• Open Access

Integrating Bioethics into Clinical and Translational Science Research: A Roadmap

Authors

  • Robyn S. Shapiro,

    1. Center for the Study of Bioethics, Department of Population Health, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, Wisconsin 53226, USA
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  • Peter M. Layde

    1. Center for the Study of Bioethics, Department of Population Health, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, Wisconsin 53226, USA
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  • 1

    See The Human Cloning Prohibition Act of 2003, HR 234; and The Human Cloning Prohibition Act of 2001, HR 2505, which would make it a crime, punishable by a $1 million fine and up to 10 years in prison, for anyone knowingly (1) to perform or attempt to perform human cloning, whether reproductive cloning or research cloning; (2) to participate in an attempt to perform human cloning; or (3) to ship or receive for any purpose an embryo produced by human cloning or any product derived from such embryo.

  • 2

    See, e.g., Calif. Health and Safety Code sec. 24185 (prohibits cloning of human beings and sale and purchase of ovum, zygote, embryo, or fetus for the purpose of cloning a human being); La. Rev. Stat., title 40, sect. 1299.36.2 (prohibits cloning of human being, attempts to clone human being, and sale or purchase of ovum, zygote, embryo, or fetus with the intent to clone a human being; does not prohibit “scientific research or a cell based therapy not specifically prohibited elsewhere by this Part”); Mich. Comp. Laws Ann., chp. 333, sec. 333.16274 (prohibits human cloning and attempts to engage in human cloning); Gen. Laws of R.I. Ann., title 23, sect. 23–16.4–2 (prohibits cloning of human beings); and Va. Code Ann., sect. 32.1–162.22 (prohibits human cloning and implantation or attempt to implant product of somatic cell nuclear transfer into uterine environment so as to initiate pregnancy).

RS Shapiro (rshapiro@mcw.edu)

Abstract

Recent initiatives to improve human health emphasize the need to effectively and appropriately translate new knowledge gleaned from basic biomedical and behavioral research to clinical and community application. To maximize the beneficial impact of scientific advances in clinical practice and community health, and to guard against potential deleterious medical and societal consequences of such advances, incorporation of bioethics at each stage of clinical and translational science research is essential. At the earliest stage, bioethics input is critical to address issues such as whether to limit certain areas of scientific inquiry. Subsequently, bioethics input is important to assure not only that human subjects trials are conducted and reported responsibly, but also that results are incorporated into clinical and community practices in a way that promotes and protects bioethical principles. At the final stage of clinical and translational science research, bioethics helps to identify the need and approach for refining clinical practices when safety or other concerns arise. The framework we present depicts how bioethics interfaces with each stage of clinical and translational science research, and suggests an important research agenda for systematically and comprehensively assuring bioethics input into clinical and translational science initiatives.

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