RT Journal Article
SR Electronic
T1 Intervening in clinical research to prevent the onset of psychoses: conflicts and obligations
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 319
OP 321
DO 10.1136/medethics-2011-100008
VO 38
IS 5
A1 Tamra Lysaght
A1 Benjimen James Capps
A1 Alastair Vincent Campbell
A1 Mythily Subramaniam
A1 Siow-Ann Chong
YR 2012
UL http://jme.bmj.com/content/38/5/319.abstract
AB A prevailing issue in clinical research is the duty clinicians have to treat or prevent the progression of disease during a study that they are conducting. While all clinical researchers have a duty of care for the patients who participate in clinical research, intervening at the onset or progression of disease may skew results and have a negative impact on the scientific validity of a study. Extreme examples of failures to intervene can be found in the Tuskegee syphilis study and in an attempt to determine if cervical smears were an accurate predictor of cancer, which was uncovered by the Cartwright Inquiry. However, the issue arises in all research where delay in intervention can cause harm. A current study in Singapore is investigating the significance of an ‘ultra-high risk’ state that may constitute the prodromal phase of psychosis. This project called ‘The Longitudinal Youth at Risk Study’ is potentially contentious because it is recruiting young people who are identified as being ‘at risk’ of developing psychosis. In this paper, the decision to offer treatment to all participants as well as a fast track for those who are assessed to have developed serious mental illness into treatment is discussed. It is argued that this approach is ethically justified because of the duty of care that is owed to research participants, and suggests that the principle of equipoise may be used to guide intervention decisions in other clinical research protocols.