Dáil Éireann Debate, Tuesday - 23 June 2020
515. Deputy Róisín Shortall asked the Minister for Health if he is considering amending the health research regulations with regard to emergency care intervention; if a provision to auto-enrol persons who arrive to hospital in an unconscious state is being considered; and if so, if the patients next of kin could withdraw consent [12391/20]
View answerThe Health Research Regulations are made under the Data Protection Act 2018. Accordingly, they deal only with the processing of personal data for health research purposes and cannot affect the law relating to emergency care interventions which is a matter for the treating clinicians. I am not considering amending the law in that area as clinicians need to be free to provide the best clinical care that they can to patients, including in emergency care situations
Research into innovative interventions in emergency care can be critical to patient survival. Such research plays an important role in obtaining knowledge for improvement in therapy, patient safety and progress in medicine. Future patients will benefit from critical care research results of today. If, in the assessment of efficacy and safety of new emergency care interventions, data is only included on less-severely affected patients, this results in a selection bias, jeopardises the balance between study arms and reduces the overall validity of the research. This renders emergency care research almost impossible and incapable of assessing how interventions may differ in patients who die early than in survivors or those who die later.
Most countries worldwide have introduced regulatory mechanisms and/or guidance to enable emergency care research, and practices vary from waivers of consent to proxy consent to deferred consent for the inclusion of patients who lack capacity to consent to their data being used for research purposes in emergency care situations.
For interventions involving medicinal products, there is provision under the Clinical Trials on Medicinal Products for Human Use Regulations 2004 (S.I.190 of 2004) (as amended) to provide for a patient to be enrolled in a clinical trial of a medicinal product that has been approved by a recognised research ethics committee where the patient lacks capacity to consent, for example in an emergency care situation, subject to the approval of the patient’s legal representative. That term is defined in the 2004 Regulations as including a person, other than a person connected with the conduct of the trial, who by virtue of his or her or her family relationship with that adult, is suitable to act as the legal representative for the purposes of that trial and is available and willing to act for those purposes. Further, from a legal and ethical perspective, the inclusion of any person in a clinical trial must always be on a clinically sound basis.
What I have been considering in relation to individuals who lack capacity to consent in emergency care situations is the following limited, qualified and specific amendment to the Health Research Regulations. In exceptional circumstances, where the principal purpose of the processing or further processing of the personal data by a controller is necessary for the provision of health care to an individual and necessary to protect the vital interests of the individual, and where the individual is, by reason of his or her physical or mental incapacity, incapable of giving consent at that time, the personal data may also be processed by that controller for a related health research purpose, where that health research has been approved by a research ethics committee. In those circumstances, the requirement for explicit consent under the Health Research Regulation is not removed or waived but deferred until such time as the individual concerned has the capacity to give or refuse such consent. This amendment, brings emergency care research in Ireland in line with the prevailing ethical and regulatory practices internationally, provides consistency and clarity for all involved. It most definitely does not provide for auto enrolment in a research study.
