News, Actions and Initiatives

 

Public meeting organised by the Irish Academy of Medical Sciences 17.30 -19.00 – 25th November 2019

Albert Lecture Theatre, RCSI, 123 Stephens Green Dublin 2.

“Implementing Health Research Regulations to ensure compliance with GDPR”

The meeting will present the Academy’s proposals for the optimum environment for Health research in Ireland that will   provide absolute compliance with GDPR and underpin the fundamental right and protection of patient confidentiality which is at the core of health research and consent.

Background

The introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland’s Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

In this context the Irish Academy of Medical Sciences commissioned a review as to what exactly is proposed by Europe’s GDPR and by Ireland’s Health Research Regulations, to ascertain the challenges presented to clinical researchers, highlight those areas which need clarification by the Department of Health and by the Data Protection Commissioner and to propose specific recommendations which would ameliorate some of the more restrictive impositions of these regulations. This review was subsequently published as a paper in the Irish Journal of Medical Science in February 2019.

This was followed by a public meeting organised by the Academy on 8th April 2019, with the objective:

  • To present and discuss the paper and enable input and response from all interested parties.
  • Assist in the definition and determination of the most appropriate actions to be taken to address this significant challenge to the provision of optimal patient care, successful clinical research and the potential social and economic benefits which accrues from both.

 

Arising from the public meeting and following a number of discussions and meetings  with those involved in the implementations  and those impacted by the introduction of the new regulations,  the Academy continues to be very concerned that the complexities of consent and ethics in healthcare and research are not fully understood by the legislators with potential devastating and far reaching consequences for research in Ireland.

The Academy seeks an attainable, appropriate and workable way forward to regulate consent, while vigorously protecting the rights of data subjects according to international best practice, in that context it was decided to hold this further meeting  to provide the Academy’s proposals as to how this could be achieved.

   

Report on the public meeting organised by the Irish Academy of Medical Sciences

8th April 2019 Cheyne Lecture Theatre, RCSI, 123 Stephens Green Dublin 2.

GDPR: an impediment to research?

The objective of the meeting was to:

  • Present and discuss the Academy’s recent paper on the implications of the introduction of the General Data Protection Regulation and Health Research Regulations by the Department of health in Ireland.
  • Disseminate and highlight the paper’s findings and recommendations and enable input and response from all interested parties.
  • Assist in the definition and determination of the most appropriate actions to be taken to address this significant challenge to the provision of optimal patient care, successful clinical research and the potential social and economic benefits which accrues from both.

 

Background to the Academy’s paper:

The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland’s Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

In this context the Irish Academy of Medical Sciences commissioned a review as to what exactly is proposed by Europe’s GDPR and by Ireland’s Health Research Regulations, to ascertain the challenges presented to clinical researchers, highlight those areas which need clarification by the Department of Health and by the Data Protection Commissioner and to propose specific recommendations which would ameliorate some of the more restrictive impositions of these regulations. This review was subsequently published as a paper in the Irish Journal of Medical Science in February 2019.

Report on meeting:

The meeting was extremely well attended by a wide representation of all impacted by the introduction of the new regulations. The invited speakers addressed the various issues associated with the conduct, organisation, management and administration of health research together with the potential consequences to patient care, clinical training and the healthcare and pharmaceutical industry in Ireland within the new regulatory environment.

This was followed by a panel discussion with a very vigorous audience participation with multiple questions and suggestions from which a consensus emerged focussed on the following outcomes:

Summary outcomes from the Meeting:

The protection of patient confidentiality is at the core of health research and consent is and always has been central to this fundamental right.

In addition to previous data protection law requirements, researchers take privacy seriously and fulfil their privacy obligations under human rights law, common law, constitutional law, professional regulation and ethics in the conduct of research.

The meeting recognised and welcomed that GDPR sets out rules for the processing of personal information. It also recognised that the purpose of GDPR is to give legitimate basis to the free flow of information, not to prevent it.

The meeting strongly welcomed the introduction of the General Data Protection Regulation 2016, Data Protection Act 2018 and Health Research Regulations 2018 together with the regulation of consent waivers which will now be granted by the newly formed Health Research Consent Declaration Committee.

However, as medical research is of significant public interest and critical to optimum patient care, the implication of the current approach to consent implemented by the Department of Health is devastating and far reaching. Accordingly, the following actions were unanimously supported:

  • An urgent review of the application of GDPR consent under the HRR.
  • The GDPR explicit consent requirement of the HRR to be replaced with the common law standard of informed consent, in line with the standard of consent for medical treatment.
  • That the regulatory footing for consent in research be brought in line with that of the UK.
  • The need to look to Europe for the formation of our health research regulation.

Summary of speaker presentations:

The invited speakers were:

Professor Gerry McElvaney, Professor of Medicine, Head of Department of Medicine and Respiratory Researcher Division, at Beaumont Hospital, Dublin, Royal College of Surgeons in Ireland. President Irish Academy of Medical Sciences.

Mary Kirwan, Barrister- at -Law and RCSI lecturer specialising in Health Law. Legal advisor to a number of academic and hospital Ethics and Research Ethics Committees. Lecturer in Kings Inns and the Royal College of Physicians Ireland in Healthcare Law.

Professor David Smith, Associate Professor of Healthcare Ethics in RCSI and Director of the MSc in Healthcare Ethics and Law in RCSI. He lectures in Trinity College Dublin, University College Dublin, and the Royal College of Physicians. He is an ethics consultant to a number of healthcare systems in Ireland and was a member of the Irish Council for Bioethics.

Professor Michael Farrell, Consultant Neuropathologist since the hospital opened in 1987. Prior to that, he worked at the Richmond Hospital, having joined that institution in 1984. He is a teacher in the Royal College of Surgeons in Ireland and has extensive research collaborations with neuroscience researchers at RCSI and Trinity College Dublin. Along with his colleagues, Dr. Farrell is involved in the running of the Dublin Brain Bank and The National CJD Surveillance Centre at Beaumont Hospital.

Professor Tim Lynch, Chief Academic Officer Ireland East Hospital Group, Vice Principal Health Affairs UCD, Consultant Neurologist at the Mater Misericordiae University Hospital (MMUH) and Beaumont Hospital, Director of the Dublin Neurological Institute at the MMUH and Professor of Neurology at University College Dublin (UCD) and Clinical Investigator at the Conway Institute, UCD.

Professor McElvaney (who chaired the meeting) introduced the speakers and highlighted the concern of all involved in healthcare research and delivery,  regarding the Health Research Regulation legislation   introduced  by the Department of Health for the implementation of GDPR in Ireland and the associated issues, which led to the Academy commissioning the paper which is the subject of the meeting. He also committed the Academy to a leadership role in having these issues resolved to protect the future of healthcare research in Ireland and ensure that the optimum standard in clinical service delivery is maintained.

Mary Kirwan reviewed the intent of GDRP regulations regarding health research. She assessed outcomes for health research in Ireland as a result of the Department of Health’s implementation of GDPR and compared how other jurisdictions successfully implemented GDPR without placing its entire health research infrastructure at risk. Finally, she proposed the appropriate actions that could be taken in Ireland, within the existing legislative framework, to ensure full compliance with GDPR and protect and maintain a successful health research environment.

GDPR identifies the importance of scientific research across Europe and carves out specific exemptions for research. Article 81 and 83 are designed to be supportive of health-related research. Its intention is not to impede research but to protect data subject rights and ensure a high level of transparency which the research community respects and welcomes.

In addition to GDPR requirements of fairness, lawfulness and transparency; purpose limitation; data minimisation; accuracy; storage limitation; security and confidentiality the HRR applies a mandatory GDPR consent standard to the conduct of research. No other sector has had this additional requirement imposed on it, including the technology sector.

A GDPR standard of consent is exceptionally high and the research community’s concern is that it is difficult to achieve in a health context, primarily due to the power imbalance which exists between healthcare provider and the patient.

The European Data Protection Board (EDPB) in its Opinion 3/2019 on Clinical Trials provides the following as an example of power imbalance where consent is not considered “freely given”;

“….. when a participant is not in good health conditions, when participants belong to an economically or socially disadvantaged group or in any situation of institutional or hierarchical dependency.”

This example relates to most health situations.

The consequence of getting a GDPR consent wrong is significant and includes the upper end of regulatory sanctions, fines, civil litigation and reputational damage.

It is important to note that a GDPR standard consent is not a requirement for conducting scientific research under the General Data Protection Regulation 2016.  Significantly the approach to consent and research that has been taken by Ireland appears to diverge from other EU Member States.

Mandatory GDPR consent has not been applied in the UK with the implementation of the Regulation. Instead, the use of health information for the purpose of research is regulated separately to data protection law. The UK regulates the common law duty of confidentiality by way of a consent waiver granted through the Confidentiality Advisory Group. While Ireland seeks to replicate this model with the introduction of the Health Research Consent Declaration Committee, it has in fact been set up on a different legal and statutory footing which is proving central to the problems arising for the Irish research community.

Meanwhile Germany takes full advantage of the allowance made under GDPR for scientific research  and applies a considerably less burdensome approach to GDPR.

It is important to draw from the example of the US and learn from how the enactment of a similar “data protection type consent” requirement 15 years ago had a serious and negative impact on research.

The Health Insurance Portability and Accountability Act (HIPAA)Privacy Rule was implemented by the U.S. Department of Health and Human Services (HHS) in April 2003. It regulates informational privacy of health data in addition to common law.

It introduced a prescriptive “Authorisation”, or “Privacy Rule”, requirement in addition to the common law consent requirement. This is similar to the Irish legislative approach. In saying that the Privacy Rule is however not as burdensome in terms of the conditions it sets out for obtaining consent, only applies to publicly funded bodies and identifiable information.  Non-compliance is also highly punitive.

