title: Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial.
abstract: The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal.
authors.affiliation: Rosh Yeshiva, Rabbi Isaac Elchanan Rabbinical Theological Seminary, the Rabbi Isaac and Bella Tendler Professor of Jewish Medical Ethics and Professor of Biology, Department of Biology, Yeshiva University, New York, USA.
authors.forename: Rabbi Moshe D
authors.initials: RM
authors.lastname: Tendler
authors.affiliation: Director of Special Programs, Center for Bioethics, Columbia University, New York, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: Loike