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  • Pre-Conference Program: Biobanking in an Era of Research Towards Precision Medicine: Approaches to the Ethical, Regulatory, and Practical Challenges

    The collection, storage, distribution and use of biospecimens from human individuals and subsequent data sharing is critical for the research advances and discoveries needed to advance precision medicine.  However, biobanking in an era of precision medicine raises significant challenges for Institutional Review Boards, institutions, regulators and policy makers, research repository managers, and funding agencies and sponsors.  Methods for obtaining consent vary from institution to institution; and the prospect of new regulatory requirements raises an element of uncertainty.  Broad sharing of biospecimens and data is absolutely essential for scientific discoveries to facilitate the development of precision medicine but raises a myriad of issues including those relating to obtaining meaningful consent; intellectual property and licensing issues as well as complex issues such as ownership of biospecimens and data, return of research results and other ethical issues.  Finally, broad specimen and data sharing are subject to current or prospective regulatory requirements that may conflict with ethical objectives relating to meaningful consent and confidentiality of participation in research activities.

    During Biobanking in an Era of Research Towards Precision Medicine: Approaches to the Ethical, Regulatory, and Practical Challenges, faculty and participants will examine these contemporary challenges, focusing on practical strategies for addressing them. This course will be an interactive, advanced educational workshop that will seek to integrate speaker and participant experiences and concerns. Program attendees should come with a thorough understanding of tissue banking issues, as fundamentals are not included in this course.  

    This program is eligible for 7.5 continuing education (CE) credit hours.

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    Agenda
    7:30-8:30 AMRegistration (breakfast on your own)
    8:30-8:45 AMWelcome and Introduction
    8:45-9:30 AM  Role of Specimens and Biobanking in Research Towards Precision Medicine and Biobank Design
    9:30-9:45 AM  Audience Questions and Answers/Panel Discussion
    9:45-10:15 AMWhat an IRB Should Look for in a Repository Protocol
    10:15-10:30 AM  Audience Questions and Answers/Panel Discussion
    10:30-10:45 AM  Break
    10:45-12:00 PM  What is Meaningful Consent for Future Use of Specimens? Best Practices in Governance and Specimen Access Policies; Stakeholder Engagement in an Era of Research Towards Precision Medicine
    12:00-12:30 PMAudience Questions and Answers/Panel Discussion
    12:30-1:30 PMWorking Lunch (please pick up your boxed lunch and return to the course room)
    1:30-2:30 PMThat's Mine! Commercial Use of Specimens, Ownership, Custodianship, Benefit Sharing, and Policies for Repositories
    2:30-3:00 PMAudience Questions and Answers/Panel Discussion  
    3:00-3:15 PM
    Break
    3:15-4:30 PMTell me, Tell me: Return of Research Results in Biobanking—When and How to do it, Efficiently, Effectively, and Ethically
    4:30-5:00 PMAudience Questions and Answers/Panel Discussion  
    5:00 PMAdjournment
    Please note this agenda is subject to change.