Proposal for HIQAs role as Ethics Committees Supervisory Body (under the clinical trials legislation)

Grace Cunningham Research Ethics Manager Health Information and Quality Authority

12 March 2013

Draft plan for role of Authority as Supervisory Body of RECs under the clinical trials legislation Draft plan only stakeholder feedback being sought at this stage Various models of research ethics governance analysed There has been some consultation on the draft plan to date with the Department of Health, the Irish Medicines Board, the Research Ethics Advisory Group and with the 13 Recognised Committees

Overview of legislation relating to clinical trials

A.

Existing clinical trials legislation

Statutory Instrument (SI) 190 of 2004 transposed European Directive 2001/20/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 Clinical Trials (repealing 2001/20/EC Directive)
Timeline for implementation 2016 HIQA to commence preparatory work during Transition Phase

Two phased plan

Because the clinical trials legislation is now expected to 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 an amending 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

Overview of legislation relating to clinical trials

A.

Existing clinical trials legislation

Statutory Instrument (SI) 190 of 2004 transposed European Directive 2001/20/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

Transition Phase

C.

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

Phase 2

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 during transition phase Co-operation / info sharing between RECs and HIQA HIQA to track applications HIQA as point of contact for communication between RECs & IMB

Preparing for the Transition Phase with the existing 13 Recognised RECs Authority to engage and collaborate with each of the 13 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. the 13 RECs will automatically be recognised by HIQA initially)
with provision for HIQA to subsequently revoke recognition as provided for in the existing legislation

Process map of Transition Phase

Phase 2 - overview
In order to meet the requirements of the new Regulation (particularly the short timelines and close collaboration required between the REC and the IMB), the Authority is proposing to establish and provide administration for a single national REC to review clinical trials (eventually replacing the existing 13 RECs). NOTE: The proposed national REC for clinical trials would not be composed of staff of the Authority The current legislation states that the Supervisory Body may establish a REC

Phase 2 overview (continued)

Phase 2 has not yet been scoped in detail. However, the following are some main points in relation to the general plan for Phase 2: the Authority (potentially using an appointing panel) will establish a pool of ~ 40 individuals from whom an appropriately constituted committee can be established on a ~ weekly basis it is hoped that the expertise on the existing committees will 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.

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 development of an information system (portal) for clinical trials, in collaboration with Member States Potential developments discussed at recent EFGCP meeting include a European-wide system for accreditation of sites and investigators

Next Steps
Receive feedback from stakeholders on the draft two-phased plan Continue meetings with the Department of Health in relation to content and timelines of forthcoming legislation Continue meetings / collaboration with the IMB Continue participation in relevant national and European meetings and workshops Collaborate with each of the 13 recognised RECs Develop the necessary IT functionality to support proposed model Enactment of Statutory Instrument - go-live Transition Phase Prepare for Phase 2

Please note that this proposed model relates to clinical trials only and does not include other research at this time

However, it is expected that HIQA will take on a regulatory role in research ethics in relation to other health and social care research involving human subjects, under the Health Information 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 research involving medical devices (currently awaiting clarification from 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 need to be given by an approved REC this could potentially be a HIQA-approved REC.

Questions/Comments?
Feedback on the Authoritys draft 2-phase plan sought from all stakeholders.
Please submit comments to researchethics@hiqa.ie by 8 April 2013