Written and verbal versions of the information will be presented to the subject detailing no less than:
- the exact nature of the research
- the implications and constraints of the protocol
- the known side effects and any risks involved
- the fact that they are free to withdraw from the trial at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.
Written participant information sheets must have the approval of a research ethics committee (REC). Participants must be allowed as much time as needed to consider the information, and to question the investigator, their GP or other independent parties. Consent will be documented on a consent form (also approved by a REC), which is signed and dated by the participant and the person who presented informed consent. A copy of the signed form will be given to the subject.
Persons taking informed consent must be appropriately trained and authorised to do so by the chief/principal investigator. The research team should be aware that the participant information sheet should, at all times, reflect the full information available for the research. Any new information should be promptly addressed in an amendment, reviewed by CTRG, then submitted to the relevant REC, HRA, host organisation and the MHRA – where applicable.