Accessing the NHS for Research –NHS R&D Permissions

Jemma HughesR&D Manager

ABMU Health Board

Working with the NHS

• NHS R&D Office• Commitment to Research & Innovation

• R&D is recognised as a Quality Target

• University Health Board• Teaching Hospital• R&D is central to attraction and retention of high

quality staff

Purpose of Permissions

• NHS Clinical Indemnity• Patient Safety• Research Governance Framework• Sponsor• Impact on the NHS Service• Oversight of compliance with legislation & Good

Clinical Practice• Insurance & Contracts• External Researchers – Research Passports

Research Governance Framework 2009 states

“…Health care organisations’ duty of quality includes research governance…”

3.10.1 – RGF 2009 2nd Edition

The role of R&D

• Within the RGF, R&D is responsible:-– as care organisation– as a host site– as a sponsor– for monitoring and QA– Governance & Risk review– to review agreements and ensure indemnity is afforded to

the HB – to sign off studies

• All Research requires a Sponsor.

Sponsors may be:- – Commercial– Non-Commercial such as MRC(Medical Research Council)– Health Boards– Universities

• In-house Health Board trials are peer reviewed by our Joint University Medical School and HB Scientific Committee

• WWORTH(West Wales Organisation of Rigorous Trials in Health) adopt ABMU sponsored trials – or equivalent!

• Distinction between Sponsors and Funders

Applicable Legislation

• Medicines for Human Use (Clinical Trial) Regulations 2004

• Human Tissue Act 2004• Mental Capacity Act 2005• Data Protection Act 1998

• Your local R&D Office should be able to offer guidance.

Applying for NHS R&D approval and for Ethical Review - IRAS

IRAS Project Filter Page

IRAS R&D and SSI forms

Process to Permission

• IRAS• MHRA• REC• R&D – Centralised Permissions• Scientific Review• Research Passports• Contract Negotiation – consider minimum levels of

Indemnity for high risk studies, use model templates available.

R&D & Ethics submission process

All NHS R&D applications are submitted to and co-ordinated by the NISCHR PCU Central office in Powys

The aim is to streamline the types and amount of governance checks being undertaken across Health Boards

For multi-centre trials, ‘global governance’ checks are undertaken by the central team and ‘local governance’ checks are undertaken by Health Board R&D Depts.

For single centre studies, all checks will be continued to be undertaken by the local R&D Office

Electronic Transfer for IRAS REC submissions (not yet available for R&D or for REC substantial amendments) – all forms must be ready to submit before you call the booking line

For REC submissions, the IRAS form must be authorised electronically by your Sponsor rep, this does not apply to substantial amendments.

New Central Booking System for RECs – visit the Health Research Authority website – www.hra.nhs.uk

Timescales• NHS/Ethics have targets to Review & issue

permissions/opinions• For NHS R&D, the current target is 40 calendar

days in total between Global & Local checks• Ethics – must give an opinion within 60 days

from submission, unless eligible for proportionate review (14 days)

• Approach as early as possible• Contracts can be agreed ahead of submission –

use the model templates where possible

Contact

ABMU R&D Dept: 01792 704056Abm.rd@wales.nhs.uk

Thank you