This class plan gives a selection of exercises out of which an instructor may build a class session around issues concerning the development of big data resources in genetics and genomics such as the materials being compiled by 23 and Me. The materials are suitable for upper division undergraduate courses in bioethics or the life and environmental sciences.
Students will be able to:
1. Before Class Assignment
Allyse, Megan. “23 and Me, We, and You: direct-to-consumer genetics, intellectual property, and informed consent.” Trends in biotechnology 31, no. 2 (2013): 68-69.
Saha, Krishanu, and J. Benjamin Hurlbut. “Research ethics: Treat donors as partners in biobank research.” Nature 478, no. 7369 (2011): 312-313.
Seife, Charles. “23andMe is terrifying, but not for the reasons the FDA thinks: the genetic-testing company’s real goal is to hoard your personal data.” Scientific American 27 (2013). https://www.scientificamerican.com/article/23andme-is-terrifying-but-not-for-the-reasons-the-fda-thinks/ Accessed on December 12, 2016.
Alyass, Akram, Michelle Turcotte, and David Meyre. “From big data analysis to personalized medicine for all: challenges and opportunities.” BMC medical genomics 8, no. 1 (2015): 33.
McGuire, Amy L., Timothy Caulfield, and Mildred K. Cho. “Research ethics and the challenge of whole-genome sequencing.” Nature Reviews Genetics 9, no. 2 (2008): 152-156.
Robinson, Ann. “DNA-testing kit 23andme: patient powered healthcare or just confusing” The Guardian. January 12, 2016. https://www.theguardian.com/sustainable-business/2016/jan/12/dna-testing-kit-23andme-patient-powered-healthcare-genetics
Stoeklé, Henri-Corto, Marie-France Mamzer-Bruneel, Guillaume Vogt, and Christian Hervé. “23andMe: a new two-sided data-banking market model.” BMC medical ethics 17, no. 1 (2016): 1-11.
Schwartz, Peter H. “The value of information and the ethics of personal-genomic screening.” The American Journal of Bioethics 9, no. 4 (2009): 26-27.
Wasson, Katherine. “Direct-to-consumer genomics and research ethics: should a more robust informed consent process be included?” The American Journal of Bioethics 9, no. 6-7 (2009): 56-58.
2. Introduction (20 minutes)
2.1 Opening conversation (18 minutes)
Ask students: “Given your readings, what are some kinds of information that individuals can expect to find out from personal genetic/genomic tests?”
Students might list examples of medical and non-medical/personal information: ancestry, predispositions to certain behaviors, diseases, etc.
Then, ask students: “Is acquiring these sorts of information in exchange for providing personal data and bio-specimens to private companies a fair exchange? Why/why not?”
2.2 Session overview (2 minutes)
Outline for students that class today is designed to enable them to think critically about the role of informed consent in genetic/genomic research, especially in the context of “direct-to-consumer” genetic testing. First, they’ll look carefully at a particular case about the “direct-to-consumer” genetic testing company, 23andMe. Second, they will consider the ethical responsibilities of the individuals participating in these sorts of endeavors (including the scientists pursuing research), as well as the groups and institutions involved in the governance of biobanks.
From Council for Big Data, Ethics, and Society:
“Some of the general questions to keep in the back of your mind include:
3. Activity: Case Study (40 minutes)
3.1 Have students read short case description & accompanying links (10 minutes)
Case Study – “Blurring Research and Practice, Science and Entertainment” - 23andMe and Personal Genomics: boyd, danah and Jacob Metcalf. 2016.
“Example “Big Data” Research Controversies.” Council for Big Data, Ethics, and Society. Accessed November 29, 2016. http://bdes.datasociety.net/council-output/example-big-data-research-controversies/
23andMe – Core Values statement: https://mediacenter.23andme.com/our-core-values/
23andMe – Privacy Statement: https://www.23andme.com/en-int/about/privacy/
23andMe YouTube Channel: e.g. https://www.youtube.com/watch?v=-1gjNUzABAY
3.2 Small group brainstorming (10 minutes)
Break class into groups of 3-6.
Have each group discuss the following questions:
3.3 Discuss questions as a class (20 minutes)
Notes for instructor to guide discussion:
Critics of “direct-to-consumer” genetic tests (Allyse, Seife):
Advocates of “direct-to-consumer” genetic tests (Saha & Hurlbut):
Tensions about notions of informed consent and its relation to the bioethical principle of autonomy (Mittelstadt & Floridi 2015):
4. Activity: How can scientists act on social responsibilities? (10-15 minutes)
Transition: The emerging concepts of consent under negotiation within this research context, and the emphasis on researchers’ duty to benefit research participants and their communities more widely, as well as the research participants’ duty to contribute to the public good, are areas of ethical deliberation intended to maintain the public’s trust in the medical profession, and scientific institutions more broadly.
Considering what you know about “direct-to-consumer” genetic tests and biobanks, and McFarland’s framework* for analyzing social responsibility in science and engineering, do scientists who work on developing and managing biobanks have social responsibilities to the research participants (those who donate their genetic information) and to the public more generally?
* McFarland, Michael C. "The public health, safety and welfare: an analysis of the social responsibilities of engineers." Technology and Society Magazine, IEEE 5, no. 4 (1986): 18-26.
5. Wrap up (5-10 minutes)
Ask students to think about the main arguments for and against “direct-to-consumer” genetics and biobanks. Then, ask students to draw up a short list of (2-3) ethical questions representative of the core issue(s) in the ethical disagreements about the governance of these biobanks.
Required Materials and Equipment