The Health Research Board (HRB) Welcomes the Opportunity to Make a Submission
Submission to the Department of Health and Children on the proposed Health Information Bill
The Health Research Board (HRB) is the lead agency in Ireland supporting and funding health research. We provide funding, maintain health information systems and conduct research linked to national health priorities. Our aim is to improve people's health, build health research capacity and make a significant contribution to Ireland's knowledge economy.
The statutoryfunctions of the HRB are to:
- promote, assist, commission or conduct health research to improve health and increase the effectiveness of the health services;
- maintain, develop and support health information systems for the purposes of research and to provide the evidence for health policy and services;
- liaise and co-operate with other research bodies in the State and outside the State in the promotion, commissioning or conduct of relevant research;
- liaise with other health information bodies in the State and, where appropriate, outside the State in the development and support of health information systems.
The HRB welcomes the opportunity to submit its views on the proposed Health Information Bill. We also acknowledge and welcome the Discussion Document, prepared by the Department of Health and Children,on the proposed Bill and the accompanying Audit Paper setting out relevant key international instruments, national laws and guidelines relating to health information for Ireland and selected other countries.
Policy objectives and legislative options
The HRB fully endorses the policy objectives of the proposed Bill and is of the view that the proposed Bill should build on what is already there and working well (e.g. existing Data Protection and Freedom of Information legislation) rather than create a stand alone health information regulatory structure. We concur with the disadvantages associated with the later approach,as outlined in the Discussion Document.
Personal Health information
Since the proposed Bill is concerned with personal health information in whatever form it is collected, kept, used and disclosed there is a need for a clear and unambiguous definition of the term ‘personal health information’. While reference is made to the term in existing legislation and policy/strategy documents, its meaning is not consistent. To avoid a continuation of this confusing ambiguity, we strongly recommend that an all encompassing definition is agreed by all relevant parties.We understand that other countries have struggled with defining this term and we would suggest that we look to some of these countries for clarity, for example Canada.
Informed consent issues and the Data Protection Acts
The proposed Bill should set minimum criteria and requirements for informed consent (oral and written) for all types of research involving enrolment of healthy volunteers and patients. Some of the issues have been covered in the Data Protection Acts but there are still issues in this complex area that might be considered and clarified in the Bill:
- Cases where adults might be able to give consent for other adults (e.g. in situations such as sufferers of Alzheimer’s disease and other disorders). This would ensure that research can be conducted in disorders where it is urgently needed but is currently hampered and restricted by consent issues.
- Clearly defining what is meant by vulnerable populations and addressing any related consent issues
- Clarity around best practice in seeking and obtaining consent from non-English speakers (oral, written) and participants unable to read/write
- Guidelines for seeking and obtaining consent for future and retrospective use
- Clarification over the use of deceased patients’ data and material for research purposes
In addition to the issues above, both within the context of clinical trials and outside, there is a need to consider informed consent standards for biobanking and unspecified future use of human tissue, samples and data. Biobanks aim to collect tissue, bio-fluid and other relevant samples from consenting individuals. However samples on their own will have very limited use and it is vital therefore that sample data is complemented by pathology data and detailed clinical data including follow up data on responses to treatment and outcomes. There is currently no international consensus with regard to consent for biobanking. While informed consent is the gold standard, it is impossible to specify all future uses of material and related data in biobanks and fully comply with the traditional theories of informed consent. In Europe, the Council of Europe produced recommendations for research on bio-materials of human origin (and associated personal data). They recommend that future use be ‘as specific as possible’. Many countries such as Germany, UK, Sweden, Iceland and Estonia permit this general or broad consent for ‘unspecified future research use’ based on the conditions that approval is sought from a research ethics committee and the participants are given the right to withdraw at any time. Other guidelines favour the use of multi-layered consent for use of samples/data for research purpose. The Bill should state clearly what approach is being taken in Ireland.
It would be the view of the HRB that for the processing of prospective identifiable health research data for research purposes, obtaining explicit consent provides the best protection for individuals. Consent forms which envisage future secondary uses and options should be devised and should be integrated into a healthcare provider’s existing systems, guidelines and protocols. One-on-one consultations should be the standard procedure for explicit consent. Furthermore, consent forms for research purposes should be distinct from and additional to surgical consent forms and should be issued by someone knowledgeable about current and future research purposes (as distinct from members of the surgical team). It is recognised however, that such procedures would increase the administrative burden of staff and could hamper scientific investigation. As such, alternative options should be explored which balance the rights of the patient to determine who has access to their health information and the needs of the health service to use patient information for a range of management and research purposes that stand to benefit society, generally.
