11:30 AM – 12:45 PM East Coast USA Time
E01 - A Dialogue With AAHRPP, Inc.Location: Room 29BA Dialogue With the Feds Track
Michelle M. Feige, MSW, LCSW-C – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 10675###Speaker @@@ Robert Hood, PhD – AAHRPP, Inc. ### 251843###Speaker @@@ Elyse I. Summers, JD – Association for the Accreditation of Human Research Protection Programs, Inc. ### 10699###Speaker @@@ Kate Vulakovich – The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 587411###Speaker @@@ Lori Kravchick – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 641618###Speaker11:30 AM – 12:45 PM East Coast USA Time
E02 - Two Offices Divided by a Common Goal: Conflict of Interest (COI) and IRBLocation: Room 22Institutional Officials and HRPP Leadership Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker11:30 AM – 12:45 PM East Coast USA Time
E03 - The Seven Habits of Highly Effective and Flexible IRBsLocation: Room 30ABBoundaries and Balances Track
Cecilia Brooke Cholka, MA, CIP – The University of New Mexico ### 585105###Speaker @@@ Jeffrey A. Cooper, MD, MMM – WIRB Copernicus Group ### 112600###Speaker @@@ Jonathan M. Green, MD, MBA – National Institutes of Health ### 420116###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E04 - Building Bridges Through IRB Education OutreachLocation: Room 31AEducating and Training Track
Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital Medical Center ### 10574###Speaker @@@ Colleen P. Gilrane, PhD – The University of Tennessee, Knoxville ### 420115###Speaker @@@ Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity ### 619387###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E05 - Correcting and Avoiding Noncompliance: Examining Real-life Cases Location: Room 32ABQA/QI and Post-Approval Monitoring Track
Martha Jones, MA, CIP – Washington University in St. Louis ### 59861###Speaker @@@ Charlotte H. Coley, MACT, CIP ### 112598###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E06 - FDA Clinical Holds and 21 CFR 50 Subpart D Location: Room 29AFDA Regulations Track
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker @@@ Kevin A. Prohaska, DO, MPH – Food and Drug Administration ### 10694###Speaker @@@ Donna L. Snyder, MD – Food and Drug Administration ### 587406###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E07 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures: Challenges, Cultural Considerations, Collaborations, and ExperiencesLocation: Room 30DGlobal Research Track
Edward E. Bartlett, PhD ### 10663###Speaker @@@ Derek Englis, MBA, EdS, CIP – Department of the Navy Human Research Protection Program (DON HRPP)/Armed Forces Services Corporation ### 585129###Speaker @@@ A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6 ### 587331###Speaker @@@ Sophea Sout – U.S Naval Medical Research Unit TWO, Phnom Penh, Cambodia ### 587408###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E08 - User Agreements in Human Subjects Research During the Burgeoning Technology AgeLocation: Room 25ABResearch Conducted in the Digital World Track
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University ### 284710###Speaker @@@ Megan Doerr – Sage Bionetworks ### 427699###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E09 - Ethical and Operational Issues Related to Clinical Trial Billing: What HRPPs and IRBs Should ConsiderLocation: Room 25CInstitutional Officials and HRPP Leadership Track
Keren R. Dunn, CIP – Cedars-Sinai Medical Center ### 10320###Speaker @@@ F. Lisa Murtha, Esq., CHC, CHRC – FTI Consulting ### 25713###Speaker @@@ Ann Rodavitch, MA – Memorial Sloan Kettering Cancer Center ### 248442###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E10 - IRB Review of Informed Consent: Moving Beyond the FormLocation: Room 33ABIRB 101 Track
Elizabeth A. Bankert, MA – Dartmouth College ### 57668###Speaker @@@ Joshua Fedewa, CIP – University of Texas Southwestern Medical Center ### 112607###Speaker @@@ Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) ### 251900###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E11 - The Role of the IRB Chair in Protocol Exceptions, Violations, Noncompliance, and Unanticipated ProblemsLocation: Room 28DEIRB Chairs Track
Jeremy J. Corsmo, MPH ### 58254###Speaker @@@ Madelon V. Baranoski, PhD, CIP – Yale University ### 433404###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E12 - Overlapping Roles of Data Safety Monitoring Boards (DSMBs) and IRBs in the Protection of Human SubjectsLocation: Room 30CIRB Operations Advanced Track
