sec.52Clinical trials

sec.52 Clinical trials

This section applies to a person who is permitted to deal with a regulated substance for a human clinical trial approved by a human research ethics committee. The person does not commit an offence against this Act to the extent the person acts in accordance with any protocol or guidelines approved for the human clinical trial by the human research ethics committee. In this section— human research ethics committee means a committee— registered with the National Health and Medical Research Council established under the National Health and Medical Research Council Act 1992 (Cwlth) , section 5B ; and operating in accordance with the human research guidelines issued under the National Health and Medical Research Council Act 1992 (Cwlth) , section 10 . (sec.52-ssec.1) This section applies to a person who is permitted to deal with a regulated substance for a human clinical trial approved by a human research ethics committee. (sec.52-ssec.2) The person does not commit an offence against this Act to the extent the person acts in accordance with any protocol or guidelines approved for the human clinical trial by the human research ethics committee. (sec.52-ssec.3) In this section— human research ethics committee means a committee— registered with the National Health and Medical Research Council established under the National Health and Medical Research Council Act 1992 (Cwlth) , section 5B ; and operating in accordance with the human research guidelines issued under the National Health and Medical Research Council Act 1992 (Cwlth) , section 10 .

• (a) registered with the National Health and Medical Research Council established under the National Health and Medical Research Council Act 1992 (Cwlth) , section 5B ; and
• (b) operating in accordance with the human research guidelines issued under the National Health and Medical Research Council Act 1992 (Cwlth) , section 10 .