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Oxford University Hospitals NHS Foundation Trust
Research and Development

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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.

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 OUH R&D Department when the Trust is Sponsor, then submitted to the relevant REC, MHRA and the relevant NHS trusts for approval.

Consent in CTIMPs involving incapacitated participants

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 extends the exception to minors as clinical trial participants.

Consent in clinical research involving incapacitated participants

Research Studies involving adults aged 16 or over who lack capacity must comply with the Mental Capacity Act 2005.