Much research has been conducted into HIPAA’s impact and some of the findings are: reduced patient recruitment, increased selection bias, reduced representation of women and minority groups, increased the costs of conducting research by requiring more paperwork, multisite trials became more difficult because of variations in interpretation of the law, and researchers abandoned important projects because of the increased number of rules and costs for operating a research study.

Unfortunately, similar impacts are currently being experienced in the Irish context since the commencement of the HRR. Of particular issue are historic data bases, biobanks and legacy or ongoing research which commenced in advance of the HRR and the explicit GDPR consent requirement.

15 years on from its implementation and the Department of Health and Human Services is seeking to revise and reform HIPAA Privacy Rule in 2019. Some of the proposals for revision have been exempting retrospective chart review from the Privacy Rule; aligning Privacy Rule with Common Rule (or the common law standard of consent); allowing the disclosure of data without consent with appropriate protections similar to direct care and treatment.

Consequently, GDRP consent as proscribed by the new Department of Health is unworkable given the range of criteria required to be met to obtain consent and the process by which consent must be given. In addition, as can be seen from the experiences in another jurisdictions of a similar regulatory regime referred to above, the new regulations will not achieve the required outcome.  Instead it will create an extremely restrictive data access environment which places existing and future health research in Ireland at great risk with consequent implications for patient care and the healthcare industry.

Professor David Smith   highlighted the problem with HRR and retrospective chart review with consequent implications for health research.  With HRR there is explicit consent required from the patient. This can be difficult to obtain and contacting patients repeatedly to review their old medical records is inefficient and intrusive to the patient. Furthermore, some hospitals have incorrectly interpreted this to pause audit based upon chart review. The DOH have set up a Consent Declaration Committee where the researcher can apply in exceptional and rare circumstances to review charts without explicit consent from the patient. It is likely that this committee will cope with hundreds of requests from multiple hospitals around Ireland when chart review is needed to ensure best clinical academic care and research. In that context this will lead to a potential cessation of a significant amount of health research with consequent impact on new healthcare treatments, practices and procedures.

Professor Michael Farrell highlighted the issues surrounding biobanks and other historical data repositories. He referred to the   letter Faculty of Pathologists in Ireland expressing their grave concern that pathology tissue banks and other biobanks will unused as explicit consent will be required for future research on stored tissues. this will be difficult as many tissues stored will be from patients who have died and often patients will not wish to be recontacted again and again each time the sample is to be reviewed. He also referred to the serious impact on the development, management, administration of health  research in the future and how the new regulations could significantly impact the initiation of new research and diminish the  of Ireland to attract local and international investment which is such an essential element of the health  research environment.

Professor Tim Lynch highlighted the role of academic medicine in the future development of healthcare and emphasised the importance of ongoing teaching, research and innovation in Healthcare. He gave  examples how the new regulations  threatens future teaching (How would he be able to use the more than  5000 existing videotapes of patients with neurological disorders in future teaching if he needed to obtain an explicit consent for different uses?), research (chart review and biobanks use will be impossible unless explicit consent done and repeated for different use) and innovation (development of new initiatives and innovations will be hampered if the research pipeline dries up).

Public meeting organised by the Irish Academy of Medical Sciences – 8th April 2019 Cheyne Lecture Theatre, RCSI, 123 Stephens Green Dublin 2.

GDPR: an impediment to research?

The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland’s Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

In this context the Irish Academy of Medical Sciences commissioned a review as to what exactly is proposed by Europe’s GDPR and by Ireland’s Health Research Regulations, to ascertain the challenges presented to clinical researchers, highlight those areas which need clarification by the Department of Health and by the Data Protection Commissioner and to propose specific recommendations which would ameliorate some of the more restrictive impositions of these regulations.

This review has now been published as a paper in the Irish Journal of Medical Science and the Academy has scheduled a public meeting in the Cheyne Lecture Theatre, Royal College of Surgeons in Ireland, 123 Stephens Green at 6.30pm on Monday April 8th, 2019 to disseminate and highlight the paper’s findings and recommendations and enable input and response from all interested parties. This will help to define and determine the most appropriate actions to be taken to address this significant challenge to the provision of optimal patient care, successful clinical research and the potential social and economic which accrues from both

Programme

Speakers include:

Professor Gerry McElvaney – Professor of Medicine, Head of Department of Medicine and Respiratory Researcher Division, at Beaumont Hospital, Dublin, Royal College of Surgeons in Ireland. President Irish Academy of Medical Sciences

Mary Kirwan – Barrister- at -Law and RCSI lecturer specialising in Health Law. She is legal advisor to a number of academic and hospital Ethics and Research Ethics Committees. She also lectures in Kings Inns and the Royal College of Physicians Ireland in Healthcare Law.

Professor David Smith is Associate Professor of Healthcare Ethics in RCSI and Director of the MSc in Healthcare Ethics and Law in RCSI and RCSI-MUB Bahrain. He lectures in Trinity College Dublin, University College Dublin, the Royal College of Physicians and Hibernia College. He is an ethics consultant to a number of healthcare systems in Ireland and was a member of the Irish Council for Bioethics.

Professor Michael Farrell, has worked at Beaumont Hospital as Consultant Neuropathologist since the hospital opened in 1987. Prior to that, he worked at the Richmond Hospital, having joined that institution in 1984. He is a teacher in the Royal College of Surgeons in Ireland and has extensive research collaborations with neuroscience researchers at RCSI and Trinity College Dublin. Along with his colleagues, Dr. Farrell is involved in the running of the Dublin Brain Bank and The National CJD Surveillance Centre at Beaumont Hospital.

Professor Tim Lynch is a Consultant Neurologist at the Mater Misericordiae University Hospital (MMUH) and Beaumont Hospital. He is also Director of the Dublin Neurological Institute at the MMUH and Professor of Neurology at University College Dublin (UCD) and Clinical Investigator at the Conway Institute, UCD. Chief Academic Officer, Ireland East Hospital Group

Schedule:

6.30pm- Professor Gerry McElvaney- Welcome and Introduction to Public Meeting

6.40pm -Mary Kirwan BL – Consent GDPR and HRR – A case for removal?

6.50pm- Professor David Smith- Capacity and Retrospective Chart Review

7.00pm- Professor Michael Farrell- Impact of HRR on Pathology Based Research

7.10pm- Professor Tim Lynch – Implications of HRR on health research in Ireland

7.20pm- Panel Discussion/ Q & A

8.00pm- Closing remarks – Professor Gerry McElvaney


Irish Academy of Medical Sciences meeting to initiate actions to address the crisis in medical staffing in Irish Healthcare.

As you are aware there is an obvious and increasing crisis in the availability and retention of medical staff in Irish healthcare.  In that context, the Irish Academy of Medical Sciences is undertaking a series of activities to ensure that the necessary urgency is given to addressing what is one of the most significant challenges facing the health service.

A major focus of these activities will be the identification of actions and initiatives to create an environment which will ensure that a resolution of this crisis is successfully achieved.

The initial step will be organisation of a major meeting which will involve representation from all who are impacted upon by the lack of medical resources. The meeting  will take place on

Wednesday 8th March 2017 at 19.00, in the Cheyne Theatre, Royal College of Surgeons, 123 St Stephen’s Green, Dublin 2.

The meeting will consist of formal presentations to be followed with a moderated open forum to provide for interaction, participation and input for all attending.

Topics to be included in the formal presentations will include:

  • Reports on the current situation within clinical service provision and the impact of the lack of clinical resources
  • Reviews of previous proposals to address these problems
  • Reviews of implementation of these proposals
  • Identification of  issues and areas which inhibit a  resolution of the crisis
  • Necessary actions to eliminate or minimise the inhibitors of a successful resolution of the crisis

Speakers providing formal presentations are:

Professor  Brian MacCraith, President DCU, Chairperson of Strategic review of medical training and career structure

Professor Eilis McGovern, National Programme Director for Medical Education, Medical

Education and Training Unit, HSE

Professor Ruairi Brugha, Head of the Department of Epidemiology and Public Health Medicine, RCSI

Dr Ciara Gough, NCHD, Specialist registrar, Pulmonary medicine, Beaumont hospital

Professor Noel G McElvaney, President of Irish Academy of Medical Sciences, Professor of Medicine RCSI

It is intended that the deliberations and the outcomes from the meeting, in addition to providing input to support the Academy’s actions in addressing this crisis, will also be widely disseminated.

Annual Scientific Symposium 2015

The Irish Academy of Medical Sciences’ Annual Scientific Symposium will take place on Tuesday 1st December 2015 in the Albert Lecture Theatre, RCSI, St. Stephens’s Green, Dublin 2.

The theme for this year’s Symposium is

“Ireland as a world class centre of excellence for clinical research – Opportunities, issues and challenges”

Morning Session  (09.00 -12.50) The environment for clinical research in the context of the current and planned governance, strategy, management and delivery of Irish healthcare.

Afternoon Session (13.45 – 15.45) Enabling the optimum environment  for  clinical research in Ireland

See below for complete speaker schedule

The Symposium is complimentary and as spaces are limited,   pre-registration is strongly recommended.

