Considerations For Informed Consent In Clinical Trials Involving Neurologic Disorders

By Linda Reuter

Informed consent is essential in clinical research. However, neurologic trials face challenges when conditions like Alzheimer’s, ALS, or Parkinson’s impair decision-making. When participants lose decisional capacity, a Legally Authorized Representative (LAR) may provide consent, following state laws prioritizing court-appointed guardians, healthcare proxies, or designated family members. The LAR’s role begins only when capacity is lost, requiring careful documentation.

To uphold ethical standards, trial protocols should include ongoing capacity assessments, re-consent procedures, and assent practices for participants who can still express their willingness to continue. Since consent is an ongoing process, sponsors must plan for transitions in decision-making authority. By integrating structured consent strategies, sponsors and investigators can safeguard participant autonomy and ensure equitable access to neurologic trials. Strengthening ethical frameworks supports patient-centered research while advancing treatment opportunities for those with fluctuating decisional capacity.