Abstract

We review recent publications pertaining to six topics: investigators, professional integrity, and sources of potential bias; scientific designs; protocol safeguards; influences on research participation decisions and perceptions of risk; informed consent--decision-making capacity, appreciation and the therapeutic misconception, and voluntarism; and informed consent--intervention studies.Little empirical work has been conducted on investigator training and potential conflicts of interest. Numerous conceptual pieces have tackled controversial issues related to study designs, with the initial focal point being the ethics of placebo-controlled studies; only a handful of reports, however, have empirically addressed these topics. Emerging findings pertinent to protocol safeguards in schizophrenia research suggest general support by individuals with schizophrenia for a variety of safeguards. Recent work on influences on participation decisions suggests that people with schizophrenia use fundamentally similar considerations as medically ill people and healthy comparison participants--a combination of personal and altruistic motives. Much of the data-based literature has focused on informed consent. We highlight studies indicating that patients living with schizophrenia show heterogeneity in consent-related abilities but may possess key strengths in the research situation, not simply greater vulnerability as suggested in the historical literature. Furthermore, consent-related abilities appear to be enhanced with educational interventions.Empirical studies focusing on a variety of ethically relevant domains in schizophrenia research are needed. Future studies should incorporate quantitative and qualitative methods, integrate perspectives of stakeholders, and investigate the effects and appropriateness of current protocol safeguards.

View details for Web of Science ID 000229498800002

View details for PubMedID 16639163