Guardianship and Clinical Research Participation: The Case of Wards with Disorders of Consciousness

Kennedy Institute of Ethics Journal, Vol. 27, No. 1, March 2017

32 Pages Posted: 2 Jul 2018

See all articles by Megan S. Wright

Megan S. Wright

The Pennsylvania State University (University Park) – Penn State Law

Michael R. Ulrich

Boston University - School of Law; Boston University School of Public Health; Yale Law School

Joseph Fins

Weill Cornell Medical College

Date Written: March 1, 2017

Abstract

We review relevant federal law about research on human subjects and state laws on guardian authority to determine whether guardians can consent on behalf of their wards to participation in research. The Common Rule is silent on the issue as are most state guardianship laws. Our analysis shows significant variation in guardians’ decision-making authority in the states that do regulate wards’ participation in research. We consider how the appointment of guardians for patients with disorders of consciousness (DOC) impacts such patients’ access to research. We assert that it is important that such persons be permitted to participate in research, so that their conditions and potential medical interventions can be studied, and that those with similar conditions can benefit from the knowledge gained from these studies. We argue that state guardianship laws should be adapted to specifically give guardians the authority to consent to research on behalf of wards who may be able to regain decisional capacity.

Keywords: research ethics, guardianship, traumatic brain injury, state law, capacity, consent, clinical research, consciousness, common rule

Suggested Citation

Wright, Megan and Ulrich, Michael R. and Fins, Joseph, Guardianship and Clinical Research Participation: The Case of Wards with Disorders of Consciousness (March 1, 2017). Kennedy Institute of Ethics Journal, Vol. 27, No. 1, March 2017, Available at SSRN: https://ssrn.com/abstract=2947807

Megan Wright

The Pennsylvania State University (University Park) – Penn State Law ( email )

Lewis Katz Building
University Park, PA 16802
United States

Michael R. Ulrich (Contact Author)

Boston University - School of Law ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States

Boston University School of Public Health ( email )

715 Albany Street
Boston, MA 02118
United States

Yale Law School ( email )

127 Wall Street
New Haven, CT 06510
United States

Joseph Fins

Weill Cornell Medical College ( email )

1300 York Avenue
New York, NY 10065
United States

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