Assistant Professor Dr. Laura Cabrera is the author of a guest editorial on “The Need for Guidance around Recruitment and Consent Practices in Intracranial Electrophysiology Research,” published in the current issue of AJOB Neuroscience. Dr. Cabrera stresses the importance of the involvement of institutional review boards and funding agencies with regard to study recruitment and participant consent.
The full text is available online via Taylor & Francis Online (MSU Library or other institutional access may be required to view this article).
Center Professor Dr. Tom Tominson and co-author Raymond De Vries have an article in the March-April 2019 issue of Ethics & Human Research, “Human Biospecimens Come from People.” The issue’s theme is “The Scientific Value and Validity of Research.”
Abstract: Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.
The full text is available online via Wiley Online Library (MSU Library or other institutional access may be required to view this article).
It was good news to learn last month that the “Golden State Killer” had at last been identified and apprehended. A very evil man gets what he deserves, and his victims and their families get some justice.
The story of how he was found, however, raised concerns in some quarters. The police had a good DNA sample from the crime scenes, which with other evidence supported the conclusion that the crimes were committed by the same person. But whose DNA was that? Answering that question took some clever detective work. Police uploaded the DNA files to a public genealogy website, GEDmatch, which soon reported other users of GEDmatch who were probably related to the killer. More ordinary police work did the rest.
Most of the concern was over the fact that the police submitted the DNA under a pseudonym, in order to make investigative use of a database whose members had signed up and provided their DNA only for genealogical purposes.
Image description: a black and white photo of the panopticon inside of Kilmainham Gaol in Dublin, Ireland. Image source: Craig Sefton/Flickr Creative Commons.
My interest in this story, however, is the way it both feeds and undermines a common narrative about our DNA—that it is uniquely identifying, and that therefore any uses of our DNA pose special threats to our privacy. As The New York Times expressed this idea, “it is beginning to dawn on consumers that even their most intimate digital data—their genetic profiles—may be passed around in ways they never intended.”
It’s true that a sample of DNA belongs uniquely to a particular individual. But the same is true of a fingerprint, a Social Security number, or an iris. More importantly, by themselves none of these pieces of information reveals who that unique individual is.
As the Golden State Killer story illustrates, it’s only when put in the context of other information that any of these admittedly unique markers becomes identifying. If the GEDmatch database contained nothing but genetic profiles, you could determine which genomes the killer was related to. But you’d have no idea who those genomes belonged to, and you’d be no closer to finding the killer.
Although an individual genome can’t by itself be identifying, it can provide a link that ties together different information sources which include that genome. It can then be that collection that points to an individual, or narrows the list of possibilities to increase the odds of identification, and the threats to privacy. Imagine the state police maintains a database of forensic DNA linked to records of criminal convictions, and provides that database to criminologists, stripped of any names or other direct identifiers. Imagine as well that one of the hospitals provides researchers with DNA from their patients along with their de-identified medical records (which can include patients’ age, race, first 3 ZIP numbers, and other demographic information).
If we put those together we can do some interesting research: use the DNA link to identify those who both committed various crimes and had a psychiatric history, so we can compare them to convicted felons without a psychiatric history.
But now it may take very little additional information to identify someone in that combined database and invade their privacy. If I’m a researcher (or hacker) who knows that my 56-year-old neighbor was convicted of assault, I can now also find out whether he has a record of psychiatric illness—and a lot more besides. What he had thought private, is no longer so.
The point of this somewhat fanciful example is that as more information is collected about us, from more sources, the threats to our privacy will increase, even if what’s contained in individual sources offers little or no chance of identification.
For this reason, the prospect of merging various data sources for “big data” health research will challenge the current research regulatory framework. Under both the current and the new rules (which haven’t yet gone into effect), the distinction between identifiable and non-identifiable research subjects is critical. Research using information that can be linked to an individual’s identity requires that person’s consent. To avoid this requirement, research data must be “de-identified”. De-identification is the regulatory backbone on which much of the current “big data” research relies, allowing the appropriation of patient medical records and specimens for use in research without consent; and it provides the regulatory basis for uploading the data collected in NIH-supported research into a large NIH-sponsored database, the database of Genotypes and Phenotypes (dbGaP), which most NIH-supported genomic studies are required to do. Data from dbGaP can then be used by other researchers to address other research questions.
The possibilities of merging such “de-identified” databases together for research purposes will only increase, including facial recognition databases being collected online and on the street. As the mergers increase, it will become more difficult to claim that the people represented in those databases remain non-identifiable. As Lynch and Meyer point out in the Hastings Center Report, at this point there will be two choices. We can require that all such research will need at least broad consent, which will have to be reaffirmed every time a person’s data is used in new contexts that make identification possible. Or we will have to fundamentally reassess whether privacy can play any role at all in our research ethics, as the very idea of “privacy” evaporates in the panopticon of everyday surveillance.