You can pre-register by  e mailing your name, work address, contact telephone number and e mail address  to ghurl@iams.ie:

 Programme

09.00 – 09.10:  Welcome – Professor Noel G. McElvaney, President, Irish Academy of Medical Sciences

09.10 – 09.35:   Mr. Dermot Mulligan, Assistant Secretary for Innovation and Investment,   Department of Jobs, Enterprise & Innovation

09.35 – 10.00:   Dr. Graham Love, Chief Executive, Health Research Board

10.00 – 10.25:   Dr. Rebecca Cramp, Scientific and Regulatory Affairs Manager, Irish   Pharmaceutical   Healthcare Association

10.25 – 10.50:   Mr. Muiris O’Connor, Assistant Secretary for Research & Development and Health   Analytics, Department of Health

11.00   – 11.30: Tea/Coffee

11.30 -11.55:   Professor Orla Hardiman, Professor of Neurology, Trinity College Dublin

11.55– 12.20:  Dr. Colm Gilligan, Medical Director, MSD Ireland

12.20 – 12.45:  Mr. Thomas Lynch, Chairperson for the Dublin East Hospital Group

12.45  – 13.45:   Lunch

13.45 – 14.10:   Professor Arnold Hill, Head of School of Medicine\Professor of Surgery, Royal College of   Surgeons in Ireland

14.10 – 14. 35:   Professor Michael Gill, Clinical Director, Wellcome Trust/HRB CRF St. James’ Hospital   Trinity Centre for Health Sciences

14.35 -15.45   Academy Working Groups  – Updates and feedback

  • “The establishment of the optimum data & information environment for   Healthcare in Ireland” – Presented and facilitated by Professor Elaine Kay, Professor of Pathology  &   Consultant Histopathologist,  Royal College of Surgeons in Ireland
  • “The establishment of the optimum ethical environment for Healthcare Research in   Ireland” – Presented and facilitated by Professor David Smith, Professor of Health Care Ethics Department of General PracticeRoyal College of Surgeons in Ireland
  • “Clinical Trial Research: Value to Ireland” – Presented and facilitated TBC

Potential implications for Research Funding arising from the European Commission’s proposal in regard to the European Fund for Strategic Investment (EFSI)

The Academy has written to the Minister for  Health and the Irish MEPs  to draw their  attention to the implications of the European Commission’s proposal in regard to funding the European Fund for Strategic Investment (EFSI)

The European Commission proposes to cut €2.7 billion from Horizon 2020 to finance EFSI. This equals a cut of 3.5% to an EU programme that already has one of the smallest budgets – yet research has a vital part to play in keeping Europe healthy and competitive. Investment in the European Research Council (ERC), one of the most important funders of excellent basic research, the Marie Skłodowska- Curie Actions,that support early-career researchers, and researchers’ access to infrastructure across Europe would all be cut.

The Academy notes the European Commission’s intention is for EFSI to also fund research projects. However, there is no formal obligation in place to ensure funds taken from Horizon 2020 is channelled back into research and innovation and it is  concerned that many organisations that conduct research – including universities, research funders, research performing organisations, charities and health services – may not be eligible for EFSI funding under the proposed wording. There is therefore a real danger of funding agreed to be for research being diverted to other purposes. EFSI is supposed to be of great benefit to the real economy. This is of great concern because research is a prerequisite for innovation, without research the pipeline to innovation is cut off. Research must be publicly funded in an appropriate way and any cuts to Horizon 2020 will result in a performance loss for the whole European research and innovation system.

Europe needs long-term, reliable and adequate funding for excellent research by the EU to deliver sustainable growth and jobs and improve the health of people living in Europe. Accordingly, in response to the European Commission’s proposal for funding the EFSI, the Academy is requesting that all Irish MEPs and the Irish Government, swiftly and assertively take steps to protect investment in Horizon 2020 and so in Irish research.

In particular the Academy has requested the Government and MEPs   to support:

  • A reversal in the cuts to Horizon 2020.
  • A formal guarantee that adequate funding in EFSI is channelled directly   into research and innovation to ensure that money committed to fund    research is not diverted to other purposes.

•           A prerequisite that funding to research and innovation projects will be   allocated competitively and on the basis of excellence

Federation of European Academies of Medicine  (FEAM) Symposium  13 May 2015, Paris: “Adolescent health: investing in the future”

Singer-Polignac Foundation, 43 Avenue Georges Mandel, 75116 Paris, France

This Symposium will explore adolescence as an important gateway to adult diseases and the focus will be the topical issues of adolescent mental health and obesity. Leading biomedical experts from across Europe will present and discuss the current scientific evidence in terms of health promotion, disease prevention, and the evaluation of genetic and environmental risk factors.

It is organised by FEAM and the French Academy of Medicine with the support of FAM(Foundation of the French Academy of Medicine) and the Singer-Polignac Foundation

Further information is available on the FEAM website – http://www.feam-site.eu/cms/

2014 Annual Scientific Symposium.  – “Clinical Trials – Now and in the Future”  

The Academy’s Annual Scientific Symposium   was held on Friday 21st November in the Albert Lecture Theatre, RCSI, St. Stephens’s Green, Dublin 2.

The symposium  featured National and International speakers with important contributions on Symposium’s topic, addressing  the current key issues in responding to  this  ever more important aspect of academic work in Ireland.

These included:

  • How Clinical trials are impacted by Ireland’s policy on science funding
  • Ethical and legal implications of current and proposed National and European legislative changes
  • The harmonisation of the regulatory environment on the protection of personal data in the EUī
  • Using research findings to inform and influence policy
  • The implications of new technologies and information environments on the conduct of Clinical Trials

Speakers  included:

  • Dr. Graham Love – Chief Executive, Health Research Board (HRB).
  • Professor Bernard Charpentier, Vice President, Federation of European Academies of Medicine ( FEAM).
  • Gillian Vale – Chief administrator, Medical Ethics, Beaumont Hospital, Dublin.
  • Prof. Garret FitzGerald, University of Pennsylvania, USA.
  • Dr. Andy Brown, Global Head, Clinical trials of the future, Novartis, Basel, Switzerland.
  • Professor Padraic Fallon, Trinity College Dublin.
  • Dr. Mark Taylor, University of Sheffield, UK.

 For Programme and speaker profiles  see Events section

The Executive of the Academy has decided on a number of actions and initiatives to support its functions and activities. These include:

The appointment of an Executive Director with responsibility for the corporate executive function of the Academy 

Key functions of the Executive Director are:

  • All administrative and executive services and supports to the Council and Fellows of the Academy.
  • To oversee and effect the management and operation of the Academy
  • Develop and implement strategic, long-term, business, operations and budgetary Plans of the Academy as directed by the Council.
  • Assure legal and fiduciary probity of the Academy in all its operations.
  • Promote the objects and activities of the Academy.
  • Maintain a members Register for the Academy.
  • Represent the Academy in its administrative dealings with third parties.
  • Act as the Accounting Officer of the Academy.

New management and organisational arrangements:

Initial actions are the establishment of an executive sub group of the Academy’s Council consisting of the President, Secretary and Treasurer, with the Executive Director. It will meet as a minimum on a monthly basis, the full Council to meet as a minimum every two months

The development of a medium term work program as the basis for a formal    strategic and business plan for the Academy.

The work program has as its initial actions:

  • The development and implementation of strategies and plans for achieving the Academy’s objectives, the formulation of policies and the availability of reference resources to support its roles and functions.
  • Actions to create awareness and recognition for the Academy’s roles and functions
  • The determination of    priority activities in the context of resource availability,   their potential to support early success and underpin promotion and recognition for the Academy
  • Define and prioritise a range of potential policy issues
  • Develop high level summary   statements for each of the priority issues identified
  • Determine which of the priority policy issues would be the most appropriate for the production of a detailed and formally commissioned/ published report
  • Establish a time table of realisable deliverables

Appointment of Executive Director

The Academy has appointed Mr. Gerard Hurl as Executive Director. Gerard was HSE National Director of Information Communication Technology (ICT) prior to taking up his position with IAMS, previously project Director – ICT Convergence Project – Dublin Academic Teaching Hospitals (DATHs) and Director of ICT at the Mater Misericordiae Hospital Dublin. He is Secretary General of the EuroRec Institute, Vice Chairman of ProRecIreland, and past Chairman of the Healthcare Informatics Society of Ireland.

One of the most important aspects of his remit over the next number of months will be to meet with all the Fellows and determine how best to invigorate the Academy and make it more pertinent to the Academic lives of its members.

Report on the public meeting organised by the Irish Academy of Medical Sciences

8th April 2019 Cheyne Lecture Theatre, RCSI, 123 Stephens Green Dublin 2.

GDPR: an impediment to research?

The objective of the meeting was to:

  • Present and discuss the Academy’s recent paper on the implications of the introduction of the General Data Protection Regulation and Health Research Regulations by the Department of health in Ireland.
  • Disseminate and highlight the paper’s findings and recommendations and enable input and response from all interested parties.
  • Assist in the definition and determination of the most appropriate actions to be taken to address this significant challenge to the provision of optimal patient care, successful clinical research and the potential social and economic benefits which accrues from both.

 

Background to the Academy’s paper:

The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland’s Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

In this context the Irish Academy of Medical Sciences commissioned a review as to what exactly is proposed by Europe’s GDPR and by Ireland’s Health Research Regulations, to ascertain the challenges presented to clinical researchers, highlight those areas which need clarification by the Department of Health and by the Data Protection Commissioner and to propose specific recommendations which would ameliorate some of the more restrictive impositions of these regulations. This review was subsequently published as a paper in the Irish Journal of Medical Science in February 2019.

Report on meeting:

The meeting was extremely well attended by a wide representation of all impacted by the introduction of the new regulations. The invited speakers addressed the various issues associated with the conduct, organisation, management and administration of health research together with the potential consequences to patient care, clinical training and the healthcare and pharmaceutical industry in Ireland within the new regulatory environment.

This was followed by a panel discussion with a very vigorous audience participation with multiple questions and suggestions from which a consensus emerged focussed on the following outcomes:

Summary outcomes from the Meeting:

The protection of patient confidentiality is at the core of health research and consent is and always has been central to this fundamental right.

In addition to previous data protection law requirements, researchers take privacy seriously and fulfil their privacy obligations under human rights law, common law, constitutional law, professional regulation and ethics in the conduct of research.

The meeting recognised and welcomed that GDPR sets out rules for the processing of personal information. It also recognised that the purpose of GDPR is to give legitimate basis to the free flow of information, not to prevent it.

