Informed consent

  • Informed consent is at the heart of ethical research
  • Informed consent should be freely given and each participant should be fully informed
  • Informed consent must be obtained from every participant, unless they are incapacitated (see below), or the research involves use of patient-identifiable information without consent
  • Informed consent is a process by which a subject voluntarily confirms willingness to take part in clinical research, after having been informed of all aspects relevant to their decision to participate

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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 the Research Governance, Ethics & Assurance Team, 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 Clinical Trials of Investigational Medicinal Products (CTIMPs) so long as:

  • consent is given by a legal representative on behalf of the participant;
  • the trial relates directly to the condition from which the participant suffers; and
  • the benefits outweigh the risks, or produce no risk at all.

The Clinical Trials Amendment (No 2) Regulations 2006 allow for inclusion of incapacitated adults in emergency research without consent by their legal representative if:

  • treatment is required urgently;
  • the nature of the trial is such that urgent action is essential (eg clinical trials in emergency care settings);
  • obtaining consent from a legal representative is not reasonably practicable; and
  • a REC has given approval.

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.