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Educational Session

Biotherapies, Cellular Therapies, and Immunotherapies

AM25-SN-18-L - Ensuring Ethical and Regulatory Compliance in Donor Collections for Advanced Therapies

Sunday, October 26, 2025
2:30 PM - 3:30 PM  PT
Location: 28BCDE

    Speaker(s)

  • Christina Lueck, MT, ASCP

    Sr. Director, Quality & Regulatory Services
    Blood Centers of America
    West Warwick, Rhode Island

    Disclosure(s): No financial relationships to disclose

    • Program Chair(s)

  • Vivienne Marshall, PhD

    Executive Director, Starting Materials & Clinical Services
    BioBridge Global
    San Antonio, Texas

    Disclosure(s): No financial relationships to disclose

    • Speaker(s)

  • Evan Delay, RN, MSN (she/her/hers)

    Director, Bloodworks Bio Donation Programs
    Bloodworks Northewest
    Seattle, Washington

    Disclosure(s): No financial relationships to disclose

Proposed Session Description: This session will explore the ethical and regulatory requirements for human subjects research compliance in donor collections for advanced therapies. As regenerative medicine advances, ensuring compliance with human research protections is essential. The session will provide an overview of key regulations, including FDA’s 21 CFR Part 1271 and HHS’s 45 CFR 46, with emphasis on subject rights, ethical considerations, and research standards when collecting and using human biological materials.
A key focus will be on determining when donor collections require human subjects research compliance and Institutional Review Board (IRB) oversight. Participants will gain clarity on federal definitions of human subjects research, informed consent requirements, and ethical considerations for using donor-derived cells in investigational therapies.
The session will also address best practices for developing donor registries and sample repositories, including ethical recruitment, reimbursement strategies, and safeguards for donor anonymity, data storage, and sharing for external research.
A detailed discussion on informed consent will cover essential elements for ensuring transparency, voluntariness, and donor comprehension of risks, benefits, and privacy protections, including HIPAA compliance for safeguarding donor health information.
Additionally, the session will cover documentation and privacy protections, outlining regulatory safeguards and best practices for record-keeping, regulatory binder guidelines, and compliance monitoring.
By the end, professionals will be equipped with the tools to navigate the regulatory landscape of donor collections, ensuring ethical research practices and donor protection.

Learning Objectives:

  • Determine When Human Subjects Research Compliance is Required – Identify scenarios in donor collections that necessitate compliance with FDA’s 21 CFR Part 1271 and HHS’s 45 CFR 46, including when Institutional Review Board (IRB) oversight is required.
  • Implement Ethical and Regulatory Best Practices – Apply ethical principles and regulatory requirements in donor recruitment, informed consent, and data privacy protections, including HIPAA compliance for handling donor health information.
  • Maintain Compliance Through Documentation and Oversight – Utilize best practices for record-keeping, regulatory binder management, and privacy safeguards to ensure compliance with human subjects research protections.