When Informed Consent Is Impossible

The answers to these questions require a principled argument, but evidence must inform how we apply those principles.

Caregiver May Be Best Proxy

The proxies of people with Alzheimer's disease are not strangers or family members who have dropped in from out of town to enroll their demented relative in research. They are caregivers. These are spouses, partners and adult children who shoulder a number of roles. They take the person to doctor visits, talk to the doctor about how their patient is doing, and help their loved one to cope with their disabilities.

Caregivers take these roles quite seriously and with great emotion. They understand that not only the benefits, but also the risks, of research affect themselves and their relative.

Jason Karlawish is associate professor of medicine at the University of Pennsylvania.

Caregivers are not self-interested strangers. They are trusted companions. They know that if research harms a patient, it harms the caregiver as well. The caregiver will face not only the burden of a decision that turned out bad but also the task of caring for a now injured loved one.

The bond between patient and caregiver supports why caregivers should be the proxy for a patient with Alzheimer's disease who is not competent to consent. What we should focus on is reducing the risks of research proxies and patients face. But what risks?

Some caregivers and patients consider Alzheimer's a dreadful disease. They are willing to take risks for the potential benefits of a promising experimental drug in the same manner as persons with cancer.

Bringing Crucial Studies Home

There is no reason why we should restrict a proxy from enrolling a loved one in a study that tests a risky but promising experimental treatment, even treatments with risks like encephalitis. Instead, we should focus on reducing the risks of research procedures.

Caregivers and patients say that one of the biggest risks and hassles of research are the frequent trips to the study site. Getting a person with Alzheimer's disease ready for a trip to the study site, driving there, and getting home are not easy tasks. And caregivers, many of them elderly, have their own health issues as well.

The solution? Study visits should be at the patients' homes. This may not be possible for all study visits. Some studies require hospital visits for tests and procedures. But just as physicians can see their patients at their homes -- and Medicare pays them to do that -- so, too, can physician-scientists come to their research participant's home to gather their data.

Jason Karlawish is associate professor of medicine at the University of Pennsylvania.

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