Services

Research governance

 

How is Research Governance carried out in the Trust?

 

The Trust adheres to the Research Governance Framework (RGF) and works to the standards set in the document. At Alder Hey, Emma Masango, the Research Governance Officer who works in R&D Department, is your best source of information regarding research governance.

 

Responsibilities

 

As well as setting standards, the framework clearly sets out the responsibilities of all those involved in research - research participants, researchers, principal investigators, research funders, sponsors, universities and other organisations employing researchers, organisations providing care, care professionals and research ethics committees.

 

Clear agreements describing the allocation of responsibilities must be reached and documented before commencing a study, in order to comply with the framework.

 

Integrated Research Application System (IRAS)

 

IRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK. It captures the information needed for approval from MHRA, R&D, Research Ethics Committees and other reviewing bodies. IRAS is the entry point to the Co-ordinated system for gaining NHS Permission (CSP, below). IRAS can be found at www.myresearchproject.org.uk.

 

National Research Ethics Service (NRES)

 

Your research ethics application is made through IRAS, but information on the ethical review body can be found on the NRES website:  www.nres.npsa.nhs.uk

 

Co-ordinated System for gaining NHS Permissions (CSP)

 

In November 2008 IRAS became the entry point for the National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP).  CSP avoids duplication of paperwork and ensures research governance standards are met. CSP standardises and streamlines the process for gaining NHS Permission in England. This will reduce both approval times and bureaucracy.  Information on CSP is available at www.ukcrn.org.uk/index/clinical/csp.html

 

REC fast track review of minimal risk studies

 

In response to recommendations of The Report of the Ad Hoc Advisory Group on the Operations of NHS Research Ethics Committees the National Research Ethics Service (NRES) conducted an internal review of applications to Research Ethics Committees (RECs) which indicated there were many studies that carried no risk and would be no or minimal intrusion on subjects. NRES has explored the ethical dimensions of "fast track" review by shadowing suitable applications (around 40% of applications) in four RECs. The report shows that "fast track" is both feasible and suitable where there is minimal risk and no material ethics issues.  Based on these findings there will now be a pilot of fast track review in South London in early 2009.  The reports can be found on the NPSA website (National Safety Patient Agency) www.npsa.nhs.uk

 

 

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