Retrospective Chart Review Studies
'A retrospective chart review study means a health research study carried out by a controller on personal data for the purposes of health research that has already been obtained by the data controller for the purposes of the provision of health care to an individual by the controller.'
(-South Infirmary University Hospital, Cork, June 2020)
Details of an interim arrangement to allow for the conduct of retrospective chart review studies without the need for 'explicit consent' were announced in a press release from the Department of Health on the 30 April 2019. The press release included information on who could conduct a retrospective chart review study without explicit consent, and what conditions (low risk/high transparency) applied for the duration of this arrangement.
The press release was helpful in its statement that retrospective chart reviews conducted for purposes other than health research e.g. clinical audit, service evaluation, and training do not fall under the Health Research Regulations 2018, and acknowledgement that differentiating between health research as opposed to non-research activities can be difficult.
The definitions of health research, clinical audit and service evaluation are on the Health Research Board website here.
In ideal circumstances, these should be referred to at an early stage in project design, in order to ensure that the project clearly meets the criteria for either health research, clinical audit or service evaluation.
While what distinguishes between each of these project types lies only in the question one seeks to answer, the decision to frame a project as 'health research' has significant implications. Where the retrospective chart review is classified as health research it becomes a 'retrospective chart review study' and the full weight of the Health Research Regulations 2018 apply.
Amendments to the Health Research Regulations took effect on the 21st January 2021 - see government announcement
Retrospective chart review studies require by law:
- research ethics committee approval
a) a statement in writing from the research ethics committee that 'the required data protection risk assessment carried out by the data controller indicates a low risk to the rights and freedoms of the data subjects whose data will be processed and used in the study'; OR
b) the 'explicit consent' of the data subjects for the processing of personal data for health research; OR
c) a 'consent declaration' from the Health Research Consent Declaration Committee (HRCDC)
- the display of posters and notices (with minimum prescribed wording) - see Beaumont Hospital Patient Privacy Notice which fulfils this requirement
(Only certain classes of persons are permitted under law to conduct a retrospective chart review study without 'explicit consent' or a 'consent declaration')
Who can conduct a retrospective chart review study?
- Employees who ordinarily have access to records e.g. healthcare professionals, medical records clerks
- Students on placement who are in training to become a 'healthcare practitioner'
(All students, including student nurses and doctors, must be "under the direction and control" of Beaumont Hospital at all times.)
Can personal data collected during a retrospective chart review study be shared?
The legislation says "personal data collected by the controller for the provision of healthcare to an individual may be used but not disclosed to another person by the controller of the study." - see S.I. No. 18/2021 - Data Protection Act 2018 (Section 36(2)) (Health Research) (Amendment) Regulations 2021
The Beaumont Hospital Patient Privacy Notice on display in the hospital advises patients that their data 'will not be disclosed to another person.'
Can the findings of a retrospective chart review study be published?
The legislation says "any findings from the study that are published shall not identify an individual whose personal data was used in the study" - see S.I. No. 18/2021 - Data Protection Act 2018 (Section 36(2)) (Health Research) (Amendment) Regulations 2021
In Beaumont Hospital, 'retrospective chart review studies' are reviewed by the research ethics committee, while retrospective chart reviews conducted for the purposes of clinical audit or service evaluation are registered with the Beaumont Hospital Clinical Governance (CG) Department. (Research Ethics Approval is not required for clinical audit or service evaluation accepted for registration by the CG Department.)