Using Subjects Who are Mentally Ill in Scientific Research

The Ethics of Research with Human Subjects who are Mentally Ill
A teaching module using scenarios and other methods to stimulate discussion of the ethics of doing research with people who are mentally ill.
What are Acceptable Risks for Human Subjects in a Treatment Study?
What should be the limits of risk and suffering to patient subjects in studies of the efficacy of treatments for major psychological illness such as clinical depression?
Suggested Approaches to Dealing With Ethical Issues in Research with Mentally Ill Patients as Subjects
Suggested methods for resolving ethical issues or reducing risks that may arise in conducting research with the mentally ill as subjects.
Blowing the Whistle on a Therapeutic Experiment
A head nurse at a private psychiatric facility suspects patient abuse in an experimental program.
Music Therapy: Research on Human Subjects with Mental Disorders
How should conflicts of interest between interested parties in the clinical setting be resolved when there is a question concerning informed consent, competence and confidentiality.
The Ethics of Research on Vulnerable Populations
A teaching module covering the ethical issues that arise in doing research on vulnerable populations.
Disagreement About Consent
A scenario meant to stimulate discussion about the ethical issues that arise when members of the health care team disagree about whether a mentally ill patient has actually given informed consent.
When Should We Accept Consent?
A scenario meant to stimulate discussion about the ethical issues that arise when a researcher is unsure if a study participant is too incapacitated to actually give informed consent.
Part I and Part II, Explanation of Federal Regulations (45CFR46) on research with human subjects.
Reading Questions for the Federal Regulations on research with human subjects.
The National Bioethics Advisory Commission's report on Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity.
Reading Questionsfor The NBAC report on Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity.

Relevant Web Resources

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A Participant's Guide to Mental Health Clinical Research
Authored by the National Institute of Mental Health, this booklet is meant "to help maintain the trust that human subjects place in the excellence of the research enterprise" by providing valuable information to those considering participating in research.
Expert Panel to the National Institutes of Health on Research Involving Individuals with Questionable Capacity to Consent
National Alliance for the Mentally Ill, NAMI's statement on the protection of human subjects in research.
National Bioethics Advisory Commission Ethical and Policy Issues in Research Involving Human Participants
Includes a summary, appendices, commissoned papers and staff analysis.
Ethics Code of The American Psychological Association
See especially Section 6 "Teaching, Training Supervison, Research and Publishing" for their discussion of informed consent.
DOE's Radiation Research Using Human Subjects
Helsinki Declaration of the World Medical Associationon Biomedical Research Using Human Subjects
Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health
Canadian Code of Conduct for Research Involving Humans

Relevant Literature on this Topic

Whitbeck, Caroline. 1998. Ethics in Engineering Practice and Research.
New York: Cambridge University Press. Other keywords for this article: ethics and prudence; preferences vs. values; negligence;trust, distrust; ambiguity; moral ambiguity; responsibilities, general; professional responsibility; public safety; worker safety; laboratory safety; design process; engineering competence;environmental issues, global; environmental issues, chemical; conflict of interest; ethical codes and guidelines from professional societies; harassment, sexual harassment and aggression; workplace relationships; research misconduct; falsification and fabrication; plagiarism; authorship; animals in scientific research.

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