NHS R&D Jessica Bisset Acting Research Operations Manager UH Bristol.

NHS R&D

Jessica BissetActing Research Operations Manager

UH Bristol

When do I need NHS R&D Approval?

If you are planning on carrying out your research on:

NHS premises

NHS staff

NHS patients

Then you will need NHS R&D approval.

*If your study is multi-site you will need R&D approval at each site where above applies*

For non-NHS sites, it is still the responsibility of the REC to undertake the site specific assessment – information on this is available on the NRES website.

http://www.nres.nhs.uk/applications/faq/after-applying/

SSA to SSI…

What was Site Specific Assessment?

From 1th April 2009 Site Specific Assessment (SSA) was transferred to NHS R&D offices.

Why? It made sense! Integrated into R&D governance reviews

Isn’t it duplication?

What we look for:

Local feasibility of the study running at our Trust.

SAFETY of our patientsAppropriate funding (we do not have a pot of money to support new research!)How is fits into our existing portfolio of studiesAppropriateness of research teamMonitoring arrangementsSupport departments ability to deliver the trialPatient population – success of the trial to time and target

Our risk assessment

Logistics of running the study All other appropriate approvals are in place – MHRA, HTA, GTAC etc.. Data protection issues (not only for patient safety but to protect the Trust

from financial penalties) Insurance/indemnity arrangements – NHSLA covers majority of NHS

lead research – would expect University insurance to be in place Local arrangements – emergency arrangements at Trust, interpreters

etc..

Not only assessing risk – looking at feasibility and facilitating the research happening at the Trust. We are here to help!

A:Select Missing Regulatory Documents Evidence of insurance Student Project (at home/supervisor)

NRES Approval Pharmacy Authorisation Plans for destruction/storage of tissue

MHRA CTA Labs Authorisation Other

MHRA No Objection (Device) Radiology Authorisation F: Research Team

ARSAC licence MEMO Authorisation Student Research

NIGB Approval Other Authorisation Inexperienced Researchers

GTACC Approval Other Documents Supervision Arrangements

Site Agreement C: Consent HCs/Passports Required

Funding Agreement No issues Conflict of Interest Identified

Material Transfer Agreement Participants Children Over-commited Research Team

HTA Licence Staff inexperienced in research consent in this patient group Team not all (ICH)GCP trained

REC/MHRA approval for any amendments Adults with Incapacity Inadequate Staff Resource

B: Select Missing Core Documents Participants particularly vulnerable Other

R&D Form Other G: Recruitment and Retention

SSI Form D: Study Type Recruitment targets/timelines unrealistic

Agreed Contract/Site Agreement IMP Recruitment targets not met in past

Material Transfer Agreement Device Over researched participant group

Protocol RCT Participants may have difficulty with compliance

CI CV Gene Therapy Competing Studies

PI CV Blinded May be difficult to recruit to

Research Team CVs Ionising Radiation H: Sponsorship and Contracts

Local PIS (departmental header and local details) Requires ARSAC No contract in place

Local Consent forms Proof of Concept/First in Man Model Agreement not used

Letters of Invitation Other Responsibility Delegation Unclear

Letter to GP/Consultant E: Data and Tissue Insurance Indemnity Arrangements

Any further patient related literature etc Outside Clinical Care Team Pharmacovigilance arrangements

Evidence of Sponsorship Identifiable data/ tissues sent outside Trust No site Monitoring

Evidence of funding Identifiable data/ tissues sent outside EU Concern about Study Design

H: Sponsorship and Contracts (cont) L: Any Other Risks Delivery sub-contracted to CTU

Our risk assessment

How to apply?

On IRAS:

When you create your project you will be asked to complete filter questions. How you answer these will determine the rest of the questions asked in the full data set and which forms are populated out of this.

You will therefore need to tick…

What do we need from you?

R&D form, SSI form and all local supporting documents to each R&D office.

When to submit..

DO not submit before contacting your relevant R&D office to talk through your research!

‘The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research…The aim is to increase the number of patients who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research…The Government’s Plan for Growth, published in March 2011, announced the transformation of incentives at local level for efficiency in initiation and delivery of research’ - National Institute for Health Research (NIHR)

As a Trust we are performance managed. We are required to submit quarterly data on our initiation and delivery of all of our clinical trials. We are also performance managed on our portfolio trials – and this data is collected every month.

*We are required to publish this performance data on our website and are at risk of incurring financial penalties if we do not show continuous improvement:

http://www.uhbristol.nhs.uk/research-innovation/our-research/performance/

Research benchmarks

Initiating clinical research:•Time taken from valid approval application received (in R&I) to First Patient First Visit. The target is 70 days.•Where 70 days is exceeded we have to produce valid reasons. These are reviewed by the NIHR

Delivering clinical research:•Whether the study is recruiting to time and target (taken off the SSI form).•Where study is not meeting time to target we have to produce valid reasons. These are reviewed by the NIHR.

Working with you..

When you have made initial contact with us we will allocate a member of staff to your study who will begin the risk assessment and will be your point of contact. They will guide you through the submission process and have continual conversations to work through the risks/issues with taking the study on at this Trust. Once issues have been resolved, all departments are on board/appropriate documentation have been submitted to us, contracts signed, financial aspects agreed then we will issue R&D approval!

There is no committee meeting like with REC approval. Therefore your study will be reviewed and worked through on a continual basis with your continual input until approval can be issued.

R&D contact lists:

This website provides useful links to acute Trusts across the UK and links to their R&D contact details:

http://www.rdforum.nhs.uk/070.asp?otype=TRUST

This website provides a list of the newly formed CCGs (replacing the PCTs):

http://www.england.nhs.uk/ccg-details/

This website provides information on the primary care research network:

http://www.crncc.nihr.ac.uk/about_us/pcrn

UH Bristol R&D contact details: [email protected]

0117 342 0233