Ethical principles and informed consent: an NIMH perspective

In conclusion, several points are worth emphasizing at this juncture: 1. Clinical researchers must attend to a set of ongoing concerns in new ways and reconsider how best to explain research protocols to potential subjects. Consent procedures and documents 5 or 10 years old may not be considered adequate by current standards. It is clearly important to ensure that consent documents, and the process by which informed consent is obtained and maintained, are state-of-the-art. 2. Many valuable sources of information are available to help researchers, family members, and potential participants learn about proper informed consent. NIMH is taking steps to improve this educational process. Members of IRBs are educated through conferences, newsletters, case books, etc. OPRR (May 1994) has also provided considerable information relevant to informed consent in clinical research. OPRR and NIMH staff may be useful sources of information concerning informed consent. 3. Research on competency and the consent process itself is needed so we can compare what was explained with what was understood and learn what research subjects want to know, what they believe has occurred, and why. 4. Progress in discovering the underlying causes of schizophrenia and other severe mental disorders, and improving their treatment, will require scientifically rigorous studies involving people affected by these disorders. Attempts to prohibit competent people with mental disorders from making decisions about participating in research protocols seem misguided, paternalistic, and stigmatizing. If we are to improve the treatment of severe mental disorders, clinical research is essential, including research that is not likely to directly benefit each individual participating. 5. This is a time of great opportunity for clinical research. New medications being tested have the potential to revolutionize the treatment of severe mental disorders. During recent years, a number of large scale projects have been focusing on underlying genetic vulnerability factors that may shed light on the etiology of these disorders, with profound implications for diagnosis, treatment, and eventually even prevention. Unfortunately, clinical research is also under attack on several fronts, including concerns about consent and the protection of human subjects with mental disorders. If we do not take steps now to ensure that the process by which we protect and inform research participants is state-of-the-art, the very progress we seek will be at risk.