Creating a thoughtful policy for proxy consent
Most laws are vague, there is some guidance for IRBs
The use of proxy consent for adults who lack the capacity to consent on their own is a complicated issue, thanks to vague and often inadequate state laws describing who can make such decisions.1
The difficulty has seriously hampered research, particularly with patients who have psychiatric illnesses, says Scott Kim, MD, PhD, an assistant professor of psychiatry and a core faculty member in the bioethics program at the University of Michigan in Ann Arbor.
"Virtually no research gets done with psychiatric patients who are incompetent," Kim says. "So as far as I know, virtually every clinical trial involving people with chronic psychosis, for example, only enrolls people who can give their own consent.
"In the majority of the states, the laws are unclear and there's very little case law, so everybody's sort of guessing what the right thing to do is."
But Kim says that in recent years, some states have bucked this trend, passing laws that while different from each other, have clear-cut guidelines about the situations in which it's permissible for a relative or caregiver to give consent for a patient and who is allowed to do so.
California, Virginia, New Jersey
Federal law requires that proxy consent for research involving adults who lack decision-making capacity must be given by a "legally authorized representative." But states may have different ideas of who that person might be.
And most state laws don't focus specifically on the use of proxies in research, Kim says.
"In most states, there are laws that could be relevant but most likely they were written years ago," Kim says.
However, three states have "modern laws" regarding the use of adult proxy consent in research, he notes.
- California, whose law allows proxy consent for research related to "the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of research participants." The proxy must have reasonable knowledge of the participant and attempt to make the decision the participant would have made if capable, or if it's not possible to know that, must act in the "best interests" of the participant.
Possible proxies (listed in order of priority) include someone holding a durable power of attorney, a conservator, a spouse, a domestic partner, an adult child, a custodial parent, an adult sibling, adult grandchild or other adult relative with "close kinship" to the participant.
Kim notes California's law does not limit research using proxies to certain defined risk categories. "They leave that open for IRBs to determine."
- Kim says Virginia's law, by comparison, is modeled closely after the risk-benefit categories outlined in pediatric research regulations, for example, forbidding non-therapeutic research if it poses a more than minor increase over minimal risk.
The categories of people who can serve as a legally authorized representative are similar to California's. The proxy must not allow research that he or she knows runs contrary to the participant's religious beliefs or values. The proxy also cannot give permission for psychosurgery, a point that Kim says might raise issues with some psychiatric research.
He notes that currently research is being conducted using deep-brain stimulation with patients with Parkinson's disease and refractory depression.
"So if an IRB in Virginia determines deep-brain stimulation to be a form of psychosurgery, and if the person is really depressed and somebody says we're not sure if he can consent, then that person would not be allowed to enroll in that research," he says.
- New Jersey's Access to Medical Research Act is the newest law, passed in 2008. It has similar risk-benefit categories to Virginia's law and lists the potential proxies in similar order.
Studies support proxy consent
And what should IRBs in the 47 other states do?
"If you're in a state that does not have clear laws, or has laws whose implications are not crystal clear — which I would consider to be most states — the best thing they can do is come up with a thoughtful institutional policy," Kim says.
Kim says IRBs leaning in one direction or another have two good models in California's and Virginia's laws.
"I think in some ways it might be better to have a statement about extra scrutiny and extra careful attention to risks and benefits without locking yourself into some rigid framework," he says. "On the other hand some IRBs might want to have an institutionally conservative posture. Many IRBs behave that way. They might go with something like what Virginia has done."
He also points out that IRBs can be fairly confident in the care that proxies give to the decisions to enroll a person in research and in patients' willingness for family members and caregivers to allow for proxy consent should they ever need it.
Kim says most studies done of proxy decision-making show that when competent patients and people whom they would trust as proxies are given information about potential studies, the "proxies" are actually more wary than the subjects themselves.
And he says his studies of older people's attitudes show support for the idea of future participation in research, including the possibility of surrogate consent.
"The more people learn about the situation and how the protection system works, the more supportive people are of some type of policy that allows family members to serve as surrogate consenters," Kim says.
Reference
- Saks ER, Dunn LB, Wimer J, et al. Proxy consent for research: The legal landscape. Yale J Health Policy Law Ethics. 2008 Winter;8(1):37-92.
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