Michael J. Linke, PhD, CIP ### 248446###Speaker @@@ Robert Silbergleit, MD – University of Michigan Medical School ### 254860###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Roger J. Lewis, MD, PhD ### 21641###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E13 - Designing and Implementing Expanded Access ProgramsLocation: Room 31CPharma/Biotech Perspectives Track
Richard Klein ### 11087###Speaker @@@ Marjorie A. Speers, PhD – Clinical Research Pathways ### 420568###Speaker @@@ Walter L. Straus, MD, MPH – Merck Co., Inc. ### 11111###Speaker @@@ Erika L. Segear, PhD, RAC – Duke University School of Medicine ### 628387###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E14 - From Shield to Sword? How the 21st Century Cures Act and NIH Policy Have Altered Certificates of Confidentiality (CoCs)Location: Room 24ABLegal Track
Leslie E. Wolf, JD, MPH – Georgia State University College of Law ### 11120###Speaker @@@ Carrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker @@@ Catherine Sutherland – University of Colorado, Denver - Anschutz Medical Campus ### 594779###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E15 - Considerations and Strategies for Maximizing Contributions and Promoting Effective Communication for Non-Scientist and Unaffiliated IRB MembersLocation: Room 24CNon-Scientist IRB Members Track
Nathalia Henry, MS, CHRC, CIP – Northwestern University ### 586792###Speaker @@@ Stephen Poppel, PhD, CFA ### 593616###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E16 - Building a Better Biobank: Promise and Challenges of the National Cancer Institute Cancer Moonshot BiobankLocation: Room 29CResearch Involving Data and Biospecimens Track
Helen M. Moore, PhD – NIH/NCI ### 593597###Speaker @@@ Janet Freeman-Daily, MS, ENG – GrayConnections.net ### 593739###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E17 - Tribal Research Futures: Resources to Strengthen Governance, Trust, and Culture in Research PartnershipsLocation: Room 23APopulations Requiring Additional Protections Track
Yvette Roubideaux, MD, MPH – National Congress of American Indians ### 587398###Speaker @@@ Amber Emerson, MPH – School of Community Health Sciences, University of Nevada, Reno ### 645727###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E18 - Nuts and Bolts of Investigator Site AuditsLocation: Room 29DQA/QI and Post-Approval Monitoring Track
David A. Borasky, Jr., MPH, CIP – WIRB-Copernicus Group ### 10124###Speaker @@@ Stephanie deRijke, RN, MSN – Emory University ### 256471###Speaker @@@ Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh ### 10578###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E19 - Intersection of Research and Electronic Health Records With Privacy and Confidentiality Concerns: Considerations for IRB ReviewLocation: Ballroom 20AResearch Conducted in the Digital World Track
Gretchen L. J Anding, MA – University of Wisconsin-Madison ### 418825###Speaker @@@ Judith Birk, JD – University of Michigan ### 11062###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E20 - Data Acquisition and Management: Concepts Every Researcher and Research Administrator Should KnowLocation: Room 23CResponsible Conduct of Research Track
Carolyn Broccardo, PhD, PMP – University of Wyoming ### 420073###Speaker @@@ Bradley R. Woods, PhD – Colorado State University ### 302148###Speaker11:30 AM – 12:45 PM East Coast USA Time
E21 - Managing Small Research Programs in Healthcare SettingsLocation: Room 31BSmall Research Programs Track
Delilah Ofosu-Barko, BMSc – Trillium Health Partners ### 420160###Speaker @@@ Jennifer L. Pacheco, MPH, CIM, CIP ### 594020###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E22 - How to Create an Undergraduate Research Training ProgramLocation: Room 30ESBER Track
Jonathan M. Girard – Harvard University ### 586785###Speaker @@@ Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E23 - You Want to Do What? Developing Best Practices for IRB Review of Research Investigating Illegal/Illicit BehaviorsLocation: Room 28ABCSBER Track
Dean R. Gallant, AB – The HRP Consulting Group ### 10127###Speaker @@@ Sarah Trautz – Beth Israel Deaconess Medical Center ### 12697###Speaker @@@ Jeffrey M. Cohen, PhD – The HRP Consulting Group ### 11067###Speaker
