Related Experiment Video
Updated: May 8, 2026

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
Published on: July 31, 2017
Designing Consent Processes for Research With Older Adults Who May Lack Decisional Capacity: A Guide for
Emily A Largent1, Stephanie R Morain2, Jason Karlawish3
1Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Researchers can ensure ethical research with older adults by using a nine-step framework for informed consent processes, addressing cognitive impairment challenges and regulatory obligations.
Area of Science:
- Bioethics
- Clinical Research Ethics
- Neuroscience
Background:
- Informed consent is crucial for ethical research.
- Older adults may face challenges in providing informed consent due to cognitive impairment.
Purpose of the Study:
- To present a nine-step framework to guide researchers in designing ethical consent processes for older adults.
- To address challenges in obtaining informed consent from participants with diminished decisional capacity.
Main Methods:
- The framework involves nine steps: identifying participants, assessing capacity, determining justification for enrollment, assessing need for consent, preparing accessible information, assessing decisional capacity, identifying surrogates, involving participants lacking capacity, and considering changes over time.
Main Results:
- The framework provides a structured approach to navigate complex consent scenarios.
- It helps researchers anticipate and manage ethical and regulatory challenges.
Conclusions:
- This framework supports researchers in fulfilling ethical and regulatory obligations when enrolling older adults, particularly those with cognitive impairments.
- It can be applied to grant applications, Institutional Review Board protocols, and research practice.
Related Concept Videos
Ethics in Research
Ethical Dilemmas II
Nurses' Legal Responsibilities I
The legal responsibilities of a nurse regarding informed consent include the following:
Drug Dosing: Geriatric Patients
Pharmacodynamics in Geriatric Patients: Effects of Age
Blind Procedures

