Ethics and Stem Cells

Selected resources from The Hastings Center.

Table of Contents

Bioethics Briefings:

Stem Cells
Stem cells hold great promise for treating degenerative conditions such as Parkinson’s disease and diabetes, understanding genetic illnesses, and answering fundamental questions about human development. The main ethical objections are to human embryonic stem cell research, because early-stage human embryos are destroyed during the process of deriving their stem cells. Induced pluripotent stem cells, created by reprogramming human somatic cells, represents a new kind of stem cell research which doesn’t involve use of human embryos. Read our briefing to consider: what are the ethical and policy issues with the derivation and use of stem cells?

From Hastings Bioethics Forum:


From Hastings Center Report:

How to Rethink the Fourteen-Day Rule

First published: 24 May 2017

Abstract

Recently, attention has been drawn to the basic principles governing the use of human embryos in research: specifically, the so-called fourteen-day rule. This rule stipulates that human embryos should not be allowed to grow in vitro past fourteen days of development. For years, the fourteen-day limit was largely theoretical, since culture techniques were not sufficient to maintain embryos up to this point. Yet in the past year, research has suggested that growing embryos beyond fourteen days might be feasible and scientifically valuable. At the same time, work with pluripotent stem cells, including human PSCs, has shown that under certain conditions, they can form structures that recapitulate developmental features of the postimplantation embryo. This raises the possibility that PSCs could generate embryo-like structures in vitro, even “synthetic embryos,” that might provoke moral concern but would not fall under most current embryo research policies. In countries that permit embryo research, the fourteen-day rule has long been the linchpin of an effective policy compromise between what remain deeply divided moral positions on the human embryo’s status. It has also, particularly in the United Kingdom, been influential in establishing a bioethics public-policy process. Any moves to change the rule must consider not just the implications for the use of embryos but also the potential impact of this model of bioethical governance of science.

Backward by Design: Building ELSI into a Stem Cell Science Curriculum

First published: 05 May 2015

Abstract

Traditional methods of instruction can fail to produce enduring ways of learning, especially in rapidly changing disciplines in the life sciences. Educators and funding agencies are thus calling for new, integrated teaching approaches to address the life sciences. Hierarchical frameworks are being proposed as ways to tackle curricula with large numbers of concepts. Comparing lecture-based and interactive formats by measuring performance with pre- and post-tests indicated significantly higher learning gains and better conceptual understanding in the more interactive course. Other work has examined how the history of biology can be used to infuse relevance into the biology curriculum. In this paper, I describe a project at Stanford to create, implement, and evaluate an integrated curriculum in undergraduate stem cell education comprised of scientific, laboratory, and ELSI topics.

Can Human Embryonic Stem Cell Research Escape Its Troubled History?

First published: 21 November 2014

Abstract

Combining human embryonic stem cells with SCNT has been a gold standard of stem cell research. Adding a particular individual’s genes to pluripotent stem cells might lead to the development of personalized tissue repair or replacement. Enthusiasm for human embryonic stem cell research had flagged in recent years due to controversy over the moral status of in vitro embryos, scientific misconduct by researcher Woo Suk Hwang, and the discovery that induced pluripotent stem cells could be produced from somatic cells. Energy shifted to research on somatic cells, but three successes in the United States during 2013 and 2014 may reinvigorate embryonic stem cell research.

Not with a Bang, but a Whimper: Sherley v. Sebelius

First published: 11 January 2013

Abstract

After a tortuous legal process that resembled nothing so much as a game of chutes and ladders, on August 24, 2012, the United States Court of Appeals for the District of Columbia Circuit decided in favor of the Department of Health and Human Services’ position that human embryonic stem cell research is not research that harms embryos, and therefore is not a violation of the Dickey-Wicker Amendment. Bioethicists have been following this case because of our interest in the ethics and politics of embryonic stem cell research, but the final decision hinged largely on a series of rather arcane points of law and procedure.

Should We Call It Fraud?