The meeting strongly welcomed the introduction of the General Data Protection Regulation 2016, Data Protection Act 2018 and Health Research Regulations 2018 together with the regulation of consent waivers which will now be granted by the newly formed Health Research Consent Declaration Committee.

However, as medical research is of significant public interest and critical to optimum patient care, the implication of the current approach to consent implemented by the Department of Health is devastating and far reaching. Accordingly, the following actions were unanimously supported:

  • An urgent review of the application of GDPR consent under the HRR.
  • The GDPR explicit consent requirement of the HRR to be replaced with the common law standard of informed consent, in line with the standard of consent for medical treatment.
  • That the regulatory footing for consent in research be brought in line with that of the UK.
  • The need to look to Europe for the formation of our health research regulation.

 

Summary of speaker presentations:

The invited speakers were:

Professor Gerry McElvaney, Professor of Medicine, Head of Department of Medicine and Respiratory Researcher Division, at Beaumont Hospital, Dublin, Royal College of Surgeons in Ireland. President Irish Academy of Medical Sciences.

Mary Kirwan, Barrister- at -Law and RCSI lecturer specialising in Health Law. Legal advisor to a number of academic and hospital Ethics and Research Ethics Committees. Lecturer in Kings Inns and the Royal College of Physicians Ireland in Healthcare Law.

Professor David Smith, Associate Professor of Healthcare Ethics in RCSI and Director of the MSc in Healthcare Ethics and Law in RCSI. He lectures in Trinity College Dublin, University College Dublin, and the Royal College of Physicians. He is an ethics consultant to a number of healthcare systems in Ireland and was a member of the Irish Council for Bioethics.

Professor Michael Farrell, Consultant Neuropathologist since the hospital opened in 1987. Prior to that, he worked at the Richmond Hospital, having joined that institution in 1984. He is a teacher in the Royal College of Surgeons in Ireland and has extensive research collaborations with neuroscience researchers at RCSI and Trinity College Dublin. Along with his colleagues, Dr. Farrell is involved in the running of the Dublin Brain Bank and The National CJD Surveillance Centre at Beaumont Hospital.

Professor Tim Lynch, Chief Academic Officer Ireland East Hospital Group, Vice Principal Health Affairs UCD, Consultant Neurologist at the Mater Misericordiae University Hospital (MMUH) and Beaumont Hospital, Director of the Dublin Neurological Institute at the MMUH and Professor of Neurology at University College Dublin (UCD) and Clinical Investigator at the Conway Institute, UCD.

Professor McElvaney (who chaired the meeting) introduced the speakers and highlighted the concern of all involved in healthcare research and delivery,  regarding the Health Research Regulation legislation   introduced  by the Department of Health for the implementation of GDPR in Ireland and the associated issues, which led to the Academy commissioning the paper which is the subject of the meeting. He also committed the Academy to a leadership role in having these issues resolved to protect the future of healthcare research in Ireland and ensure that the optimum standard in clinical service delivery is maintained.

Mary Kirwan reviewed the intent of GDRP regulations regarding health research. She assessed outcomes for health research in Ireland as a result of the Department of Health’s implementation of GDPR and compared how other jurisdictions successfully implemented GDPR without placing its entire health research infrastructure at risk. Finally, she proposed the appropriate actions that could be taken in Ireland, within the existing legislative framework, to ensure full compliance with GDPR and protect and maintain a successful health research environment.

GDPR identifies the importance of scientific research across Europe and carves out specific exemptions for research. Article 81 and 83 are designed to be supportive of health-related research. Its intention is not to impede research but to protect data subject rights and ensure a high level of transparency which the research community respects and welcomes.

In addition to GDPR requirements of fairness, lawfulness and transparency; purpose limitation; data minimisation; accuracy; storage limitation; security and confidentiality the HRR applies a mandatory GDPR consent standard to the conduct of research. No other sector has had this additional requirement imposed on it, including the technology sector.

A GDPR standard of consent is exceptionally high and the research community’s concern is that it is difficult to achieve in a health context, primarily due to the power imbalance which exists between healthcare provider and the patient.

The European Data Protection Board (EDPB) in its Opinion 3/2019 on Clinical Trials provides the following as an example of power imbalance where consent is not considered “freely given”;

“….. when a participant is not in good health conditions, when participants belong to an economically or socially disadvantaged group or in any situation of institutional or hierarchical dependency.”

This example relates to most health situations.

The consequence of getting a GDPR consent wrong is significant and includes the upper end of regulatory sanctions, fines, civil litigation and reputational damage.

It is important to note that a GDPR standard consent is not a requirement for conducting scientific research under the General Data Protection Regulation 2016.  Significantly the approach to consent and research that has been taken by Ireland appears to diverge from other EU Member States.

Mandatory GDPR consent has not been applied in the UK with the implementation of the Regulation. Instead, the use of health information for the purpose of research is regulated separately to data protection law. The UK regulates the common law duty of confidentiality by way of a consent waiver granted through the Confidentiality Advisory Group. While Ireland seeks to replicate this model with the introduction of the Health Research Consent Declaration Committee, it has in fact been set up on a different legal and statutory footing which is proving central to the problems arising for the Irish research community.

Meanwhile Germany takes full advantage of the allowance made under GDPR for scientific research  and applies a considerably less burdensome approach to GDPR.

It is important to draw from the example of the US and learn from how the enactment of a similar “data protection type consent” requirement 15 years ago had a serious and negative impact on research.

The Health Insurance Portability and Accountability Act (HIPAA)Privacy Rule was implemented by the U.S. Department of Health and Human Services (HHS) in April 2003. It regulates informational privacy of health data in addition to common law.

It introduced a prescriptive “Authorisation”, or “Privacy Rule”, requirement in addition to the common law consent requirement. This is similar to the Irish legislative approach. In saying that the Privacy Rule is however not as burdensome in terms of the conditions it sets out for obtaining consent, only applies to publicly funded bodies and identifiable information.  Non-compliance is also highly punitive.

Much research has been conducted into HIPAA’s impact and some of the findings are: reduced patient recruitment, increased selection bias, reduced representation of women and minority groups, increased the costs of conducting research by requiring more paperwork, multisite trials became more difficult because of variations in interpretation of the law, and researchers abandoned important projects because of the increased number of rules and costs for operating a research study.

Unfortunately, similar impacts are currently being experienced in the Irish context since the commencement of the HRR. Of particular issue are historic data bases, biobanks and legacy or ongoing research which commenced in advance of the HRR and the explicit GDPR consent requirement.

15 years on from its implementation and the Department of Health and Human Services is seeking to revise and reform HIPAA Privacy Rule in 2019. Some of the proposals for revision have been exempting retrospective chart review from the Privacy Rule; aligning Privacy Rule with Common Rule (or the common law standard of consent); allowing the disclosure of data without consent with appropriate protections similar to direct care and treatment.

Consequently, GDRP consent as proscribed by the new Department of Health is unworkable given the range of criteria required to be met to obtain consent and the process by which consent must be given. In addition, as can be seen from the experiences in another jurisdictions of a similar regulatory regime referred to above, the new regulations will not achieve the required outcome.  Instead it will create an extremely restrictive data access environment which places existing and future health research in Ireland at great risk with consequent implications for patient care and the healthcare industry.

Professor David Smith   highlighted the problem with HRR and retrospective chart review with consequent implications for health research.  With HRR there is explicit consent required from the patient. This can be difficult to obtain and contacting patients repeatedly to review their old medical records is inefficient and intrusive to the patient. Furthermore, some hospitals have incorrectly interpreted this to pause audit based upon chart review. The DOH have set up a Consent Declaration Committee where the researcher can apply in exceptional and rare circumstances to review charts without explicit consent from the patient. It is likely that this committee will cope with hundreds of requests from multiple hospitals around Ireland when chart review is needed to ensure best clinical academic care and research. In that context this will lead to a potential cessation of a significant amount of health research with consequent impact on new healthcare treatments, practices and procedures.

Professor Michael Farrell highlighted the issues surrounding biobanks and other historical data repositories. He referred to the   letter Faculty of Pathologists in Ireland expressing their grave concern that pathology tissue banks and other biobanks will unused as explicit consent will be required for future research on stored tissues. this will be difficult as many tissues stored will be from patients who have died and often patients will not wish to be recontacted again and again each time the sample is to be reviewed. He also referred to the serious impact on the development, management, administration of health  research in the future and how the new regulations could significantly impact the initiation of new research and diminish the  of Ireland to attract local and international investment which is such an essential element of the health  research environment.

Professor Tim Lynch highlighted the role of academic medicine in the future development of healthcare and emphasised the importance of ongoing teaching, research and innovation in Healthcare. He gave  examples how the new regulations  threatens future teaching (How would he be able to use the more than  5000 existing videotapes of patients with neurological disorders in future teaching if he needed to obtain an explicit consent for different uses?), research (chart review and biobanks use will be impossible unless explicit consent done and repeated for different use) and innovation (development of new initiatives and innovations will be hampered if the research pipeline dries up).

Public meeting organised by the Irish Academy of Medical Sciences – 8th April 2019 Cheyne Lecture Theatre, RCSI, 123 Stephens Green Dublin 2.

GDPR: an impediment to research?

The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland’s Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

In this context the Irish Academy of Medical Sciences commissioned a review as to what exactly is proposed by Europe’s GDPR and by Ireland’s Health Research Regulations, to ascertain the challenges presented to clinical researchers, highlight those areas which need clarification by the Department of Health and by the Data Protection Commissioner and to propose specific recommendations which would ameliorate some of the more restrictive impositions of these regulations.