As not all information can be received in anonymous format and the gold standard consent situation outlined above is not always feasible, the HRB welcomed the specific exemptions noted in the Data Protection Acts. However, clarification is needed in relation to the ‘medical purpose’ exemption. Specifically, the words ‘necessary for medical research’ requires further clarification. We would suggest that in arguing that obtaining explicit consent is not practicable or will defeat or seriously compromise the research proposed, the research proposal should be forwarded to a Research Ethics Committee and the Committee should consider in detail the purpose and justification of each protocol and document the balance of competing interests. Notification and approval of the Data Protection Commissioner should also be involved in this process. In studies involving identifiable data which is being used for secondary purposes, investigators should seek a waiver of consent from Research Ethics Committees and the latter should consider the potential damage/distress to individuals of the further processing and whether consent is impossible or involves a disproportionate effort.
The most desirable option is where research can be conducted on anonymous data as the Data Protection Act does not apply to this and consent is irrelevant as the individual cannot be identified. However, receipt of data in this format is not always possible or desirable for research. It may be necessary to consider legislation similar to that in the UK in relation to limited access to patient identifiable data in research on limited grounds and in the case of the ‘public interest’ exemption. In teasing out the ‘substantial public interest’ exemption, lessons should be drawn from the issues that have arisen in other jurisdictions. This exemption, which is vital for the establishment of national disease registers or other specific projects of national public health importance, could be dealt with by legislation or regulations (similar to the National Cancer Registry legislation) or without legislation (as adopted in Scotland).
Clarity is needed as to whether the ‘Research and Fair Processing’ exemption only applies to old records or whether it also applies to current medical records where fair processing information cannot be given and where consent cannot be sought. While the Data Protection Acts only apply to data pertaining to a living person, the duty of confidentiality still exists and proposals to utilise data or material from the dead should still involve Research Ethics Committee approval. A researcher should seek to ascertain whether anonymisation can be utilised or if neither possible nor desirable this should be explained and justified clearly to the Research Ethics Committee.
It would also be helpful in the Health Information Bill to be clear about the language used in the existing Data Protection and Freedom of Information Acts as this can be the source of confusion. The meaning of words such as ‘anonymisation’ and ‘anonymise’ and ‘unidentifiable’ should be clarified and standardised as has happened in Member States such as Germany and Spain. The Bill provides an opportunity to reflect on the differences in definitions of ‘personal data’ in the Data Protection and Freedom of Information Acts (especially as the Data Protection Act only relating to living individuals who can be identified).
While it is clear that if a researcher receives identifiable data, they should make every possible attempt to render data anonymous or make it indirectly unidentifiable at the earliest stage possible, clarity is needed as to whether the process of anonymisation is considered ‘processing’ under the Data Protection Act and therefore whether it is permissible without the consent of individuals. We recommend that the techniques utilised to render data anonymous should be accredited/approved/peer reviewed and must themselves ensure safeguards to protect confidentiality and privacy.
All of these issues above are covered in greater detail in a recently published HRB Report entitled “Data Protection Acts 1998 and 2003: someimplications for public health and medical research”( This report was commissioned by the HRB in response to numerous and consistent queries from our stakeholders as there are a number of key issues that are still not clear to researchers, data controllers and those involved in designing and managing health information systems and projects. While the ‘Guidelines on research in the Health Sector’, published by the Data Protection Commissioners Office in 2007, was welcomed by all, we feel that the issues that we have highlighted above are complex, need to be considered in the context of best practice, legal regulations, the Data Protection and other Acts and, as such, should be addressed and clarified in the proposed Health Information Bill.
Unique Healthcare Identifier
The introduction of a unique healthcare identifier (UHI) is an essential pre-requisite to
harnessing the full potential of health research for improved patient care. A UHI would allow the unique identification of individuals across the entire healthcare system, enable access to patient informationfrom multiple locations, and so ensure continuity of care. It can also contribute toepidemiological research by assisting in the study of the patterns, causes, and controlof disease in populations.We would support the National Health Information Strategy’s recommendation that the approach for unique health identification in Ireland should be the utilisation of the Personal Public Service Number (PPS Number) together with its supporting inter-sectoral infrastructure. The alternative, less favoured approach, would be to develop an entirely separate national identifier that is specific to the health sector and uses its own supporting infrastructure. We understand that there is opposition to the use of the PPS Number in the healthcare sector, however it should be stressed that the PPS Number is already in use by the General Medical Services (Payments) Board for Medical Card holders and the Drugs Payment Scheme. Whatever approach is adopted it is vital that the introduction of a UHI is underpinned by legislation and has the support of stakeholders and the general public.
