Practical Research Ethics in Psychiatric Clinical Trials: A Guide for Investigators.

The conduct of clinical psychiatric research is critical to advance the science and efficacy of treatment while also safeguarding the interests of participants. This article emerges from the authors' experience, providing practical guidance to colleagues seeking input on how to design and implement clinical research protocols in accordance with key ethical considerations. Thus, the intent of this article is to provide (1) an overview of common ethical considerations when conducting psychiatric clinical research along with (2) practical advice for preparing Institutional Review Board applications and associated materials in the ethical conduct of psychiatric clinical research.

Ethics Oversight in Psychiatry: Data from a Model of Organizational Monitoring.

Hallmarks of professions include self-regulation. The American Psychiatric Association fulfills this responsibility by delegating the handling of ethics complaints against members to each of 72 District Branches (DBs). The authors sought to explore the number and typology of ethics complaints received by member DBs, the handling of complaints, the relationship between the DB and state licensing authorities, the challenges and resources needed for conducting complaints, and the overall attitude of DBs regarding ethics review. This analysis presents the results of the survey and outlines how the process may be useful for professional medical organizations adhering to principles of transparency and empirically informed policy.

Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies.

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration (FDA) regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission.