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  1. Home

  • Sunday, Dec 3rd
    10:15 AM – 11:15 AM ET
    A03 - [IN-PERSON ONLY] Privacy on Display: What Kind of Private Information Is Open to the Public and How Does That Make Sense?
    Location: Room 152A
    Speaker: Mary Hanabury, PhDc, CIP (she/her/hers) – Northern Arizona University
    Speaker: Gencie Turner, PhD, CIP – OHRPP, University of California, Los Angeles
    Speaker: Rachel A. Wenzl, MPH, CIP – Research Compliance Services, University of Nebraska - Lincoln
    Resource Person: Ivor A. Pritchard, PhD (he/him/his) – Office for Human Research Protections, U.S.DHHS
    Informed ConsentResearch Conducted in the Digital WorldSBERLegal Considerations in Research Oversight
  • Sunday, Dec 3rd
    3:30 PM – 4:30 PM ET
    C02 - [IN-PERSON/RECORDED] Evaluating the Use of Third Party Sites in Online Research
    Location: Room 152B
    Speaker: Casey Mumaw, MA, CIP (he/him/his) – Indiana University
    Speaker: Laura Odwazny, JD, MA – US DHHS
    SBEREmerging Research Challenges and Breaking IssuesInformed ConsentLegal Considerations in Research OversightResearch Conducted in the Digital World
  • Sunday, Dec 3rd
    3:30 PM – 4:30 PM ET
    C06 - [ON-DEMAND] Major League Research With Minor League Players: Studies With Children Outside the Classroom Setting
    Presenter: Andrew Hedrick, MPA, CIP – The Ohio State University
    Presenter: Tiffany Chenneville, PhD (she/her/hers) – University of South Florida
    Informed ConsentPopulations Requiring Additional ProtectionsSBERHRPP/IRB Administration/Management and Process
  • Monday, Dec 4th
    1:00 PM – 2:00 PM ET
    A03 - [IN-PERSON/RECORDED] The Use of Artificial Intelligence (AI) for Informed Consent Form Development
    Location: Ballroom AB
    Speaker: Cecilia Brooke Cholka, PhD, CIP (she/her/hers) – Weill Cornell Medicine
    Resource Person: Michael Grippaldi, Esq., CIP (he/him/his) – The Office for Human Research Protections (OHRP), DHHS
    Speaker: Joel Seah, BSc – National University of Singapore
    Informed ConsentEmerging Research Challenges and Breaking Issues
  • Monday, Dec 4th
    2:15 PM – 3:15 PM ET
    B07 - [IN-PERSON ONLY] Supporting Informed Decision Making: How to Foster the Development of Understandable Research-Related Information
    Location: Room 201
    Speaker: Sylvia Baedorf Kassis, MPH – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
    Resource Person: Jaime O. Hernandez, JD, M.Be. (he/him/his) – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
    Speaker: Behtash Bahador (he/him/his) – Center for Information and Study on Clinical Research Participation
    Communication With the PublicEducation, Qualifications, and TrainingInformed Consent
  • Monday, Dec 4th
    3:45 PM – 4:45 PM ET
    C11 - [IN-PERSON ONLY] An Adult Lacks Capacity to Consent to Research... Now What Do I Do?
    Location: Room 150 AB
    Speaker: David Wendler, PhD – National Institutes of Health
    Speaker: Katherine D. Blizinsky, PhD (she/they) – National Institutes of Health
    Informed ConsentPopulations Requiring Additional Protections
  • Monday, Dec 4th
    3:45 PM – 4:45 PM ET
    C04 - [IN-PERSON/RECORDED] Exception From Informed Consent (EFIC): Overview and Common Pitfalls
    Location: Room 145 AB
    Speaker: Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I (she/her/hers) – Yale University
    Speaker: Pablo Morales, MD – Office of Clinical Policy / US Food and Drug Administration
    Speaker: Kevin A. Prohaska, DO, MPH (he/him/his) – Food and Drug Administration
    FDA Regulated ResearchInformed Consent
  • Tuesday, Dec 5th
    10:15 AM – 11:30 AM ET
    [IN-PERSON/LIVESTREAMED] Plenary Session: Informed Consent Perspectives from Those in the Room
    Location: Hall E
    Moderator: Stephanie S. Cargill, PhD MSPH (she/her/hers) – Saint Louis University
    Panelist: Devan Vaughn, CIP, CCRP (she/her/hers) – Cincinnati Children's Hospital Medical Center
    Panelist: Erin Chin, BS (she/her/hers) – Wisconsin Alzheimer's Disease Research Center
    Panelist: Stephanie A. Kraft, JD (she/her/hers) – Seattle Children's Research Institute
    Informed Consent
  • Tuesday, Dec 5th
    1:00 PM – 2:00 PM ET
    D01 - [IN-PERSON/RECORDED] Finding Our True North: Informed Consent as the Moral Compass in the SBER Seas
    Location: Room 145 AB
    Speaker: Andrew Hedrick, MPA, CIP – The Ohio State University
    Speaker: Tonya Ferraro, MEd (she/her/hers) – Boston Children's Hospital
    Resource Person: Marianna Azar, BA, MA, PhD ABD (she/her/hers) – Office for Human Research Protections (OHRP)
    Education, Qualifications, and TrainingInformed ConsentSBERHRPP/IRB Administration/Management and Process
  • Tuesday, Dec 5th
    4:00 PM – 5:00 PM ET
    E03 - [IN-PERSON/RECORDED] Key Information Sections Four years In: Where Are We and Where Should We Be Going?
