GM1 ARA.MED.330 Special medical
circumstances
ED Decision 2016/008/R
GENERAL
(a) Ā Ā Ā Ā When the terms āmedical assessment protocolā, āresearch protocolā and
āprotocolā (as mentioned in ARA.MED.330 and its associated AMC) are used,
they all refer to a āmedical assessment protocolā.
(b) Ā Ā Ā The protocol is to enable experience to be gained in special medical
circumstances in a controlled manner. This is to facilitate a better
understanding of the treatment or condition, so that an evidence-based
decision concerning its implementation may be considered.
(c) Ā Ā Ā Ā The protocol and its implementation should comply with the principles
described in the following publication of the World Medical Association (WMA):
āWMA Declaration of Helsinki - Ethical Principles for Medical Research
Involving Human Subjectsā, as last amended.
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