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Guidance on Supporting Documents

Participant Information Leaflet

Template HSSREC Participant Information Leaflet (PIL)

Though we do ask that the University templates are used, we do also recognise that a one-size-fits-all approach is not always appropriate. As such, here are the necessary pieces of information that would need to be included in a participant information sheet:

  • The study title;
  • Contact details for the researcher/s;
  • The purpose of the study;
  • What participation will involve;
  • That participation is entirely voluntary, that participants can withdraw at any time* without any adverse consequences;
  • Details of any risks/disadvantages associated with participation;
  • Details of any possible benefits of taking part;
  • What the data be used for, and how it will be stored;
  • That ethical approval has been awarded;
  • Details on the complaints procedure.

* - Note that any timing restrictions for requests to withdraw data must be made clear to participants.

Applicants must ensure the language used in their information sheet is suitable for the audience it is aimed at. Where different participant groups are being recruited, the need for an information sheet applicable to each group should be considered, particularly if research related activities may differ.

Abridged Participant Information Leaflet

Template HSSREC Abridged Participant Information Leaflet

Most research projects will require a full PIL, as exemplified by the first document presented on this page. However, for some projects that are limited to administering anonymous questionnaires, an abridged PIL may be appropriate.

The linked example above can be used as a starting point for an abridged PIL. Please note, the HSSREC may request that this is updated to include further information when reviewing your project.

Consent Form

 Template Consent Form

The consent form should briefly cover the core statements which the participant is being asked to agree to. As with the information sheet, we do ask that the template consent form provided is used, particularly where written consent is being sought. However, where a study is being conducted online, or where return of a questionnaire is considered to be consent, flexibility with the format of consent can be considered.

Where written consent is being sought the participant should normally be given the opportunity to agree or disagree to each statement, via a box next to each statement allowing them to initial their consent.

Applicants must ensure that any specific research related activities noted in the information sheet should also have a corresponding statement of consent, for example:

  • I consent to the interview being audio-recorded
  • I consent to the use of anonymised verbatim quotations in publications resulting from this study

Applicants should also consider whether there is the potential for the data to be used in future research and obtain explicit consent for this. Consent for future use of data should not be assumed!

Both the Participant Information Sheet and Consent Form should be on University of Warwick branded documents.

Please note:

The linked documents are templates for adaption to any study. Where studies are aimed at children, overseas participants or vulnerable individuals, researchers need to ensure that the documentation is culturally appropriate and age specific to meet the needs of the participant group. For further information on seeking informed consent, please refer to the Consent and Participant Information Guidance developed by the Health Research Authority (HRA) and Medical Research Council (MRC). The HRA also provides guidance on applying proportionality to seeking consent.

Further sources of guidance include:

It is advised that researchers seek out discipline specific guidance and refer to this in their applications as appropriate.

Risk Assessment

For research projects deemed to be higher risk, a risk assessment for research activities may be requested by HSSREC. Where this is the case the following table can be used as a template:

Research activity Person at risk Level of risk Control measures Additional mechanisms (specific to this study)
State the research activity, e.g. focus group(s), individual interview(s), observation(s), etc. Researcher/Participant Low, Medium, High What is currently in place to lessen this risk? Is there anything in addition to the existing control measures that can be done to lessen this risk?

More risk assessments can be accessed University Health and Safety Webpages