Mentally Disabled Research Subjects:  The Enduring Policy Issues

Rebecca Dresser, JD
JAMA. 1996;276(1):67-72. doi:10.1001/jama.1996.03540010069034.
Text Size: A A A
Published online

Mentally disabled adults often serve as subjects in research on mental illness, developmental disabilities, dementia, and other conditions associated with mental impairment. Since US regulatory policy fails to resolve many ethical issues presented by such research, investigators and institutional review boards must determine the appropriate standards and procedures for studies involving adults with mental disabilities. Procedures for capacity assessment and information disclosure should enhance the autonomy of capable subjects and accurately identify subjects incapable of independent choice. Research teams should inform proxy decision makers of their ethical responsibilities. Decisionally incapable adults objecting to research involvement should rarely be included in studies. Researchers, institutional review boards, advocacy groups, and federal officials should collaborate to improve evaluation of risks and potential benefits to decisionally incapable subjects. These groups should also seek consensus on appropriate risk limits in studies presenting no prospect of direct benefit to decisionally incapable subjects. Finally, subject populations should be represented in research planning and review activities.


Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours




Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).


Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.