2. Information on Data Anonymisation
More information on data anonymisation can be found in MRC Data Anonymisation Workshop Outputs by the MRC Regulatory Support Centre.
Let’s explore this last aspect with a couple of examples:
Sometime the data has been through a process to remove personal identifiers – it is “de-personalised” or "pseudo-anonymised" – but it might still be possible to reverse that process and re-identify someone, so consent to use it is still important. It is just like a blurred photo of someone. We can’t immediately see who the person is, but we know it is a specific person. It may also be possible to work out who someone is by joining together information from different sources - like joining together different pieces of a jigsaw puzzle.
Therefore, even a service evaluation conducted by the care team from routine data might require consent if there is reason to believe that (e.g. for small sample sizes, very specific service, etc.) it might be possible to re-identify someone.
Likewise, a case study / report of an individual is – by its very nature – identifiable, regardless of the use of pseudonyms and/or masking of other personal details. So consent should always be obtained from service users who are the subject of an individual case study / report
However, it is possible to write a case study / report about a group in general terms without reference to individual members; this might include areas such as an overview of the demographics and clinical presentations of service users, and the interventions and processes used in the therapy. In such an example, individual consent from participants need not be sought, although members of the group should be made aware that the group may be discussed and written about, and this discussion should be recorded in the standard group notes.
If, however, the group case study / report includes a focus on an individual within the group, for example to explore clinical material in more depth, prior written consent must be obtained and recorded in the service user's medical record.
Remember that Confidentiality applies to both the living and the deceased.
It is, therefore, important to consider, on a case-by-case basis, your potential need to obtain consent. No class of study (e.g., service evaluations) and no type of investigator (e.g., students or trainees) are automatically exempt from the duty of confidentiality.
In all situations, investigators should be very clear in documenting the justification for omitting consent in the relevant Service Evaluation / Development Proposal or the Case Study Governance template.
3. Use of Non-routine Data
A study might include collecting non-routine data without in itself otherwise triggering confidentiality and the need to obtain informed consent. Nevertheless, the investigators should provide participants with clear information regarding:
- the non-routine data, why it is being sought and by whom, and the uses which will be made of it;
- that participation is voluntary and withdrawing from the study at any time is allowed without any impact on care
The individual's cooperation in providing the non-routine data implies sufficient consent in this context.