Introduction to Research Introduction to Research Governance for NHS Governance for NHS

Research Research

Session ObjectivesSession Objectives

Introduction of the Research Governance Framework.

Awareness of what is required by the Research Governance Framework.

Be informed regarding the process for obtaining Research Governance approval.

AgendaAgendaDefinition & history of Research

Governance Framework.

What is it?

What is involved?

Where to get further information

Research Governance Framework Research Governance Framework The DefinitionThe Definition

“Research Governance improves research quality and safeguards the public by:

Enhancing ethical and scientific quality,Promoting good practice,

Reducing adverse incidents and ensuring lessons are learned,

Preventing poor performance and misconduct”

History History Research Ethics Committees in use since 1966

– direct response to WWII atrocities.

Research Governance implemented in 2001 – direct response to Bristol and Alder Hey investigations into retained organs scandals.

Both Ethics & R&D approval need to be obtained before research commences

What is Research Governance?What is Research Governance?

A framework in which approval from an NHS Trust (Acute or PCT) and Ethics Committee is sought to undertake research within that Institution.

What is Involved?What is Involved?Peer review.

Ethics Committee approval.

Data Protection

Staff Contracts.

Indemnity

Financial Probity

Dissemination of Results

Peer ReviewPeer Review

All proposals must be subjected to review by experts in the relevant fields able to offer independent advice on its quality.

For many student research projects the university supervisor may provide an adequate level of review.'

In all cases, researchers should check local requirements.

Research Ethics Committee Research Ethics Committee ApprovalApproval

Create a user account with COREC

Complete online Ethics Committee application form – COREC website.

Single centre study - parts A, B & C

Multi centre study –parts A & B and a part C for each centre.

Research Ethics Committee Research Ethics Committee ApprovalApproval

Send COREC form electronically to REC within 4 days of booking REC submission!

Send signed hard copy of form, research protocol and CV’s to REC.

You will be sent a letter of receipt of your application and invited to attend the meeting.

Research Ethics Committee Research Ethics Committee ApprovalApprovalAfter meeting you will receive a letter stating

whether you have approval / conditional approval or rejection of your project.

NB – Both Ethics & Trust approval are conditional upon you obtaining approval from the other party!

Data ProtectionData ProtectionData Protection Act (DPA) 1998 has

strengthened the rights of patients to privacy of their personal information.

The DPA only relates to live patients and not deceased.

The Act does not relate to anonymised data.

It applies to manually held records as well as electronic records.

Data ProtectionData Protection

Patient identifiable data must be held securely.

Electronic data must be password protected.

Identifiable data must not be stored on PC hard drives/laptops.

Staff Employment Contracts Staff Employment Contracts

Everyone involved in research within a Trust or PCT involving patients, tissues or samples, or identifiable patient/staff data must hold a substantive or honorary contract with NHS Organisation.

Health and security clearances (CRB checks) are required. 

Staff Employment ContractsStaff Employment Contracts

Employees from organisations outside the Trust cannot access patients, identifiable tissues, samples or data unless they hold an honorary contract.

Indemnity Indemnity

All staff holding a contract with an NHS Trust/PCT are covered by CNST insurance for negligence.

Financial ProbityFinancial Probity

Use of Public Funds for research demand financial probity – rules set down by H.M. Treasury.

Local signatures or checks may be required by R&D Dept relating to research funding – check locally.

Dissemination of ResultsDissemination of Results

All NHS research to be registered on the National Research Register – publicly accessible database.

Results of research MUST be published and disseminated to wider audience.

Research is not ethical / justifiable if results not published.

Where do I start – R&D Approval?Where do I start – R&D Approval?Trust R&D Office will require a copy of parts

A, B & C of the Ethics application form plus the national NHS R&D form.*

NHS R&D form is accessed via COREC web account.

Internal signatures/authorisations will usually be required*.

*Check local R&D Office requirements

The Application ProcessThe Application Process

Apply to Trust R&D & REC in parallel.

Contact local R&D Dept as soon as possible to discuss local requirements for R&D approval.

Remember – Both Ethics & Trust approval are conditional upon you obtaining approval from the other party!

ReportsReports

A project report must be sent to the REC annually and/or at the end of the project whichever is soonest.

Trust R&D Offices monitor a random 10% sample of research projects.

Inform R&D Dept when project has completed.

Issues affecting Student Issues affecting Student ResearchResearch

Who is the sponsor?

– Usually will be Co-Sponsored by the University & Trust.

Who is the Chief Investigator

– Your supervisor.

The Warner Report 2005The Warner Report 2005The “Warner” Report published 2005 made

recommendations for the re-organisation of REC’s.

It is proposed that Student projects will not be required to go to full REC but are reviewed by new National REC Advisors.

The consultation on the Implementation Plan for the recommendations of the Warner Report closed 21st April 2006

ConclusionConclusionYou will need to provide evidence of peer

review – your supervisor will help with this.

Start early! Contact R&D & Ethics ASAP – full ethics approval can take up to 60 days.

Use Trust R&D contacts for advice & guidance through process.

Keep informed re progress of REC organisational changes.

Where to get more informationWhere to get more informationCentral Office for Research Ethics Committees

web site www.corec.org.uk

Department of Health Research Governance Framework www.dh.gov.uk

Local R&D Office

Your Supervisor!