Protecting Children and Decisionally-Impaired Adults
in Biomedical and Behavioral Research: Is Bioethics Enough?

Summer Ethics Institute
National Catholic School of Social Service
The Catholic University of America
Washington, DC
June 6, 2003

ABSTRACT

Politics of Protection:

Regulating Research with Decisionally-Impaired Individuals

Karen J. Maschke, Ph.D.

This paper provides an analysis of the sociopolitical context in which regulatory protectionist policies involving research with decisionally impaired individuals have been proposed, rejected, and adopted.  The paper begins with a review of what I call “accommodationist protectionism.”  This version of protectionism is the dominant paradigm of research ethics discourse and policy in the United States.  Accommodationist protectionism is based on the premise that it is possible to reconcile the tension between the needs of science and the rights of prospective research subjects and participants of medical experiments by establishing procedural mechanisms to ensure that 1) risks to subjects are minimized and reasonable in relation to anticipated benefits, 2) subjects of human research are selected equitably, and 3) subjects (or their legally authorized representative) give informed consent to participate in research studies.   

An alternative definition of protectionism offered here is based on the premise that it is ethically defensible to place limitations on the research enterprise for the purpose of protecting individual rights and liberties.  What I call substantive protectionism resonates from the Nuremberg Code’s principle of first-person informed consent and is at the core of principle-based civil and human rights perspectives.      

In 1996, the Food and Drug Administration (FDA) issued a regulation that permits Institutional Review Boards (IRBs) to waive the requirement for both subject and proxy consent for emergency critical care research. In 2002, the governor of California signed a bill that makes it easier for researchers to obtain informed consent by proxy for research conducted with individuals who are decisionally impaired.  Yet other policy initiatives that reflect accommodationist protectionism involving matters of proxy research consent, research advance directives, and research risk have not been implemented.  Using dementia research as the framework for analysis, this paper identifies the sociopolitical factors that were influential in either derailing or implementing accommodationist protective policies governing research with individuals who are decisionally impaired.  Specific attention will be given to policy proposals involving proxy research consent and the use of research advance directives.

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