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The University of Cambridge expects that free and informed consent will normally be obtained from all human participants in research at an appropriate point in the research process. Where it is not possible, due to the nature of the research or participants, it is normally expected that the project will undergo the appropriate ethical review process to approve the use of participant data without free and informed consent.

Failure to obtain free and informed consent may unnecessarily restrict your ability to use data, publish results and share data.

While it is sometimes possible to obtain oral consent for research (e.g. where data is collected through audio or video recordings) it is normally most appropriate to obtain consent through provision of a participant information sheet (PIS) and consent form in either written or electronic form.

This page provides guidance to help researchers prepare PIS and consent forms. This guidance is designed to be applicable across the University and is not intended to replace local (departmental or School) guidance. Links to existing guidance provided locally is provided at the end of this page. Local guidance should be consulted and observed where applicable.

Participant Information Sheets

The PIS should provide potential participants with the necessary understanding of the purpose, methods, risks and benefits of the research and the planned use of the data to be collected to make an informed decision as to whether to participate in your research project. It will also provide potential participants with details of sources of further information to answer any further questions that they might have. The PIS is likely to be the more detailed of the two documents provided, allowing the consent form to be clear, short and concise.

The content and form of each PIS will depend on the nature of, and the level of risk posed by, the specific research project for which they have been designed. In general, however, the PIS should be a clear document that provides the necessary information while being easily understood by those for whom it has been written (for example it should be age appropriate).

While each PIS is likely to be different, there are some core pieces of information that will normally be included:

  • Details of the research project (title, funding source, sponsoring institution, source of ethical review etc.);
  • The purpose of the research;
  • What participation will involve;
  • The benefits and disadvantages/risks of participation;
  • A clear statement that participation is entirely voluntary and that participants can withdraw from the project at any time without prejudice, now or in future;
  • Details of what will happen to the data collected and the results of the research, including:
    • How the data collected will be handled and protected (e.g. confidentiality, anonymisation, data protection);
    • How results will be disseminated;
    • Plans for storage, archiving, sharing and re-use of data (see below for more details).
  • Details of who to contact for further information and how to file a complaint.

Consent forms

The consent form should be a short document (usually no longer than a side of A4) that concisely covers the core statements to which the participant is being asked to agree in clear and concise language. The participant should normally be given the opportunity to agree or disagree with each statement (usually through yes/no tick boxes or signing/initialling each statement) and should be asked to sign, print their name and date the form. Space should also be provided on the consent form for the investigator taking the consent to sign, print their name and date the form.

Electronic consent forms may be used where appropriate (e.g. online or computer-based studies), but written and signed consent forms are preferable for research that poses more than minimal risk to participants. Your local research ethics committee/departmental ethics contact can advise on specific cases. 

While consent forms may differ according to the project, they should normally include at least the following or similar statements:

  • I have read and understood the Participant Information Sheet;
  • I have been given the opportunity to ask questions and have had them answered to my satisfaction;
  • I agree to take part in this project;
  • I understand that my participation is voluntary and that I am free to withdraw at any time without giving a reason;
  • A statement that asks the participant to consent to procedures for handling any personal data collected (e.g. confidentiality, anonymisation, etc.);
  • A statement that asks the participant to consent to proposals for data storage, archiving, sharing and re-use for future research;
  • (If relevant) A statement that asks the participant to consent to any planned audio or visual recording.

Data sharing and re-use

It is increasingly a condition of research funding that research data should be shared with other researchers and made open for re-use (within legal and ethical frameworks).

The possibility of the re-use of data for research purposes should be considered when preparing a PIS and/or consent form. Normally this will take the form of a statement in the consent form asking for consent for suitably anonymised research data to be shared for research purposes.

Researchers are advised not to unnecessarily restrict the consent requested for data sharing and data re-use. Unless there is a good reason for placing a restriction on the use of data, consent forms should normally clearly request consent for data to be used for research purposes beyond the specific project for which they were collected. Consent forms should also not unnecessarily restrict consent for use of data to researchers based in Cambridge, in academia or the UK.

Further guidance

University guidance

The following University research ethics committees provide their own guidance on PIS and consent forms. Those seeking ethical review from these committees should read and comply with this guidance:

External guidance

Additional guidance on consent processes and the writing of consent forms and PIS is available from the following external providers: