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Informed Consent for Individuals with a Mental Illness

Summer 1999

Introduction

This article provides some background in the area of informed consent and describes research conducted by the MIRECC to help answer these questions.

Historical Background

Formal debates on the use of human subjects in research have been in process for more than 50 years, since the Nuremberg trial of Nazi camp physicians who used camp inmates for research without their consent. As a result of the trial, 10 principles were proposed as guidelines when conducting research on human subjects. These were known as the Nuremberg Code. The first principle, "The voluntary consent of the human subject is absolutely essential" indicates how important the concept of "consent" was to the judges in the Nuremberg trial. The code, though accepted in principle by each of the 51 original members of the Charter of the United Nations, had no means for implementation. In 1953, the Clinical Center of the National Institute of Health (NIH) provided a policy and a method for review of research protocols by an independent group of individuals, the beginning of the Institutional Review Board (IRB) system in effect today.

As the Federal government expanded funding of clinical research in the 1960's there was increased interest in safeguarding against abuses of human subjects. The World Health Organization recognized the need for broader guidelines for clinical research and adopted The Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. It was first adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964 and revised several times since. Three of the 12 basic principles relate to informed consent, again an indication of how important the concept of "consent" was to the policy makers.

The NIH developed the first Public Health Service Policy on the Protection of Human Subjects, issued in 1966. It addressed using appropriate methods for obtaining informed consent and required that the consent be documented and signed by the subjects or their representatives. The discovery in the early 1970's of the Tuskegee Syphilis Study, where black men were denied penicillin as treatment for syphilis, intensified efforts to protect human subjects. The Senate committee on Labor and Human Resources held hearings on this and other studies with alleged abuses and as a result enacted The National Research Act of 1974. This act requires the Department of Health, Education and Welfare (HEW) to codify its policy for the protection of human subjects into Federal regulations. They also formed the national Commission for the Protection of Human subjects of biomedical and Behavioral Research which in turn released the Belmont Report: Ethical Principles and guidelines for the Protection of Human Subjects of Research.

In 1981, the now renamed Department of Health and Human Services (DHHS) approved Title 45, Code of Federal Regulations (CFR), Part 46, Protection of Human Subjects. A revised 45 CFR Part 46 is currently the policy that governs all federally supported research. Subpart A of this policy is often referred to as the Common Rule and is the set of regulations independently adopted by 17 federal agencies that support or conduct research with human subjects.

In 1995, President Clinton appointed a National Bioethics Advisory Commission (NBAC) to advise the federal government on bio-ethical issues, particularly the rights and welfare of human research subjects. This commission issued a report, Research Involving Persons with Mental Disorders That May Affect Decision-making Capacity in December of 1998. The commission recommended the adoption of additional regulations as guidance for IRBs and to enhance the publics trust in its research institutions. They also recommended that additional resources be allocated to foster research in the area of decision-making capacity and enhancement of the informed consent process.

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Can Patients with Mental Illness truly be Informed?

Even before the NBAC report, scientists have attempted to answer the question "can patients suffering from psychosis understand information given to them about anti-psychotic medications? At least one study indicates that although patients claim to understand information about the medication, subsequent objective testing proves that in many cases, they do not. Studies carried out on psychiatric patients found that there were large differences among patients with serious psychiatric illnesses in their ability to understand the components of informed consent. Other studies have indicated that discrepancies occur between assessments given to patients to determine their competency to consent to treatment and between legal standards used to assess competency

MIRECC investigators are developing a rigorous informed consent procedure. In a paper published in the American Journal of Psychiatry in 1998 (Ref), Drs. Wirshing, Wirshing, Marder, Liberman and Mintz developed an informed consent procedure and evaluated its efficacy in producing truly informed research subjects. They found that the majority of patients asked to participate in this study were able to understand and retain enough detail about the research protocol to make an informed decision after completion of the thorough informed consent procedures that were developed for this study.

Current legal standards for assessing a patients' competency to provide informed consent include abilities to: 1) express a choice; 2) understand information relevant to the decision about treatment; 3) appreciate the significance, for one's own situation, of the information disclosed about the illness and the possible treatments; and 4) manipulate the information rationally (or reason about it) in a manner that allows one to make comparisons and weigh outcomes. The authors developed an informed consent survey, which took into account these legal standards as well as the conditions unique to the particular clinical study.

Each patient with an illness qualifying them for participation in a randomized clinical study of antipsychotic medication, received an introduction and explanation of the study protocol by their treating physician. If the patients were interested in participating in the study, the consent form was read and explained to them by a research staff member. If the patient had questions about the study, they were answered during this process. The patient was then administered the informed consent survey developed by the authors. This survey assessed the patient's level of comprehension. When a patient answered a survey question incorrectly, that portion of the informed consent form was re-explained until the patient could answer the survey question correctly. If a patient could not answer critical questions correctly during this process, he/she was excluded from the study.

The patients were asked to re-take the informed consent survey one week later (7 days). The same process of review until all questions could be answered correctly was followed. The results indicated that most patients are able to comprehend and retain critical components of informed consent only when thorough and systematic methods are used to present the most important elements of the informed consent form. Certainly more work remains to be done to assess a patient's ability to retain details of informed consent over longer periods of time, such as one would find in a clinical study, but inroads have been made in the process of defining a successful informed consent procedure. Other related issues continue to be debated. For example, should family members be authorized to act on behalf of mentally ill person with diminished capacity to provide informed consent? This will be the subject of future articles.

The MIRECC is also participating in an NIMH-funded study of the informed consent process in psychiatric and medical treatment research. Participants are individuals with schizophrenia or bipolar disorder, or coronary transplant patients without mental illness who are in the process of being recruited to participate in a treatment study. The consent project is examining how diagnosis, cognitive abilities, psychiatric status and emotional state affect the consent process. It is also examining the value of an educational, multimedia program designed to improve the consent process in treatment research by informing prospective research participants of their rights and the researchers' responsibilities.

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Discussion

The report by the National Bioethics Advisory Commission (NBAC) has been an important contribution of the field, although some of its recommendations have been criticized by some researchers. One of the controversial recommendations would include nearly all patients with psychiatric illnesses in a group that requires additional protections. This has been criticized since many patients with psychiatric illnesses do not have impairments that affect their abilities to give consent. Including all these patients in a group, tends to stigmatize psychiatric patients. Another recommendation would require that an individual who is not a member of the study staff monitor each consent. Researchers are concerned that implementing this procedure would be costly and might impair the abilities of some researchers to carry out their studies.

The focus on informed consent has caused some discomfort to both consumers and researchers. Critics of psychiatric research have alleged that there are serious abuses in some research settings and have even suggested that some practices have resembled those used by the Nazi's. These allegations are absurd. On the other hand, the media has reported instances (including one at the VA Greater Los Angeles Health Care System, a MIRECC site) where IRB's have not been properly administered and in this sense, patients have not been adequately protected. Although the immediate effect of these media reports has been to undermine trust between patients and investigators, the longer-term effect will be to develop research processes that more effectively protect patients. MIRECC investigators are planning additional studies that will hopefully contribute to the development of policies that are based on scientific evidence.

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Reference

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