This review has now been published as a paper in the Irish Journal of Medical Science and the Academy has scheduled a public meeting in the Cheyne Lecture Theatre, Royal College of Surgeons in Ireland, 123 Stephens Green at 6.30pm on Monday April 8th, 2019 to disseminate and highlight the paper’s findings and recommendations and enable input and response from all interested parties. This will help to define and determine the most appropriate actions to be taken to address this significant challenge to the provision of optimal patient care, successful clinical research and the potential social and economic which accrues from both

Programme

Speakers include:

Professor Gerry McElvaney – Professor of Medicine, Head of Department of Medicine and Respiratory Researcher Division, at Beaumont Hospital, Dublin, Royal College of Surgeons in Ireland. President Irish Academy of Medical Sciences

Mary Kirwan – Barrister- at -Law and RCSI lecturer specialising in Health Law. She is legal advisor to a number of academic and hospital Ethics and Research Ethics Committees. She also lectures in Kings Inns and the Royal College of Physicians Ireland in Healthcare Law.

Professor David Smith is Associate Professor of Healthcare Ethics in RCSI and Director of the MSc in Healthcare Ethics and Law in RCSI and RCSI-MUB Bahrain. He lectures in Trinity College Dublin, University College Dublin, the Royal College of Physicians and Hibernia College. He is an ethics consultant to a number of healthcare systems in Ireland and was a member of the Irish Council for Bioethics.

Professor Michael Farrell, has worked at Beaumont Hospital as Consultant Neuropathologist since the hospital opened in 1987. Prior to that, he worked at the Richmond Hospital, having joined that institution in 1984. He is a teacher in the Royal College of Surgeons in Ireland and has extensive research collaborations with neuroscience researchers at RCSI and Trinity College Dublin. Along with his colleagues, Dr. Farrell is involved in the running of the Dublin Brain Bank and The National CJD Surveillance Centre at Beaumont Hospital.

Professor Tim Lynch is a Consultant Neurologist at the Mater Misericordiae University Hospital (MMUH) and Beaumont Hospital. He is also Director of the Dublin Neurological Institute at the MMUH and Professor of Neurology at University College Dublin (UCD) and Clinical Investigator at the Conway Institute, UCD. Chief Academic Officer, Ireland East Hospital Group

Schedule:

6.30pm- Professor Gerry McElvaney- Welcome and Introduction to Public Meeting

6.40pm -Mary Kirwan BL – Consent GDPR and HRR – A case for removal?

6.50pm- Professor David Smith- Capacity and Retrospective Chart Review

7.00pm- Professor Michael Farrell- Impact of HRR on Pathology Based Research

7.10pm- Professor Tim Lynch – Implications of HRR on health research in Ireland

7.20pm- Panel Discussion/ Q & A

8.00pm- Closing remarks – Professor Gerry McElvaney


Irish Academy of Medical Sciences meeting to initiate actions to address the crisis in medical staffing in Irish Healthcare.

As you are aware there is an obvious and increasing crisis in the availability and retention of medical staff in Irish healthcare.  In that context, the Irish Academy of Medical Sciences is undertaking a series of activities to ensure that the necessary urgency is given to addressing what is one of the most significant challenges facing the health service.

A major focus of these activities will be the identification of actions and initiatives to create an environment which will ensure that a resolution of this crisis is successfully achieved.

The initial step will be organisation of a major meeting which will involve representation from all who are impacted upon by the lack of medical resources. The meeting  will take place on

Wednesday 8th March 2017 at 19.00, in the Cheyne Theatre, Royal College of Surgeons, 123 St Stephen’s Green, Dublin 2.

The meeting will consist of formal presentations to be followed with a moderated open forum to provide for interaction, participation and input for all attending.

Topics to be included in the formal presentations will include:

  • Reports on the current situation within clinical service provision and the impact of the lack of clinical resources
  • Reviews of previous proposals to address these problems
  • Reviews of implementation of these proposals
  • Identification of  issues and areas which inhibit a  resolution of the crisis
  • Necessary actions to eliminate or minimise the inhibitors of a successful resolution of the crisis

Speakers providing formal presentations are:

Professor  Brian MacCraith, President DCU, Chairperson of Strategic review of medical training and career structure

Professor Eilis McGovern, National Programme Director for Medical Education, Medical

Education and Training Unit, HSE

Professor Ruairi Brugha, Head of the Department of Epidemiology and Public Health Medicine, RCSI

Dr Ciara Gough, NCHD, Specialist registrar, Pulmonary medicine, Beaumont hospital

Professor Noel G McElvaney, President of Irish Academy of Medical Sciences, Professor of Medicine RCSI

It is intended that the deliberations and the outcomes from the meeting, in addition to providing input to support the Academy’s actions in addressing this crisis, will also be widely disseminated.

Annual Scientific Symposium 2015

The Irish Academy of Medical Sciences’ Annual Scientific Symposium will take place on Tuesday 1st December 2015 in the Albert Lecture Theatre, RCSI, St. Stephens’s Green, Dublin 2.

The theme for this year’s Symposium is

“Ireland as a world class centre of excellence for clinical research – Opportunities, issues and challenges”

Morning Session  (09.00 -12.50) The environment for clinical research in the context of the current and planned governance, strategy, management and delivery of Irish healthcare.

Afternoon Session (13.45 – 15.45) Enabling the optimum environment  for  clinical research in Ireland

See below for complete speaker schedule

The Symposium is complimentary and as spaces are limited,   pre-registration is strongly recommended.

You can pre-register by  e mailing your name, work address, contact telephone number and e mail address  to ghurl@iams.ie:

 Programme

09.00 – 09.10:  Welcome – Professor Noel G. McElvaney, President, Irish Academy of Medical Sciences

09.10 – 09.35:   Mr. Dermot Mulligan, Assistant Secretary for Innovation and Investment,   Department of Jobs, Enterprise & Innovation

09.35 – 10.00:   Dr. Graham Love, Chief Executive, Health Research Board

10.00 – 10.25:   Dr. Rebecca Cramp, Scientific and Regulatory Affairs Manager, Irish   Pharmaceutical   Healthcare Association

10.25 – 10.50:   Mr. Muiris O’Connor, Assistant Secretary for Research & Development and Health   Analytics, Department of Health

11.00   – 11.30: Tea/Coffee

11.30 -11.55:   Professor Orla Hardiman, Professor of Neurology, Trinity College Dublin

11.55– 12.20:  Dr. Colm Gilligan, Medical Director, MSD Ireland

12.20 – 12.45:  Mr. Thomas Lynch, Chairperson for the Dublin East Hospital Group

12.45  – 13.45:   Lunch

13.45 – 14.10:   Professor Arnold Hill, Head of School of Medicine\Professor of Surgery, Royal College of   Surgeons in Ireland

14.10 – 14. 35:   Professor Michael Gill, Clinical Director, Wellcome Trust/HRB CRF St. James’ Hospital   Trinity Centre for Health Sciences

14.35 -15.45   Academy Working Groups  – Updates and feedback

  • “The establishment of the optimum data & information environment for   Healthcare in Ireland” – Presented and facilitated by Professor Elaine Kay, Professor of Pathology  &   Consultant Histopathologist,  Royal College of Surgeons in Ireland
  • “The establishment of the optimum ethical environment for Healthcare Research in   Ireland” – Presented and facilitated by Professor David Smith, Professor of Health Care Ethics Department of General PracticeRoyal College of Surgeons in Ireland
  • “Clinical Trial Research: Value to Ireland” – Presented and facilitated TBC

Potential implications for Research Funding arising from the European Commission’s proposal in regard to the European Fund for Strategic Investment (EFSI)

The Academy has written to the Minister for  Health and the Irish MEPs  to draw their  attention to the implications of the European Commission’s proposal in regard to funding the European Fund for Strategic Investment (EFSI)

The European Commission proposes to cut €2.7 billion from Horizon 2020 to finance EFSI. This equals a cut of 3.5% to an EU programme that already has one of the smallest budgets – yet research has a vital part to play in keeping Europe healthy and competitive. Investment in the European Research Council (ERC), one of the most important funders of excellent basic research, the Marie Skłodowska- Curie Actions,that support early-career researchers, and researchers’ access to infrastructure across Europe would all be cut.

The Academy notes the European Commission’s intention is for EFSI to also fund research projects. However, there is no formal obligation in place to ensure funds taken from Horizon 2020 is channelled back into research and innovation and it is  concerned that many organisations that conduct research – including universities, research funders, research performing organisations, charities and health services – may not be eligible for EFSI funding under the proposed wording. There is therefore a real danger of funding agreed to be for research being diverted to other purposes. EFSI is supposed to be of great benefit to the real economy. This is of great concern because research is a prerequisite for innovation, without research the pipeline to innovation is cut off. Research must be publicly funded in an appropriate way and any cuts to Horizon 2020 will result in a performance loss for the whole European research and innovation system.

Europe needs long-term, reliable and adequate funding for excellent research by the EU to deliver sustainable growth and jobs and improve the health of people living in Europe. Accordingly, in response to the European Commission’s proposal for funding the EFSI, the Academy is requesting that all Irish MEPs and the Irish Government, swiftly and assertively take steps to protect investment in Horizon 2020 and so in Irish research.

In particular the Academy has requested the Government and MEPs   to support:

  • A reversal in the cuts to Horizon 2020.
  • A formal guarantee that adequate funding in EFSI is channelled directly   into research and innovation to ensure that money committed to fund    research is not diverted to other purposes.

•           A prerequisite that funding to research and innovation projects will be   allocated competitively and on the basis of excellence

Federation of European Academies of Medicine  (FEAM) Symposium  13 May 2015, Paris: “Adolescent health: investing in the future”

Singer-Polignac Foundation, 43 Avenue Georges Mandel, 75116 Paris, France

This Symposium will explore adolescence as an important gateway to adult diseases and the focus will be the topical issues of adolescent mental health and obesity. Leading biomedical experts from across Europe will present and discuss the current scientific evidence in terms of health promotion, disease prevention, and the evaluation of genetic and environmental risk factors.

