Realizing Benefit Sharing: Is There a Role for Ethics Review? - Benefit Sharing - page 176

Fig. 8.1 Simplified Ethical Review Process
Since 1975, repeated revisions of the Declaration of Helsinki have specified in
increasing detail what is implied by ethics committee review. Principle 15 of the
current (2008) declaration reads:
The research protocol must be submitted for consideration, comment, guidance and
approval to a research ethics committee before the study begins. This committee must be
independent of the researcher, the sponsor and any other undue influence. It must take into
consideration the laws and regulations of the country or countries in which the research
is to be performed as well as applicable international norms and standards but these must
not be allowed to reduce or eliminate any of the protections for research subjects set forth
in this Declaration. The committee must have the right to monitor ongoing studies. The
researcher must provide monitoring information to the committee, especially information
about any serious adverse events. No change to the protocol may be made without consid-
eration and approval by the committee (WMA 2008).
Until the end of the twentieth century, ethics committee review concentrated
on pre-start approval, but nowadays it is increasingly seen as a process that does
not stop until the research has been completed. For instance, funding bodies such