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Tutorial: the Basic Science of Human Embryonic Stem Cell Research, and some Foundational Legal and Bioethical Issues

Two experts will conduct this tutorial on some of the basic scientific principles and legal and bioethical issues underlying human embryonic stem cell research.
- Michael Shelanski (Columbia University)
- Pilar Ossorio '97 (University of Wisconsin at Madison Law School ~ Visiting at Boalt Hall School of Law, UC Berkeley) (Requires RealPlayer)

 

 

Subject Listings (some entries may be cross-listed)

Ethics

  • The Hunting of the Snark: The Moral Status of Embryos, Right-to-Lifers, and Third World Women
  • Revisiting Sex Selection: The Growing Popularity of New Sex Selection Methods Revives an Old Debate
  • Legal and Ethical Approaches to Stem Cell and Cloning Research: A Comparative Analysis of Policies in Latin America, Asia, and Africa
  • What Are the Roles and Responsibilities of the Media in Disseminating Health Information?
  • Cloning/Embryonic Stem Cells
  • Stem Cells and Xenotransplantation: Ethics, Patents and Politics (Transcript)
  • Questioning Commodification (Book Review)
  • Will it never end?
  • Making Parents: Ontological Choreography, a Biomedical Mode of Reproduction, Methods, Reading This Book, and Where I Stand

Policy

  • Legislators as Lobbyists: Proposed State Regulation of Embryonic Stem Cell Research, Therapeutic Cloning and Reproductive Cloning
  • The Hunting of the Snark: The Moral Status of Embryos, Right-to-Lifers, and Third World Women
  • The California Stem Cell Research Program at One Year: A Progress Report
  • How Can You Patent Genes?
  • Antitrust for Patent Pools: A Century of Policy Evolution
  • California's Biomedical Industry: 2004 Report
  • Cloning/Embryonic Stem Cells
  • Stem Cells and Xenotransplantation: Ethics, Patents, and Politics - An Industry Roundtable (Transcript)
  • "Assemblymember Dave Jones discusses the hearing on Proposition 71" (Interview)
  • "Implementation of Proposition 71: Options for Handling Intellectual Property Associated With Stem Cell Research Grants" (Transcript)
  • Comparative Perspectives and Policy Learning in the World of Health Care
  • Profit Neutrality in Licensing: The Boundary Between Antitrust Law and Patent Law
  • Property Rights Theory and the Commons: The Case of Scientific Research
  • Policy Brief: The Painful Implementation of California’s Stem Cell Research Program
  • Property, Privacy, and the Human Body
  • Debate grows over return from stem cell program
  • Testimony of Joan I. Samuelson, President, Parkinson's Action Network, Before the Senate Appropriations Subcommittee on Labor, Health and Human Services Education and Related Agencies
  • Medical Error and Patient Safety: Understanding Cultures in Conflict 
  • Time for stem cell research: Protect our investment by resolving all issues

Research

  • Issues in Oocyte Donation for Stem Cell Research  (Subscription Req'd)
  • Doug Melton: Crossing Boundaries (Serialization from The Geneticist Who Played Hoops with My DNA)
  • All Motifs are not Created Equal: Structural Properties of Transcription Factor - DNA Interactions and the Inference of Sequence Specificity
  • Incremental Treatment Costs in National Cancer Institute-Sponsored Clinical Trials
  • Cloning/Embryonic Stem Cells
  • A New Era in the Ethics of Human Embryonic Stem Cell Research
  • Academic patent quality and quantity before and after the Bayh–Dole act in the United States
  • "Open and Collaborative” Research: A New Model for Biomedicine
  • The Charitable Trust as a Model for Genomic Biobanks

 

 

Alphabetical Listings

Title: Legislators as Lobbyists: Proposed State Regulation of Embryonic Stem Cell Research, Therapeutic Cloning and Reproductive Cloning
Author: Lori Andrews
Date: 2004
Publication: Monitoring Stem Cell Research: A Report of the President's Council on Bioethics (Government Printing Office)
Abstract: In a paper commissioned for President Bush's Council on Bioethics, Andrews highlights discrepancies in the current state law landscape with respect to therapeutic cloning, reproductive cloning, and embryonic stem cell research. She suggests that due to widespread media attention and increased public debate, lawmakers have encountered difficulty in their attempts to form a cohesive legislative framework from which broad policies can be inferred.

