By Henry S. Richardson
A huge amount of ethical angst swirls around the topic of informed consent. Can lay people who are considering signing up as subjects in a medical study really be made to understand the risks they are facing? Can information about these risks be communicated across cultural and educational gulfs? What degree of informed understanding should we expect subjects to have, anyway?
Underlying the process of informed consent, though, is a simpler and more fundamental issue. The one-sided focus of the medical-research ethics establishment on preventing harms and abuses has obscured this core function from view. We need to remember why consent is needed for participation in medical research in the first place. It is needed because the researchers need the subjects’ permission to do things that otherwise would be wrong to do. It is wrong to examine and touch people’s naked bodies in the ways researchers need to do, to collect samples of their blood, urine, and feces, and to collect detailed information on their medical histories without getting their permission. Their permission, or consent, is needed for a study to go on in a way that does not violate their rights not to be viewed or touched, not to have their tissue samples collected, and not to have detailed information about their medical histories shared without their permission. For short, we can call all of these “privacy” rights. These privacy rights are “don’t intrude” rights, not “don’t spill my secrets” rights. The latter, confidentiality rights, apply only after the bodies have been probed and assessed, the tissue samples have been examined and tested, and the medical histories stored.
Medical researchers are often not the personal physicians of their research subjects. To them, their research subjects are not their patients. Such medical researchers thus presumably do not owe the full set of moral responsibilities to their subjects that physicians do to their patients. Nonetheless, by asking their research subjects for special permission to touch or probe them, to collect tissue or fluid samples from them, or to elicit and transcribe their medical histories, medical researchers become morally entangled in the lives and needs of their subjects. This happens because they have asked these people to waive some of their privacy rights – their “don’t intrude” rights — and these people have complied with this request.
We can think of a moral entanglement as an obligation that arises unintentionally from a morally innocent or blameless transaction. A moral entanglement is the opposite of a promise. When I make a promise, I think out carefully in advance what I want to obligate myself to do. Then I say to another, “I promise that I will do X,” and the other says “OK.” Moral entanglements we stumble into even if no one intends it. We’re familiar with this phenomenon from everyday life. You start chatting with a stranger on a plane or a bus stop. Suddenly, you’re finding out facts about this person that reveal an urgent need – one the other might not be aware of, but that you are able to recognize and to address. Sometimes, one can break away with a clear conscience. Sometimes not.
We are particularly prone to becoming morally entangled with others’ needs when we invite them to waive some of their rights. When I successfully ask a friend to let me borrow his car, two things are going on. The fundamental one is that I get some limited permission to use the car. The other, more hidden layer is that I also get some special responsibility to take care of the car. It is hard to say exactly what the boundaries of that special responsibility are. They will depend on the context. Perhaps, if your friend’s car gets dinged while you’ve left it in a parking lot, you have a special responsibility to spend some time on the phone with the person who (hopefully) left a note with their insurance information.
When medical researchers successfully solicit waivers of privacy rights from prospective research subjects, they too take on special responsibilities. These special responsibilities center on the purpose and matter of those rights waivers. These researchers probe bodies and collecting samples and medical histories in order to extract information. The subjects’ waivers of their privacy rights thus conveys, not merely a simple permission to touch, probe, and collect, but also a special responsibility with regard to how the researchers treat this information. These special responsibilities ties back to the needs and interests of the people who gave them the special permissions that enable them to carry on with their research. This is the central explanation of why medical researchers get morally entangled with the lives and needs of their subjects.
The result is that medical researchers have special obligations of beneficence towards their research subjects — obligations that they do not have to similarly needy people who are not their research subjects. At an intuitive level, most medical researchers seem to feel that they do have special obligations towards their research subjects. This story about privacy-based moral entanglements explains why.
Concretely, these special obligations center on the information researchers glean by carrying out study procedures — by viewing and proving the subjects’ bodies, collecting samples from them, and eliciting their medical histories. This is the central reason why medical researchers have obligations to address their subjects’ need for ancillary care – medical care that their research subjects need but that is not necessary to conducting worthwhile and sound research in a safe manner. These special obligations are not the only basis of ancillary care duties. Some urgent needs are well-supported by a general duty of rescue that we each owe to every other person. Medical researchers’ special ancillary care obligations go beyond that. They cannot reasonably be viewed as covering all of the ancillary care needs that study procedures uncover, but how to articulate these reasonable limits in a concrete and practically useful way is a topic for another day.
Henry S. Richardson is a Professor of Philosophy, Georgetown University. He is the author of Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers and Democratic Autonomy. Read his previous article on the OUPblog.
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