Ethical considerations and challenges in herbal drug trials with the focus on scientific validity and risk assessment

Abstract

Scientific validity and risk assessment are two main ethical issues which raise specific challenges and are unique to clinical trials investigating crude extracts/fractions from herbal materials. There are considerable challenges for both clinical investigators and ethics committee members in dealing with such issues, many of them remain unresolved, resulting in a large variation in ethical requirements, justification, and decisions. Despite a remarkable surge in herbal medicine research globally, a number of clinical investigators or even ethics committee members have limited confidence in dealing with related ethical issues. In this article, we extensively review and discuss the two main ethical issues (i.e., scientific validity and risk assessment) and highlight key considerations that are important for ethical review and justification for the conduct of herbal drug trials.

The Challenges of Ethical Review in Clinical Research of Traditional Chinese Medicine

“…According to international principles, a large proportion of TCM studies can start directly at the clinical trial stage by providing information on toxicology and safety dosage, and the requirement of laboratory research may not be necessary or be simplified at the beginning of clinical drug development processes [33]. Risk assessment may be acceptable when herbs are tested in the same formulation at the dose and duration no longer than their historical and traditional usage [34]. However, the results cannot be predicted when the formula is applied to a completely different environment or conditions without traditional roots [35].…”