First published: January 2012

Abstract

I recently had the opportunity to chair an interdisciplinary workshop on stem cell tourism—the practice, that is, of marketing unproven stem cell therapies for a wide range of diseases and disabilities, drawing patients from around the world. The goal of the event was to produce a statement to educate Canadian family physicians about this troubling and exploitative phenomenon. We wanted to keep the statement basic and straightforward. “Let’s simply call stem cell tourism what it is. It is fraud,” someone suggested. I wrote the word “fraud” on the flipchart at the front of the room, and everyone seemed comfortable with this frank declaration. But when I went to write up the first draft of our statement, I hesitated.

First published: May 2008

Abstract

President Bush’s compromise policy on human embryonic stem cell research, announced on August 9, 2001, provides federal funding for the research. However, it restricts the funding to research on cell lines derived before the announcement from embryos left over from infertility treatment and donated with informed consent. This policy would, said Bush, allow “us to explore the promise and potential of stem cell research without crossing a fundamental moral line, by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life.” The National Institutes of Health now has a registry of twenty-one lines that are eligible for funding and available for distribution.

Stem Cells from Skin Cells: The Ethical Questions

First published: January 2008

Abstract

Recently, research teams led by Shinya Yamanaka and James Thomson published separate reports that they had genetically modified human skin cells to behave like embryonic stem cells. Like their embryonic counterparts, these induced pluripotent stem cells (iPS cells) were capable of forming all three germ layers both in vitro and in immunodeficient mice, demonstrating their remarkable pluripotential character. Furthermore, the two teams’ iPS cell colonies were genetically matched to the human skin cells from which they were derived, thus enlivening the possibility that one day (perhaps soon) patient- and disease-specific pluripotent stem cells could be generated for research that could later yield downstream clinical benefits.

Human Research Cloning, Embryos, and Embryo-Like Artifacts

First published: September 2006

Abstract

Research suggests that cloning is incapable of producing a viable embryo when it is used on primate eggs. In fact, the entity created may not qualify as an embryo at all. If the results stand, cloning avoids the moral objections typically lodged against it, and cloning is itself an “alternative source” of stem cells.

The “Hinxton Group” Considers Transnational Stem Cell Research

First published: May 2006

Abstract

Science today is a transnational activity: scientists work across borders. The regulation of science is a national activity, however. Laws and ethical standards frequently differ across countries, of course, and this impedes science. Nowhere is the problem of variable national regulation more apparent than in human embryonic stem cell research, entangled as it is with controversies over the destruction of human embryos and their production through the process of nuclear transfer, or cloning. While there is a global consensus to ban human reproductive cloning, the regulation of therapeutic cloning and embryonic stem cell research varies among nations. The notorious scientific misconduct of Woo-Suk Hwang, which involved fraudulent claims that embryonic stem cell lines had been derived from cloned human embryos, prominently featured collaboration between U.S. and Korean researchers who had to deal with differing legislative and ethical regulations.

Stem Cells: A Status Report

First published: January 2006

Abstract

As stem cells move from basic science to clinical trials and eventually, perhaps, toward doctors’ offices, questions about the moral status of the embryo give way to questions about the conduct of the research and the development of therapies. This special set of essays assesses the state of play in the science and in the new debates attending it.

Stem Cell Research: The California Experience

First published: January 2006

Abstract

It has been nearly a year since the groundbreaking passage of Proposition 71, the law that created the California Institute for Regenerative Medicine (CIRM) and authorized bonds that would provide $3 billion in funding for stem cell research. As the first anniversary approaches, what is the state of human embryonic stem cell research?

Stem Cells: The Next Steps

First published: January 2006

Abstract

Often enough, moral debates are settled more by acclamation than by rational argumentation, and often acclamation means a preponderance of opinion rather than universal support, and frequently that preponderance is reached only by degrees, and reflected only in a change in the questions people are thinking about, rather than in any decisive exchange. One wakes up one morning and suddenly realizes that the debate has moved on, even though the initial question was perhaps never fully resolved. We may be at this point in the debate about whether to destroy embryos in order to do research on the embryonic stem cells they contain. In fact, perhaps the related debate about whether to engage in cloning in order to create new stem cell lines is also over.

