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.
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.)
The interim arrangement has now been superseded by amendments to the Health Research Regulations which took effect on the 29th January 2021 - see government announcement