It is organised by FEAM and the French Academy of Medicine with the support of FAM(Foundation of the French Academy of Medicine) and the Singer-Polignac Foundation

Further information is available on the FEAM website – http://www.feam-site.eu/cms/

2014 Annual Scientific Symposium.  – “Clinical Trials – Now and in the Future”  

The Academy’s Annual Scientific Symposium   was held on Friday 21st November in the Albert Lecture Theatre, RCSI, St. Stephens’s Green, Dublin 2.

The symposium  featured National and International speakers with important contributions on Symposium’s topic, addressing  the current key issues in responding to  this  ever more important aspect of academic work in Ireland.

These included:

  • How Clinical trials are impacted by Ireland’s policy on science funding
  • Ethical and legal implications of current and proposed National and European legislative changes
  • The harmonisation of the regulatory environment on the protection of personal data in the EUī
  • Using research findings to inform and influence policy
  • The implications of new technologies and information environments on the conduct of Clinical Trials

Speakers  included:

  • Dr. Graham Love – Chief Executive, Health Research Board (HRB).
  • Professor Bernard Charpentier, Vice President, Federation of European Academies of Medicine ( FEAM).
  • Gillian Vale – Chief administrator, Medical Ethics, Beaumont Hospital, Dublin.
  • Prof. Garret FitzGerald, University of Pennsylvania, USA.
  • Dr. Andy Brown, Global Head, Clinical trials of the future, Novartis, Basel, Switzerland.
  • Professor Padraic Fallon, Trinity College Dublin.
  • Dr. Mark Taylor, University of Sheffield, UK.

 For Programme and speaker profiles  see Events section

The Executive of the Academy has decided on a number of actions and initiatives to support its functions and activities. These include:

The appointment of an Executive Director with responsibility for the corporate executive function of the Academy 

Key functions of the Executive Director are:

  • All administrative and executive services and supports to the Council and Fellows of the Academy.
  • To oversee and effect the management and operation of the Academy
  • Develop and implement strategic, long-term, business, operations and budgetary Plans of the Academy as directed by the Council.
  • Assure legal and fiduciary probity of the Academy in all its operations.
  • Promote the objects and activities of the Academy.
  • Maintain a members Register for the Academy.
  • Represent the Academy in its administrative dealings with third parties.
  • Act as the Accounting Officer of the Academy.

New management and organisational arrangements:

Initial actions are the establishment of an executive sub group of the Academy’s Council consisting of the President, Secretary and Treasurer, with the Executive Director. It will meet as a minimum on a monthly basis, the full Council to meet as a minimum every two months

The development of a medium term work program as the basis for a formal    strategic and business plan for the Academy.

The work program has as its initial actions:

  • The development and implementation of strategies and plans for achieving the Academy’s objectives, the formulation of policies and the availability of reference resources to support its roles and functions.
  • Actions to create awareness and recognition for the Academy’s roles and functions
  • The determination of    priority activities in the context of resource availability,   their potential to support early success and underpin promotion and recognition for the Academy
  • Define and prioritise a range of potential policy issues
  • Develop high level summary   statements for each of the priority issues identified
  • Determine which of the priority policy issues would be the most appropriate for the production of a detailed and formally commissioned/ published report
  • Establish a time table of realisable deliverables

Appointment of Executive Director

The Academy has appointed Mr. Gerard Hurl as Executive Director. Gerard was HSE National Director of Information Communication Technology (ICT) prior to taking up his position with IAMS, previously project Director – ICT Convergence Project – Dublin Academic Teaching Hospitals (DATHs) and Director of ICT at the Mater Misericordiae Hospital Dublin. He is Secretary General of the EuroRec Institute, Vice Chairman of ProRecIreland, and past Chairman of the Healthcare Informatics Society of Ireland.

One of the most important aspects of his remit over the next number of months will be to meet with all the Fellows and determine how best to invigorate the Academy and make it more pertinent to the Academic lives of its members.

Report on the public meeting organised by the Irish Academy of Medical Sciences

8th April 2019 Cheyne Lecture Theatre, RCSI, 123 Stephens Green Dublin 2.

GDPR: an impediment to research?

The objective of the meeting was to:

  • Present and discuss the Academy’s recent paper on the implications of the introduction of the General Data Protection Regulation and Health Research Regulations by the Department of health in Ireland.
  • Disseminate and highlight the paper’s findings and recommendations and enable input and response from all interested parties.
  • Assist in the definition and determination of the most appropriate actions to be taken to address this significant challenge to the provision of optimal patient care, successful clinical research and the potential social and economic benefits which accrues from both.

 

Background to the Academy’s paper:

The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland’s Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

In this context the Irish Academy of Medical Sciences commissioned a review as to what exactly is proposed by Europe’s GDPR and by Ireland’s Health Research Regulations, to ascertain the challenges presented to clinical researchers, highlight those areas which need clarification by the Department of Health and by the Data Protection Commissioner and to propose specific recommendations which would ameliorate some of the more restrictive impositions of these regulations. This review was subsequently published as a paper in the Irish Journal of Medical Science in February 2019.

Report on meeting:

The meeting was extremely well attended by a wide representation of all impacted by the introduction of the new regulations. The invited speakers addressed the various issues associated with the conduct, organisation, management and administration of health research together with the potential consequences to patient care, clinical training and the healthcare and pharmaceutical industry in Ireland within the new regulatory environment.

This was followed by a panel discussion with a very vigorous audience participation with multiple questions and suggestions from which a consensus emerged focussed on the following outcomes:

Summary outcomes from the Meeting:

The protection of patient confidentiality is at the core of health research and consent is and always has been central to this fundamental right.

In addition to previous data protection law requirements, researchers take privacy seriously and fulfil their privacy obligations under human rights law, common law, constitutional law, professional regulation and ethics in the conduct of research.

The meeting recognised and welcomed that GDPR sets out rules for the processing of personal information. It also recognised that the purpose of GDPR is to give legitimate basis to the free flow of information, not to prevent it.

The meeting strongly welcomed the introduction of the General Data Protection Regulation 2016, Data Protection Act 2018 and Health Research Regulations 2018 together with the regulation of consent waivers which will now be granted by the newly formed Health Research Consent Declaration Committee.

However, as medical research is of significant public interest and critical to optimum patient care, the implication of the current approach to consent implemented by the Department of Health is devastating and far reaching. Accordingly, the following actions were unanimously supported:

  • An urgent review of the application of GDPR consent under the HRR.
  • The GDPR explicit consent requirement of the HRR to be replaced with the common law standard of informed consent, in line with the standard of consent for medical treatment.
  • That the regulatory footing for consent in research be brought in line with that of the UK.
  • The need to look to Europe for the formation of our health research regulation.

 

Summary of speaker presentations:

The invited speakers were:

Professor Gerry McElvaney, Professor of Medicine, Head of Department of Medicine and Respiratory Researcher Division, at Beaumont Hospital, Dublin, Royal College of Surgeons in Ireland. President Irish Academy of Medical Sciences.

Mary Kirwan, Barrister- at -Law and RCSI lecturer specialising in Health Law. Legal advisor to a number of academic and hospital Ethics and Research Ethics Committees. Lecturer in Kings Inns and the Royal College of Physicians Ireland in Healthcare Law.

Professor David Smith, Associate Professor of Healthcare Ethics in RCSI and Director of the MSc in Healthcare Ethics and Law in RCSI. He lectures in Trinity College Dublin, University College Dublin, and the Royal College of Physicians. He is an ethics consultant to a number of healthcare systems in Ireland and was a member of the Irish Council for Bioethics.

Professor Michael Farrell, Consultant Neuropathologist since the hospital opened in 1987. Prior to that, he worked at the Richmond Hospital, having joined that institution in 1984. He is a teacher in the Royal College of Surgeons in Ireland and has extensive research collaborations with neuroscience researchers at RCSI and Trinity College Dublin. Along with his colleagues, Dr. Farrell is involved in the running of the Dublin Brain Bank and The National CJD Surveillance Centre at Beaumont Hospital.

Professor Tim Lynch, Chief Academic Officer Ireland East Hospital Group, Vice Principal Health Affairs UCD, Consultant Neurologist at the Mater Misericordiae University Hospital (MMUH) and Beaumont Hospital, Director of the Dublin Neurological Institute at the MMUH and Professor of Neurology at University College Dublin (UCD) and Clinical Investigator at the Conway Institute, UCD.

Professor McElvaney (who chaired the meeting) introduced the speakers and highlighted the concern of all involved in healthcare research and delivery,  regarding the Health Research Regulation legislation   introduced  by the Department of Health for the implementation of GDPR in Ireland and the associated issues, which led to the Academy commissioning the paper which is the subject of the meeting. He also committed the Academy to a leadership role in having these issues resolved to protect the future of healthcare research in Ireland and ensure that the optimum standard in clinical service delivery is maintained.

Mary Kirwan reviewed the intent of GDRP regulations regarding health research. She assessed outcomes for health research in Ireland as a result of the Department of Health’s implementation of GDPR and compared how other jurisdictions successfully implemented GDPR without placing its entire health research infrastructure at risk. Finally, she proposed the appropriate actions that could be taken in Ireland, within the existing legislative framework, to ensure full compliance with GDPR and protect and maintain a successful health research environment.

GDPR identifies the importance of scientific research across Europe and carves out specific exemptions for research. Article 81 and 83 are designed to be supportive of health-related research. Its intention is not to impede research but to protect data subject rights and ensure a high level of transparency which the research community respects and welcomes.

In addition to GDPR requirements of fairness, lawfulness and transparency; purpose limitation; data minimisation; accuracy; storage limitation; security and confidentiality the HRR applies a mandatory GDPR consent standard to the conduct of research. No other sector has had this additional requirement imposed on it, including the technology sector.

