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"Talking about drug treatments--who should say what to whom?"--the second DTB symposium.

Information about medicines is as important as the quality of the medicines themselves. Without sufficient, accurate and understandable information the doctor cannot decide on the best treatment regimen to offer and ultimately the patient cannot decide what treatment to accept. The second annual Drug and Therapeutics Bulletin symposium, held in March, considered the provision of information, its production and distribution, and the legal, ethical and professional codes by which it is shaped. These issues were addressed by Ian Dodds-Smith (legal aspects), Nick Barber (pharmacy matters), Bonnie Sibbald (communication between hospital and general practice), Barbara Altounyan (the media), David Dickinson and Marianne Rigge (consumers), Gwen Parr and Justin Greenwood (the pharmaceutical industry) and Joe Collier (provision of consensus advice). The audience also made important contributions.

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When should "riskier" subjects be excluded from research participation?

The exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulation is addressed by a specific account of a "condition on inclusion risks" (CIR), a condition under which potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.

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Teaching professionalism within a community context: perspectives from a national demonstration project.

Most medical schools now include some component of professionalism in their curriculum, ranging from "white coat" ceremonies to didactic and small-group, case-based discussions. Often this format does not provide a context for the course content nor does it necessarily make the curricular themes relevant to population groups and communities most vulnerable to the inequities and injustices present in health care. The authors describe a community-based professionalism curriculum for preclinical and clinical year medical students and report evaluation data from three years (2001-2003) of this national demonstration project. The curriculum emphasized four themes: service, community, advocacy, and ethical behavior and was based on a service-learning pedagogy applied within community-based organizations. As part of the program evaluation, 95 students from 33 medical schools between the years 2001 and 2003 (response rate: 84.8%) completed an anonymous questionnaire. When asked what did they learn about professionalism that they did not learn (or expect to learn) in their medical school curriculum, the most common themes were (1) factors and influences affecting professional behavior, with many specifically citing pharmaceutical companies and insurance carriers (46.3%); (2) the role and importance of physician advocacy on behalf of their patients (37.9%); and (3) issues specific to the needs of vulnerable and disadvantaged populations (20.0%). This project demonstrates that community-based experiences can provide unique and relevant learning in a professionalism curriculum that can complement existing medical-school-based efforts.

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Views of people with schizophrenia regarding aspects of research: study size and funding sources.

Serious mental illness research poses many ethical questions, including important considerations pertaining to how large a study is and its source of funding. Little is known about how people with schizophrenia understand these ethical considerations and whether these factors may influence their decisions to participate in research. Structured interviews were conducted with 60 people with schizophrenia. Participants were asked about levels of suffering and the importance of research for healthy people and for people with serious illnesses. Participants also rated helpfulness and harmfulness to society, and their likelihood of participating in studies involving 10 subjects, 1000 subjects, 1 research institution, or 10 research institutions and in studies funded by various organizations. Participants viewed all types of research positively and indicated willingness to volunteer. Likelihood of participating in research was correlated with perceived helpfulness to society and inversely correlated with perceived harmfulness. Research by pharmaceutical companies was seen as less helpful to society than research sponsored by federal or state government or by private foundations. Larger studies conducted at multiple sites were seen as more helpful to society than smaller studies or those at single sites. Larger studies conducted at single sites, however, were seen as more harmful. Respondents endorsed a positive view of medical research and expressed a willingness to participate in projects of all scales with diverse funding sources. The pattern of responses suggests the capacity for a nuanced understanding of ethically salient aspects of medical research by individuals with schizophrenia.

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