Stem Cell Trials: Lessons from Gene Transfer Research

First published: January 2006

Abstract

Since 1998, when James Thomson and John Gearhart reported the first successful derivation of human embryonic stem cells and human embryonic germ cells, respectively, the scientific community has championed the therapeutic potential of these cells. Indeed, despite the restrictions on embryo research in some jurisdictions and despite the recent controversy surrounding the validity of the stem cell research conducted by Woo Suk Hwang, stem cells may soon enter their first human trials—possibly within a year.

Stem Cell Politics: The NAS Prohibitions Pack More Bark Than Bite

First published: November 2005

Abstract

Frustrated stem cell scientists in the United States have responded enthusiastically to the voluntary guidelines for human embryonic stem cell research published by the National Academy of Sciences in April 2005. One likely reason for their considerable enthusiasm: the guidelines include very few prohibitions on embryonic stem cell research. In fact, the NAS guidelines preclude only three research activities involving either human embryos or human embryonic stem cells: (1) the research use of human embryos beyond fourteen days (or the appearance of the primitive streak, if that comes first); (2) the creation of embryonic chimeras involving the transfer of human embryonic stem cells into nonhuman primate blastocysts or the transfer of any embryonic stem cells into human blastocysts; and (3) the breeding of any chimeras into which human embryonic stem cells have been transferred at any stage of development. None of these prohibitions is particularly prohibitive.

Stem Cell Protocols: The NAS Guidelines Are a Useful Start

First published: November 2005

Abstract

The National Academies’ Guidelines for Human Embryonic Stem Cell Research are not the first document to speak to the conduct of human embryonic stem cell research in the United States. The Clinton administration issued detailed guidelines for federal funding of embryonic stem cell research in 1999, President Bush issued his now famous version in 2001, and both the National Bioethics Advisory Council and the President’s Council on Bioethics have weighed in on the issue. Yet the previous guidance was of limited use. Some of it was formulated only for federally funded research, some of it could be considered out of date, and some of it was probably just too restrictive to meaningfully guide institutions and researchers who have already decided to move forward with the research. Thus the National Academies’ guidelines were received as filling a policy vacuum.

Stem Cells, Biotechnology, and Human Rights: Implications for a Posthuman Future

First published: March 2005

Abstract

If stem cell research led to therapies that changed the natural contours of human life, it would unsettle our ethical commitments, including the very notion of a human right, and encourage us to see the entire natural world, the human body along with it, as having the status only of material to be manipulated.

Public Stem Cell Banks: Considerations of Justice in Stem Cell Research and Therapy

First published: November 2003

Abstract

If stem cells fulfill their therapeutic promise, moving them from the laboratory into the clinic will raise several concerns about justice. One concern is that, for biological reasons alone, stem cell-based therapies might not be available for every patient who needs one. Worse, depending on how we address the problem of biological access, they might benefit primarily white Americans. We can avoid this outcome—although at a cost—by carefully selecting the stem cells we make available.

CONCEPTION to Obtain Hematopoietic Stem Cells

First published: May 2002

Abstract

A couple may have a child to provide stem cells for another child. They may also use preimplantation testing—even, troubling though it is, prenatal testing and selective abortion—to ensure a close tissue match.

Special Reports

Creating Chimeric Animals: Seeking Clarity on Ethics and Oversight

November/December 2022, Volume 52, Issue S2

Abstract

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human-nonhuman chimeric research.

Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human-nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human-centered questions about the ethics of “humanization” and this research’s potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less-siloed governance and oversight and more-comprehensive public communication.


