Grandma has Alzheimer's disease - should you sign her up for a new research study, even if she doesn't really understand what it entails?
What if the research has real risks, is unlikely to benefit her, but could lead to advances that will help future patients with Alzheimer's? A new study sheds light on these questions, which may come up more often as potential treatments require more involved and invasive research.
"As potential new therapies such as vaccines, gene therapy, and new drugs are being tested, the need for research must be balanced with the need to protect vulnerable adults," said Scott Y. H. Kim, MD, PhD, of the University of Michigan Medical School in Ann Arbor. "This continues to be an area with unsettled policy, and there is little data to guide policymakers. It doesn't seem ideal to leave these important ethical questions solely to politics. This study shows that it's possible to learn the views of key stakeholder groups, and they can provide important insights."
People at heightened risk for Alzheimer's disease - 229 people who were over 70 and had at least one close relative with the disease - took part in the study, which is published in the November 8, 2005, issue of Neurology, the scientific journal of the American Academy of Neurology.
The participants were given 10 research scenarios and asked if the research portrayed was acceptable when it involves people with Alzheimer's who cannot give their own informed consent and are enrolled with a family member's permission.
They were asked to consider three perspectives: whether the research was acceptable from a societal perspective, from their own perspective (whether the participants would want a loved one to make the decision for them), and from the perspective of a surrogate (how they would make a decision for a loved one).
The 10 scenarios ranged from low-risk studies involving observation or routine blood draws to higher-risk studies like testing a potential vaccine or a neurosurgical gene-transfer intervention. The survey participants were told about the risks and any potential benefits to subjects or to society.
More than 90 percent of the participants felt that minimal risk studies as well as randomized clinical trials of new medicines should be allowed with incompetent Alzheimer's subjects if family members give permission. A smaller proportion, but still a majority, felt that even the scenarios with the most risk (for example, early phase experiments testing gene-transfer) were acceptable.
In general, participants endorsed family consent for research most strongly when applied to themselves as future research subjects and least strongly when placing themselves in the position of the surrogate having to decide for a loved one. For example, for a study that would involve a lumbar puncture (also known as a spinal tap), family consent for research was endorsed by 69 percent when applied to themselves as future subjects, by 65 percent from a social policy perspective, and by 61 percent as something they would allow for a loved one.
Participants were more likely to find the research scenarios acceptable if they had a generally supportive attitude toward biomedical research. The study participants were already taking part in an Alzheimer's disease anti-inflammatory prevention research study. The researchers note that the participants could be more supportive of research than the typical person at risk for Alzheimer's.
"However, those taking part in the study were fairly typical demographically to people taking part in other studies of Alzheimer's disease, so they may be quite similar to those likely to be considered for future research studies," Kim said.