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Historical Context of the Ethical & Political Stem Cell Debate You should generally understand the aspects

of political/social change that occurred in the 1960s/early 1970s. All about recombinant DNA 1. What is recombinant DNA? rDNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, such as combining the genetic material of two humans, or a human and animal, etc. 2. How is recombinant DNA created? Include enzymes. DNA is cleaved from two different sources with the same restriction enzyme (such as EcoRI). The fragments are mixed. The stick ends of the fragments will join by base pairing. The strands should then be incubated with DNA ligase to link both strands covalently. 3. Why was rDNA such an issue in the first few years after the method was discovered? Why were people worried about rDNA? Explain what happened in the early to mid-1970s both scientifically and politically (e.g. the first Gordon conference, the Berg letter, the AsilomarConference). Not necessary for the exam but just if youre interested: theres an interesting Wiki article on the Asilomar conference. The mixing of DNA from two different species, even though this was not always true, frightened people. There were possibilities of contamination, concerns of health issue, etc. Many people also feared the creation of monster hybrid creatures, such as humans with mice features. 4. Why does the rDNA debate in the 1970s matter for the current hESC debate? Consider how scientists, government officials and the public dealt with this important new scientific technology and how this may have set an example or created context for the current debate. The controversy over rDNA would lead to the Asilomar Conference, which was the beginning of molecular genetics and biomedical sciences to the public eye. From then on, politics and science would gradually begin to mix, and of course, politics is a major part of hESC research today. They were both highly controversial. Gene therapy Issues 5. What is the basic idea behind gene therapy? Essentially, inserting, altering, or removing genes from an individuals cells and tissues to treat a specific disease. 6. What happened when researchers tried to bring gene therapy into the clinic Genes were inserted in patient Jesse Gelsinger to cure his diseases. However, he suffered a major immune reaction against the vector that transported the genes, leading to his eventual death. 7. What were possible reasons for the difficulties/tragedies and what can we learn from that for doing hESC clinical trials? A major reason was the researchers did not fully understand the implications of transporting the gene via a vector. They should have done more research and learned every little detail before conducting a clinical trial. So with hESC clinical trials, tests must be run constantly. More research has to be done to ensure that the cells are as safe as can be. Otherwise, scientists run risk of killing their patients prematurely due to ignorant practice. IVF 8. What is IVF (for reproductive purposes)? How does it work? Explain the process starting with when a couple comes to a fertility clinic. IVF, in vitro fertilization, is an artificial insemination outside the body, creating embryos. Women must first go through hormonal therapy to stimulate the production of extra oocytes, which are then extracted from the ovary. The embryos are implanted into the woman after three to five days following fertilization. Extra embryos must be created, as quality can vary and there is a high chance of failure of implantation. Once pregnancy is confirmed, the rest of the embryos, called supernumerary embryos, are frozen at -310 F. They may be preserved if the couple wishes. However, payments are due annually. The embryos may also be donated to other couples, to medical research, or discarded. 9. What are the risks for the woman? There are a few. In some cases, hyperstimulation of the ovaries may occur, resulting in swollen, painful ovaries. There is also a chance of bleeding, infection, and damage to surrounding area. Also, in moderate cases, the

