Research & Development Directorate

Link to Trust website

Carrying out Research > Governance

In this section:  
 
Department of Health Guidance Good Clinical Practice
 
Human Tissue Act 2004 Maintaining Separate Clinical & Research Records
 
MHRA Inspections Peer Review
 
Public Involvement Research Passport
 
Responsibilities of Researchers
 

Department of Health Guidance
 
On nominating a consultee for research involving adults who lack capacity to consent
 

Good Clinical Practice
 

Knowledge of ICH GCP is essential for anyone carrying out clinical research. The guidelines can be downloaded here. Please also look at our CTIMP page if your study involves a medicinal product.

 
Mock Trial Master File
 
Information Governance in Health and Social Care Research
 
Trust SOPs for use in research
 
DH document on regulations relating to the retention of research records
 
MRC Ethics and Research Governance Library
 
Test your GCP Knowledge - to see which areas you need to brush up on, take the GCP challenge at http://www.pharmaschool.co.uk/gcpchallengeindex.asp
 

Human Tissue Act 2004
 
The Human Tissue Act 2004 came into force in April 2006.  The following are links to some useful guidance on practical implications of the Act:
 
Example Material Transfer Agreement
 
Presentation given by the Trust DI, Andrew Maines, on 18 October 2006
 

Trust SOPs 13-13f relating to the Human Tissue Act


Human Tisssue Authority Licence for South Manchester University Hospitals NHS Trust

 

Human Tisssue Authority Licence for Mycognostica Limited

 

Maintaining Separate Clinical & Research Records
 
Department of Health - Gateway Reference 11985 - 22 June 2009:
 

Maintaining Separate Clinical & Research Records

 

MHRA Inspections
 
Information relating to MHRA Inspections:
 

MHRA Inspections What To Expect

 

Pharmacovigilance

 

Peer Review
 

All projects must undergo independent peer review.  For own account studies there is a system available to all researchers in the North West.  See Peer Review NoW for full details.

 

Public Involvement
 

The NHS R&D strategy is committed to involving members of the public in the work it undertakes - not as "subjects" of research, but as active participants. Members of the public should be involved at all stages of the R&D process, including deciding what research should take place; commissioning and undertaking research; and disseminating the findings. When talking about "the public" we mean people who are:

  • patients and potential patients;
  • informal (unpaid) carers;
  • people who use health and social services.

As well as:

  • members of the public who may be targeted by health promotion programmes;
  • organisations that represent the interests of people who use health and social care services;
  • groups asking for research because they believe they have been exposed to potentially harmful substances or products, such as asbestos or pesticides
 
The North West Users Research Advisory Group provides information and advice on developing user involvement as a means of enhancing research performance.  For more information see their Information for Researchers.
 
Guidelines for involving the public in research from Involve.
 
People In Research aims to help members of the public make contact with organisations that want to actively involve people in clinical research.
 

Research Passport
The Trust forms part of the NHS Research Passport system, which means that if you have already been issued with a 'Research Passport' (honorary contract) by another NHS Trust you are not required to undergo the same pre-employment checks more than once.
 
If you already have a Research Passport, please send us a copy along with your CV and details of the projects you will be working on.

If you wish to apply for a Research Passport for the first time, please go to the Research Passport web page, where you will find an application form for completion, which you should then send to us here in the R&D Directorate (see address) along with any supporting documentation outlined in the guidance document.

 

Responsibilities of Researchers
UK Research Integrity Office : Procedure for the investigation of misconduct in research

The Research Governance Framework (RGF) outlines the responsibilities of individuals acting as principal investigators in a study, as well as members of the research team. A summary is available here.

The Trust also has a policy for Research Misconduct and Fraud.

 
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