From Hastings Center Bioethics Timeline

1996: Birth of Dolly

Dolly is cloned by researchers at the Roslin Institute in Scotland from an adult cell taken from the mammary gland of a 6-year-old Finn Dorset sheep and an egg cell taken from a Scottish Blackface sheep. Dolly’s birth demonstrates that specialized cells can be used to create an exact copy of the animal they came from. The birth of Dolly creates an awareness that ordinary cells can be reprogrammed to become pluripotent stem cells that can be grown into any tissue. Thus, Dolly led to advances in stem cell research.

https://dolly.roslin.ed.ac.uk/facts/the-life-of-dolly/index.html

1998: Deriving and Maintaining Human Embryonic Stem Cells

Dr. James Thomson and colleagues publish a paradigm shifting article in Sciencein which they report deriving human embryonic stem cells (ESCs) used in experimentation from donated embryos originally produced for in vitro fertilization. After informed consent and institutional review board approval, the human embryos are cultured and supported so that cells have the developmental potential to form derivatives of all three embryonic germ layers (endoderm, mesoderm, and ectoderm). These cell lines are thought to have great potential to be useful in human developmental biology, drug discovery, and transplantation medicine. Thompson’s experimentation paves the way for future experiments utilizing human ESCs.

https://science.sciencemag.org/content/282/5391/1145/

https://www.nytimes.com/2007/11/22/science/22stem.html/

2001: President George W. Bush’s Ban on Funding for Research on Human Embryonic Stem Cell Lines

President Bush presents a policy on federal funding for research on newly created human embryonic stem cells (ESC). President Bush acknowledges the importance of issues surrounding ESC research, presents different arguments in favor of and against ESC research, and explains his decision to limit but not completely eliminate potential federal funding for ESC research. More specifically, the policy specifies that federal funds can only be used for research on existing stem cell lines that are derived with the informed consent of the donors, from excess embryos created solely for reproductive purposes, and without any financial inducements to the donors. The policy specifies that research on lines created prior to that date continue to be eligible for funding. As a result, seventy-one cell lines meet the eligibility criteria, and researchers who wish to investigate these lines can still receive grants through the National Institutes of Health. However, only 21 stem cell lines are available and viable for research purposes. In the same speech, Bush establishes a registry of stem cell lines and announces the creation of a special council to oversee stem cell research. The ban against using federal funds for ESC research forces some researchers to create dichotomous research environments; one based on federal funding and another based on private funding. The ban also impacts international collaboration and communication.

https://embryo.asu.edu/pages/president-george-w-bushs-announcement-stem-cells-9-august-2001/

2004: California Proposition 71 (California Stem Cell Research and Cares Act)

The Act establishes the sale of general obligation bonds for stem cell research and research facilities. Proposition 71 establishes the California Institute for Regenerative Medicine.

M. T. Longaker, L. C. Baker, H. T. Greely, “Proposition 71 and CIRM—Assessing the Return on Investment,” Nature Biotechnology 25, no. 5 (2007): 513-21.

10.1038/nbt0507-513.

2007: Publication of John Harris’s Enhancing Evolution: The Ethical Case for Making Better People

In his 2007 book, John Harris endorses genetic engineering, stem-cell research, designer babies, and cloning. He argues that biotechnology makes human enhancement possible and in so doing biotechnology is good morally, for individuals, social policy, and good for future generations that need serious improvement. Biotechnology could allow us to live longer, healthier, and happier lives by, for example, providing us with immunity from cancer and HIV/AIDS. Biotechnologically driven enhancement could influence evolution to yield improved reasoning, concentration, and memory, strength, stamina, and reaction speed. He argues that it may not only be permissible but morally obligatory.

J. Harris, Enhancing Evolution: The Ethical Case for Making Better People (Princeton: Princeton University Press, 2007). https://press.princeton.edu/books/paperback/9780691148168/enhancing-evolution

2009: Funding of Embryonic Stem Cell Research 

The Obama administration announces it would expand National Institutes of Health funding for human embryonic stem research, which had been restricted under the Bush administration.

https://www.npr.org/templates/story/story.php?storyId=101653356