Abstract
Regenerative medicine has grown to include many kinds of cells, materials, and novel techniques. As the field matures, new questions arise about how best to deal with ethical, legal, and social issues arising from emerging knowledge and innovations and what kind of governance is appropriate. Such issues are usually related to broader social and political currents occurring contemporaneously. Yet much of the ethics and policy literature continues to focus on older issues characterizing earlier phases of the field. This chapter provides an overview of the book plus additional perspectives on trends in law, policy, social climates and technological as well as institutional innovations that may affect future practices. Attention to the way emerging ethical, legal, and technological aspects of regenerative medicine affect each other rather than viewing them as discrete domains would help researchers, policymakers, project managers, and ethicists more effectively engage with the issues.
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Notes
- 1.
In a survey of tissue engineering journal articles, for example, embryo use and cloning overwhelmingly dominated the range of potential ethical topics of interest (de Vries et al. 2008).
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- 3.
A collection of reflections by philosophers and religious leaders appears in Holland et al. (2001). Discussions of issues important in early stages of determining public policy can be found in an archive of the National Bioethics Advisory Commission reports on stem cell research, at http://bioethics.georgetown.edu/pcbe/reports/past_commissions/nbac_stemcell1.pdf. See also Cohen (2007) for US debates and for Europe, Gottweis et al. (2009). Debates about the use of embryos in research in general can also be found in Brock (2010), Singer and Kuhse (1986), and the original NIH Human Embryo Research Panel Report (1994).
- 4.
Debates about the use of embryos in research in general can also be found in Singer and Kuhse (1986) and the original NIH Human Embryo Research Panel Report (1994). The debates primarily pitted potential therapeutic benefit of the research against cultural and religious meanings of nascent life. There are also important matters related to the derivation of lines from embryos, the timing and manner of request for donation, and disposition of embryos, which are discussed in Chap. 6, Sects. 6.2.2 and 6.3.1 of this volume.
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Cosignatories of the complaint included Nightlight Christian Adoptions (a nonprofit, licensed adoption agency dedicated to protecting and finding adoptive parents for human embryos conceived through in vitro fertilization), the Christian Medical Association, and “all individual human embryos whose lives are now at risk”.
- 7.
The DHHS authorizes funds for the NIH, the major federal funder of research in the USA. Part 45 CFR 46.204 and 207 of Public Health Service Act defines an embryo as: “any organism not protected as a human subject under 45 CFR 46 as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.” SEC. 509 of the code specifies that (a) none of the funds made available in this act may be used for (1) the creation of a human embryo or embryos for research purposes or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act [1](42 U.S.C. 289g(b)) (Title 42, Section 289g(b), United States Code).
- 8.
HR2433 found at http://www.govtrack.us/congress/bills/113/hr2433.
- 9.
Developmental biologist Karen Downs, among others, argues that fertilization is a process rather than a single instant and that in mammals, individuation does not occur until the point at which embryonic cells become entirely separate from extraembryonic tissue that surround it (2008). This may not sway some philosophers, abortion foes, and some religious traditions which hold that every cell is sacred because of the potential to become a human life. Charo takes up the arguments about potentiality and describes how various policy bodies in the USA have tackled the problem of potential in the context of cloning, which might also be applied to the later development of induced pluripotent stem cells (2001; see also the rebuttal from DiSilvestro 2006).
- 10.
Currently, the proposed bill states that every human being shall have all the legal and constitutional attributes and privileges of personhood and defines a human as “each and every member of the species homo sapiens at all stages of life, beginning with the earliest stage of development, created by the process of fertilization, cloning, or its functional equivalent.” The term “fertilization” is defined as “the process of a human spermatozoa penetrating the cell membrane of a human oocyte to create a human zygote, a one-celled human embryo, which is a new unique human being.” The complete text of the most recent bill at the time of publication is found at http://thomas.loc.gov/cgi-bin/query/z?c113:H.R.23.
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It is generally thought that about 70 % of fertilized eggs never implant (Downs 2008). Arizona’s legislation was modeled on the “Pain-Capable Unborn Child Protection Act” forwarded by the National Right to Life Committee. Other states are considering similar language.
- 12.
Dubow (2011) provides an excellent analysis of the history of politics around the fetus. She describes long-standing attempts to view fetuses as separate individuals rather than as a neutral entity or a part of the gestational mother. The first US court case regarding a legal claim on behalf of a fetus was Dietrich v Northampton, in 1884, in which a woman sued a city for loss of life when she miscarried after a fall on city property. Definitions of fetuses as “patients” and “deceased minors” are increasingly beginning to appear in state legislatures for purposes beyond abortion. Wisconsin Assembly Bill 160 (2013) states that for purposes of a medical malpractice claim, the term “patient” includes an unborn child and defines “unborn child” as a human being from the time of fertilization to the time of live birth.
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- 14.
From the Memorandum opinion: “this admission [that process of culturing cells involves many steps] supports the conclusion that the biological characteristics of the cells change during the process employed by Defendants, resulting in more than minimal manipulation of the HCT/Ps originally extracted from the patient.” Regarding the interstate commerce clause, the finding was that “one or more of its components is shipped via interstate commerce and because it substantially affects interstate commerce by depressing the market for FDA-approved out-of-state drugs by encouraging individuals to travel to Colorado to have the Regenexx Procedure performed instead. Therefore, because a component of the drug in this case is shipped through interstate commerce prior to its administration to the patient, the ‘interstate commerce’ requirement is also met.” For the full opinion of U.S. v Regenerative Sciences, LLC, see https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2010cv1327-47.
- 15.
- 16.
HR 2272, the “America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science” (America COMPETES Act) is intended to strengthen research and education in the USA related to science, technology, engineering, and mathematics. The Act also establishes an Office of Innovation and Entrepreneurship to foster innovation and the commercialization of new technologies, in order to promote economic growth in the USA. It specifically contains provisions for open data sharing and responsible conduct of research, mandating RCR training for recipients of National Science Foundation grants (sec 7009–7012.) The Act was reauthorized in 2010 (HR 5116).
- 17.
Asahi Shimbun (editorial), found at http://ajw.asahi.com/article/views/AJ201306280044.
- 18.
- 19.
cf Moore v Regents of the University of California (51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479. An excellent discussion of the legal and ethical issues of ownership in human biomaterials is found in (Charo 2006).
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Hogle, L.F. (2014). Contemporary Issues in Regenerative Medicine Research Ethics and Governance: An Overview. In: Hogle, L. (eds) Regenerative Medicine Ethics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9062-3_1
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