Ethics review procedures

The ethical principles laid out in these Guidelines, although initially aimed at medical research, are regarded as universal and, as a general aim, should be upheld in the ethical review of all research protocols. This version of the Guidelines broadens the scope of the 2002 Guidelines from “biomedical research” to “health-related research”. The current scope covers the classic activities that fall under health-related research with humans, such as observational research, clinical trials, biobanking and epidemiological studies. However, there is no clear distinction between the ethics of social science research, behavioural studies, public health surveillance and the ethics of other research activities and protections afforded within these guidelines are essential in safeguarding the health and the rights of humans that participate in research. The current guidelines emerged as a document building on previous guidelines, initially formulated in 1982. The aim of the guidelines was (and still is) to provide internationally vetted ethical principles and detailed commentary on how universal ethical principles should be applied, with particular attention to conducting research in low-resource settings.