In clinical trials for Alzheimer’s disease it is becoming more common for researchers to invite people at an increased risk of developing the disease, in the hopes of developing treatments that can stop or slow it down. But it is sometimes unclear whether this risk status should be shared with participants. A new paper published in the journal Ethics & Human Research looks at the existing guidelines and suggests policies for when this information should be disclosed. The study was supported by the Innovative Medicines Initiative (IMI) through the EPAD and AMYPAD projects.
When testing a new treatment to potentially stop or slow the onset of Alzheimer’s disease, researchers want to find participants who both have little to no cognitive symptoms and are either in the very early stages of the disease, or at a risk of developing it. This risk can be determined either by genetic testing or searching for the disease’s ‘biomarkers’ in brain scans, cerebro-spinal fluid, and other methods.
But these biomarkers come with their own challenges. They are not a definite indication that a person will get the disease, and there are still no effective options to treat or prevent it. This means that researchers face an ethical dilemma when participants ask for their Alzheimer’s biomarker results while it is still unclear what these results may mean for their future cognitive health. Researchers naturally want to let participants know about relevant medical information, but researchers have yet to determine the relevance of these biomarkers. Also, doing so might also be harmful to the participants who may be unnecessarily worried or make life changes based on incomplete information.
“There is a growing consensus that individual research results that are potentially relevant should be reported to research participants,” said paper co-author Dr Eline Bunnik, an associate professor at Erasmus MC, University Medical Centre Rotterdam, in the Netherlands. “But data are not always informative, and information is not always beneficial,” says Bunnik. “I believe many researchers may be struggling with these dilemmas.”
She and her co-authors decided to bring together three sets of ethical guidance literature on the topic. The first set discussed returning individual research results, the second was about the ethics of accessing personal data, and the third about the ethics of enrolling research participants in clinical trials.
Based on their research, they were able to create coherent, general recommendations for Alzheimer’s disease research. For example, it should not be routine to share Alzheimer’s biomarkers with participants in observational studies until the biomarker’s clinical usefulness can be clearly established. But when enrolling participants with Alzheimer’s biomarkers in clinical trials, they should be informed why they were chosen to take part. And following data protection legislation, if an individual explicitly asks for their personal data from a study, Alzheimer’s biomarkers should be included.
These policies were also shared with the co-author’s partners in the EPAD project, which used cognitive, clinical, neuroimaging and biomarker tests to collect data on the early stages of Alzheimer’s disease. This data was then used to develop accurate models of how Alzheimer’s disease progresses before the onset of dementia.
“Our work was positively received by the EPAD project partners, and formed the basis for the set-up and the conduct of the study,” says Bunnik, adding that she and colleagues from the project now plan to develop an ethical framework for disclosing biomarkers in other Alzheimer’s disease studies, specifically onset prediction biomakers in potential carriers of heritable frontotemporal dementia.
EPAD and AMYPAD are supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.