<p>Appendix 2 SkillSET 2.0</p><p>SkillSET 2.0 *</p><p>SkillSET Instructions Below is a hypothetical involving a graduating biomedical engineering student, a job offer, and a set of controversial ethical and policy issues related to the work involved in that job. The hypothetical is followed by 5 questions. Please envision yourself in this graduating student’s position, regardless of your major and future job plans, and answer the 5 questions accordingly. </p><p>SkillSET Case You are graduating this spring from a first-class biomedical engineering department and have been offered a position at an in-state biotech startup firm specializing in human embryonic stem cell (hESC) research. If you accept, you will work with a research team that hopes to begin a Phase I clinical trial (focusing on safety) of a potential hESC-based treatment for Parkinson’s disease. You are aware of the clinical promise of hESC-based treatments, and the prospect of working to develop a cure for Parkinson’s disease is very appealing. You are also aware, however, of some of the ethical and policy controversies associated with hESC research. Human embryonic stem cells are extracted from human embryos at the blastocyst stage (about 5 to 6 days after fertilization) and grown in the laboratory to develop hESC lines for research purposes. Human embryonic stem cells are pluripotent, which means they can develop into any kind of cell type in the body. This makes hESCs potentially very promising in developing treatments for diseases, including Parkinson's and Type I diabetes, and for spinal cord injuries. However, extracting the cells to develop the hESC lines destroys the embryos, giving rise to controversy. The U.S. public is divided about whether hESC research should receive federal or state public funding or should be permitted to proceed at all, with public or private funding. Most Americans favor providing public funding for research on hESC lines derived from surplus embryos created for reproductive purposes for in vitro fertilization (IVF) procedures. However, the potential derivation of hESCs from cloned embryos—embryos created by removing the nuclei of human eggs and inserting complete complements of DNA from patients’ somatic cells, such as skin cells—is far more contentious. Deriving hESC from cloned embryos might yield safer and more effective hESC-based treatments because of the genetic match between cloned embryos and patients. However, it would involve the creation and destruction of embryos solely for research purposes. A minority of Americans opposes public funding for any hESC research or opposes permitting the research at all, regardless of the source of the hESCs (surplus IVF embryos or cloned embryos) or the source of the funding (public or private). Federal and state policymakers in the U.S. have also been divided about permitting and providing public funding for hESC research. At the federal level, their disagreement has focused on the terms under which federal funding might be made available to support hESC research. The federal government has not imposed restrictions on conducting hESC research supported by private funding.</p><p>1 Appendix 2 SkillSET 2.0</p><p>The possibility of providing public funding for hESC research first emerged during the administration of President Clinton. Guidelines developed during the Clinton administration would have provided federal funding for research on hESC lines subject to two limitations: (1) Federal funding would be available for research using hESC lines derived from surplus embryos from IVF procedures, not for lines derived from cloned embryos created for research purposes. (2) Federal funding could be used for research using hESC lines but could not be used to fund the actual process of extracting hESCs from embryos to grow hESC lines. These guidelines were developed late in the Clinton administration but had not been implemented by the time President Bush assumed office and never went into effect. Instead, on August 9, 2001, President Bush announced the first federal funding policy for hESC research. Under President Bush’s policy, federal funding would be made available for hESC research subject to the two limitations in the Clinton administration guidelines plus an additional limitation. The additional limitation permitted federal funding for research only on hESC lines that had been derived before August 9, 2001. President Bush explained the reason for this additional limitation: it would be unacceptable to provide “taxpayer funding that would sanction or encourage further destruction of human embryos.” After President Bush announced this policy, on two occasions, the U.S. Congress voted in favor of federal legislation that would have replaced his policy with guidelines similar to those developed under the Clinton administration. These Congressional enactments would have permitted federal funding for hESC research using hESC lines derived both before and after August 9, 2001. The reason for removing the August 9, 2011 restriction was to increase the number of potentially useful hESC lines available for research supported by federal funds. President Bush vetoed both Congressional enactments. President Bush’s policy was later overturned by an executive order issued by President Obama shortly after he assumed office in 2009. The new guidelines for federal funding of hESC research, issued soon thereafter, were similar to those developed under the Clinton administration. While these guidelines—which permit federal funding for research on hESC lines derived before and after August 9, 2011—remain in effect today, they have been subject to a series of court challenges. Furthermore, several states have considered enacting restrictions on hESC research conducted within their states in response to the new federal funding guidelines.