Clinical Research Seminars

Offered monthly, Clinical Research Seminars provide a learning opportunity for the research community on a number of topics within human subjects research. These seminars often include important ethical, regulatory, or implementation content. Organized by the CRRO, the seminar series is supported by the Clinical Translational Science Institute and the Office of Human Research Affairs.

Seminars are sixty minutes in length and are held remotely. Zoom meeting information will be provided prior to the seminar (usually 24 hours before) and will be sent only to those who have registered in advance. 

Seminars are designed for BU Medical Campus and BMC staff or those from affiliated institutions. Individuals from non-affiliated external organizations or institutions are unable to attend. Registrations must be completed using an institutional email address, no personal email addresses will be accepted. 

All previous seminar recordings and slides are available in our Seminar Library. 

Suggestions for future seminars are always welcome and can be submitted by completing our Training and Education Recommendation Form. 

 

Academic Year 2024-2025 Seminar Offerings – All seminars are scheduled for Wed. at 12-1pm (unless otherwise noted)
Check back often as information is continuously updated when topics and presenters are confirmed. Registration forms are available by clicking on the date for each seminar. 

Wednesday, May 21, 2025, 12pm – From Collection to Collaboration: Making the Most of Repositories and Retained Samples

Presenters:

  • Jamie Merrill, MPH, CIP – IRB Director, BMC/BUMC
  • Elizabeth Duffy, MA – Director, Laboratory and Biorepository Research Services Core, BMC

Synopsis:

This seminar offers an overview of the ethical, regulatory, and operational frameworks surrounding repository studies. Participants will learn how to distinguish between repositories and individual studies that retain materials for future use, clarifying key differences in purpose and oversight. The seminar will address the inherent limitations of repository studies and when obtaining consent for future unspecified use is appropriate. Finally, the seminar will explore essential operational considerations for maintaining repositories, including long-term funding strategies, data and material sharing mechanisms, and the development of appropriate agreements such as Data Use Agreements (DUAs) and Material Transfer Agreements (MTAs).

Learning Objectives:

By the end of the seminar, participants will be able to:

  1. Distinguish between a repository and a study that retains data/samples for ‘extra use’.
  2. Describe the limitations of repository studies, including why repositories cannot have their own scientific aims.
  3. Identify when consent for future unspecified use is required and how it applies to downstream/recipient studies.
  4. Determine when a recipient study qualifies as “not human subjects research” versus another human subjects research review path.
  5. Recognize key operational considerations for repositories, including maintenance, funding, and sharing agreements (DUAs/MTAs).

Wednesday, June 11, 2025, 12pm  – De-Identification of Data: Helpful HIPAA for Investigators

    Presenters:

    • Patricia Bass – Associate General Counsel, BMC

    Synopsis:

    This month’s seminar will discuss various data types and the regulations surrounding the protection of this data; we will delve into Protected Health Information, De-identified data, Limited Data sets, anonymous data, as well as European General Data Protection Regulation (GDPR) laws. We will discuss how this data is used, as well as common legal issues that arise when data is mishandled.

    Learning Objectives:

    By the end of the seminar, participants will be able to:

    1. Review HIPAA’s pathways for use and disclosure of PHI
    2. Learn to distinguish between a HIPAA limited dataset vs. deidentification
    3. Learn what de-identification means practically and legally, its limitations and applicability in case report forms and research study articles
    4. Ascertain the applicability of Data Use Agreements

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