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Title: The Hunting of the Snark: The Moral Status of Embryos, Right-to-Lifers, and Third World Women

Author: R. Alta Charo
Date: 1995
Publication: Stanford Law & Policy Review vol. 6, no. 5
Abstract: Policy dilemmas in areas such as embryonic life often focus on questions of moral status and �bioethics.� Charo suggests an alternative approach based on political philosophy and "political ethics" as a means of resolving these policy dilemmas.

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Title: Issues in Oocyte Donation for Stem Cell Research  (Subscription Req'd)
Authors: Mildred K. Cho and David Magnus
Date: June 17, 2005
Publication: Science vol. 308. no. 5729, pp. 1747 - 1748
Abstract: Stem cell research on human embryonic stem cells derived through use of oocytes originally obtained specifically for research and not for reproductive or medical purposes creates a new class of research subject. In this Policy Forum, the authors explore the ethical issues for those who perform such studies and for research donors.

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Title: Revisiting Sex Selection: The Growing Popularity of New Sex Selection Methods Revives an Old Debate
Author: Marcy Darnovsky
Date: January-February 2004
Publication: GeneWatch vol. 17, no. 1
Abstract: This article discusses various concerns regarding the growing use of prenatal sex selection techniques. Beginning with a general overview of historical reasons for sex selection and other forms of screening, Darnovsky argues that the selection debate is different from that of abortion politics. Current social preferences that may influence selection choices and the slippery slope towards eugenics are also addressed.

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Title: The California Stem Cell Research Program at One Year: A Progress Report
Authors: Marcy Darnovsky and Jesse Reynolds
Date: January 2006
Published by: The Center for Genetics and Society
Abstract: In November 2004 California voters approved Proposition 71, a ballot initiative authorizing $3 billion in tax-payer-supported bonds to support stem cell research. As part of this effort, the proposition established the California Institute for Regenerative Medicine (CIRM) to distribute funds and oversee the program. This progress report seeks to evaluate the performance of CIRM in three major areas: honoring the promises in Proposition 71, its record in establishing itself as an accountable and responsible governing body, and its record in establishing ethical safeguards and research standards. The report then assigns a grade to each area, provides a set of recommendations for improvement, and identifies key challenges that the program faces in the coming year and beyond.

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Title: Doug Melton: Crossing Boundaries (Serialization from The Geneticist Who Played Hoops with My DNA)
Author: David Ewing Duncan
Date: June 2005 Issue
Publication: Discover Magazine
Abstract: In this portrait of Dr. Doug Melton, a molecular biologist and the head of Harvard University's new stem cell institute, Duncan focuses on the eminent researcher's crusade to find a cure for diabetes. Melton's research and political advocacy became personal when his 6-month old son and later his 14 year-old daughter were diagnosed with the disease. His work outlived the Clinton presidency and predated both the Bush presidency and the discovery of the human genome. This article touches on the direction of Melton's research, his struggles to fund his research, and his personal views on the ethics of embryonic stem cell use.

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Title: All Motifs are not Created Equal: Structural Properties of Transcription Factor - DNA Interactions and the Inference of Sequence Specificity
Author: Michael Eisen
Date: 2005
Publication: Genome Biology 6:P7.
Abstract: Eisen challenges the widespread belief that a given transcription factor is equally likely to bind to any DNA motif. Rather, he and his colleagues suggest that transcription factors are targeted to specific DNA sequences, and that the specificity of interaction might direct searches for where on DNA transcription factors bind. Eisen advocates combining the rules of biochemistry and statistical analyses to predict where a given factor will bind, in order to further our understanding of the genome.

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Title: How Can You Patent Genes?
Author: Rebecca Eisenberg '79
Date: 2005
Publication: In Genetics: Science, Ethics and Public Policy: A Reader 131-45 (Originally published under the same title in Who Owns Life?, edited by D. Magnus et al., 2002.)
Abstract: In an attempt to answer �the question that [she] is asked most frequently and persistently,� Professor Eisenberg turns to the issue of gene patents and highlights the inherent difficulty of stretching the traditional patent system to cover genes and DNA. She points out that the traditional patent doctrines were made for a �bricks and mortar� world that could not have anticipated the advent of the era of the human genome. Nevertheless, Eisenberg suggests that the current means of offering gene patents is in accordance with the bedrock principle of awarding innovation on which the patent system rests.

