Pluripotent Stem Cells Debate: Ethics Module
Summary: Ethics debate assignment on pre-implantation genetic diagnosis
Background on Pluripotent Stem Cells: Ethics Module
New Scientific Results
Last week Science published a startling article out of a research lab in Europe on pluripotent stem cells (PSCs). This article demonstrated strong evidence that the process of freezing stem cells in liquid nitrogen negatively impacts the cells. PSCs discussed in this paper were generated in the laboratory using egg and sperm and were not frozen in liquid nitrogen. These “fresh” stem cells demonstrated the following characteristics as compared to stem cells which have been frozen (termed “frozen” stem cells):
- Fresh stem cells were much easier to cultivate and maintain in cell culture. As a consequence, the authors of the article predicted that research costs on PSCs would be lower and that fewer cell lines would need to be created and maintained in vitro.
- Fresh cells were appropriately sensitive to biochemical signals. In other words, fresh stem cells required in vivo levels of cytokines, hormones, etc. to trigger differentiation, whereas frozen stem cells required up to 10 times the in vivo levels to see the same response. This suggests that the process of freezing stem cells affects their biochemical sensitivity and possibly their true pluripotency.
Policy Background
The National Institutes of Health (NIH) Guidelines for Research Using Pluripotent Stem Cells (Effective August 25, 2000, 65 FR 51976; Corrected November 21, 2000, 65 FR 69951) permit federal funding to be used to conduct research on pluripotent stem cells isolated from fetal tissue and from embryos. The stem cells from human embryos must be derived from human embryos that were created for the purpose of fertility treatment and were in excess of the clinical need to the individuals seeking treatment. During the process of fertility treatment, human embryos are created in vitro. Some embryos are implanted in the mother’s womb whereas others are stored in liquid nitrogen for future use (in the event that the first implantation treatment fails). Thus, all human embryos used in stem cell research in federally funded labs in the U.S. have been frozen in liquid nitrogen.
Research Activity in the U.S.
The NIH is the major source of funding for biomedical researchers in the U.S. While the NIH Guidelines permit funding for research on PSCs, the Guidelines disallow federal funds to pay for the derivation of PSCs from human embryos. In other words, in the U.S., industrial money must be used for the costly process of establishing stem cell lines. A practical consequence of the NIH Guidelines is that stem cell research has been severely curtailed in the U.S. In August 2001, President George W. Bush decided to permit limited funding for research only on existing stem cell lines. This decision will allow some basic research to be done on the existing stem cells’ cell lines, but it is unlikely that under this policy any clinical applications will be realized in the short term (5-8 years).
Promises of Stem Cell Research
Because of stem cells’ pluripotency, researchers have predicted that these cells can be used to grow replacement cells, tissues, and organs for individuals who are suffering from diseases and/or inherited genetic defects. Recent promising research has been in the areas of Parkinson’s disease and diabetes.
Ethical Issues
The ethical and moral issues surrounding the short-term and long-term derivation and use of PSCs are complex and grave. Issues regarding the definition of “life” (one cell, multiple cells, fully formed human being), the sanctity of human life, the “intended use” of the embryonic cells, the possibility of inappropriate uses of PSCs, etc. must be considered.
Oral Arguments on Pluripotent Stem Cells: Ethics Module
Situation
As a result of the recent research findings, an NIH Committee is charged with the task of determining what types of research projects using Pluripotent Stem Cells (PSCs) ought to receive federal funds and how the NIH Guidelines should be amended to reflect the Committee’s decision. Several stakeholders with technical expertise and/or personal experience related to PSCs have been called to participate in an NIH Committee hearing. The NIH Committee will listen to the stakeholders’ comments, which will influence the Committee’s decision regarding the Guidelines.
Specific Task of the NIH Committee
In what way, if any, should the NIH Guidelines be amended given the new research data, which shows that PSCs, which have not been frozen, are easier to cultivate and maintain and have biochemical responses very similar to in vivo conditions. Focus on Sections I, II.A.2 (a, b, c), and III of the NIH Guidelines for Research Using Pluripotent Stem Cells (Effective August 25, 2000, 65 FR 51976; Corrected November 21, 2000, 65 FR 69951). Specific questions regarding NIH funding include:
- Should research using PSCs derived from human embryos that were created for the purpose of fertility treatment and are in excess of the clinical need be supported?
