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Ethics of Cancer Gene Transfer Clinical Research

  • Jonathan KimmelmanEmail author
Protocol
Part of the Methods in Molecular Biology™ book series (MIMB, volume 542)

Summary

Cancer gene transfer is a relatively novel intervention strategy. In part because of this novelty, trials often present greater uncertainties than those investigating more conventional approaches. In the following review, I examine how this greater uncertainty might affect how clinical studies are designed, when they are initiated, their degree of risk, and whether such risk can be justified in terms of therapeutic benefit. The review also discusses two other ethical issues presented by gene transfer clinical research: fairness in subject selection and communications with the public. I conclude with a series of recommendations directed toward researchers, policymakers, and ethics committee members.

Keywords

Cancer correlative studies ethics gene transfer informed consent phase 1 risk uncertainty value 

Notes

Acknowledgments

This work was funded by the Canadian Institutes of Health Research.

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Copyright information

© Humana Press, a part of Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Department of Social Studies of MedicineBiomedical Ethics Unit/McGill UniversityCanada

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