How to guide: Receiving consent
This guide outlines some general guidance on receiving consent.
Key information you should be aware of:
Informed consent is a fundamental principle of research and it is vital that consent is given freely, with full information of what a participant is consenting to being provided. Either the participant must have capacity to consent or it must be received by means of a process involving a consultee or legal representative (where this is appropriate and allowed for in the study). Consent should be received only by a member of staff who is appropriately trained and approved to do so. Consent may be withdrawn and withdrawal should be respected wherever possible.
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The practice is responsible for ensuring that all staff who may be involved in a study have an understanding of what is involved.
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Staff involved in the consenting of patients may need to complete Good Clinical Practice (GCP) training. This is a legal requirement for Clinical Trials of Investigational Medicinal Products (CTIMPs) and may be a requirement specified by the study protocol.
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All staff involved in research at the practice must have completed study specific training where this is required for the study.
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Consent must have been received before any research activity relating to the patient and/or their personal data takes place.
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The consent process must be conducted in line with GCP principles and the study protocol.
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Consent is not always written, and there may be instances where researchers can use verbal consent, online consent, or other proportionate methods to reduce burden for both the participant and the study.
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There could be instances where it is not possible for participants to be completely withdrawn, e.g. if the data or samples have already been processed, anonymised and aggregated, but this should be fully explained within the consent process as well as the study protocol.
Highlights
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Preparation
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Consent process
See also
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Getting your practice ready to do research guide
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Roles and terminology guide
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Site selection / initiation visit (SiV) guide
Full guide
Preparation:
The Health Research Authority (HRA) approvals process includes ensuring that the consent process for approved research is ethical and legal. Therefore, it is vital that the consenting of participants is carried out in line with what is stated in the current HRA approved study protocol.
Staff involved in the consenting of participants must be:
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adequately qualified as outlined in the study protocol or by the study team (this may be specific to particular studies i.e. some studies may require that the consenting of participants must be done by a nurse or GP);
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approved to do so by the Principal Investigator of the local site (GP practice) and this must be included in the Delegation Log.
For CTIMP studies or if specified in the protocol, staff receiving consent should be GCP trained and have a certificate that is recent enough for the requirements of the study (usually within 2 years – if in doubt, this should be checked with the study team);
Consent process:
Participants must be fully informed and in a position to consent (having capacity to consent or by means of a process involving a consultee or legal representative where this is appropriate and allowed for in the study). See GCP or Informed consent training for further information.
Examples where someone may not be able to consent for themselves are children, those with diminished capacity or people who are unconscious.
The term 'receive consent' is preferred rather than 'take consent'.
The HRA is encouraging a proportionate approach to consent for low risk studies https://www.hra.nhs.uk/about-us/news-updates/hra-publishes-new-proportionate-consent-guidance/
Consent must have been received before any research activity relating to the patient and/or their personal data takes place.
Consent must be documented and filed in line with the study protocol.
Since consent is an ongoing process, staff involved with study participants should ensure they are happy to continue during study follow-up visits etc. and must respect any wishes to withdraw consent.
Specific training is available via NIHR Learn on consent for children, adults lacking capacity and for different communities (https://learn.nihr.ac.uk)
Further general guidance on the subject of consent in research can be found online: http://www.gov.uk/service-manual/user-research/getting-users-consent-for-research#what-informed-consent-is
Glossary of Acronyms and Terms:
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HRA - Health Research Authority
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GCP - Good Clinical Practice