Opinion - Health
Fri July 18, 2014
Facebook, Baby's Blood, and the Debate Over Informed Consent
Every once in a while I wonder if I’ve just been part of a research study that didn’t require consent. Now I know this is a trick of the mind—I know about so many such studies that I’m ready to think I might be involved in one.
Some of my favorite studies like this include Isen and Levin’s (1972) demonstration that finding a dime in the coin return increases helpfulness, Darley and Batson’s (1973) demonstration that seminary students in a hurry were less likely to help others in distress, and Baron’s (1998) demonstration that sweet smells increase our willingness to help others.
In all of these cases, individuals were part of human subjects research before they were asked. No one got their consent.
It recently came to light that Facebook did something similar. Facebook adjusted the News Feed of some individuals to see how it would affect what those members post. Would more positive posts in a News Feed lead to more positive posts by the individual?
Importantly, Facebook did not notify or try to get the consent of those who were experimented on. For all you or I know, we may have been unwitting participants in Facebook’s research. Perhaps predictably, this gave rise to concerns about the ethics of the research, which in turn gave rise to concerns about these concerns.
It also recently came to light that the state of Indiana has been storing newborn blood samples without parental consent for more than 20 years. While the samples have perhaps been rendered useless for research purposes (they were stored in an uncontrolled environment), some have claimed that these samples, if they’re usable, should not be used for research.
Both cases touch on two entangled issues that bear teasing out. First, who should decide the ethical character of such research? Second, should the research subjects (or their parents) have been offered the choice of opting out before hand?
Judging the Ethical Character of Human Subjects Research
Simplicity, efficiency, and expertise indicate that researchers should determine whether their own research is ethically justified. They are, after all, the experts. The history of medical research (i.e. Tuskegee Syphilis Study and Willowbrook Hepatitis Study) suggests some outside body should determine what counts as ethical research. Institutional Review Boards (IRB) commonly fill this role, but only organizations with government funding are asked to have an IRB. Businesses like Facebook are not. Accordingly, businesses like Facebook are left to determine the ethical nature of any research they run.
But what of the newborn blood samples that the state of Indiana was keeping for unknown research purposes? How should we judge the ethical character of research that hasn’t yet been designed?
In our book on the Human Microbiome, I and some colleagues recommend what we call ‘process consent’ for these cases. When consent is impractical or impossible to obtain, research subjects should consent to a process that will be used to evaluate future research studies. For example, in the case of the newborn’s blood spots, parents could consent to have the blood samples used for research, so long as that research was approved by a special appointed board that would includes scientists, healthcare practitioners, and, most importantly of all, other Indiana parents.
Skipping Informed Consent
One aspect of the Facebook and the Indiana newborn blood spot cases that has drawn the ire of the public is the lack of consent. Facebook users and Hoosier parents alike were never given the choice to opt out.
In human subjects research, getting consent beforehand isn’t always necessary. In the Facebook study and the in studies I mentioned at the beginning, getting informed consent beforehand risks corrupting and making useless the results of the studies. If you or I know that we’re being evaluated on how helpful we’re being or how positive our posts to Facebook are, we’re likely to change our helpfulness and positivity because we know we’re being evaluated.
Typically, then, in these cases research subjects are “debriefed” or given the option of opting out of the research after the fact. Informed consent delayed.
But in some cases of human subjects research, informed consent is just unnecessary. As a group I worked with wrote in 2011 (subscription required), for some potentially beneficial research, the risk is small enough (a de minimis risk) that informed consent simply isn’t needed. If feasible, opportunities to consent should still be offered to subjects, but this is not necessary for the research to be ethical.
On this view, it seems that neither the Facebook research, nor any research on the Indiana newborn’s blood spots gathered over the last 20 years would require informed consent.
On this past Tuesday (July 15) my second son was born. Before discharge, I signed the form allowing his de-identified leftover blood samples to be used for research by the State of Indiana. But I did so with some disappointment.
First, they plan to keep the blood samples for only three years. This unnecessarily limits how much we might learn. Second, the consent did not indicate how they would determine the ethical nature of this future research. There was no identifiable process for evaluating potential research studies. Third, I don’t think the consent was necessary. It allows some to opt out of their responsibility of contributing to our medical system and public health.
In cases like this, where the risks to the subjects are de minimis, medical researchers should learn all they can to improve health care and public health. The bigger the data pool, the more reliable and robust the conclusions—and so the researchers need as many research subjects as possible. But by offering parents the chance to opt out, they limit what they can learn.
I’m grateful for the advances in medical science that allow us to sleep easier that my son is healthy and well. And I agree with Rhodes’ argument (subscription required) that when we take advantage of such a system, we have a responsibility to contribute to that system as well.
Abraham Schwab is an associate professor of philosophy and medical ethicist at IPFW.
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