Facilitating world-class research
Written and verbal versions of the information will be presented to the subject detailing no less than:
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.
The Clinical Trials Regulations 2004 allow for inclusion of incapacitated adults in a CTIMP so long as:
The Clinical Trials Amendment (No 2) Regulations 2006 allow for inclusion of incapacitated adults in emergency research without consent by their legal representative if:
The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 extend the exception to minors as clinical trial participants.
Research studies involving adults aged 16 or over who lack capacity must comply with the Mental Capacity Act 2005.