Balancing Individual Rights with the Communal Right to Know: Health Care Research and Public Policy

Article excerpt

The nature of health care research creates competing ethical conflicts. On the one hand, research procedures should protect individual privacy and autonomy. Information obtained from subjects should be held in confidence, individuals should not be coerced into participating in research, and they should have full knowledge of the risks and benefits of participation. On the other hand, in pursuit of a clearer understanding of health problems and to guard society from harm, some identifying information is necessary to protect the public good. Debates about the public right to know are heightened when society experiences epidemics or public health crises. Also, research may be needed on population groups who may not fully understand the risks and benefits of a research project.

Many factors in conducting research have the potential for infringement on clients' rights to privacy and autonomy. Research subjects are often in a compromised and vulnerable state because of medical conditions, disabilities, mental status, or other problems that have the potential to affect comprehension, judgment, and reasoning. We must deliberate how a researcher obtains informed consent from a person who is in the beginning stages of dementia, a minor child, a person who is visually impaired and cannot read the consent form, a person with developmental disabilities, a person whose primary language is not English, and a client in need of emergency medical or psychiatric care.

Models and examples exist of how informed consent may be obtained and autonomy preserved, even with the most challenging of circumstances. In these cases, special procedures such as surrogate decision makers, interpreters, and modifications are in place to accommodate disabilities (American Geriatrics Society Ethics Committee, 1998; Cohen-Mansfield, Kerin, Pawlson, Lipson, & Holdridge, 1988; Cuenod & Gasser, 2003; Philipson, Doyle, Gabram, Nightingale, & Philipson, 1995). Informed consent and preservation of autonomy can be maintained with foresight and planning. Our society needs continued debates about what constitutes ethical research practices. How can we continue to balance the rights of individuals with the rights of the greater society? We must continue to examine how much we are willing to sacrifice in pursuit of common knowledge.

The protection of the rights of research participants was a major tenet of the Nuremberg Code. Created in response to the atrocities of medical experimentation conducted in concentration camps, the Nuremberg Code is a 10-point statement on medical ethics. Among other factors, the document emphasizes voluntary consent to experimentation. The Nuremberg Code dealt with informed consent and is the first accepted international document that set guidelines in this area. This document declares that each subject be adequately informed of the aims, methods, anticipated benefits, and potential hazards of the study. The document stipulates that close relatives of subjects can provide consent in the event that a subject cannot give consent. The Code recommended that reports of experimentation out of compliance with these principles not be accepted for publication ("Trials of War Criminals," 1949). Since then, obtaining voluntary and informed consent has been recognized to be of utmost importance in the protection of human subjects.

In the United States procedures for protecting human subjects are outlined in the Federal Policy for the Protection of Human Subjects. Referred to as the Common Rule, this policy requires reviews of research proposals and approval to conduct such research from an institutional review board (IRB). Researchers conducting secondary analyses must also conform to these regulations. As part of the IRB process, researchers must also demonstrate how data will be held in confidence. Another part of this review requires proof of informed consent procedures used for the research project. …