GM1 ARA.MED.330 Special medical circumstances

• ED Decision 2016/008/R found in: Aircrew (1178/2011) Part-FCL Part-MED Part-CC Part-ARA Part-ORA Part-DTO (Aug 2023)

GM1 ARA.MED.330 Special medical circumstances ED Decision 2016/008/R GENERAL (a) When the terms ‘medical assessment protocol’, ‘research protocol’ and ‘protocol’ (as mentioned in [ARA.MED.330](#_DxCrossRefBm1199964055) and its associated AMC) are used, they all refer to a ‘medical assessment protocol’. (b) 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) The protocol and its implementation should comply with the principles described in the following publication of the World Medical Association (WMA): “WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects”, as last amended. GM1 ARA.MED.330 Special medical circumstances ED Decision 2016/008/R GENERAL (a)      When the terms ‘medical assessment protocol’, ‘research protocol’ and ‘protocol’ (as mentioned in [ARA.MED.330](#_DxCrossRefBm894735364) and its associated AMC) are used, they all refer to a ‘medical assessment protocol’. (b)     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)      The protocol and its implementation should comply with the principles described in the following publication of the World Medical Association (WMA): “WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects”, as last amended.