A GDPR standard of consent is exceptionally high and the research community’s concern is that it is difficult to achieve in a health context, primarily due to the power imbalance which exists between healthcare provider and the patient.

The European Data Protection Board (EDPB) in its Opinion 3/2019 on Clinical Trials provides the following as an example of power imbalance where consent is not considered “freely given”;

“….. when a participant is not in good health conditions, when participants belong to an economically or socially disadvantaged group or in any situation of institutional or hierarchical dependency.”

This example relates to most health situations.

The consequence of getting a GDPR consent wrong is significant and includes the upper end of regulatory sanctions, fines, civil litigation and reputational damage.

It is important to note that a GDPR standard consent is not a requirement for conducting scientific research under the General Data Protection Regulation 2016.  Significantly the approach to consent and research that has been taken by Ireland appears to diverge from other EU Member States.

Mandatory GDPR consent has not been applied in the UK with the implementation of the Regulation. Instead, the use of health information for the purpose of research is regulated separately to data protection law. The UK regulates the common law duty of confidentiality by way of a consent waiver granted through the Confidentiality Advisory Group. While Ireland seeks to replicate this model with the introduction of the Health Research Consent Declaration Committee, it has in fact been set up on a different legal and statutory footing which is proving central to the problems arising for the Irish research community.

Meanwhile Germany takes full advantage of the allowance made under GDPR for scientific research  and applies a considerably less burdensome approach to GDPR.

It is important to draw from the example of the US and learn from how the enactment of a similar “data protection type consent” requirement 15 years ago had a serious and negative impact on research.

The Health Insurance Portability and Accountability Act (HIPAA)Privacy Rule was implemented by the U.S. Department of Health and Human Services (HHS) in April 2003. It regulates informational privacy of health data in addition to common law.

It introduced a prescriptive “Authorisation”, or “Privacy Rule”, requirement in addition to the common law consent requirement. This is similar to the Irish legislative approach. In saying that the Privacy Rule is however not as burdensome in terms of the conditions it sets out for obtaining consent, only applies to publicly funded bodies and identifiable information.  Non-compliance is also highly punitive.

Much research has been conducted into HIPAA’s impact and some of the findings are: reduced patient recruitment, increased selection bias, reduced representation of women and minority groups, increased the costs of conducting research by requiring more paperwork, multisite trials became more difficult because of variations in interpretation of the law, and researchers abandoned important projects because of the increased number of rules and costs for operating a research study.

Unfortunately, similar impacts are currently being experienced in the Irish context since the commencement of the HRR. Of particular issue are historic data bases, biobanks and legacy or ongoing research which commenced in advance of the HRR and the explicit GDPR consent requirement.

15 years on from its implementation and the Department of Health and Human Services is seeking to revise and reform HIPAA Privacy Rule in 2019. Some of the proposals for revision have been exempting retrospective chart review from the Privacy Rule; aligning Privacy Rule with Common Rule (or the common law standard of consent); allowing the disclosure of data without consent with appropriate protections similar to direct care and treatment.

Consequently, GDRP consent as proscribed by the new Department of Health is unworkable given the range of criteria required to be met to obtain consent and the process by which consent must be given. In addition, as can be seen from the experiences in another jurisdictions of a similar regulatory regime referred to above, the new regulations will not achieve the required outcome.  Instead it will create an extremely restrictive data access environment which places existing and future health research in Ireland at great risk with consequent implications for patient care and the healthcare industry.

Professor David Smith   highlighted the problem with HRR and retrospective chart review with consequent implications for health research.  With HRR there is explicit consent required from the patient. This can be difficult to obtain and contacting patients repeatedly to review their old medical records is inefficient and intrusive to the patient. Furthermore, some hospitals have incorrectly interpreted this to pause audit based upon chart review. The DOH have set up a Consent Declaration Committee where the researcher can apply in exceptional and rare circumstances to review charts without explicit consent from the patient. It is likely that this committee will cope with hundreds of requests from multiple hospitals around Ireland when chart review is needed to ensure best clinical academic care and research. In that context this will lead to a potential cessation of a significant amount of health research with consequent impact on new healthcare treatments, practices and procedures.

Professor Michael Farrell highlighted the issues surrounding biobanks and other historical data repositories. He referred to the   letter Faculty of Pathologists in Ireland expressing their grave concern that pathology tissue banks and other biobanks will unused as explicit consent will be required for future research on stored tissues. this will be difficult as many tissues stored will be from patients who have died and often patients will not wish to be recontacted again and again each time the sample is to be reviewed. He also referred to the serious impact on the development, management, administration of health  research in the future and how the new regulations could significantly impact the initiation of new research and diminish the  of Ireland to attract local and international investment which is such an essential element of the health  research environment.

Professor Tim Lynch highlighted the role of academic medicine in the future development of healthcare and emphasised the importance of ongoing teaching, research and innovation in Healthcare. He gave  examples how the new regulations  threatens future teaching (How would he be able to use the more than  5000 existing videotapes of patients with neurological disorders in future teaching if he needed to obtain an explicit consent for different uses?), research (chart review and biobanks use will be impossible unless explicit consent done and repeated for different use) and innovation (development of new initiatives and innovations will be hampered if the research pipeline dries up).

Public meeting organised by the Irish Academy of Medical Sciences – 8th April 2019 Cheyne Lecture Theatre, RCSI, 123 Stephens Green Dublin 2.

GDPR: an impediment to research?

The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland’s Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

In this context the Irish Academy of Medical Sciences commissioned a review as to what exactly is proposed by Europe’s GDPR and by Ireland’s Health Research Regulations, to ascertain the challenges presented to clinical researchers, highlight those areas which need clarification by the Department of Health and by the Data Protection Commissioner and to propose specific recommendations which would ameliorate some of the more restrictive impositions of these regulations.

This review has now been published as a paper in the Irish Journal of Medical Science and the Academy has scheduled a public meeting in the Cheyne Lecture Theatre, Royal College of Surgeons in Ireland, 123 Stephens Green at 6.30pm on Monday April 8th, 2019 to disseminate and highlight the paper’s findings and recommendations and enable input and response from all interested parties. This will help to define and determine the most appropriate actions to be taken to address this significant challenge to the provision of optimal patient care, successful clinical research and the potential social and economic which accrues from both

Programme

Speakers include:

Professor Gerry McElvaney – Professor of Medicine, Head of Department of Medicine and Respiratory Researcher Division, at Beaumont Hospital, Dublin, Royal College of Surgeons in Ireland. President Irish Academy of Medical Sciences

Mary Kirwan – Barrister- at -Law and RCSI lecturer specialising in Health Law. She is legal advisor to a number of academic and hospital Ethics and Research Ethics Committees. She also lectures in Kings Inns and the Royal College of Physicians Ireland in Healthcare Law.

Professor David Smith is Associate Professor of Healthcare Ethics in RCSI and Director of the MSc in Healthcare Ethics and Law in RCSI and RCSI-MUB Bahrain. He lectures in Trinity College Dublin, University College Dublin, the Royal College of Physicians and Hibernia College. He is an ethics consultant to a number of healthcare systems in Ireland and was a member of the Irish Council for Bioethics.

Professor Michael Farrell, has worked at Beaumont Hospital as Consultant Neuropathologist since the hospital opened in 1987. Prior to that, he worked at the Richmond Hospital, having joined that institution in 1984. He is a teacher in the Royal College of Surgeons in Ireland and has extensive research collaborations with neuroscience researchers at RCSI and Trinity College Dublin. Along with his colleagues, Dr. Farrell is involved in the running of the Dublin Brain Bank and The National CJD Surveillance Centre at Beaumont Hospital.

Professor Tim Lynch is a Consultant Neurologist at the Mater Misericordiae University Hospital (MMUH) and Beaumont Hospital. He is also Director of the Dublin Neurological Institute at the MMUH and Professor of Neurology at University College Dublin (UCD) and Clinical Investigator at the Conway Institute, UCD. Chief Academic Officer, Ireland East Hospital Group

Schedule:

6.30pm- Professor Gerry McElvaney- Welcome and Introduction to Public Meeting

6.40pm -Mary Kirwan BL – Consent GDPR and HRR – A case for removal?

6.50pm- Professor David Smith- Capacity and Retrospective Chart Review

7.00pm- Professor Michael Farrell- Impact of HRR on Pathology Based Research

7.10pm- Professor Tim Lynch – Implications of HRR on health research in Ireland

7.20pm- Panel Discussion/ Q & A

8.00pm- Closing remarks – Professor Gerry McElvaney


Irish Academy of Medical Sciences meeting to initiate actions to address the crisis in medical staffing in Irish Healthcare.

As you are aware there is an obvious and increasing crisis in the availability and retention of medical staff in Irish healthcare.  In that context, the Irish Academy of Medical Sciences is undertaking a series of activities to ensure that the necessary urgency is given to addressing what is one of the most significant challenges facing the health service.

A major focus of these activities will be the identification of actions and initiatives to create an environment which will ensure that a resolution of this crisis is successfully achieved.

The initial step will be organisation of a major meeting which will involve representation from all who are impacted upon by the lack of medical resources. The meeting  will take place on

Wednesday 8th March 2017 at 19.00, in the Cheyne Theatre, Royal College of Surgeons, 123 St Stephen’s Green, Dublin 2.

The meeting will consist of formal presentations to be followed with a moderated open forum to provide for interaction, participation and input for all attending.