ovaries may swell and fluid can accumulate in the abdominal cavities, causing symptons such as abdominal pain, nausea, vomiting, etc. 10. What options do parents have for surplus embryos? Discard, donate to other couples, donate to research, store at a price. Abortion and Roe v. Wade: 11. Be able to discuss the political abortion debate what are the main movements in the US? The pro-choice movement, in which people say that it is a womans right to do what she has to on her own body, and therefore abortion is legal and morally permissible. The pro-life movement, in which people say that abortion is morally wrong and should be deemed illegal. 12. What was Roe v. Wade about? Describe the decision overall and with regard to the timeline of pregnancy. You need to be able do discuss Roe v. Wade in as much detail as we covered in lecture. The trial was a Supreme Court case in 1973. A Texas state law had prohibited abortion, and Jane Roe (Norma McCorvery) went up against Dallas County attorney Hendry Wade. The decision of the trial was that the Texas law violated the right to privacy under the due process clause in the Fourteenth Amendment, allowing women to have a decision. However, there were restrictions. During the first trimester, the abortion decision and its effectuation would be left to the medical judgment of the womans attending physician. In the second trimester, the state may choose to regulate the abortion procedure in ways that are reasonably related to maternal health. In the third stage, the State, in promoting its interest in the potentiality of human life, may choose to regulate and prohibit abortion except when it is absolutely necessary for the preservation of the life or health of the mother. 13. What kind of trade-off lies at the heart of the ethical abortion debate? If the mothers health is in danger because of the pregnancy, should abortion be permissible? 14. What are similarities and differences between the abortion and stem cell debate? Abortion Stem Cell Similar y Both involve the destruction and killing of an unborn, developing human. y Both are highly controversial. y Society potential benefits (cultivation of EGCs in abortion.) Different y Abortions occur posty hESC are cultivated preimplantation. implantation. y The mother and/or couple y Society potentially benefits. benefit(s). y One destroyed embryohow many people benefit? y One babyone mother benefits. hESC Ethical Debate Overall issues 1. What is the core of the hESC ethical debate? What do most people agree and disagree on? The core of the ethical debate is the moral status of the embryo, and therefore whether it is morally permissible to destroy the embryos. Most people agree that development of new therapies is desirable, as it can help many people. 2. Define the term moral status in your own words. Note the difference between moral status and full moral status. Something that every living being has, in which we essentially assign a status to them to represent how they should be treated, and when it is okay to do certain things for beneficial reasons, at the possible expense at their lives. Gradualist and Restrictive Perspectives 3. Discuss the key features of the restricted position and those of the gradualist position. What are differences, what are similarities? Restricted: y From the zygote stage, human embryos have deserve unrestricted protection as granted to any born individual. y The reason for this is that the embryo has the potentiality to become a born human being.

Gradualist: y Moral status of the early embryo differs from later stages; level of protection to be granted increases as certain stages of development are reached. y Embryo/fetus is granted same level of protection only if certain qualities are characteristic of the moral subject. Both: y Early human life is a good which has value independent of the approval of other individuals and therefore ought to be respected. 4. What is the basic idea of the potentiality argument? Is this argument based on a restrictive or gradual perspective? Essentially, if the embryo has the potential to develop into a born human being, then it deserves the full moral status of any other born human being. It is based on a restrictive perspective. 5. How does Lizza augment the potentiality argument? What does he propose is right and how does he support his view? What are his assumptions? Outline Lizzas reasoning step-by-step. Is hisargument based on a restrictive or gradual perspective? In the US Presidents Council on Bioethics, it is argued that, first of all, that an embryo, from the start, has the characteristic of becoming a fully developed human person. It then talks about embryos created outside the body, such as IVF embryos, arguing that though they may be limited in their ability to realize their natural capacities, it does not affect their potential, and therefore their moral status. It provides the example of a bird forced to live in a cage, never learning to fly. This does not mean it lacks the potentiality to fly. Lizza counters this argument by saying that potentiality is not determined by definition. Instead, it is empirical, involving the actual physical conditions. These conditions must be assessed, as they may restrict the embryos potential to become human. If it is assumed that the potential for embryos to become human gives them a special moral status, then some human embryos, such as ones with abnormal defects, do not have this status. Thus, he concludes by noting that if there are moral and legal reasons to create spare embryos to treat infertility, then there are moral and legal reasons to destroy the embryos if the parents give consent, therefore denying potentiality and removing moral status. 6. Discuss whether and when weighing protection of an embryo is allowed against other goods. Consider both restrictive and gradual positions. Restrictive: y Usually not allowed unless it is relative to the most highly valued goods. Gradualist: y It can be ethically justifiable, but an embryo that is a high-ranking good can only be comparable to other high-ranking goods. 7. Explain the individuality argument. Is this argument based on a restrictive or gradual perspective? A human embryo should be treated as an individual human life from the time when it is clear that twinning is no longer possible. This is usually around 14 days post-fertilization. The embryo should still be respected, but only individual human life must be protected. This is based off the gradualist perspective. 8. Explain the personhood argument in terms of when a human being has full moral status (i.e. theright to be protected). Explain the distinction this argument makes between a member of Homosapiens and a person. The argument makes a clear distinction between a human (member of Homo sapiens) and a person. A human who possesses the qualities of personhood, such as awareness of self, having an interest in its own continuing existence, etc. is considered a person. Therefore, persons are special, not humans, and they are the ones granted special moral status. Thus, since human embryos to not fit these qualities of personhood, they should not be granted moral status. Utilitarianism 1. What is the principle behind utilitarianism?