    Location: Ballroom AB
    Speaker: Luke Gelinas, PhD – Advarra
    Speaker: Natalie M. Klein, PhD, CIP (she/her/hers) – DHHS Office for Human Research Protections
    Speaker: Nora Hutchinson, MD,CM (she/her/hers) – Department of Medicine, University of California, San Francisco
    Informed ConsentIRB Basics
  • Wednesday, Dec 6th
    8:30 AM – 9:45 AM ET
    [IN-PERSON/LIVESTREAMED] Plenary Session: Ethical Considerations for Using Generative Artificial Intelligence (AI) in Human Subjects Research‐‐Implications for IRB Regulation
    Location: Hall E
    Moderator: Brenda L. Curtis, PhD, MSPH (she/her/hers) – National Institutes of Health
    Panelist: Donnella S. Comeau, MD, PhD (she/her/hers) – Beth Israel Deaconess Medical Center
    Panelist: Mark Dredze – Johns Hopkins University
    Panelist: Jack Gallifant, MBBS, MSc – Masschusetts Institute of Technology (MIT)
    Emerging Research Challenges and Breaking IssuesInformed ConsentResearch Conducted in the Digital World
  • Wednesday, Dec 6th
    10:15 AM – 11:15 AM ET
    F04 - [IN-PERSON/RECORDED] Supported Decision‐Making: From the Law to the Bedside
    Location: Room 144 AB
    Speaker: Benjamin C. Silverman, MD – Mass General Brigham
    Speaker: Leslie Francis, PhD, JD (she/her/hers) – University of Utah
    Legal Considerations in Research OversightAdvancing Equity and Justice in ResearchInformed ConsentPopulations Requiring Additional Protections
  • Wednesday, Dec 6th
    11:30 AM – 12:30 PM ET
    G10 - [IN-PERSON ONLY] Innovative Strategies to Improve Readability of Informed Consent Forms
    Location: Room 202 AB
    Speaker: Marianna Azar, BA, MA, PhD ABD (she/her/hers) – Office for Human Research Protections (OHRP)
    Speaker: Ianthe Bryant-Gawthrop, MS, CRA, CIP (she/her/hers) – Purdue University
    Speaker: Rachel A. Wenzl, MPH, CIP – Research Compliance Services, University of Nebraska - Lincoln
    Speaker: Chris Witwer, CIP (she/her/hers) – National Institutes of Health, Intramural Research Program
    Informed Consent
  • Wednesday, Dec 6th
    11:30 AM – 12:30 PM ET
    G12 - [IN-PERSON ONLY] Recent Updates from FDA Guidances on Informed Consent and IRB Review for Expanded Access Use of Investigational Drugs
    Location: Room 150 AB
    Speaker: Jill Manning de Sousa, MPH (she/her/hers) – Boston Children's Hospital
    Speaker: Atasi Poddar (she/her/hers) – CDER/FDA
    FDA Regulated ResearchInformed Consent
  • Wednesday, Dec 6th
    1:45 PM – 2:45 PM ET
    H03 - [IN-PERSON/RECORDED] The Speech Act of Informed Consent
    Location: Room 145 AB
    Speaker: Stephanie A. Kraft, JD (she/her/hers) – Seattle Children's Research Institute
    Speaker: Ivor A. Pritchard, PhD (he/him/his) – Office for Human Research Protections, U.S.DHHS
    Informed Consent