Research Policy & Management RACD INTRODUCTION TO RESEARCH GOVERNANCE.

Research Policy & ManagementRACD

INTRODUCTIONTO

RESEARCH GOVERNANCE


• Why Research Governance• Research Governance Framework for

Health and Social Care• What do you need to do to get approval

for your research– Consultation– Sponsor– NHS R&D approval– Ethics

The plan for today


We’re all good people. Aren’t we?


Research Governance Framework for Health and Social Care


Scope…

“All research that is concerned with the protection and promotion of public health”


Ethics• Independent ethical scrutiny

Science• Independent scientific review

Information• Systems to protect IP• Access to research findings• Dissemination plan

Health & Safety• Adherence to regulations• Safety of all involved is paramount

Finance• Financial Probity• Sufficient insurance provision

Standards…

Quality Research Culture• Accountability• Openness• Honesty• Leadership


Roles and Responsibilities…

Submit proposals for ethical review Conduct research according to agreed protocol & in accordance with legal requirements Ensure participant welfare Record keeping Adverse Event reporting Dissemination of results

Assure of scientific quality of proposed research Ensure ethics approval obtained Ensure arrangements in place for management & monitoring of research

Promote quality research culture Ensure researchers understand & discharge their responsibilities Ensure independent scientific review Ensure research is properly managed & monitored

Authorises all research involving their patients, staff or facilities Ensure research meets standards of RGF Ensure ethics committee approval obtained Duty of Care to participants

PI & other Researchers

Sponsor

Employing Organisation

Care Organisation


• Duty of Care

• Sponsor required

• Independent scientific review

• Independent ethical review

• Defined responsibilities

….summary of key implications


Discuss Roles &identify ‘Sponsor’

Partner Consultation

Set up TMF

Secure Funding

Develop Protocol

Develop trial docs

Confirm Sponsor

EhicsHost

Organisation

Checklist

Begin

Approvals

Development

Consultation

Sponsor Approval

Set up

Research Idea

* Clinical Trial of an IMP only

The Research Governance Process

Finalise Trial docs

Finalise roles and contracts


What is the ‘Sponsor’?

A company, institution or organisation which takes responsibility for the

initiation, management and/or financing a research project


Applying to CU to act as ‘Sponsor’…

SPON form• is the registration form

•Research Governance Declaration

•To be signed by CI/PI. Confirms CI/PI is aware of RG requirements.

Research Protocol & Patient Info Sheet• provides details of project for Sponsor Risk Assessment / insurance

PI to complete and submit the following to RACD

SPON and declaration forms can be obtained at

http://www.cardiff.ac.uk/racdv/resgov/forms/forms-procedures-sops-and-guidelines.html


The Integrated Research Application System (IRAS):

• single system for applying for approvals for health and social care research in the UK

• enter information once• Uses filters to ensure questions asked and approvals

required are appropriate to the type of study• Retains familiar aspects of the NRES form system

ARSACGTACMHRA

Ministry of Justice NHS / HSC R&D offices

Research Ethics Committees Patient Information Advisory Group (PIAG)


What forms will be generated?

• Dependant on answers to filter questions

• Self populates from full dataset

• Common forms:–NHS REC Form–NHS R&D Form–NHS SSI Form

https://www.myresearchproject.org.uk/ELearning/IRAS_E_learning.htm


• Project has had Scientific Review– Submission for REC and NHS R&D

approval in parallel.

• Project has not had Scientific Review– Submission to NHS R&D first

I’ve completed my IRAS forms, where do I go next?


NHS R&D approval


NHS Trust R&D Office

Local Health Board

Obtain approval from the relevant host organisation…

use the Integrated Research Application System (IRAS), which is available at www.myresearchproject.org.uk

Complete R&D Form and NHS SSI From and send to each individual Trust R&D Office

Contact individual Trust R&D Office:

http://www.rdforum.nhs.uk/links/rdlinks.htm


Multi-Site Research

• All Wales Primary Care Research Management & Governance Office: Streamlined NHS Permissions Approach to Research – Cymru (SPARC)

• NIHR Coordinated System for gaining NHS Permission (NIHR CSP) – England only


• Submission to R&D Office

• Review by committee (usually monthly)

• Letter of approval / amendments

• Honorary contracts / Research Passport


NHS Research Ethics Committees


NHS REC application

Is the research project a clinical trial of an IMP?

Is the project taking place in >1 domain?

Is the project taking place in >1 site within

one domain?

Telephone CAS

Contact NHS REC but may apply via CAS

No

Contact your Local REC

No

No

Yes

Yes


Ethics Process…

• REC acknowledges application in 5 days• REC has 60 days in total to make a final decision on new

application• Investigators invited to attend meeting• Decisions available:

– Favourable– Provisional Favourable– Unfavourable


Further Information

http://www.cf.ac.uk/racdv/resgov/index.html

Chris Shaw – Research Governance Coordinator

Matthew Harris – Research Governance Officer

Nic Betty - Research Governance Admin Assistant

x79277

[email protected]

Research Policy & Management RACD INTRODUCTION TO RESEARCH GOVERNANCE.

Documents

research governance

research idea

research project slide

social care research

research governance

research cymru sparc

management andor

racd spon