With the Medical Research Council (MRC) we provide an online tool that gives guidance on the preparation of participant information sheets (PIS) and consent forms. 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, recommended content as well as 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; and
- May be downloaded as a PDF, if required.
- 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.
- Informed consent in Clinical Trial of an Investigational Medicinal Product (CTIMPs)
- Making written information easier to understand for people with learning disabilities: guidance for people who commission or produce Easy Read information – Revised Edition 2010