The Research Directorate recently submitted an application to the HRCDC (Health Research Consent Declaration Committee) seeking approval for the use of a large digital dataset for research purposes.
Our engagement with the HRCDC team was excellent and highly informative, and it provided considerable clarity regarding the circumstances in which certain clinical datasets may be used without the need to apply for a consent declaration.
While the advice provided to HRCDC was specific to the dataset and project submitted, we believe the guidance is clear and may be useful to others undertaking similar research. We therefore felt it would be helpful to share this information, as it may assist in the planning and conduct of your research.
The Secretariat’s understanding was that this study involved the following:
- It is a retrospective study that will process clinical data that has already been obtained by the HSE for the purposes of the provision of health care.
- The HSE is the data controller (i.e., owner) of this pre-existing data and is also the data controller of the research study itself. Only HSE personnel will be processing the data for the purpose of the research study.
- The documents submitted to the HRCDC outline that this has been considered a low-risk study.
Ultimately it is up to the controller of the study to determine if a consent declaration is required; however, based on this information, the ‘retrospective chart review’ amendment of the Health Research Regulations may indeed be applicable to this study and therefore consent, or a consent declaration, would likely not be required (this would be subject to ensuring that the various requirements of the amendment are met, including with regards to transparency measures).
A retrospective chart review study is defined in the amendment as: ‘a health research study carried out by a controller on personal data only for the purposes of health research that has already been obtained by that controller for the purposes of the provision of health care to an individual by the controller’
Department of Health guidance on this amendment can also be found here: https://assets.gov.ie/static/documents/guidance-on-retrospective-chart-review-amendment-to-the-health-research-regulations-ja.pdf.