Informed consent is the backbone of ethical research practice. But is ritual being used to delude patients? Pamela Sankar talks with the Bulletin about how she discovered the problem.

Pamela Sankar is studying the ritualization of informed consent to medical research. In particular, she's interested in how researchers ritualize consent sessions in order to gain the participation of potential research subjects in Phase I Protocols, the earliest stage of testing treatments on human subjects. Sankar has observed that researchers may organize sessions to suit the schedules of potential subjects or give them business cards with the researchers' home phone numbers scrawled on the back. These practices invert the normal routine of doctor-patient relationships and create the sense that researcher and subject are equals, partners who are part of the same team. Sankar sat in on consent sessions with a group of terminally ill patients who consented to become part of a drug toxicity study despite the fact that it would have no impact on their disease. Though none were willfully misinformed, when queried most revealed that what they wanted to gain from the study was help or a cure for their illness.

Sankar is an assistant professor at the Center for Bioethics at the University of Pennsylvania and Senior Fellow of the Leonard Davis Institute of Health Economics.

How would you describe the current practice of informed consent?
One important distinction to make is whether you're talking about informed consent for clinical work or for research. My concern is with research, which is voluntary, but at the end of it, there often dangles the carrot of possible cure. Some research, however, is dangerous to the subjects. And there has been lots of emphasis over the last 30 years on trying to figure out ways to improve the informed consent procedure to make people aware of the risks.

Much of what has gone on in the last three decades has been making policy and then figuring out how to impose that on physician researchers who are extremely autonomous beings. For research subjects, the Federal Office for Protection from Research Risk has attempted to impose a standardization of policies and procedures. The research institute has to absorb the rules. But once physician-researchers get approval from the Institutional Review Board (IRB), no mechanism is in place to check up on them.

How did you become interested in the issue?
By and large, the informed consent process works. But I'm interested in the subtle ways in which it doesn't. There hasn't been a lot of research where people actually watch the consent session. When I sat in on one, I thought, That's really interesting. On a certain level they did it right. But I implicitly felt that the patient didn't understand what they were doing. What physicians will say, though, is, "I did my best, but I can't bridge this communication gap."

How does the concept of "ritualization" apply to informed consent?
Ritualization is a resource that all of us use at various points in our lives. It's a kind of communicative behavior that people learn over time and take on as a resource. In my paper, I use the example of the Thanksgiving dinner and how it's set apart from a normal meal by being served on special plates. This both distinguishes and privileges the event and the values that it implies. Researchers highlight consent sessions to privilege what happens there. But the researchers are really in control of the situation. They have much more equanimity at such times and that allows them to figure out the best strategies. They have a need or a desire, and implicitly or unconsciously they think about the best way to fulfill it. They draw on ritualization as a resource.

Is this the result of intentional obfuscation on the part of researchers?
I don't really think it is. As a group, they're no different from other citizens. I believe they're being earnest. I don't think they think they're tricking people when they say they're giving adequate information. But when you're dealing with terminally ill people, you have a particularly vulnerable group.

How should informed consent be handled?
I think there should be changes, but so far even implementing small reforms has been an enormous struggle. The next step is going to take a long time. It will probably involve strengthening of IRB oversight and monitoring or evaluation of consent procedures. But to get physician-researchers to agree to that is going to be very difficult. The system cultivates a certain kind of person to become a physician-researcher. They have immense autonomy. They want to control their own domain. They tend to agree to regulations because they don't have much choice. Many think it's a good idea that patients should understand, but they don't place a lot of value on outside review.

If there are changes in informed consent, will it put an end to certain kinds of research?
An important counterbalance to what I've said is that there is a subgroup of patients out there who know they are dying and want their deaths to be meaningful, and so they do become research subjects, but this tends to gloss over patients who agree to be subjects when that's not the case. You have to be extremely clear about what options patients have. One of the federal rules of informed consent is that you must outline alternatives to the patient. What researchers usually say is, "You can do my protocol or you can do protocol B." What they don't say is, "You could go home, go to hospice, be with your family." That's the part that never gets added in.