Documenting consent

Consent, in any format, should include an explicit statement confirming that information about the research has been given to the participant and has been understood. It is important that participants don't mistake any collection of health-related data from them for any form of medical screening. This might lead them to be less vigilant in relation to seeking medical attention for risks or symptoms of illness.

Normally, where written consent is taken, two copies of a consent form should be signed by the researcher and the consenting participant, and/or their parent or guardian. One copy should be retained by the participant and the other stored by the researcher. The participant's copy should give details of a contact for any queries. For certain types of research, for example where there are identifiable risks, it will also be appropriate for the consent to be witnessed and signed by an independent third party. All records of consent, including audio recordings, should be stored in the same secure conditions as research data, with due regard to the confidentiality and anonymity protocols of the research which will often involve the storage of personal identity data in a location separate from the linked data.

These pages have been adapted from the GCU code of good practice in research, the GCU research ethics booklet, and the BPS code of human research ethics.