The principle behind utilitarianism is to think of all feasible decisions to make in a situation. Consider and compare these alternatives, and choose the one that will bring the greatest total amount of happiness. 2. How does the process of applying utilitarianism work, i.e. what is the method of utilitarianism? What and whom should one consider? y Consider your options. y Consider each options consequences. y Imagine the consequences on each person who will be affected. y Compare the options. y Choose the one that will bring the greatest total amount of happiness. 3. Apply utilitarianism to the hESC ethical debate. How can one justify hESC research or argue against hESC research using utilitarian thinking? Your options: no hESC research, limited hESC research, or fully endorsed hESCH research. Using utilitarian thinking, one has to consider each of these three options. How will they affect everyone who is involved? This includes the embryos themselves, patients, the couples, researchers, religious groups, doctors, cell therapy advocacy groups, etc. One can justify for or against one of these arguments by saying that in total, the option will bring the most or least amount of happiness. Kantian Ethics 4. What did Kant mean with reason and a rational being? Reason: a special faculty to find and set universal laws. Rational being: a being who possesses this faculty of reason. (Sense of duty): determination to do what one must do. 5. What is Kants basic idea of what we should do as moral human beings? We must respect our special faculty of reason, so we must use our sense of duty in proper ways and respect all persons who have this sense of duty. 6. Discuss the two main moral principles we examined. y The Formula of Universal Law: act only in accordance with that maxim through which you can at the same time will that it become a universal law. Use the same universal law in all similar situations. y The Formula of an End in Itself: So act that you use humanity, whether in your own person or in the person of any other, always at the same time as an end, never merely as a means. Use them only if they are willing to help and you repay them in some way. 7. Apply Kantian ethics to the hESC debate. Can Kants way of thinking be used pro or con hESCresearch or both? Pro-hESC research: Blastocysts do not have the ability to reason, so we do not have to respect them. Con-hESC research: Blastocysts have the potential for the ability to reason, so we must respect them. Throughout the policy part, you need to be very clear about the distinction of regulation of funding and regulation of research as well as regulation of embryo research and regulation of hESCresearch. Unless otherwise specified in the study questions, I expect you to know the sequence ofimportant events but you do not need to know the particular years presented in the policy lectureswith the exception of those pieces of legislation/regulation/policy that were marked in red onthe lecture slides. International Examples of hESC and Embryo Research Policy 1. What are the four major policy options for hESC research, i.e. what different kinds of limits can be set on hESC research and derivation? Restrictive: all human embryo research is prohibited, including that of ES cells Compromise: no production or destruction of human embryos for creating new ESC lines but research within existing lines (prior to a specific date) is allowed. Moderate: destruction of extra IVF embryos allowed to derive new ESC lines, but no production of human embryos for ESC research is allowed (no NT). Permissive:Production of human embryos for research is allowed through IVF or NT. 2. Be able to compare and contrast the policies of the countries we discussed in detail as case studies for the different policy options: Norway, Germany, Canada as well as the UK (and the US )

