Guidelines for informed consent

Potential participants must be given sufficient information to allow them to decide whether or not they want to take part in a research study.

Where research involves face to face, telephone or video software (e.g. Skype) interviews, focus groups, recording of digital or monitoring data, direct observation or similar methods of data collection, participants should be given an information sheet (or leaflet) along with a privacy notice to explain how their data will be collected and used, and be asked to give their consent to participate. Templates for this supporting documentation are given below.

Questionnaires/Surveys

Previously, consent to complete a questionnaire/survey was implied by the completion and return of a form. Following the implementation of the General Data Protection Regulations (GDPR) participants must be able to demonstrate that they agree to the completion of a questionnaire/survey. The most suitable way to do this would be to add a sentence to the questionnaire asking participants to confirm that they agree to complete the questionnaire with yes/no tick boxes.

Participant Information Sheet

An information sheet should be written in a simple, non-technical language and be easily understood by a lay person. While it is always important to ensure that adequate information is given, the way in which the information is presented will need to be adapted to the individual circumstances of the study, for example a younger age group. Multiple information sheets may be required for some studies.

Consent form

Participants should understand the purpose and nature of the study, what participation in the study requires, what benefits are intended to result from the study and what will happen to the data collected. Consent cannot be inferred from inaction. Consent requires clear affirmative action, such as a written statement, electronic means or an oral statement. Participants should take deliberate and specific action to agree to participate in a study. Clear evidence must be obtained that the participant has given informed consent to take part in the study. This will usually be in the form of a signed consent form although other evidence may be acceptable (for example by audio recording consent). The consent form template should be modified for each research study to only include the clauses that are relevant to that study.

GDPR compliant privacy notice

Research data containing personal information is subject to the same legal requirements as any other personal information. In addition there may be other legal considerations such as intellectual property, copyright or design rights to think about. In collaboration with the Information Compliance Team, UREC have produced a GDPR-compliant privacy notice template for researchers.

The research participants (data subjects) must be informed of the data processing activities. Privacy notices must set out how personal information is used and what the data subjects’ (research participants) rights are.

Should the research participant withdraw their consent for use of their personal information at any time and this has implications for the validity of the research project, the researcher is advised to seek the advice of the IT Services Information Management team info.sec@brookes.ac.uk or 01865 485420.