Substitute consent to data sharing: a way forward for international dementia research?

A deluge of genetic and health-related data is being generated about patients with dementia. International sharing of these data accelerates dementia research. Seeking consent to data sharing is a challenge for dementia research where patients have lost or risk losing legal capacity. The laws of most countries enable substitute decision makers (SDMs) to consent on behalf of incapable adults to research participation. We compare regulatory frameworks governing capacity, research, and personal data protection across eight countries to determine when SDMs can consent to data sharing. In most countries, an SDM can consent to data sharing in the incapable adult's best interests. Best interests typically include consideration of the individual's previously expressed wishes, values and beliefs; well-being; and inclusion in decision making. Countries differ in how these considerations are balanced. A clear previous consent or refusal to share data typically binds the discretion of an SDM. Though generally permissive, National patchworks of laws and guidelines cause confusion. Clarity on the applicable law and processes to enhance ethical decision making are needed to facilitate substitute consent. Researchers can encourage patients to communicate their research preferences before a loss of capacity, and educate SDMs about their ethical and legal duties. The research community must also continue to promote the importance of data sharing in dementia.