Part I: Answer 3 of the following questions (worth 25 points each) using approximately 750 words each: So, choose 3 of them and answer them.
1. The NSABB described the H5N1 (bird flu) gain-of-function experiments controversy as an “Asilomar-type moment”. Was it? Why or why not? In the debates around Human Genome Editing, Asilomar has been held up as a model for how to govern uses of controversial, new technologies. Briefly explain: what ethical and policy questions are at stake in the bird flu research and in human genome editing, and what are their similarities and differences. Then, evaluate: is the approach to scientific self-regulation taken at Asilomar appropriate for governing this sort of research? What implications does the Asilomar model have for the role of the public in shaping ethical debate and policy in these areas? Does it strike the right balance between expert decision-making and public oversight of scientific research? Why or why not?
2. How informed does one need to be for consent to be genuinely informed consent? Pick three examples from the following list and explain whether and in what ways the practices pose ethical problems regarding consent and why: the use of “tacit consent” in 1950s NIH clinical center research involving “normals”; producing gene edited babies; someone with limited science education and a lot of student loans participating in paid clinical trial research; contributing your blood sample to the Mayo Clinic biobank; a woman donating (i.e. selling) her eggs.
3. Gestational surrogacy and (paid) egg donation are largely unregulated in the United States. Briefly review why this is the case, and what consequences this has had where questions of parental identity, rights, and responsibilities have arisen in relation to IVF. Then offer a set of well-justified recommendations for policy reforms around these practices. First explain what (if anything) should have been done differently in the late 1970s, and then explain what reforms should be made now. Your recommendations should be grounded in well-reasoned arguments.
4. Compare Edwards and Steptoe’s experiment that produced Louise Brown to He Jiankui’s experiment that produced the gene edited twins in China. Both produced children through an untested and controversial technique. Pointing to ethically salient similarities and differences between the two experiments, offer a well-supported and well-reasoned argument about whether the experiments were ethically acceptable (or unacceptable) and why.
5. Are trolley problems useful to bioethics? Choose a problem in bioethics that we have discussed during the course and re-construe it in terms of a trolley problem (such as gene editing , etc). Then analyze the benefits and/or limitations of using the trolley problem as a framework for ethical analysis of your chosen problem. Then discuss what role (if any) you think such techniques of ethical analysis can/should play in bioethics advice for policymaking, and what are the limitations or problems (if any) with such techniques.
6. The Belmont Principles, interpreted through Institutional Review Boards (IRBs), are meant to protect human subjects in research. Explain: What are the Belmont principles, in what ways were the Belmont Principles a sufficient or insufficient response to the Tuskegee study? Evaluate: How well do the Belmont Principles and the IRB system work to protect human subjects? Select a case drawn from the course (e.g. genomic biobank-based research, international pharmaceutical research in places like India and Uganda, the Hela or Havasupai cases, or the Chinese genome edited twins) and analyze it terms of the principles. Then discuss the strengths and limitations of using the principles as the basis for analysis. What, if anything, is clarified? What, if anything, is overlooked, ignored or left out of a Belmont-based analysis?
7. Should human blood samples be treated as human research subjects? Why or why not? What ethical and governance questions does research involving human biomaterials raise? What reforms, if any, are needed in approaches to governance? In your answer, you should discuss two of the following three cases: HeLa, Arizona Board of Regents v. Havasupai Tribe, and 23andMe troubles with FDA. Your recommendations should be grounded in well-reasoned arguments.
8. The advent, and, recently, the application of CRISPR/cas-9 to engineering human embryos has led to a debate about whether and under what circumstances it would be acceptable to make heritable edit the genomes of future children. What’s at stake? In the first part of your answer, use one or two of the assigned readings to (1) identify and explicate some of the key issues and concerns that the authors raise, and (2) offer your own assessment of whether these are the right concerns, and what other issues (if any) you think warrant attention. What prior lessons in bioethics should guide our approach to gene editing? In the second part, identify similarities and differences between this issue and at least one other controversy that we have explored in this class, e.g. recombinant DNA, IVF, or research on human subjects. Point to the relevant lessons from this prior controversy (or controversies) for gene editing, drawing out and connecting relevant ethical lessons learned from the prior issues, and/or explaining what lessons we can learn about prior approaches to deliberating about and regulating controversial research/technology should inform the gene editing debate, and why?
