesday, Nov 19
3:45 pmD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom A
Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Laura Odwazny, JD, MA – US DHHS -
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 pmD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea R. McDowell, PhD – Seattle University; Rachel Zand, PhD – University of Toronto -
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 -
Tuesday, Nov 19
3:45 pmD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State University -
Tuesday, Nov 19
3:45 pmD20 - Staying Current and Keeping Pace—A Primer for IRB Chairs
Location: Room 104
J. Andrew Bertolatus, MD – University of Iowa; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Kerry A. Agnitsch, PhD – Iowa State University -
Tuesday, Nov 19
3:45 pmD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312
John A. Guidry, PhD – TRX Development Soutions; Matan Benyishay, MPP – AIDS Action Committee/Fenway Health; Dana J. Pardee, BS – The Fenway Institute -
Tuesday, Nov 19
3:45 pmD22 - The Keys to Key Information—An Interactive Workshop
Location: Room 103
Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Jerry A. Menikoff, MD, JD – Office for Human Research Protections -
Tuesday, Nov 19
3:45 pmD23 - Challenges and Lessons for Implementing New Exemption 4(iii)—Secondary Research Involving Only Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule-Protected Identifiable Health Information
Location: Room 102
Kim Fowler, CIP, CIM – University of Georgia; Megan McFarland, MS, CIP, CCRP – Army Human Research Protections Office (AHRPO) -
Wednesday, Nov 20
10:00 amRepeat Breakout Session (A9): The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 302
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
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 (C3): Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Room 312
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer Institute -
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
10:00 amRepeat Breakout Session (E2): Strategies for IRB Member Education
Location: Room 304
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine; Toby L. Schonfeld, PhD – Prime Review Board -
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 amE07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309
Janet C. Donnelly, RAC – FDA; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of Kentucky -
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. -
IRB Members, Chairs, and Vice Chairs
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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
1:00 pmA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis -
Monday, Nov 18
1:00 pmA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of Health -
Monday, Nov 18
1:00 pmA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – Consultant -
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 pmA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug Administration -
Monday, Nov 18
1:00 pmA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health -
Monday, Nov 18
1:00 pmA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura Consulting -
Monday, Nov 18
1:00 pmA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting Group -
Monday, Nov 18
1:00 pmA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of Florida -
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 pmA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of Health -
Monday, Nov 18
1:00 pmA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric Institute -
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 pmA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical Center -
Monday, Nov 18
1:00 pmA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science Foundation -
Monday, Nov 18
1:00 pmA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico -
Monday, Nov 18
1:00 pmA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of Health -
Monday, Nov 18
1:00 pmA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New Hampshire -
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 pmB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – Advarra -
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 pmB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLP -
Monday, Nov 18
2:45 pmB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate<