With the Medical Research Council (MRC) we provide an online tool that gives guidance on consent and the preparation of information for participants. We do not expect applicants to simply follow a template, so our guidance will help you to design appropriate and proportionate information.
Our online consent guidance:
- provides information on the principles of consent and how these principles relate to the preparation and use of participant information and consent forms
- recommended content of participant information and consent form as well as information about the design and style of a participant information sheet and consent form
- covers consent in adults, children, young people and adults not able to consent for themselves (in both emergency and non-emergency) and takes into account UK-wide requirements
- has separate sections that provide examples, templates and useful links
- may be downloaded as a PDF, if required.
Other resources:
- Applying a proportionate approach to the process of seeking consent. This guidance complements the existing HRA online guidance for consent and participant information sheets and reinforces our view that people who volunteer to take part in research should be provided with succinct, relevant, user-friendly information in a proportionate manner. We are reviewing this guidance to bring it in line with General Data Protection Regulations (GDPR). In the meantime, please ensure that you also refer to the HRA’s specific GDPR guidance.
- Informed consent in Clinical Trial of an Investigational Medicinal Product (CTIMPs).
- Making written information easier to understand for people with learning disabilities. This guidance is for people who commission or produce Easy Read information – Revised Edition 2010.
- Joint HRA and MHRA statement on seeking consent by electronic methods. This joint statement, supported and endorsed by the Devolved Administrations, sets out the legal and ethical requirements for seeking and documenting consent using electronic methods. The primary focus is clinical trials of investigational medical products (CTIMPs) but the basic principles can be applied to all research conducted within the United Kingdom. This statement is aligned with the existing HRA online guidance for consent and participant information.
- GDPR resource for children and young people. This engaging and age-appropriate resource has been created by the HRA, Penta Foundation, University College London and UK Research and Innovation MRC Clinical Trials Unit, to help children and young people understand what will happen to their personal data if they take part in a research study. The HRA recommends that sponsors use this resource as the basic for any GDPR information provided to children as part of the consent process for taking part in research.