Gene Therapies: Probing the Ethics - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Topic: Gene Therapies: Probing the Ethics (open to all)

There is understandable excitement about the potential for cellular products and gene therapies to transform the therapeutic landscape for many medical conditions. Although a number of cell and gene therapy therapies have already been approved and are available on the market, hundreds more are in various stages of research and development. However, this new class of therapeutics raises distinctive ethical issues that deserve careful consideration. Cell and gene therapies may have a transformative impact on research participants, manifesting not only in extended benefit but also in the need for additional safety monitoring far beyond what is typical in clinical research. Further, individuals can generally participate in only one of several clinical trials investigating possible treatments for the same condition and may need to forego alternative treatments that are developed in the future.  Finally, there are issues of access to these experimental therapies. These features of cell and gene therapies can raise the stakes, making questions about how to apply traditional bioethical principles of autonomy, beneficence, non-maleficence, and justice more challenging.  How can researchers and developers of cell and gene therapies design trials with due consideration for the distinct ethical issues raised by these therapies? Given the significance of the choice to receive cell and gene therapies and how this may impact and/or limit future options, what are best practices for the informed consent process?  What key information should be disclosed to potential participants and caregivers and what measures should be taken to ensure comprehension? How does the acuity, instability, and chronicity of the disease impact these decisions? In this session, we will consider these ethical issues and others, assessing them in light of the need for scientifically robust research on cell and gene therapies while striving to do justice to research participants, patients, and their families.

Please find the suggested pre-reads here:

https://mrctcenter.org/wp-content/uploads/2023/12/Ward-Clinical-Therapeutics-2022.pdf

https://mrctcenter.org/wp-content/uploads/2023/12/Bateman-House-et-al-Pharmaceutical-Medicine-2023.pdf

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This meeting is part of the MRCT Center’s 2023 Annual Meeting in Boston on December 13-14 and is open to all registrants at no cost. Guests are welcome to attend the entire program or individual sessions. While in-person attendance is encouraged, virtual participation is welcome.

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Deliverables