Tuesday, 16 June 2020
Department of Health
693. To ask the Minister for Health the reason the genetic material and data of patients who had a brain tissue sample taken in Beaumont Hospital between 1987 and 2018 is being given to an organisation (details supplied). [11476/20]
694. To ask the Minister for Health the reason patients who had a brain tissue sample taken in Beaumont Hospital between 1987 and 2018 must opt-out instead of opt-in to consent for their genetic material and data to be given to an organisation (details supplied). [11477/20]
722. To ask the Minister for Health the reason there was not a greater onus on a company (details supplied) to make patients or family members of patients aware that the genetic material and data of patients who had a brain tissue sample taken in Beaumont Hospital between 1987 and 2018 was to be given to it as of 12 June 2020. [11596/20]
I propose to take Questions Nos. 693, 694 and 722 together.
The Minister for Health does not make decisions in individual cases of health research. However, I can set out the regulatory and ethical processes that apply in relation to carrying out health research in Ireland.
Persons are free to carry out health research as long as it complies with the law and applicable ethical requirements. That means that, in practice, all health research in Ireland has to be ethically approved by research ethics committees. Those committees are composed of expert and lay members to ensure a wide-ranging societal and scientific perspective is applied to consideration of the research. Some health research involves collaboration between hospitals, academic institutions and commercial companies. That collaboration is predicated on the view that each participating partner brings a distinct value to the research. If hospitals or academic institutions wish to collaborate with a commercial company that is their decision and there is an individual and collective responsibility on all parties to ensure compliance with all legal and ethical requirements.
Opt-in consent is the default requirement under the Health Research Regulations made by the Minister. It is important to note that without those Regulations there would be uncertainty about whether and in what circumstances consent would be required. That uncertainty would be unhelpful for protecting individuals and their health and genetic data. Accordingly, the Regulations provide clarity, certainty and consistency on the range of safeguards that apply when it is intended to collect, use or disclose an individual’s personal data for health research.
Consistent with the approach in other jurisdictions, the Regulations provide for a clearly defined and limited statutory consent declaration process. The process, which emerged after extensive engagement with the Data Protection Commission, enables a data controller proposing to carry out health research using personal data to apply for a consent declaration which means that the consent of the individual is not required for the obtaining and use of his or her personal information for the health research concerned. To be successful, the applicant must be able to demonstrate to the independent Health Research Consent Declaration Committee or Appeal Panel that the public interest in carrying out the health research significantly outweighs the public interest in requiring the explicit consent of the data subject, that it would not be feasible to obtain such consent and that the applicant is willing to ensure a wide range of specified safeguards will be put in place, including carrying out a full Data Protection Impact Assessment, securing ethical approval from a research ethics committee and having a lawful basis for carrying out the research.
As a further safeguard, the Regulations contain an express provision stating that there will be no disclosure of the personal data obtained by a person with a consent declaration unless that disclosure is required by law or the data subject has given his or her explicit consent to the disclosure. That provision is purposely designed to stop data controllers who obtain a consent declaration from revealing, including by way of selling, any personal data they have obtained as a result of the declaration.
I am informed that, in the particular study referred to in the questions, the Health Research Consent Declaration Committee did not approve the application made but the independent Appeal Panel on the basis of the evidence put before it (which included additional evidence) did agree to issue a declaration subject to the a number of strict requirements. In recognising that requiring informed consent on an opt-in basis was not feasible, it took the decision that one of the safeguards should be an opt-out mechanism and it required a publicity campaign to help reach the widest audience.
While I have no role in decisions of independent statutory bodies I did express the view in the Dail last Thursday that an extension should be granted to the opt-out period in light of the exceptional covid-19 circumstances. I am pleased to note that Beaumont have agreed to extend the timeframe by three months until 14 September. Finally, under data protection law, decisions on compliance and matters of enforcement lie with the Data Protection Commission.