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Title: Antitrust for Patent Pools: A Century of Policy Evolution
Author:
Richard J. Gilbert
Date:
2004
Publication:
2004 Stanford Technology Law Review 3
Abstract:
A history of the evolution of legal analysis in antitrust cases dealing with patent pooling arrangements. Restrictive licensing terms has been the most decisive factor in courts' determination of whether patent pooling arrangements have violated antitrust laws. If patents are not substitutes for each other, economic analysis suggests that restrictive licensing terms should not necessarily raise competition concerns.

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Title: Incremental Treatment Costs in National Cancer Institute-Sponsored Clinical Trials
Author: Dana P. Goldman et al
Date: 2003
Publication: Journal of the American Medical Association, 289(22)
Abstraction: As a result of uncertainty about the incremental costs from clinical trial enrollment, insurance companies are generally reluctant to reimburse direct patient care provided as part of a a clinical trial. Research of a NCI-sponsored clinical trial suggests that imcremental treatment costs for an adult patient are, on average, only 6.5% higher over a period of two years.

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Title: California's Biomedical Industry: 2004 Report
Authors: David L. Gollaher and Tracy Lefteroff
Date: June 2004
Published by: California Health Institute
Abstraction: An overview of California's biomedical industry: the industry defined, social and political threats, and addressing the issues.

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Title: What Are the Roles and Responsibilities of the Media in Disseminating Health Information?
Author: Merril Goozner et al
Date: July 2005
Publication: PLoS Medicine 2(7)
Abstraction: When reporting on the latest "breakthrough," medical reporters need to properly weigh the importance of the medical studies, to ask the right questions of researchers and their sponsors to determine the significance of the results, to present the data in a fashion meaningful to health-care customers, and to inform the readers of reseachers' conflicts of interests.

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Title: Cloning/Embryonic Stem Cells
Author: Kathi E. Hanna
Date: 2002
Published by: National Human Genome Research Institute, Ethical Boundaries Workshop
Abstraction: A review of the ethical and policy concerns surrounding the cloning of mammals and research using human embryonic stem cells.

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Title: Stem Cells and Xenotransplantation: Ethics, Patents, and Politics - An Industry Roundtable (Transcript)
Author: N/A
Date: June 2002
Published by: BioPharm
Abstraction: A transcript of a roundtable discussion of stem cell and xenotransplantation technology with legal experts and scientists, including Elizabeth A. Howard. Federal restrictions on research, the ethical questions surrounding the patenting of human biological materials, and the political ramifications of research are some of the topics discussed.

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Title: Legal and Ethical Approaches to Stem Cell and Cloning Research: A Comparative Analysis of Policies in Latin America, Asia, and Africa
Author: Rosario M. Isasi
Date: Winter 2004
Publication: Journal of Law, Medicine & Ethics vol. 32, no. 626
Abstract: This article surveys policies for human embryonic stem cell research and cloning in sixteen countries in Asia, Africa, and Latin America. It details policy development within each country and examines both the current policy framework as well and possible future directions.

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Title: "Assemblymember Dave Jones discusses the hearing on Proposition 71" (Interview)
Authors: Dave Jones and Marc Strassman
Date: October 31, 2005
Published by: Etopia Media News Network
Abstract: Assemblymember Dave Jones discusses the issues raised during the Oct. 2005 Joint Informational Hearing on Proposition 71 with Etopia Media News reporter Marc Strassman. Click here to go to the Etopia page for this interview.

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Title: �Implementation of Proposition 71: Options for Handling Intellectual Property Associated With Stem Cell Research Grants� (Transcript)
Author: N/A
Date: October 31, 2005
Publication: N/A
Abstract: Transcript of a Joint Informational Hearing of the Senate Health Committee, the Senate Subcommittee on Stem Cell Research Oversight, the Assembly Health Committee, and the Assembly Judiciary Committee, featuring testimony from Assemblymember Dave Jones and Perry Israel.

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Title: A New Era in the Ethics of Human Embryonic Stem Cell Research
Author: Bernard Lo et al
Date: 2005
Publication: Stem Cells vol. 23, pp. 1454–1459
Abstract: Increased funding and activity in the area of stem cell research has raised questions about privacy and informed consent. This article discusses the ethical issues surrounding research with and transplantation of human embryonic stem cells.