</p><p>Meanwhile, research has proceeded on alternatives to hESCs, such as induced pluripotent stem cells (IPSCs) and adult stem cells. IPSCs are created from somatic cells, such as skin cells, and are thought to have the same pluripotent properties as hESCs. There are no controversies associated with the derivation of IPSCs, but there are concerns about the safety of IPSC-based treatments and about whether IPSCs are truly equivalent to hESCs. Research has also continued on non-embryonic human stem cells, called "adult stem cells." Adult stem cells are multipotent, which means they can develop into a limited set of cell types. Some adult stem cell-based treatments have already been used successfully in treating certain diseases. There are no controversies associated with the derivation of </p><p>2 Appendix 2 SkillSET 2.0 adult stem cells. However, adult stem cell-based treatments are believed to have fewer potential clinical applications than hESC-based or IPSC-based therapies. The company you are thinking about joining has used private funding to carry on its hESC research to date. Hence, its research on hESC lines has not been subject to any of the limitations that apply to hESC research conducted with the support of federal funding. However, given the terms of the new guidelines under the Obama administration, in the future, the company plans to partner with academic institutions to pursue federally funded research on hESC lines derived from surplus IVF embryos. In addition, if it becomes scientifically feasible to extract hESCs from cloned embryos, the company also intends to pursue this research with the support of private funding, since no federal funding is available for research involving cloned embryos. While your job offer is pending, the company’s plans for future research have come to light. Prominent media commentators have denounced the company and its plans, and there have been public protests at the office park where the company is located. The media coverage of the company and the protests has drawn the attention of the state legislature. Some state legislators have indicated that they favor enactment of new state policies to restrict or ban hESC research in response to the expanded opportunities for federally funded hESC research under the Obama administration. Other state legislators have welcomed the new federal funding guidelines and have indicated they favor new state policies to make the state more inviting to and supportive of academic and industry bioscience research. State legislative committee hearings on hESC research have been scheduled. Various committee members, who hold a range of views, have indicated their intention to study the ethical and policy issues surrounding hESC research and develop a policy resolution for their state. </p><p>SkillSET Questions 1. How important are the ethical and policy issues surrounding hESC research to your decision whether or not to take the job offer with the biotech startup firm? Please select your answer: Extremely important Very important Somewhat important Of minor importance Not at all important Please explain your answer:</p><p>2. If the state legislative committee members asked you to provide input to the committee on the ethical and policy issues surrounding hESC research and the potential policy resolutions to these issues, how willing would you be to do so? Please select your answer: Definitely willing</p><p>3 Appendix 2 SkillSET 2.0</p><p>Probably willing Possibly willing Probably not willing Definitely not willing Please explain your answer:</p><p>3. Imagine that you have agreed to offer input to the state legislative committee. Assuming that the committee is open to any kind of advice about how to arrive at a policy resolution regarding the ethical and policy issues surrounding hESC research, what advice would you offer?</p><p>4. Imagine that the state legislature arrived at a policy resolution for the ethical and policy issues surrounding hESC research one month ago, and you have decided to write an editorial in the local paper assessing how well the legislature did its job. What assessment criteria would you discuss in your editorial?</p><p>5. Given all the circumstances surrounding hESC research, how likely do you think it is that a state legislature might succeed in effectively analyzing the ethical and policy issues and developing a policy resolution? Please select your answer: Extremely likely Very likely Somewhat likely Unlikely Very unlikely Please explain your answer:</p><p>* This work is licensed under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/ or send a letter to Creative Commons, 444 Castro Street, Suite 900, Mountain View, California, 94041, USA. The first version of this Skills for Science/Engineering Ethics Test (SkillSET) questionnaire was developed by Roberta M. Berry and Robert Kirkman, with the assistance of Aaron D. Levine. This version of the questionnaire, SkillSET 2.0, includes revisions by Roberta M. Berry, Sharon Norman, and Ruchir Karmali, with the assistance of Laura Palucki Blake. Contact Authors: Roberta M. Berry <[email protected]>; Ruchir N. Karmali <[email protected]>; Sharon E. Norman <[email protected]>; Laura Palucki Blake < [email protected]></p><p>4</p>