Consent and Participant Information Sheet
Preparation Guidance

Content: Participant Information Sheet - Invitation and Summary

The purpose of the first section of your Participant Information Sheet is to enable potential participants to decide if they wish to learn more about your study or not. It should briefly give some background and invite their participation.

There are two elements to be included.

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Invitation

You should make it clear that you are inviting potential participants to consider taking part in your research and that participation is entirely voluntary.

You should explain briefly how potential participants have been identified and why they have been selected.

Example text:

We'd like to invite you to take part in our research study. Joining the study is entirely up to you, before you decide we would like you to understand why the research is being done and what it would involve for you. One of our team will go through this information sheet with you, to help you decide whether or not you would like to take part and answer any questions you may have. We'd suggest this should take about XX minutes. Please feel free to talk to others about the study if you wish.

The first part of the Participant Information Sheet tells you the purpose of the study and what will happen to you if you take part.

Then we give you more detailed information about the conduct of the study.

Do ask if anything is unclear.

Inviting Adults not able to consent for themselves

When recruiting adults who lack the capacity to consent to your research, you will need to invite either their legal representative or consultee to give consent / provide advice (For more guidance visit 'Content > PIS > Adults not able to consent for themselves').

You must ensure that you inform legal representatives / consultees:

  • What you are asking them to do. (i.e. provide consent or advice?)
  • Why you are asking them.
  • What they must consider when making their decision / providing advice.
  • That their role is voluntary; they are not obliged to take on the role.

Further guidance on the legal and ethical principles involved is provided in our 'Principles' section.

Summary

You should provide a short summary of the proposed research, which covers the following:

  • Why?
  • What research question is being addressed?
  • How is it of relevance and importance to participants / patients and public?
  • What?
  • Broadly what areas (disease, therapy or service) are being studied?
  • What drug, device or procedure is being tested?
  • What will the participant have to do?
  • What will it mean to participants to take part?
  • Who?
  • Who would be eligible?
  • Where?
  • The sites where the study will be conducted
  • How, when?
  • How long will the study last; when will it start and end?

Do not to go into too much detail but try to ensure that potential participants can get a clear but concise picture of the research you are asking them to take part in.

To see an example of how you might improve your study summary we recommend that you see the Participant Information Sheet for Newland Hill before and after in 'Examples & Templates'. We would also recommend that you read the guidance in our 'Style' section.