Tom Tomlinson, PhD, is Director and Professor in the Center for Ethics and Humanities in the Life Sciences in the College of Human Medicine, and Professor in the Department of Philosophy at Michigan State University.
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Center Director and Professor Dr. Tom Tomlinson is first author of the article “Effect of deliberation on the public’s attitudes toward consent policies for biobank research,” published in the February 2018 issue of the European Journal of Human Genetics. The work of Dr. Tomlinson and co-authors Raymond G. De Vries, H. Myra Kim, Linda Gordon, Kerry A. Ryan, Chris D. Krenz, Scott Jewell, and Scott Y. H. Kim was supported by the NIH-funded project “Public Preferences for Addressing Donors’ Moral Concerns about Biobank Research.”
Abstract: In this study, we evaluate the effect of education and deliberation on the willingness of members of the public to donate tissue to biobank research and on their attitudes regarding various biobank consent policies. Participants were randomly assigned to a democratic deliberation (DD) group, an education group that received only written materials, and a control group. Participants completed a survey before the deliberation and two surveys post-deliberation: one on (or just after) the deliberation day, and one 4 weeks later. Subjects were asked to rate 5 biobank consent policies as acceptable (or not) and to identify the best and worst policies. Analyses compared acceptability of different policy options and changes in attitudes across the three groups. After deliberation, subjects in the DD group were less likely to find broad consent (defined here as consent for the use of donations in an unspecified range of future research studies, subject to content and process restrictions) and study-by-study consent acceptable. The DD group was also significantly less likely to endorse broad consent as the best policy (OR = 0.34), and more likely to prefer alternative consent options. These results raise ethical challenges to the current widespread reliance on broad consent in biobank research, but do not support study-by-study consent.
The full text is available online through Springer Nature (MSU Library or other institutional access may be required to view this article).
Center Director and Professor Dr. Tom Tomlinson presented a talk on the “Effect of Deliberation on Attitudes Toward Biobank Consent Options” at the International Society for Biological and Environmental Repositories (ISBER) Annual Meeting held in Toronto on May 9-12. The talk presented findings from democratic deliberations held in 2015 as part of a larger NIH-funded project investigating the effect that people’s moral, cultural or social concerns (“non-welfare interests” or NWI) about possible future research uses of donated specimens and data might have on their willingness to donate and on their preferences regarding biobank consents.
The presentation focused on what effect the deliberations in themselves had on preferences among biobank consent options, as opposed to any effects attributable to the educational materials provided during the deliberation day. The study design made it possible to separate these, since participants were randomized into the deliberation group, an education-only group that received paper copies of the presentations with notes, and a control group that received no information. A logistic regression analysis revealed that compared to the education and control groups, the deliberators moved away from a blanket consent to any and all future research uses toward consents that in a variety of ways acknowledged or accommodated donors’ NWIs. These findings supported recommendations for increased transparency, stronger donor participation in biobank governance, and greater efforts to identify concerns among biobanks’ donor communities.
The 3rd Annual Great Lakes Biorepository Network (GLBRN) Scientific Meeting was held on October 28, 2016 at the University of Michigan in Ann Arbor. Center Director and Professor Dr. Tom Tomlinson spoke on “Preferences for Biobank Consent Policy are Sensitive to Concerns about Future Research Uses.”
The current research ethics framework gauges the level of ethical protections to the degree of risk to the participant. The lower the risk, the less stringent the requirements for informed consent; when the risk is virtually zero, as with the research uses of de-identified biospecimens and related clinical and demographic data, it is no longer research on a human “subject.”
This framework forgets why people donate their specimens and data to biobanks. They are not merely concerned with what later research will do to or for them. They are hoping their donation may do some good; and correlatively, assuming that it will do no wrong, in ways they would find morally concerning:
Some research might threaten a donor’s world view –such as research to better understand human evolution and history.
Some donors might be concerned by research that might lead to the stigmatization of others –such as research that looks at genes associated with violence.
Or some research may be contrary to the moral, cultural, or political values of the donor – such as research related to abortion or research leading to large commercial profits.
To emphasize the contrasts with the conventional framework, Dr. Tomlinson and his colleagues call these people’s non-welfare interests in later research uses of their donations.
In the talk Dr. Tomlinson presented evidence that such concerns affect people’s preferences among various biobank consent policies, drawn from both a national survey that his research team conducted in 2014 and a series of democratic deliberations held in 2015. The evidence shows that the more people are aware of the range of possible research uses of biobank donations that might be of concern to them or others, the more negative their attitudes are toward blanket consent. In this consent, a donor gives permission up front to any future uses that the biobank would allow, without any further consent or information provided. This is the most common form of biobank consent, but their research shows that a bare majority finds it “acceptable,” and a sizeable minority (38%) think it’s the “worst” option among those presented. Interestingly, the team found similar attitudes expressed toward specific, study-by-study consent, the option that gives each donor the most control over later research uses.
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