- Should the derivation of PSCs from human embryos that were created for the purpose of fertility treatment and are in excess of the clinical need be supported?
- Should research using PSCs derived from fresh stem cells generated in the laboratory explicitly for research purposes be supported?
- Should the derivation of PSCs from fresh stem cells generated in the laboratory explicitly for research purposes be supported?
The NIH Committee must listen to the various positions supported by the stakeholders and, relying on their arguments, make recommendations on whether the NIH Guidelines regarding the use of PSCs should be revised, and if so, how they ought to be revised.
Background Information on Perspectives
Listed below are three perspectives from which individuals often base their ethical positions or arguments. For the assignment, you will be asked to argue from the individual and/or the group perspective.
- Individual Interests: These people’s intentions, actions, and attitudes are motivated by what they want and desire. Their choices are a function of self-interest. They ask, “What is best for me?” Examples include a patient or a patient’s relative who may eventually benefit from stem cell research, a renowned researcher, or someone with strong religious convictions who opposes the use of stem cells.
- Group Interests: These people’s intentions, actions, and attitudes are motivated by the desire to maintain social order. They want to establish policies, laws, or rules that protect their particular group’s interests. They ask, “What is best for our group?” Examples include biotech companies, government agencies, foundations that advocate on behalf of patient populations, religious groups, or academic institutions.
- Global Interests: These people’s intentions, actions, and attitudes are guided by ideals. They are interested in what is just. They ask, “What is best for humanity?” Examples include the World Health Organization or Doctors without Borders.
Stakeholder Participation
Each team of students will include the NIH Committee Chair and 3 or 4 stakeholders who have specialized technical expertise and/or personal experience. The stakeholders will take one of the following positions. You must construct a stakeholder identity that represents your assigned position. Stakeholder positions will be assigned on Day 1 of the Ethics Module.
- Stakeholder A: You are the parent of a child with diabetes. You are a leader in the Juvenile Diabetes Research Foundation and a strong advocate for research on a number of different promising treatment options, including research with PSCs. You have an individual interest in PSC research because of the illness of your child. You must respectfully present the position of a parent of a child with a debilitating illness.
- Stakeholder B: You are a Bishop in the Catholic Church. The Catholic Church is very consistent in its position regarding the sanctity of human life and that life begins at the union of two haploid cells. The Catholic Church is opposed to in vitro fertilization (because of the wasting of extra embryos), abortion at any time during pregnancy, and any type of research with PSCs. You must respectfully represent the position of the Catholic Church.
- Stakeholder C: You are a scientist currently engaged in stem cell research at a University. You have been working on one aspect of nerve cell differentiation for the past three years. You are also a member of the scientific committee, the American Association for the Advancement of Science (AAAS). You believe that your research and that of your colleagues is productive and will soon yield clinical applications. You have an individual and group interest in the NIH Guidelines as a scientist because the Guidelines impact the ability of scientists to conduct research that may mitigate many dreadful diseases. You must respectfully represent your opinion and that of the AAAS.
- Stakeholder D: You are an individual with Parkinson’s disease who strongly self-identifies as Pro-Life. While Parkinson’s disease is robbing you of your of muscle tone and ability to talk, you do not believe that embryos or fetuses should be used in any type of medical research. You must respectfully represent your individual interest in this contentious issue.
Stakeholder Preparation
Read through the case materials, conduct independent research, analyze the issues, and carefully prepare arguments that someone with your assigned position would use to argue in favor of or against research using PSCs and any changes to the NIH Guidelines. Consider the following questions:
- What definitions and premises inform your position? For example, how would a person arguing from your perspective define the sanctity of human life?
- What is at stake for you or your group?
- Do you support any type of research involving PSCs? Should federal funds be used for the derivation of PSCs or to conduct research on PSCs?
- Does the origin of the embryos (i.e. left over from in vitro fertilization versus freshly created in the laboratory for research purposes) matter to you? Why or why not? Does the reason for initially creating the embryos matter to you? Why or why not?
- How does your personal experience (e.g. family members with inheritable and/or advanced diseases) affect your position?
- How do your religious upbringing and your beliefs affect your position?
