Procedural Framework to Facilitate Hospital-Based Informed Consent for Dementia Research

Area of Science:

• Gerontology and Geriatric Medicine
• Clinical Research Ethics
• Neuroscience and Neurology

Background:

• Improving care for Alzheimer's disease and related dementias (ADRD) necessitates robust research across the care continuum.
• Informed consent for ADRD patients in research presents significant logistical and ethical hurdles, particularly in acute care settings.
• Challenges include assessing capacity, surrogate consent, identifying legal representatives, and balancing patient autonomy.

Purpose of the Study:

• To develop and evaluate a procedural framework for obtaining informed consent from hospitalized individuals with ADRD and their caregivers for minimal-risk research.
• To address challenges of rapid enrollment, capacity determination, and surrogate consent in acute care settings for ADRD research.

Main Methods:

• Collaborated with an Institutional Review Board to create a specialized consent framework for minimal-risk interventions.
• Framework emphasizes rapid surrogate identification for patients lacking decision-making capacity (e.g., via healthcare power of attorney).
• Incorporated individualized formal assent procedures for patients unable to provide full consent.

Main Results:

• The procedural framework proved effective in facilitating hospital-based recruitment for an ongoing randomized controlled trial.
• Demonstrated successful enrollment of hospitalized individuals with ADRD and their caregivers in a minimal-risk care intervention study.
• The methods support increased access to acute care clinical research for persons with ADRD.

Conclusions:

• The developed consent framework effectively overcomes barriers to recruiting individuals with ADRD in acute care settings.
• Streamlined consent procedures during acute illness are crucial for boosting research participation.
• Enhancing research access is vital for advancing high-quality care delivery for people with ADRD.