Topics to be included in the formal presentations will include:

  • Reports on the current situation within clinical service provision and the impact of the lack of clinical resources
  • Reviews of previous proposals to address these problems
  • Reviews of implementation of these proposals
  • Identification of  issues and areas which inhibit a  resolution of the crisis
  • Necessary actions to eliminate or minimise the inhibitors of a successful resolution of the crisis

Speakers providing formal presentations are:

Professor  Brian MacCraith, President DCU, Chairperson of Strategic review of medical training and career structure

Professor Eilis McGovern, National Programme Director for Medical Education, Medical

Education and Training Unit, HSE

Professor Ruairi Brugha, Head of the Department of Epidemiology and Public Health Medicine, RCSI

Dr Ciara Gough, NCHD, Specialist registrar, Pulmonary medicine, Beaumont hospital

Professor Noel G McElvaney, President of Irish Academy of Medical Sciences, Professor of Medicine RCSI

It is intended that the deliberations and the outcomes from the meeting, in addition to providing input to support the Academy’s actions in addressing this crisis, will also be widely disseminated.

Annual Scientific Symposium 2015

The Irish Academy of Medical Sciences’ Annual Scientific Symposium will take place on Tuesday 1st December 2015 in the Albert Lecture Theatre, RCSI, St. Stephens’s Green, Dublin 2.

The theme for this year’s Symposium is

“Ireland as a world class centre of excellence for clinical research – Opportunities, issues and challenges”

Morning Session  (09.00 -12.50) The environment for clinical research in the context of the current and planned governance, strategy, management and delivery of Irish healthcare.

Afternoon Session (13.45 – 15.45) Enabling the optimum environment  for  clinical research in Ireland

See below for complete speaker schedule

The Symposium is complimentary and as spaces are limited,   pre-registration is strongly recommended.

You can pre-register by  e mailing your name, work address, contact telephone number and e mail address  to ghurl@iams.ie:

 Programme

09.00 – 09.10:  Welcome – Professor Noel G. McElvaney, President, Irish Academy of Medical Sciences

09.10 – 09.35:   Mr. Dermot Mulligan, Assistant Secretary for Innovation and Investment,   Department of Jobs, Enterprise & Innovation

09.35 – 10.00:   Dr. Graham Love, Chief Executive, Health Research Board

10.00 – 10.25:   Dr. Rebecca Cramp, Scientific and Regulatory Affairs Manager, Irish   Pharmaceutical   Healthcare Association

10.25 – 10.50:   Mr. Muiris O’Connor, Assistant Secretary for Research & Development and Health   Analytics, Department of Health

11.00   – 11.30: Tea/Coffee

11.30 -11.55:   Professor Orla Hardiman, Professor of Neurology, Trinity College Dublin

11.55– 12.20:  Dr. Colm Gilligan, Medical Director, MSD Ireland

12.20 – 12.45:  Mr. Thomas Lynch, Chairperson for the Dublin East Hospital Group

12.45  – 13.45:   Lunch

13.45 – 14.10:   Professor Arnold Hill, Head of School of Medicine\Professor of Surgery, Royal College of   Surgeons in Ireland

14.10 – 14. 35:   Professor Michael Gill, Clinical Director, Wellcome Trust/HRB CRF St. James’ Hospital   Trinity Centre for Health Sciences

14.35 -15.45   Academy Working Groups  – Updates and feedback

  • “The establishment of the optimum data & information environment for   Healthcare in Ireland” – Presented and facilitated by Professor Elaine Kay, Professor of Pathology  &   Consultant Histopathologist,  Royal College of Surgeons in Ireland
  • “The establishment of the optimum ethical environment for Healthcare Research in   Ireland” – Presented and facilitated by Professor David Smith, Professor of Health Care Ethics Department of General PracticeRoyal College of Surgeons in Ireland
  • “Clinical Trial Research: Value to Ireland” – Presented and facilitated TBC

Potential implications for Research Funding arising from the European Commission’s proposal in regard to the European Fund for Strategic Investment (EFSI)

The Academy has written to the Minister for  Health and the Irish MEPs  to draw their  attention to the implications of the European Commission’s proposal in regard to funding the European Fund for Strategic Investment (EFSI)

The European Commission proposes to cut €2.7 billion from Horizon 2020 to finance EFSI. This equals a cut of 3.5% to an EU programme that already has one of the smallest budgets – yet research has a vital part to play in keeping Europe healthy and competitive. Investment in the European Research Council (ERC), one of the most important funders of excellent basic research, the Marie Skłodowska- Curie Actions,that support early-career researchers, and researchers’ access to infrastructure across Europe would all be cut.

The Academy notes the European Commission’s intention is for EFSI to also fund research projects. However, there is no formal obligation in place to ensure funds taken from Horizon 2020 is channelled back into research and innovation and it is  concerned that many organisations that conduct research – including universities, research funders, research performing organisations, charities and health services – may not be eligible for EFSI funding under the proposed wording. There is therefore a real danger of funding agreed to be for research being diverted to other purposes. EFSI is supposed to be of great benefit to the real economy. This is of great concern because research is a prerequisite for innovation, without research the pipeline to innovation is cut off. Research must be publicly funded in an appropriate way and any cuts to Horizon 2020 will result in a performance loss for the whole European research and innovation system.

Europe needs long-term, reliable and adequate funding for excellent research by the EU to deliver sustainable growth and jobs and improve the health of people living in Europe. Accordingly, in response to the European Commission’s proposal for funding the EFSI, the Academy is requesting that all Irish MEPs and the Irish Government, swiftly and assertively take steps to protect investment in Horizon 2020 and so in Irish research.

In particular the Academy has requested the Government and MEPs   to support:

  • A reversal in the cuts to Horizon 2020.
  • A formal guarantee that adequate funding in EFSI is channelled directly   into research and innovation to ensure that money committed to fund    research is not diverted to other purposes.

•           A prerequisite that funding to research and innovation projects will be   allocated competitively and on the basis of excellence

Federation of European Academies of Medicine  (FEAM) Symposium  13 May 2015, Paris: “Adolescent health: investing in the future”

Singer-Polignac Foundation, 43 Avenue Georges Mandel, 75116 Paris, France

This Symposium will explore adolescence as an important gateway to adult diseases and the focus will be the topical issues of adolescent mental health and obesity. Leading biomedical experts from across Europe will present and discuss the current scientific evidence in terms of health promotion, disease prevention, and the evaluation of genetic and environmental risk factors.

It is organised by FEAM and the French Academy of Medicine with the support of FAM(Foundation of the French Academy of Medicine) and the Singer-Polignac Foundation

Further information is available on the FEAM website – http://www.feam-site.eu/cms/

2014 Annual Scientific Symposium.  – “Clinical Trials – Now and in the Future”  

The Academy’s Annual Scientific Symposium   was held on Friday 21st November in the Albert Lecture Theatre, RCSI, St. Stephens’s Green, Dublin 2.

The symposium  featured National and International speakers with important contributions on Symposium’s topic, addressing  the current key issues in responding to  this  ever more important aspect of academic work in Ireland.

These included:

  • How Clinical trials are impacted by Ireland’s policy on science funding
  • Ethical and legal implications of current and proposed National and European legislative changes
  • The harmonisation of the regulatory environment on the protection of personal data in the EUī
  • Using research findings to inform and influence policy
  • The implications of new technologies and information environments on the conduct of Clinical Trials

Speakers  included:

  • Dr. Graham Love – Chief Executive, Health Research Board (HRB).
  • Professor Bernard Charpentier, Vice President, Federation of European Academies of Medicine ( FEAM).
  • Gillian Vale – Chief administrator, Medical Ethics, Beaumont Hospital, Dublin.
  • Prof. Garret FitzGerald, University of Pennsylvania, USA.
  • Dr. Andy Brown, Global Head, Clinical trials of the future, Novartis, Basel, Switzerland.
  • Professor Padraic Fallon, Trinity College Dublin.
  • Dr. Mark Taylor, University of Sheffield, UK.

 For Programme and speaker profiles  see Events section

The Executive of the Academy has decided on a number of actions and initiatives to support its functions and activities. These include:

The appointment of an Executive Director with responsibility for the corporate executive function of the Academy 

Key functions of the Executive Director are:

  • All administrative and executive services and supports to the Council and Fellows of the Academy.
  • To oversee and effect the management and operation of the Academy
  • Develop and implement strategic, long-term, business, operations and budgetary Plans of the Academy as directed by the Council.
  • Assure legal and fiduciary probity of the Academy in all its operations.
  • Promote the objects and activities of the Academy.
  • Maintain a members Register for the Academy.
  • Represent the Academy in its administrative dealings with third parties.
  • Act as the Accounting Officer of the Academy.

New management and organisational arrangements:

Initial actions are the establishment of an executive sub group of the Academy’s Council consisting of the President, Secretary and Treasurer, with the Executive Director. It will meet as a minimum on a monthly basis, the full Council to meet as a minimum every two months

The development of a medium term work program as the basis for a formal    strategic and business plan for the Academy.

The work program has as its initial actions:

  • The development and implementation of strategies and plans for achieving the Academy’s objectives, the formulation of policies and the availability of reference resources to support its roles and functions.
  • Actions to create awareness and recognition for the Academy’s roles and functions
  • The determination of    priority activities in the context of resource availability,   their potential to support early success and underpin promotion and recognition for the Academy
  • Define and prioritise a range of potential policy issues
  • Develop high level summary   statements for each of the priority issues identified
  • Determine which of the priority policy issues would be the most appropriate for the production of a detailed and formally commissioned/ published report
  • Establish a time table of realisable deliverables

Appointment of Executive Director

The Academy has appointed Mr. Gerard Hurl as Executive Director. Gerard was HSE National Director of Information Communication Technology (ICT) prior to taking up his position with IAMS, previously project Director – ICT Convergence Project – Dublin Academic Teaching Hospitals (DATHs) and Director of ICT at the Mater Misericordiae Hospital Dublin. He is Secretary General of the EuroRec Institute, Vice Chairman of ProRecIreland, and past Chairman of the Healthcare Informatics Society of Ireland.

One of the most important aspects of his remit over the next number of months will be to meet with all the Fellows and determine how best to invigorate the Academy and make it more pertinent to the Academic lives of its members.