Streamlined system for single opinion from Research Ethics Committees
Ethics committee review of clinical trials on medicinal products in Ireland is governed by the European Communities Regulations 2004-2006 (Clinical Trials on Medicinal Products for Human Use). These regulations supersede the Control of Clinical Trials Acts 1987-1990 for clinical trials involving medicinal products. Based on this legislation, the Department of Health and Children is the supervisory body for 13 Recognised Ethics Committees in Ireland designated to give a single opinion for approval of a clinical trial. These 13 ethics committees are located throughout the country and are hospital-associated, with the exception of the IrishCollege of General Practitioner ethics committee and three Health Services Area committees. Sponsors may submit proposals for clinical trials projects to any one of these committees for approval and all committees are required to follow the EU Guidelines for Good Clinical Practice (CPMP/ICH/135/95 and subsequent amendments).
The definition of a clinical trial under the regulations covers studies on clinical, pharmacological, pharmacodynamic or pharmacokinetic effects of studies to identify adverse reactions to investigational medicinal products. Ethics committee approval of all other types of investigation outside of medicinal products is not governed by the above legislation and this requires research ethics committee approval at each site of actual conduct, adding to the complexity, time and cost of the research.
A key recommendation in the HRB submission to the Department of Health and Children during the consultation around the implementation of the EU Clinical Trials Directive in 2004, and in subsequent correspondence, was that the opportunity should be seized in Ireland to generate a system of streamlined ethical review for all health and social care research, not just clinical trials of medicinal products. This would incorporate reviews of medicinal devices/diagnostics and combined products and would incorporate research proposals in health services, health systems and population health. It would facilitate large national studies such as the Longitudinal Study of Children and would facilitate collaborative studies including academia, clinical practice and the community.
The HRB supports health and social care research across a continuum from basic biomedical sciences to clinical, health services, health systems and population health research. The majority of translational and clinical research projects aimed at improving health delivery and outcomes are multi-centre and don’t fall under the definition of a clinical trial under the Directive. As such, research teams have to submit their protocol to a number of research ethics committees, each with different timelines, operating procedures, forms, competence etc. This process can often take up to nine months for multi-centre projects and usually necessitates funding for a dedicated co-ordinator or manager to co-ordinate the application process and amendments and secure approval at each site. For example, the HRB funded a multi-centre study (8 sites) evaluating two different methods of follow-up of patients with Type 1 diabetes participating in a structured education programme. As the study did not involve the evaluation of a ‘medicinal product’ the study was not covered by the EU Directive. Likewise, because the study did not involve the ‘administration of a substance’ it was not covered by the Control of Clinical Trials Act 1987. Although this was a low risk study from an ethical standpoint, the investigators had to contact each site separately for ethics approval and the commencement of the research study proper was delayed by almost a year.
As the HRB strives to develop Ireland’s clinical research capacity and to build a research culture for health services, systems and population health research in Ireland, a streamlined system for ethical review is essential if we are to incentive investigators to engage in Research Development and if we are to yield better value for money and greater success form our investment. Furthermore, the HRB works closely with the IDA, EnterpriseIreland, the Irish Medical Devices Association and the Irish Pharmaceutical Healthcare Association to make Ireland a more attractive place in which to conduct high quality research and development. A streamlined and clear framework for ethical review of health research is crucial in this respect. Indeed, numerous reports from key stakeholders in recent years have highlighted the urgent need for streamlining and clarifying procedures and processes for ethical review:
- Forfas, Advisory Council for Science, Technology and Innovation, November 2006, Towards Better Health: Achieving a Step Change in Health Research in Ireland.
- The IMDA Cross Sectoral Clinical Trials Taskforce, October 2006, Enhanced Clinical Trials Infrastructure Required to Benefit Public Health.
- HSE, 2008 (awaiting publication), Report on Review of Research Ethics Committees and Processes in Republic of Ireland.
Other countries in the EU, such as the UK, used the opportunity and timing of implementation of the EU Directive to establish a single framework for the review of all health-related research and this has resolved many of the difficulties previously encountered by researchers in those countries.