You need to know what kind of policy (broadly speaking) each country currently has. You should also know the major pieces of legislation/guidelines or reports (e.g. the Warnock report) for these countries that I stressed in lecture. You should be able to describe whether & how a countrys regulation has changed over time (e.g. Norway started out highly restrictive and within a few years become moderate) I expect you to know this in broad strokes (but you dont need to know every single group that contributed to a given change) Are these policies old (i.e. prior to 1998) or recent (post 1998)? Why is 1998 an important year for determining old and new in the hESC context? Which countrys policy regulates hESC/embryo research through funding (i.e. which research is specifically supported) and/or legislation (i.e. which kinds of research are expressly legal/illegal)? Policy Legislation Restrictive Biotechnology Act Update 2003: Government Norway Moderate determines it is ethically unacceptable to use therapeutic cloning to produce hESCs. Research on human embryos is still prohibited as in 1994. Also, research on hESC lines is prohibited. Biotechnology Act Update 2007: Government will allow research on supernumerary fertilized eggs under strict ethical guidelines. Compromise 1990: Embryo Protection Act: Germany Strict ban on any manipulation involving human embryos, except in the preservation of embryos. Stem Cell Act (2002): Imports of ESC lines allowed. April 2008: Parliament passes a new cut-off deadline for working with ESC lines: those created before May 1, 2007. Moderate Canada March 2002: Human Pluripotent Stem Cell Research Guidelines: Derivation of hESC lines from IVF embryos allowed if they were leftovers intended for reproduction, there is informed consent, if 3rd party donor consents to research, and if there is no money exchange. Creation of embryos for the purpose of deriving these cells specifically was prohibited. 2004 Assisted Human Reproduction (AHR) Act: Reproductive cloning prohibited. IVF regulated. AHR-related research (infertility, etc.) regulated. Applies only to derivation of stem cells from human embryos, not research on established lines. Use of IVF embryos allowed for hESC derivation under specific circumstances. Permissive 1984 WarnockReport: UK Prompted by IVF procedures. The embryo has a special status, though protection of early embryo (<14 days) may be traded off to achieve good for other human beings. 1990 Human Fertilization & EmbryologyAct: Licenses research in public and private sector on case-by-case basis. Originally was for embryo

research for infertility, miscarriage and congenital disease. Current HFEA: Derivation from surplus IVF embryos, IVF embryos created for research, or embryos created via SCNT for research. Licensing still required. US Funding

2. Give an example for why history matters in developing hESC legislation (e.g. Warnock report in England). Consider how Germanys recent history (20th century) influences its policy regarding embryo research. During the Holocaust, Nazi Germany was known for taking human subjects and conducting cruel experiments to them. Though hESC research is not nearly as bad, the public outcry against this could be damaging to Germanys reputation. Opponents could easily refer back to the Holocaust and compare hESC research to those acts of cruelty. US Federal Policy Federal policy in general 1. What is the Dickey-Wicker Amendment? Who is responsible for creating/maintaining the amendment? What does it regulate? During which administration was it created? Was/is it in effect during other administrations? Dickey-Wicker bans funding for human embryo research (specifically, destruction or creation of human embryos) except for reproductive purposes. It has been in effect every year since its passing in 1996. It was created by Congress. 2. You should generally be able to draw a meaningful comparison between the Clinton, Bush and Obama administrations. You should be able to place this in the general context of what was going on research-wise (e.g. when were the first hESC lines created). Administration Policy Clinton 1993 NIH Revitalization Act: Clinton gives NIH authority to fund human embryo research. 1996 Dickey-Wicker Amendment: Congress bans the use of federal funds for any experiment that creates/destroys human embryos. 1999: Dickey Amendment does not apply to hESC research, but creating or destroying embryos is still banned. Bush August 9th, 2001: Bush proposed cut-off date to the hESC lines being researched on for funding. Stem Cell Research Enhancement Act 2005/2007: Never became actual laws, but would have allowed funding of research on new hESC lines created from surplus embryos. National Academy of Science (NAS) 2005: Educated the public on the regulations of hESC research. Intended to enhance integrity of privately funded hESC research both in publics perception and actuality. Obama March 9th,2009: NIH funding allowed for hESC research, but only for hESC lines meeting the following conditions y Derived from surplus IVF embryos y Created for reproductive purpose, but no longer needed for said purpose y Informed consent requirements (Dickey Amendment still in effect.)

