proposal for hiqa’s role as ethics committees supervisory body (under the clinical trials...
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Proposal for HIQAs role as
Ethics Committees Supervisory Body
(under the clinical trials legislation)
Grace CunninghamResearch Ethics Manager
Health Information and Quality Authority
12 March 2013
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Draft plan for role of Authority as Supervisory
Body of RECs under the clinical trials legislation
Draft plan only stakeholder feedback being soughtat this stage
Various models of research ethics governanceanalysed
There has been some consultation on the draft plan
to date with the Department of Health, the IrishMedicines Board, the Research Ethics AdvisoryGroup and with the 13 Recognised Committees
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Overview of legislation relating to clinical trials
A. Existing clinical trials legislation
Statutory Instrument (SI) 190 of 2004 transposed European Directive2001/20/EC (this has since been amended with several amending SIs)
Minister of Health is Supervisory Body of RECs
B. Expected Statutory Instrument to amend the existing legislation
Transfer of role of Supervisory Body to HIQA Timeline for implementation of Statutory Instrument ~ Q3 2013
C. European Commissions proposal for a new Regulation on ClinicalTrials (repealing 2001/20/EC Directive)
Timeline for implementation 2016
HIQA to commence preparatory work during Transition Phase
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Two phased plan
Because the clinical trials legislation is now expectedto change twice over the next 3-4 years, the
Authoritys plan for clinical trials involves 2 separate
phases: Transition Phase - to begin with the Authority
taking on the role of Supervisory Body via anamending Statutory Instrument to the existing
legislation, and lasting ~18-24 months Phase 2 - to be in operation in advance of
commencement of the new Regulation
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Overview of legislation relating to clinical trials
A. Existing clinical trials legislation
Statutory Instrument (SI) 190 of 2004 transposed European Directive2001/20/EC (this has since been amended with several amending SIs)
Minister of Health is Supervisory Body of RECs
Transition PhaseB. Expected Statutory Instrument to amend the existing legislation
Transfer of role of Supervisory Body to HIQA Timeline for implementation of Statutory Instrument ~ Q3 2013
Phase 2C. European Commissions proposal for a new Regulation on Clinical
Trials (repealing 2001/20/EC Directive)
Timeline for implementation 2016
HIQA to commence preparatory work during Transition Phase
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Transition phase
This will be first legal remit for Authority in this area
Proposing a simple system initially:
13 RECs to continue to receive applications directly duringtransition phase
Co-operation / info sharing between RECs and HIQA
HIQA to track applications HIQA as point of contact for communication between RECs
& IMB
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Preparing for the Transition Phase with the
existing 13 Recognised RECs
Authority to engage and collaborate with each of the13 currently recognised RECs
Obtain information, e.g. REC composition, meeting schedules etc Prepare together for go-live with HIQA taking over role of
Supervisory Body
Provisional / transitional recognitions (i.e. the13 RECs will automatically be recognised by HIQAinitially)
with provision for HIQA to subsequently revoke recognition asprovided for in the existing legislation
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Process map of Transition Phase
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Phase 2 overview (continued)
Phase 2 has not yet been scoped in detail. However, thefollowing are some main points in relation to the generalplan for Phase 2:
the Authority (potentially using an appointing panel) willestablish a pool of ~ 40 individuals from whom an
appropriately constituted committee can be establishedon a ~ weekly basis
it is hoped that the expertise on the existing committeeswill be retained by encouraging current members to join
the pool the Authority will provide facilities and administrative
support for the committee meetings
the Authority will communicate with both the IMB and the
sponsor (where appropriate) on behalf of the REC.
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Further details of proposed Phase 2
Training and education sessions for REC members
Standard operating procedures (SOPs) to be developed
System for appeals to be implemented
System for site-specific assessments to be addressed
European Commission beginning process of developmentof an information system (portal) for clinical trials, incollaboration with Member States
Potential developments discussed at recent EFGCPmeeting include a European-wide system foraccreditation of sites and investigators
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Next Steps
Receive feedback from stakeholders on the draft two-phasedplan
Continue meetings with the Department of Health in relationto content and timelines of forthcoming legislation
Continue meetings / collaboration with the IMB
Continue participation in relevant national and Europeanmeetings and workshops
Collaborate with each of the 13 recognised RECs
Develop the necessary IT functionality to support proposedmodel
Enactment of Statutory Instrument -go-live TransitionPhase
Prepare for Phase 2
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Please note that this proposed model relates to clinicaltrials only and does not include other research at this time
However, it is expected that HIQA will take on a regulatoryrole in research ethics in relation to other health and socialcare research involving human subjects, under the HealthInformation Bill (except for research involving Medical
Devices) - the timeline for this is not yet known. It is also thought that HIQA could take on a role similar to
Supervisory Body in relation to RECs which review researchinvolving medical devices (currently awaiting clarificationfrom the Department of Health on if / how this could come
under the remit of HIQA). In the current draft of the Human Tissue Bill there is
provision that approval for research under the Bill may needto be given by an approved REC this could potentially be aHIQA-approved REC.
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Questions/Comments?
Feedback on the Authoritysdraft 2-phase plan sought from all
stakeholders.
Please submit comments to
[email protected] 8 April 2013