Consent arrangements: Consent process

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It is always best practice to obtain consent whenever this is practicable, and in most situations it is a legal requirement. To find out more, please visit Should consent be sought?

Within this station you can access information on writing participant information sheets and consent forms, you should also visit the following stations for more detailed information, if applicable:

Obtaining consent is an iterative process, and plenty of time for consideration and discussion should be provided.

Consent is only regarded as valid if it is informed, voluntary, the patient has the capacity to provide consent and in practice it is indicated.

An important tool which supports the consent process and helps potential participants make an informed decision is the information sheet. The information sheet should be written in lay language, with the level of detail being dictated by the type of study. Having had plenty of time to consider the study and ask any questions, potential participants will be asked to sign a consent form if they would like to participate.

Research Ethics Committees in particular look very closely at the expertise of those seeking consent, information sheets and consent forms, and it is important that these are written appropriately for the study population.

The Health Research Authority (HRA), have worked in partnership with the MRC Regulatory Support Centre, to develop online guidance on consent and the documents which support the consent process (1st resource below).  This guidance explores what information to provide to participants to address the aspects that you think they may be concerned about. It complements guidance developed by the MRC for studies that involve personal information (2nd resource below) or tissue samples (3rd resource below).

In England and Wales, for studies which require identifiable Registration, Cancer or GP Administration data from NHS Digital specific wording in the information sheet is recommended (see Central NHS and other data approvals for details). Note: This does not apply to Scottish data.

Under the Human Tissue legislation, who can give consent in particular circumstances is documented in law. The 4th resource below summarises these requirements in England, Wales and Northern Ireland; and the 5th resource is for research in Scotland.

It is worth noting however that it is good practice to obtain consent wherever practicable, and Research Ethics Committees will review what is appropriate.

The General Medical Council has produced good practice principles for research which are available in the 6th resource below.