August Protecting the rights, safety, dignity and well-being of all actual and potential research participants. Promoting and facilitating ethical research Dr Janet Wisely Director National Research Ethics Service (NRES)

August Aim of Presentation Present recent management information for REC service Update on some key initiatives –National Research Ethics Advisers - Screening Pilots –Local Research Ethics Advisers- Flagged RECs –NRES structure-Training strategy –NHS service user perspectives- IRAS

August NRES Head Office - 25 RECs in England REC Co-ordinators CTIMPs Volunteers (REC Chairs and Members) Applications per year - 9,000 Registered users for ethics form - 65,000

August Research Ethics Committee (REC) Membership Volunteers: –54% REC members employees of NHS –57% REC meetings held out of hours –Significant preparation time for all REC membership data (2006) – broadly in line with census data

August Number of Applications 04-05, & & 07-08

August Number of CTIMPs & & 07-08

August Application Duration 1 August 2004 to 30 June 2007

August % UK Decisions by Type (October 2005 – March 2007)

August % UK Provisional Outcomes ( October 2005 – March 2007)

August NRES Head Office Re-structuring ongoing, new departments established Wider re-organisation within NPSA, NRES one division alongside the patient safety function and NCAS Each has Divisional Management Groups, reporting to a senior management team for NPSA NRES Head Office to move to Maple Street

August Training Strategy Priorities identified across the NRES departments – QA, Operations, Policy, Corporate Affairs Priorities agreed by NRES divisional management group Training delivered through Operations Training evaluated through QA

August Developments - Flagged REC system Legal flag – CTIMP recognition Long standing operational flag – prison research Visibly and practically link training to operation: –Medical devices –Human Tissue Bank –Mental Capacity Act Plus, student research, social science methodology and others

August NHS Service User perspective Advisory Group established – NRES (including REC community), INVOLVE, R&D forum. Chaired by NPSA Director for patient and public experience Two training events in October REC membership survey Exploring other issues to develop agenda

August Integrated Research Application System (IRAS) One study information form – Ethics, R&D, GTAC, PIAG, ARSAC Dataset managed by researcher and appropriate snapshot taken for particular submission Functionality to support management of dataset No dominant approval or dictated order for generation of new datasets Data transfer from existing ethics form and exploring import from other systems Issue for use and consultation – January 2008

August Integrated Research Application System Form development using NRES platform and therefore this element being taken forward by NRES, which is only one part of an overall IT agenda within ‘Best Research for Best Health’ Project structure includes reference group: – based (no actual meetings) –Used to test form and system before issue for use and consultation –Need new members please!

August “We are a good news story, but not everyone has realised it yet” Maintain and build on communications to REC community – Bulletin, From the Hub, Network Events, Road Shows Development of strategy for communications to researchers Increase public profile?

August Local Research Ethics Advisers Findings from early provision of advice pilot suggest further work is required to develop these roles and functions, to provide support to individuals and to ensure consistency Further work required to establish boundaries with others roles and responsibility within wider framework for research Implementation next year, but interim appointments to be made to support development of function and expansion of pilot Chairs honorarium to be paid until new structures in place

August National Research Ethics Advisers Role needs to be established within GAfREC to be effective, no current timetable for GAfREC version 2 Current thinking to establish roles to capture principles of non Executive representation on Board Appointments unlikely to be until next financial year, but work ongoing to establish and develop functions and further ‘interim’ appointments to be made

August Screening pilots – what have we learnt? Early provision of advice –Potential to make a difference, but –Need to be clear of role for NRES –Need to provide support and training –Need to determine resource required

August Screening pilots – what have we learnt? Fast track review –Potential to fast track –Demonstrated feasibility in principle –Significant numbers of studies that present no risk (at least to those involved to date--)

August Screening pilots, what can we do next? Acknowledge need to do a great deal of work to get buy in to the ethical framework Requires revision to GAfREC or DH agreement to run as a live pilot Requirements of scheme dependent on REC remit Pressure continues to be levied, particularly regarding student research and difficult to justify the ‘process’ for some studies

August GAfREC section 3.1 and review under section 3.2 Large volume of queries regarding requirement for review – locally and nationally, how consistent are we? Pilot has revealed studies being reviewed outside of remit – inadvertently or knowingly under 3.2

August Early Provision of advice – next steps To establish posts to provide central advice to support consistency locally A head office function in development, ultimately to be rolled out locally within the local research ethics advice function To widen pilot with new committees

August Fast track review – next steps To continue with existing ‘dummy’ scheme to test and develop the ethical framework To encourage wider debate on the framework for ‘No Material Ethical Issues’ – within REC community and also potential research participants To work up options for expansion of pilot – including proposals to DH for a ‘live’ pilot

August No Material Ethical Issues? Questionnaire issued in GP surgery (waiting room) asking what they knew about symptoms of heart attack. Optional to complete –Are there ethical issues? –Does it need 30 minutes of committee time to determine if there are ethical issues? –Could an informed individual (or two) make the decision? –Would potential research participants / NHS Service users / general public wish this to go through a system for committee review at cost of around £700?

August No Material Ethical Issues (2)? Study comparing range of motion achieved after knee replacement – bandaged straight vs bent. Peer review established there is uncertainty as to which is better

August National Research Ethics Service --Volunteer based and professional-- Thank you Questions?