Proposal for HIQA’s role as Ethics Committees Supervisory Body (under the clinical trials legislation)

7/28/2019 Proposal for HIQAs role as Ethics Committees Supervisory Body (under the clinical trials legislation)

1/14

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


2/14

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


3/14

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


4/14

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


5/14

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


6/14

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


7/14

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


8/14

Process map of Transition Phase


9/14


10/14

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.


11/14

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


12/14

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


13/14

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.


14/14

Questions/Comments?

Feedback on the Authoritysdraft 2-phase plan sought from all

stakeholders.

Please submit comments to

[email protected] 8 April 2013

Documents

Proposal for HIQA’s role as Ethics Committees Supervisory Body (under the clinical trials legislation)