A time of promise, a time of promises: ethical issues in advancing psychopharmacological research.

In this extraordinary time of scientific discovery and heightened awareness of the burden of mental illness throughout the world, research to develop effective psychopharmacological treatments for diverse psychiatric diseases holds great promise (Murray and Lopez 1996; DOHSS 1999, 2003). Each day brings valuable findings from studies in the basic, translational, and clinical sciences. Recent efforts to create precise, beneficial medications have been undertaken collaboratively in many nations and in academic, industry, and government settings, leading to remarkable progress (Tallman 1999; Maubach 2003). Interventions for persons with mental illness have already been found to be more helpful than those for other chronic and disabling physical conditions (Agency for Health Care Policy and Research 1999). Taken together, these advances have led to the expectation that the suffering of mental illness will be substantially lessened within the lifetimes of many of our patients. Pursuing this goal has emerged as an imperative for our society. This is a time of justified optimism. This sense of promise exists because of other promises, however. These are the promises made by investigators to honor the scientific and ethical standards of the biomedical research community (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979; Faden 1996; Brody 1998). These are the promises made by institutions and agencies to assure that participants of human studies are treated respectfully, honestly, and fairly and are safeguarded from inappropriate risks (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979; Levine 1986; Roberts 1999). These are the promises that research volunteers are invited into the scientific process with the hope of creating scientific knowledge that will help people now and in the future. These are the promises, implicit and explicit, made by biomedical professionals in fulfilling their responsibilities to a society that has increasingly supported biomedical science as a means of bettering human experience (Bulger 1994; Moreno 1995, 2003; Kelch 2002). This special issue seeks to help fulfill these important promises by highlighting the importance of ethical considerations in psychopharmacological research and related areas. It was the inspiration of one of us (J.K.) and was enthusiastically supported by the international editorial group who shepherd the journal. In creating this special issue, we sought to touch upon several areas of complexity and diversity that exist in the field of psychopharmacology. Our approach to this special issue was also informed by the basic assumption that the empirical study of ethical considerations in psychopharmacology research and intentional efforts to enhance ethics education for investigators will help support the advancement of ethically sound psychopharmacological studies in the future. Accordingly, this peer-reviewed special issue has a three-part structure. First, we highlight pieces on ethical issues in basic and clinical research. Second, we include papers and commentaries that focus on ethical considerations related to psychopharmacology studies and other forms of clinical research involving individuals who L. W. Roberts ()) Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin, Milwaukee, WI, 53226, USA e-mail: robertsl@mcw.edu