Q&A: University of Michigan study looks into medical research consent

Amanda C. Hamon By Amanda C. Hamon The Ann Arbor News
on February 07, 2009 at 6:33 PM, updated February 07, 2009 at 6:41 PM
Scott Kim
What happens when medical research requires participants who, because of their disease, can't give consent to be studied?

Medical research institutions sometimes must limit their research of Alzheimer's disease because many state laws aren't clear about how to obtain consent from patients suffering from dementia.

New research from lead author Scott Kim, a University of Michigan psychiatry professor and bioethicist, found that a majority of older Americans support family surrogate consent, or consent given by family members.

Q. What's the ethical issue involved in dementia research?

A. In research, people almost always have to give their own informed consent. However, devastating illnesses such as Alzheimer's affect people's cognition, so that creates a dilemma. It's such a bad disease. We need to do a lot of research about it to help people. But on the other hand, because it affects people's thinking, it's difficult to get their informed consent.

Q. How does the law handle the issue of surrogate consent?

A. Laws are very unclear about what's permissible and what's not. The federal law says yes, in theory, if you get a legally authorized representative to give permission (for a patient to participate in a study), it's OK. However, the federal law also says the definition of a legally authorized representative is up to the states and local government to make up. But very few places have done that.

So over the years, there have been controversies about who can provide (consent) and in what types of research they can provide it. The federal government has in the past asked certain institutions to stop doing research based on surrogate consent until they can prove to the government that the local and state laws are clear enough. Even within one city, medical schools will interpret these laws in different ways. One medical school might say it's OK to do this kind of (surrogate consent-based) research, whereas another hospital might say no, you can't do that. ... Some risk-adverse institutions may unnecessarily block research ... and ... without clear guidance, I think the subjects are also vulnerable, too.

Q. How did you and your team do your study, and what did you find?

A. This survey was a survey of ... people who are over 50 years old. We asked them their opinions about surrogate consent for dementia research. We asked questions about a broad range of research types, from fairly low risk (research) to quite invasive (research) involving brain surgery.

We found that there is a strong and clear majority support in two senses. One, most people (ranging from 68 percent to 83 percent) feel that (there) should (be) a policy that allows family members to give permission. And secondly, most people (57 to 80 percent), when they apply this issue to themselves, would consider participating in research like this should they become incapacitated in the future.

Q. What do these results tell you?

A. This is a pretty strong endorsement, it seems to me. It's a clear majority of people who would favor a policy of surrogate consent for this type of research. So when bioethicists or various lawmakers comment on clarifying these policies, they should take this (research) into account.

Q. Can you describe your current research involving this issue?

A. One of the things my research team is doing is using a method called deliberative democracy, where we bring in ordinary citizens for a day-long session where they hear national experts discuss clinical research (of Alzheimer's and dementia) as well as the ethics on law issues (involved). (The citizens) deliberate amongst themselves about what the best policies might be, and then we ask their opinions.

What we're doing is going beyond just the cross-sectional surveys now. We're trying to get much more considered, educated opinions of our citizens. This is a very important issue, proposing you conduct research that involves risk with people who can't give their own consent. ... We want to make sure that when we make policies on that, it's based on the informed opinions of our citizens.