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Title: Comparative Perspectives and Policy Learning in the World of Health Care
Authors: Theodore R. Marmor, Richard Freeman and Kieke Okma
Date: December 2005
Publication: Journal of Comparative Policy Analysis vol. 7 no. 4
Abstract: Marmor, Freeman, and Okma seek to discover how competent learning in the field of health policy can occur among nations. The authors find that there is a great imbalance between the speed of information flows and the capacity of policymakers to learn useful lessons from them. Most policy debates are still parochial affairs which address national problems and emphasize national developments in pensions, medical finance, and transportation.

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Title: Profit Neutrality in Licensing: The Boundary Between Antitrust Law and Patent Law
Authors: Stephen M. Maurer and Suzanne Scotchmer
Date: June 2004
Publication: NBER Working Paper Series
Abstract: Patent licensing is an area where patent and antitrust law appear to conflict. Maurer and Scotchmer interpret caselaw and commentary to find three unifying principles for in patent licensing. The authors argue that these principles rationalize important decisions in the twentieth century and justify the Supreme Court's controversial decision in General Electric, holding that patentholders can set prices charged by their licensees.

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Title: Property Rights Theory and the Commons: The Case of Scientific Research
Author: Robert P. Merges
Date: 1996
Publication: Scientific Innovation, Philosophy, and Public Policy (Cambridge University Press)
Abstract: In this article Professor Merges addresses the contention that the availability of patents for scientific research has resulted in the over-commercialization of science in general. Merges opposes the view that property rights should be eliminated de facto from scientific research. He suggests that rather than blanket property rights, scientific research should be subjected to a more carefully crafted system in two specific ways: first, that certain �pure� and federally funded research be exempt from infringement; and second, that a cost-benefit analysis be applied to certain areas of research, which might result in their overall exclusion from the patent system.

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Title: Academic patent quality and quantity before and after the Bayh–Dole act in the United States
Authors: David C. Mowery and Arvids A. Ziedonis
Date: February 26, 2001
Publication: Research Policy 31.3
Abstract: This paper summarizes the results of empirical analyses of data on the characteristics of the pre- and post-1980 patents of three leading US academic patenters—the University of California, Stanford University, and Columbia University. We complement the analysis of these institutions with an analysis of the characteristics of the patents issued to all US universities before and after 1980.

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Title: Policy Brief: The Painful Implementation of California’s Stem Cell Research Program
Author: Roger Noll
Date: October 2005
Published by: Stanford Institute for Economic Policy Research
Abstract: This brief discusses the controversies surrounding the launch of the California Institute for Regenerative Medicine (CIRM), focusing on the main economic issue that has arisen: allocating the financial payoff from human embryonic stem cell (HESC) research.

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Title: "Open and Collaborative” Research: A New Model for Biomedicine
Author: Arti Rai
Date: August 10, 2004
Published by: SSRN
Abstract: According to the author, biomedical research has become increasingly proprietary and secretive. With this trend comes the concern that further advancement in the field will be stifled by overly restrictive limits to access and burdensome licensing requirements. One prominent solution is what has been termed �open and collaborative� science. This approach is similar to the �open source� methods of innovation applied in software development. In this article, the author provides observations on how the open and collaborative model actually works and whether such an approach is likely to promote socially desirable biomedical innovation.

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Title: Property, Privacy, and the Human Body
Author:
Radhika Rao
Date:
2000
Publication:
Boston University Law Review
Abstract:
What kind of autonomy do we have in our bodies? Is it the autonomy that individuals possess over a piece of property? Or is it the autonomy guaranteed under the constitutional right of privacy? The author addresses these questions within the context of privacy analysis and constitutionality.

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Title:Debate grows over return from stem cell program
Author:
Sandy Kleffman
Date:
November 01, 2005
Publication:
Contra Costa Times
Abstract:
This article addresses some of the prominent issues concerning government financing of stem cell research. The primary choice presented is between bond financing with special licensing agreements between the state and the researchers, financing while abandoning requirements for special royalties and licensing, or financing while guaranteeing lower prices for low-income Californians. Jean M. Ross argues that taxpayers should not be charged twice; once for funding the research and then again for the therapies once they are developed.