9. A laboratory at Harvard has approached a research oversight committee to seek guidance in determining how to evaluate what sort of “synthetic human entities with embryo like features” (SHEEFs) are ethically acceptable to construct for experimental purposes. Help the researchers by (1) Offering guidance about what sorts of perspectives (scientific, religious, philosophical, etc.) should inform ethical evaluation of experiments; (2) a discussion of what form these should take—e.g. a standard like the 14 day rule or the definition of death; empowering experts to decided which experiments acceptable where rules will evolve with research, as with recombinant DNA; general principles like the Belmont principles that are used to evaluate each experiment; or individual choice, leaving decisions to individual researchers or laboratories); or some other approach. Finally, (3) offer one or a few recommendations, supported with well-reasoned arguments, about some feature(s) of humanness should be taken into consideration in setting guidelines or limits.
10. In public health in general, and certainly in the context of an epidemic, there is often a tension between individual autonomy/liberty and public safety. COVID-19 has elicited the most significant nation-wide public health response in the US in more than a century. The social distancing and stay-at-home policies instituted by most states have disrupted social life and destroyed jobs and businesses even as they have sought to save lives. To be effective in protecting the lives of everyone, from the most vulnerable (e.g. the elderly and healthcare workers) to the ostensibly healthy, everyone must comply with rules and practices of “social distancing.” Most people have been remarkably willing to comply voluntarily, yet there is growing resistance and dissent. At the same time, there is increasing enforcement of local rules in the name of protecting the public. (E.g. As your professor was in the middle of writing this question, his wife, who is a criminal defense attorney, told him about her colleague’s new client who yesterday was pulled over, detained, held in the back of the police cruiser and, ultimately, cited for driving without a facemask.) Are current practices of social distancing a matter of individual choice (and responsibility), or a duty that can and should be imposed upon everyone with penalties for those who violate them and place others at risk of harm? Write a memo to the Governor arguing for or against creating and enforcing criminal penalties for failure to comply with social distancing requirements. Your argument should be well-reasoned and should anticipate and respond to possible objections. You should be clear about: what behaviors should be treated as matters of individual choice versus requirements (with penalties for noncompliance) and why. Clearly lay out the ethical and policy reasons that justify your position. In your argument, you should consider what consequences your proposed policy might have, e.g. for particular vulnerable groups, what precedent(s) it might set, and whether these considerations matter.
11. (Note: This question is identical to the prompt for paper 3. If you submitted a draft to your TA, you may turn in a revised version as your answer to question 11.) In the last few years there has been a growing interest in applying genome editing techniques to human embryos. Developing and evaluating the safety and efficacy of these techniques for clinical use (i.e. in reproductive medicine) would require producing large numbers of human embryos for experimental use only. These experiments require human eggs. Those eggs must be fresh and of “high quality,” meaning that they have passed quality control tests. Once a woman is identified as having high quality eggs, she may be invited and paid (but not required) to go through up to six cycles of superovulation in order to supply as many eggs as possible. There has long been a market for human eggs in the US for reproductive purposes, but for almost two decades the state of California has had a law that limits compensation for egg “donation” for research to a small amount of money. This makes it difficult for researchers in that state to find women who will supply eggs, and thus virtually impossible to acquire the large number of human eggs required for embryo editing experiments. Some states like Oregon and New York do not impose limits on how much researchers can pay women for providing their eggs for research, giving researchers in those states a competitive edge. A proposed bill in California would remove limits on how much researchers can pay women for their eggs. Make a well-reasoned argument either in favor of or against this change in law. Be sure to be systematic in laying out your argument, offering clear premises, justifying your assumptions, and showing how they build to support your conclusion. Then, in a short paragraph, offer the strongest objection you can think of to your own argument. Finally, offer a response to the objection. Your response should be consistent with, and should build upon, your original argument.