- How would you or your group benefit from present or future research on PSCs?
- What are some negative or possible unintended consequences of your position?
- What counter-arguments to your position should you anticipate?
- What criteria should be used to determine the proper course of action? What criteria should be used to determine what kinds of research the NIH should fund?
- Ideally, what would be the desired outcome for someone representing your position?
- Which points are negotiable in the NIH Guidelines? Which points are not negotiable?
NIH Committee Chair Preparation
As an NIH Committee Chair, you must balance the many issues raised by the stakeholders in order to develop coherent, comprehensive and ethically sound NIH Guidelines for Research Using Pluripotent Stem Cells. To prepare, read through the case materials, conduct independent research, analyze the issues, and carefully consider the major arguments that the stakeholders are likely to raise either in favor of or against research using PSCs and any changes they would likely suggest to the NIH Guidelines. Your focus will be to facilitate the discussion, ask illuminating questions, and finally to make recommendations for changes (if any) regarding the NIH Guidelines. Review the questions above, and consider the following questions:
- What definitions and premises inform the debate? For example, how should human life be defined?
- What is at stake for the nation and for the individuals of the nation?
- What are the benefits of research involving PSCs?
- Does the origin of the embryos (i.e. left over from in vitro fertilization versus freshly created in the laboratory for research purposes) matter to you? Why or why not? Does the initial reason for creating the embryos matter to you? Why or why not?
- How does your personal experience (e.g. family members with inheritable and/or advanced diseases) affect your position as NIH Committee Chair?
- How do your religious upbringing and your beliefs affect your position as NIH Committee Chair?
- What criteria should be used to determine the proper course of action? What criteria should be used to determine what kinds of research the NIH should fund?
- What conflicts do you see arising during the NIH Committee Panel discussion? What are some ways to negotiate compromise among strongly opposing positions?
- What are some negative or possible unintended consequences of the Guidelines?
Format for the NIH Committee Panel Discussion
On the third day of the Ethics Module, there will be a facilitated discussion from 2-3:30 p.m. The NIH Committee (the student Chair and instructor) will meet and listen to the remarks of each stakeholder. The NIH Committee Chair will facilitate the conversation. Each stakeholder will have 5 min to present opening remarks and state her/his position. Discussion will follow. By 3:00 p.m., each stakeholder should have articulated his/her position regarding the Guidelines and the NIH Committee Chair should try to float any revisions to the Guidelines he/she deems scientifically and ethically sound. While it may not be possible to reach a consensus, each stakeholder needs to consider which aspects of her/his position are negotiable and which are not and participate in the conversation with honest intention.
| 2:00 | Introductory Remarks by NIH Committee Chair |
| 2:05 | Opening Statement of Stakeholder A |
| 2:10 | Opening Statement of Stakeholder B |
| 2:15 | Opening Statement of Stakeholder C |
| 2:20 | Discussion of Ethical Issues |
| 3:00 | Discussion of Guidelines |
| 3:30 | Discussion Ends |
Tips for Participants
During your Opening Statement, introduce yourself. Your introduction should address the following questions: Why is stem cell research of interest to you? In other words, briefly state why you are speaking to the NIH Committee. What are your credentials? Are you affiliated with an institution, organization, or corporation? If so, what is its mission?
- During your Opening Statement, state your position on the issue of research using PSCs and the status of the NIH Guidelines. Provide compelling evidence to support your reasoning.
- Listen carefully to the arguments put forward by the other stakeholders. Respond to other stakeholders’ comments from your assigned position.
- The NIH Committee Chair will consider your arguments and use them to justify his/her decision on whether or not to change the NIH Guidelines.
Stakeholder Grade
- Coherence and articulation of position in Opening Statement.
- Coherence of position during Discussion of Ethical Issues and Guidelines.
- Ability to listen and to respond.
- Ability to identify negotiable and non-negotiable aspects of research policy and Guidelines.
NIH Committee Chair Grade
- Facilitation of NIH Committee meeting with stakeholders.
- Ability to listen and to respond.
- Ability to incorporate scientific and ethical concerns into revised Guidelines.
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Last edited by The Cain Project in Engineering and Professional Communication on Jun 10, 2008 2:26 pm GMT-5.