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Title:Testimony of Joan I. Samuelson, President, Parkinson's Action Network, Before the Senate Appropriations Subcommittee on Labor, Health and Human Services Education and Related Agencies
Author:
Joan Samuelson '77
Date:
May 22, 2002
Published by:
Parkinson's Action Network
Abstract:
Testimony of Joan Samuelson before the Senate on the cost Parkinson's disease, efforts to stop it, and the necessity of federal support for the effort to develop a cure.

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Title: Will it never end?
Author: Jeff Sheehy
Date: June 21, 2001
Publication: Bay Area Reporter
Abstract: This article describes the horror, frustration, and profound sadness that many people associate with AIDS. Written as a personal account, this article explores Jeff Sheehy's thoughts on the disease, including his belief that the situation will deteriorate before any meaningful treatments are discovered.

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Title: Questioning Commodification (Book Review)
Author: Marge Shultz '76
Date: December 1997
Publication: California Law Review vol. 85, no. 1841
Abstract: In Contested Commodities , Professor Margaret Radin concludes that commodification of such items as children, body parts, sexual relations, votes, and opinions, is a significant threat to personhood. Professor Marge Shultz takes issue with Radin's conclusion because of the possibility of a compatible relationship between human flourishing and commodification. Specifically, because Professor Shultz believes that subordination is the more significant problem, and also that personhood can be compatible with commodification, she prioritizes subordination, not commodification, as the focal problem. The case of Moore v. U.C. Regents is presented as an illustratration of the necessity of finding a way to accommodate both Radin's noncommodified, humanistic worldview and the market-commodity-alienability model Radin critiques.

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Title: Making Parents: Ontological Choreography, a Biomedical Mode of Reproduction, Methods, Reading This Book, and Where I Stand
Author: Charis Thompson
Date: 2005
Publication: MIT Press
Abstract: Assisted reproductive technology (ART) makes babies and parents at once. Drawing on science and technology studies, feminist theory, and historical and ethnographic analyses of ART clinics, Charis Thompson explores the intertwining of biological reproduction with the personal, political, and technological meanings of reproduction.

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Title: Medical Error and Patient Safety: Understanding Cultures in Conflict
Author: Joanna Weinberg
Date: April 2002
Publication: Law & Policy vol. 24, no. 2
Abstract: Evidence documenting the high rate of medical errors to patients has taken a prominent place on the health care radar screen. This paper discusses the multiple factors responsible for the change in the culture of health care. First, the culture has shifted from a clinician cantered system, in which decision making is one-and patient, and, often, between administrator or payer. Second, the nature of quality in health care has changed due to the geometric increase in the availability of technological and pharmaceutical enhancements to patient care. Third, the health care culture continues to rely on outdated models of conflict resolution. Finally, the regulatory structure of health system oversight was set in place when fee-for-service care governed physician-patient relationships and where few external technologies were available. In the current health care culture, that structure seems inadequate and diffuse, with multiple and overlapping federal and state regulatory structures that make implementation of patient safety systems difficult.

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Title: Time for stem cell research: Protect our investment by resolving all issues
Authors: Dana Welch
Date: February 19, 2006
Publication: San Francisco Chronicle
Abstract: Stem cell bill Prop 71 has endured a variety of delays, setbacks, and legal attacks. BCLBE Executive Director Dana Welch discusses these and other obstacles, highlighting the need to carefully examine the bill's legal, ethical and medical ramifications.

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Title: The Charitable Trust as a Model for Genomic Biobanks
Authors: David E. Winickoff and Richard N. Winickoff, M.D.
Date: September 18, 2003
Publication: The New England Journal of Medicine vol. 12, no. 349
Abstract: Advances in bioinformatics and genetics have made collections of biologic specimens and medical information valuable for pharmacogenomic research. Private biobanks are amassing millions of samples, and health centers seem ready to supply them. Several problems arise from the storage of biologic specimens, including issues with informed consent, institutional review boards, and property rights and benefits. This paper proposes a charitable trust model to remedy the problems created by the collection of biologic specimens. It is argues that the charitable trust is a promising legal structure for handling such a set of obligations, for promoting donor participation in research governance, and for stimulating research that will benefit the public.

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