Research is a cornerstone of the National Alliance for the Mentally Ill (NAMI) policy and advocacy. You will not find a more ardent group of individuals than our members coming to hear a researcher speak at a "Research Update" or an "Ask the Doctor" session at our annual convention. And if you are a researcher, you will probably have few more gratifying encounters.
Research offers hope—hope for symptom control, hope for rehabilitation, hope for recovery, and ultimately, the hope for prevention of these terrible illnesses. Research has already led to remarkable advances in the treatment of most significant mental illnesses. Just the past decade has brought us both the atypical antipsychotics and the newer antidepressants, developments that have both improved the care of many of the most severely ill and broadened the range of illnesses treated with psychopharmacology. The last two decades have brought solid evidence of the benefits of structured psychosocial therapies, ranging from cognitive—behavioral interventions for specific disorders to the Program of Assertive Community Treatment to reach difficult patients and keep them engaged in treatment. Services research provides data essential to advocates arguing for nondiscriminatory coverage of mental illnesses. In short, research gives us the evidence-base to fight stigma, to eliminate discrimination, and to insist on evidence-based therapies.
The advances in neuroscience, genomics, and molecular biology offer both stunning insights into the miracles of the brain and mind and exciting possibilities for more tailored interventions in mental illnesses. The doubling of the NIH/NIMH budgets in 5—6 years continues on track, and three neuroscientists associated with mental illness research and/or funded by the NIMH were awarded the Nobel Prize. Yes, it is an exciting time, despite the pressures of managed care, the competition for grant awards, and the controversies about research ethics.
Yet there is discontent in the land. Fundamental research is faring well—and increasingly requires either a Ph.D. or an unusual career. In contrast, the number of physician—researchers is declining; and many claim these researchers are not accorded the same stature and respect as basic scientists. In this commentary, we will focus on the training of the next generation of clinical researchers. We would argue that these individuals are precisely those the NIH must find the means to support and encourage—in part, because we believe they are crucial to improving the relevance of basic research, the appropriateness and meaningfulness of clinical research, the design of research that appeals to potential participants, and the quality of the clinical care delivered.
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So What Does That Mean About Clinical Research Training?
In fact, we will have little to say about clinical research training per se, deferring to the experts the complex issues of how to recruit and retain skilled individuals, how to finance the training, how to fit it into a crowded set of residency requirements, and how to encourage the mentorship that is vital to the research career of a physician—scientist. We will focus instead on the somewhat strange assertion that the most important part of clinical research training is clinical training—and, beyond that, a particular quality of mind that contributes to good research and good clinical care.
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The Prime Directive (and theSecondary and Tertiary)
Elvin Semrad was particularly good at conveying the "prime directive" to the trainees at the Massachusetts Mental Health Center: "Listen to your patient." That piece of advice was critical and is today particularly hard to sustain in an era of managed care and fragmented rotations. It was more than learning how to elicit critical information in the course of evaluation or treatment—information that would also be essential in any research endeavor. It was more than the idea that we learn from our patients throughout our residency and later in our careers. As practiced in Boston, it also conveyed the obligation to form a continuing relationship. The notion of continuing responsibility for the clinical care of a patient across 3 years—and the notion that you would continue to learn about the person and the illness over that time—seems quaint in the present day, but it has an important corollary: It is that commitment to the long-term well-being of the patient (whether or not we are actually responsible for the care) that helps us design ethical research by asking: "How could this research fit better with this person's long-term best interests?"
The second directive would be "Listen to your patient's family." So, to improve research training (and in the process, all training), I would follow the example of the fine program at the Medical College of Ohio, which introduces trainees to the family's and consumer's experience of serious mental illness in their first month of training. We would expect this sensitivity and modeling to carry over into the research arena, where family and/or consumers can play vital roles at various stages of the research process. For example, various centers have an advisory group from the community providing consultations about design and ethical issues early in the course of protocol development—consultations that can increase the appeal of protocol participation and, frankly, both help recruitment and help protect against criticisms from individuals who take more extreme views. Family members have also served as members of institutional review boards, scientific peer review committees, special ethical review committees, and data- and safety-monitoring boards.
The third directive is "learn to collaborate." Normally, this would be heard as: "establish good relationships with your scientific colleagues," but we have a different collaboration in mind. Just as good clinical care involves forging a working alliance, good research also involves a collaboration between researcher and research participant. The operating principle should be that we do research with people, not on people.
So excellent clinical training is essential to good clinical research. But the reverse is also true: exposure to good research during training is essential to developing the qualities of mind important in today's psychiatrist.—These qualities include rigorous thought, a knowledge of the evidence-base and its limitations and the ability to approach each individual as an opportunity for "N-of-one" collaborative research, with the appropriate target symptoms and outcome measures. We would endorse routine exposure to research during residency training—at a minimum, required participation in research-literature seminars to learn critical thinking about psychiatric research and, at best, actual participation in laboratory and/or clinical research.
The topic of research ethics needs to be mentioned. It is not an esoteric branch of philosophy. It is not the domain of "ethics specialists." It is not the experience of appearing before an Institutional Review Board to answer questions about a protocol. It is not studying to pass a multiple-choice test to qualify as an investigator. It is, instead, a way of thinking about our responsibilities to one another—about respect, truthfulness, caring, and collaboration. It is vital that this mode of thinking, this effort to put oneself in the position of a research participant and consider the person/patient's best interests, be modeled by mentors and become an integral part of the learning experience of the researcher-in-training.
Learning a fundamental regard for the long-term well-being of the patient will help avoid the worst examples of research—research driven by curiosity or ambition that treats the patient as a means to an end, research that needlessly prolongs distress because of the protocol design, or researchers who lose interest after the last day of the study—in short, research that an investigator would not recommend to his or her own loved ones if they were similarly affected by the illness.
The clinical researcher who advances knowledge while caring for his or her participant-collaborators is held in high esteem in the NAMI world. NAMI members understand that improvement in their lives and the lives of their loved ones depends on research. The clinical researcher is our admirable ally.
In the course of training, we would hope that you come to view advocates and research participants as your allies, to be treated with respect, told the unvarnished truth, and involved as a true collaborator in planning and carrying out research.