New in the Hastings Center Report: Next steps for epigenetics, big data and informed consent, whatever happened to human ‘experimentation,’ and more in the January-February 2016 issue
Epigenetics in the Neoliberal "Regime of Truth": A Biopolitical Perspective on Knowledge Translation
Charles Dupras and Vardit Ravitsky
Recent findings in epigenetics have been attracting much attention from social scientists and bioethicists because they reveal the molecular mechanisms by which exposure to socioenvironmental factors, such as pollutants and social adversity, can influence the expression of genes throughout life. Some epigenetic modifications may also be heritable. Therefore, epigenetics research might be useful for developing environmental and social strategies for improving public health. But the authors are concerned that funding and interest will go mostly the other way, toward ever more "molecular" interventions–the development of new clinical tools fostering "personalized" or "precision" medicine. Dupras is a PhD candidate in bioethics, and Ravitsky teaches in the bioethics program at the University of Montreal.
Balancing Benefits and Risks of Immortal Data: Participants' Views of Open Consent in the Personal Genome Project
Oscar A. Zarate, Julia Green Brody, Phil Brown, Mónica D. Ramírez-Andreotta, Laura Perovich, and Jacob Matz
Big data is shifting research to include large numbers of participants who provide diverse types of data, some of it placed in online repositories shared with researchers and members of the public. "But these data become 'immortalized' in ways that may create lasting risk as well as benefit," write the authors. Why do participants provide genetic and other data about themselves? How well do they understand the terms of their consent- that their data can be broadly shared and that privacy or anonymity is not guaranteed? Are they aware of the risks of health-data disclosure to themselves and their families? To find out, the authors surveyed participants in the Personal Genome Project, a large project launched at Harvard University that aims to sequence the genomes of 100,000 volunteers and to share the information with scientists and the public. Based on the findings, the authors make recommendations for strengthening ethical consent practices and protocol reviews for big data research. Zarate, the lead author, is a doctoral student in statistics at Northwestern University and a former researcher at the Silent Spring Institute.
A related piece, The Promise and Perils of Open Medical Data, elaborates on the kinds of data that are open to any visitor of the Personal Genome Project's website- including participants' names, their date of birth, sex, weight, height, blood type, health conditions, medications-and recommends laws and other policies to protect privacy and reduce discrimination.
Whatever Happened to Human Experimentation?
The language used to describe research has changed. The phrase "human experiment" is rarely used anymore; it is now almost always associated with abuses. In the early days of American bioethics, however, scholars used the word "experimentation" in the same neutral way that they later began to use "research study" and "clinical trial." Elliott, a professor at the University of Minnesota's Center for Bioethics, suggests that the change in language reflects an effort to deflect concerns about the treatment of research participants.
Also in this issue:
At Law: Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule
Holly Fernandez Lynch, Barbara E. Bierer, and I. Glenn Cohen
Last September, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, known as the Common Rule. The proposed changes include more restrictions on the use of biospecimens and data for "secondary" research-research conducted by different individuals or institutions or for purposes other than the original collection. The authors argue that both the status quo and the proposal are critically flawed, and they suggest proposals for better reform of the Common Rule.