Informed consent

One of the guiding principles of research ethics is that participants should be fully informed before they consent to participate in a research study. Participant consent should also be freely given.

When planning their research project, OU Researchers need to consider and include the following:

1. All potential participants in OU research should be provided with participant information so they are fully aware of what the study involves. This can be offered in leaflets, email communications acting as invitations, or as welome text, for example, at the start of questionnaires.
2. All participants should provide consent or, in the case of those below the age of lega consent or assessed to be unable to give consent, assent support by consent by legal guardians/approved adults. This is usually by being invited to sign a consent form so there is an auditable record of each participant's consent to take part in the research. In the case of consent linked to online surveys, alternative arrangements for indicating consent can be built into the start of a survey, eg 'by proceeding to the survey you indicate your consent'. If other mechanisms for gaiing consent are considered appropriate, this should be proposed in the HREC application and a case made
3. Participant information or consent forms should include principal investigator contact details as well as an alternative contact not directly involved in the research, to whom participants should be guided in the case of any concerns. The alternative contact must be a member of OU staff.  Postgraduate research degree students should use their supervisor as their alternative contact. 
4. It is essential that researchers provide participants with information on how and when they can withdraw from a piece of research. For reasons of practicality it will not be possible to exclude a participant’s data from a data set once it has been de-identified (anonymised) and amalgamated. Therefore, consent forms must specify a date after which it will not be possible for participants to withdraw their consent (e.g. the date by which you anticipate you will have completed your data analysis). In the case of withdrawal from online surveys or online meetings, withdrawal arrangements can include inviting participants to discontinue with the task/exit the room and close their browser.
5. There is no requirement to retain physical consent forms, as long as they have been scanned and secured online and they should be securely destroyed as soon as practically possible. A case should be made on the Information Asset Register entry as to why and for how long digitised consent forms will be retained.  
6. Participants should be given information about how long their data will be kept and/or when it will be destroyed. A date for data destruction should be given. Research data (usually anonymised, deidentified and/or aggregated datasets) is required to be retained for up to 10 years from project completion (depending on funder and institutional (internal link only) requirements). If it is to be stored on an open research database such as ORDO, which would allow its reuse by other researchers, this should be explained to potential participants. Please see the frequently asked question for further advice on research data storage.
7. Participants should be given information about any planned research outputs e.g. reports or publications and how the data they have provided will be used and might appear in this dissemination.
8. The Human Research Ethics Committee Information and consent page provides further guidance about obtaining participant consent.
9. The Human Research Ethics Committee Guidance notes for gaining informed consent in research with children provide advice about obtaining participant assent and consent from children and young children.
10. HREC approved consent templates can be found on the Human Research Ethics Review Process page.