National Alliance on Mental Illness
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Ethical Challenges in Schizophrenia Research

Advocate May/June '00

Research on schizophrenia using human subjects poses ethical challenges to researchers-and to advocacy organizations-even though we know it is vital to understanding the illness and developing better treatments. The crux of the challenge is the fact that this profoundly disabling disorder may impair a person's ability to understand the facts about the research and their implications and, therefore, to make well-reasoned judgments about participation. Particularly where the risk is more than minimal and there is no immediate direct benefit to the participant, the researcher must do whatever is needed to protect the people volunteering for the study and to ensure that they provide meaningful, informed consent throughout the trial.

The Maryland Psychiatric Research Center has paid close attention to these issues. In 1995, Dr. William T. Carpenter, Jr., the center's director, became aware of the ethical questions raised during psychiatric research at large and decided his program had to incorporate even more safeguards than those provided by the routine review of research by an institutional review board (IRB) and routine approaches to consent. He took his staff on a day-long retreat to develop new approaches for protecting consumers. The center's resulting program, recently reviewed by the federal Office of Protection from Research Risks, illustrates a number of ways to enhance ethical protections and informed consent.

  • The center developed a booklet for current and prospective consumers, family members, and referral sources that clarifies the purpose of the center's research, describes how research differs from clinical care, and explains the availability of alternative treatments.
  • A panel including a consumer, a family member, a representative of a community treatment system, and a clinician reviews research proposals.
  • The panel's recommendations are often accepted by the research group, but even when they are not, they are sent to the IRB, which reviews and must approve the research before it starts and has the power to require changes.
  • The IRB includes a NAMI family member who was trained at the NAMI IRB training course during last summer's convention.
  • Each clinical research unit has an omnibusperson available to explore issues that consumers may hesitate to discuss with an investigator or doctor.
  • Investigators from the state protection and advocacy organization visit the consumer participants' state hospital units (and the research center) to talk to consumers about any complaints or allegations of mistreatment. Instructions for making complaints are posted on the unit. (The center's research unit, not surprisingly, generates very few complaints compared with the number generated by participants from standard clinical-care units.)
  • When it is time for written informed consent, those slated to participate are tested so investigators can accurately assess how well they understand the research and the meaning of their involvement.
  • If a potential participant does not fully grasp what he or she needs to know about the research, staff put in extra effort to help the consumer understand. Research on this educational process shows that consumers who are initially below normal on the Macarthur Decisional Capacity evaluation can, and often do, develop the ability to make reasoned research decisions that compare well to the normal range.

Other research locations have developed other educational aids, have assigned specific staff to advocate for participants, or hold weekly meetings with consumers about their research program and specific research protocols to promote better understanding.

  • The NIH Clinical Center has developed a consent procedure based on the durable power of attorney, a document that appoints a specific person (often a family member) to participate in the consent process and help make decisions about research when the participant's ability to understand or decide is impaired by illness. This approach provides a person the participant trusts to make certain that his or her wishes and best interests become guides during research.
  • NAMI's IRB training presents questions we believe must be answered when reviewing research protocols, which ask about protections during drug trials involving placebos, medication discontinuation, and challenge studies.

Unfortunately, these "best practices" are far from universal. NAMI must establish models for how research and researchers interact with us and our relatives and advocate actively until best practices become routine practices.