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The Ethics of Research With Human Subjects Who are Mentally Ill


Author(s) Stuart Youngner Atwood D. Gaines

A module meant to stimulate discussion among researchers about the ethical issues that arise in conducting research with human subjects who are mentally ill; including topics such as consent, privacy, conflict of interest.

By Stuart J. Youngner, MD and Atwood D. Gaines, Ph.D., MPH

Background and Module Content

Millions of people in the United States suffer from serious, debilitating mental illness such as schizophrenia, bipolar disorder, and major depression-- at great social, emotional, and economic cost. The number of afflicted individuals constitutes a national problem and makes imperative the research concerning the mechanism(s), treatment(s), and prevention of these forms of mental illness. Research based on biological models will necessarily require the use of somatic interventions or exclusions which use research subjects who are the very people who suffer from the serious forms of mental illness under study.

Patients suffering from mental illnesses are particularly vulnerable as research subjects. At the same time, pressure on those who conduct research have developed and which complicate research issues. Today, private industry increasingly supports psychiatric and neuropsychiatric research. And professional advancement in the medical academy is largely dependent upon extra mural funding, government or private. It is upon research data that publications are based which, in turn, often leads to increased and additional funding and, hence, recognition and status. These developments increase pressures on researchers who conduct biological and pharmacological studies of the mentally ill.

Two research strategies have caused particular concern-- especially when the balance of risks and benefits are taken into account when making decisions regarding research: (a) "Challenge Studies," in which researchers intentionally give patients pharmacological agents in order to induce and study psychiatric symptomology; and, (b) drug "washout" studies, in which patients are removed from all psychiatric medication to study baseline states or pure effects of new drug treatments. An incident at UCLA, in which a former research subject committed suicide after participating in a washout study, was well publicized in the national media and investigated by the Office for Protection from Research Risks (OPRR).

Many approaches have been suggested to aid researchers in facing ethical issues raised by vulnerable patients/subjects such as the mentally ill. For example, ethical issues such as conflict of interest, risk/benefit concerns, consent and surrogate are often suggested. However, it is also well to remember that social identity may increase subjects' vulnerability as when subjects are members of denigrated ethnic, age, religious, or gender groups in addition to being afflicted with mental illness.

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Method and Scenarios

Distribution of scenarios to the students and faculty.

Panel discussion based on those scenarios and questions and any others that students or faculty wish to add.

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Reading (recommended for discussion of scenarios)

  • Explanation of Federal Regulations (45CFR46) on research with human subjects, Part I and Part II.
    • Reading Questions for the Federal Regulations on research with human subjects can be found here.
  • National Bioethics Advisory Commission (NBAC) Report on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity, December 1998.
    • Reading Questions for NBAC's report on Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity can be found here.


  • Understanding of key ethical questions that arise in research with human subjects who are mentally ill and an understanding of the possible approaches in answering these questions.
  • Increased ability to apply these approaches to particular situations and a recognition of their shortcomings.
  • Increased ability to discuss these ethical issues and to prevent misunderstandings.

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Bibliography (for further reading)

  • Appelbaum, Paul, et al., "False Hopes and Best Data: Consent to Research and the Therapeutic Misconception." Hastings Center Report 17(2): 20-24, April 1987.
  • Miller, Franklin and Rosenstein, Donald. "Psychiatric Symptom-Provoking Studies: An Ethical Appraisal." Biological Psychiatry 42(5): 403-409, 1997.
  • Shamoo, Adil E. and Keay, Timothy. "Ethical Concerns About Relapse Studies," Cambridge Quarterly of Healthcare Ethics 5: 373-386: 1997.

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Year 2006
Publisher provided Keywords BIOLOGY Human Research Subject MEDICINE PSYCHOLOGY SCIENCE Vulnerable Populations
Publisher National Academy of Engineering, Online Ethics Center
Language English
Cite this page: "The Ethics of Research With Human Subjects Who are Mentally Ill" Online Ethics Center for Engineering 9/10/2006 OEC Accessed: Sunday, December 4, 2016 <>