1. When must consent be sought?
If the study is defined as research, informed consent must be sought from participants and recorded in the service user's medical record.
For all other types of studies, whether or not prior consent is required depends on the confidentiality of the data – the study design or type, i.e., as a service evaluation or case report, is irrelevant.
Consent is used to prevent what would otherwise be a breach of confidentiality; therefore, prior written consent must be obtained (and recorded in the service user’s medical record):
- by investigators outside the care team, even for the use of routine clinical data
- where any form of visual / audio recording is made
- to publish, e.g., in a journal or thesis, data which could be considered identifiable; to be exempt from confidentiality requirements, the data being published must be sufficiently anonymous.