5/16/19

1

Changes now and in the pipe line to support NHS/HSC research across the UK

Mary Cubitt Four Nations Compatibility Programme Manager

Sally DohertyOperational Lead for Northern Ireland

5/16/19

2

Working together

Four Nations Compatibility Programme• continuing to

streamline processes• to maintain

compatible health research systems across the UK

• to support cross border researchers

5/16/19

3

IRAS Form

• delivered 28 June 2018– e-submission for

DA led studies

IRAS Formoutcome• rolling out joined up

validation

5/16/19

4

UK Local Information Pack• consistent paperwork

across the UK• benefit to cross

border researchers• launches 5 June • guidance and

templates published in IRAS Help 15 April

• In future develop in IRAS

From 5 June 2019

• NHS/HSC SSI Forms removed from IRAS

• packs shared using standard templates

• commercial and non-commercial

5/16/19

5

Site Specific Information

submission in Northern Ireland

and Scotland

Local Information Pack

IRAS Form

Documents as part of IRAS submission

Localised Organisation Information Document

Outline Organisation Information Document

Statement of Activities for non-

commercial in England and Wales

What are the main changes?

Organisation Information Document

• replaces SSI Form in Scotland and NI

• replaces Statement of Activities in England and Wales

• applies to both commercial and non-commercial

5/16/19

6

Schedule of Events/SoECAT

• component part of non-commercial Local Information Packs

• clarity over cost attribution

Preparing for change

5/16/19

7

Preparing for change

5 June 2019

Guidance

SOPs

Support

Non NHS SSI Formoutcome• for CTMIPs and

Medical Device studies

• from 5 June being replaced by a simple non-NHS/HSC Site Assessment Form

• reviewed by REC

5/16/19

8

Study wide review standards -current position

• core UK study-wide review criteria, shared and accepted across nations since 2014

• updated for GDPR 2018

• national specific aspects undertaken in each nation

Study wide review standards - future• updated UK study-

wide criteria incorporating refreshed UK agreed study-wide aspects

• further strengthen consistency across Four Nations

5/16/19

9

Study wide review standards - how we get there

• stakeholder consultation – we need your views

• look out for request later in the year

Combined Ways of Working Pilot

• piloting combined MHRA and REC review

• one application• one set of queries• one outcome• Integrating study wide

review • Being ready for CTR

5/16/19

10

Ongoing IRAS development

• to accommodate the combined ways of working

• make more flexible for change

• update user interface• documents visible to

sponsors• respond to feedback

Quick round up of other UK wide activities

• Model agreements• GDPR• GAfREC• Radiation Technical

Assurance• Pharmacy Technical

Assurance• Amendments

5/16/19

11

UK Operational LeadsEngland: Alastair Nicholson Northern Ireland: Sally DohertyScotland: Joanne RodgerWales: Rossela Roberts

Review of HR Good Practice Resource Pack

Liz CooteHR Good Practice Project Lead

5/16/19

12

Background to HR Good Practice Resource Pack & Research Passport

• purpose: to minimise bureaucracy for those undertaking research in the NHS

• provides a streamlined approach for handling pre-engagement checks for those undertaking research in the NHS.

• implemented in UK 2009/2010

Other ArrangementsNHS to NHS ArrangementsResearch Passport System

HEI Substantive employees

Students carrying out research (no healthcare

placement)

HEI Employees with NHS honorary clinical contracts

(Clinical Academics)

Students on formal healthcare placements

HEI Students who are also employed by the NHS

NHS Substantive Employees

Trial Data Monitors

HR Good Practice Resource Pack

Commercial Research Staff

5/16/19

13

Phase 1 – Review • compliance with GDPR

• data minimisation

• transparency statement included

• released 4th April 2019

• moved from NIHR website to IRAS Help

Phase 2 – Detailed Review

• Four Nations Working group

• Issues with HR Good Practice Resource Pack

5/16/19

14

Workshop• group Sessions – mixed

• workshop topics

• experiences to date of HR Good Practice Pack & Research Passports

• feedback and recommendations

Workshop – Topics (1)

• general issues & concerns

• primary care & independent contractors

• recording information

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Workshop – Topics (2)

• causes of delays to RP/HRC/LoA

• cross border issues

• student research

5/16/19

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Liz CooteHR Good Practice Project LeadLiz.coote@nhs.net