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  1. Nov 26, 2020 · The participant information sheet and/or consent form must state that sponsor and regulatory authorities’ personnel can access a trial participants medical/health records and explicit...

  2. Examples & Templates. This section of the site is a platform to share good practice. It provides practical examples and templates, which illustrate how to implement specific elements to help improve your consent documentation.

  3. In this section we cover general guidance on design and style of a Participant Information Sheet (PIS). We highlight what to consider when your research involves: Adults not able to consent for themselves, Children and Young people and/or Emergency research.

  4. Guidance on Completing a Participant Information Sheet. Central to human subject research is the informed consent process. This process must ensure that research participants are provided with all the relevant information they need in order to decide if they would like to participate in a study.

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  5. Recruitment documents help people make informed choices about whether to participate in a research study. Find out how to write a Participant Information Sheet, example forms and further guidance.

  6. Nov 27, 2023 · The Participant Information Quality Standards will be applied UK-wide by research ethics staff who will check if the participant information is compliant when a research application is validated for the research ethics review.

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  8. Jun 19, 2024 · Participant information quality standards and design review principles. These outline what’s expected of research in regard to how participants are informed and how consent is obtained.

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