Clinton Administration

3. What was the hESC policy under Clinton in the last year of his office? Explain what Clinton allowed and congress prohibited with regard to embryo research and later hESC research (post 1998). Clinton allowed the NIH to fund human embryo research with the NIH Revitalization Act in 1993. He would note that the Dickey Amendment, which Congress passed to prohibit funding for destruction/creation of human embryos, would not be applied to hESC research. In other words, stem cell lines could be research on. 4. Would hESC research have been funded had his administrations policy continued during the Bush administration? Yes, it would have, as Clinton and the NIH allowed hESC researching funding. Bush Administration 5. What was the policy of the Bush administration? (I expect you to be specific about the cut-off date for lines that could be funded by the NIH.) Bushs hESC policy stated that hESC lines would be researched and funded by the federal government, but the cut-off date to those lines would be August 9th,2001. 6. Why did the NIHs ban on hESC research using lines created after the cut-off date under the Bush administration have an important negative impact on hESC research? Consider to what extent hESC research is basic research and how basic research is typically funded in the US. Since the NIH is the organization that can provide the most funding to any type of research, it is important for it be funding research. However, if lines created after the cut-off could not be funded by the federal government, then scientists would have a very limited supply to work on if they were funded by the federal government. Furthermore, as hESC was new at the time, private funding had yet to make its impact. 7. What were the Stem Cell Enhancement Acts from 2005 and 2007? What was the content, did they pass the senate/house of representatives, was there a veto, did these bills actually become legislation? Stem Cell Enhancement Acts of 2005 and 2007: They were bills (proposed laws) but never became legislation. They would both allow funding of research on new hESC lines created from surplus embryos. Both were passed by Congress but vetoed by Bush. In 2005, override of veto by House did not succeed, and in 2007, override was not attempted. Obama Administration 8. What did the executive order Obama signed on 3/9/09 specifically change? March 9th,2009: NIH funding allowed for hESC research, but only for hESC lines meeting the following conditions y Derived from surplus IVF embryos y Created for reproductive purpose, but no longer needed for said purpose y Informed consent requirements (Dickey Amendment still in effect.) 9. What is allowed under the current NIH guidelines: consider research on hESC lines, derivation of hESC lines from surplus IVF embryos, from embryos created for research via SCNT or IVF. Research and derivation of hESC lines still allowed, but creating and destroying embryos will not be funded. No more cut-off date. 10. Is the Dickey-Wicker Amendment still an obstacle to hESC research? Yes. It has still been renewed. California & CIRM; WARF hESC Patents Funding of research in general 1. What is basic research and how is it typically funded? Basic research serves to advance the knowledge about the human world. It mainly explains. It is typically funded by the federal government, which grants money to the NIH to allocate accordingly. 2. What does private and public funding refer to? Is funding by states considered private or public?

Public funding refers to funding from the federal government. Private funding refers to funding from other sources. State funding is private. State funding in general 3. Are states relatively homogenous in their legislation regarding permitting hESC research? Not at all. Some states, like California, have been integral parts in funding hESC research. Others, like Louisiana, have not funded it at all. 4. Name two states that encourage stem cell research and two states whose legislation prohibits hESCresearch (see also informed consent lecture). Encourage: California, New York, New Jersey Prohibit: South Dakota, Louisiana 5. What benefits do states expect to get from funding stem cell research? Discuss three different benefits. Could possibly reduce health care costs if diseases could be treated with stem cell therapies. Can generate millions in new state revenues from royalties and new jobs. People can potentially be cured of their horrible diseases. About California 6. What was Prop 71, what did it create, and how does it work? Established the California Institute for Regenerative Medicine to regulate SC research and provide funding. Through issuance of general obligation bonds of up to $3 billion in ten years ($350 million limit per year), the institute can allocate gained funds for research. 7. When and how was Prop 71 decided? (no need to know the # of votes, just the outcome was the majority clear or not?) Decided in 2004 by approximately a 60/40 vote, so the majority was clear. 8. Make an argument for why you would/would not have voted for Prop 71. The proposition would be extremely helpful in advancing stem cell research, a potentially powerful field to be researching. The faster research progresses, the faster the race to the cure it promises is reached. More money will help to quicken the process. 9. What does CIRM stand for, how is it structured and where does the money come from? How does the state plan to pay the money back? California Institute for Regenerative Medicine.Headed by Robert Klein, it consists of a governing committee of representatives of groups and institutions who are likely to receive funding, appointed by officials and UC chancellors. Money comes from general obligation bonds, which the state will pay back, with interest, over the course of 30 years. 10. Discuss the early years of CIRM were there legal challenges? Yes, there were. Various organizations filed lawsuits against the constitutionality of Prop 71, and therefore the CIRM. However, this came to an end in 2007, when California Supreme Court declined to review two lower court decisions. In the meantime, CIRM had funded its grants and operations with loans. 11. Why is California different from other states that have stem cell funding? The funding is far beyond what other states have decided, at $3 billion. No other state comes close. Furthermore, it has created the CIRM, an organization designed specifically to monitor the process. 12. What do you think - do we still need CIRM with Obamas more permissive policy?