Integrated Research Application System - IRAS

A single, integrated application system has been developed to simplify applying for approval or permission to conduct a piece of research in the Health Service. The system allows researchers to enter information about their study in one place and is designed to save time and effort by preventing duplication of information in separate application forms for each type of approval. PIAG supports the development of the new integrated research application system (IRAS); for more information, please see the IRAS website.

Download IRAS leaflet

Application form and guidance

Section 60 of the Health and Social Care Act 2001 guidance and application form intended for:

• Those wishing to obtain identifiable patient information;
• Data controllers who are asked to supply identifiable patient information;
  

Research Ethics Committees who are asked to advise on the ethical disclosure and use of identifiable patient information.
in circumstances where:

• Patient consent has not been obtained, and
  
• There is no other reliable basis in law to permit the disclosure and use of identifiable patient information

Guidance and application form

It should be noted that this guidance is not up to date and is currently being reviewed.
PIAG has agreed that research applicants should now use IRAS instead of the application form included in the guidance. Where applicants have already started to use the form then PIAG will continue to accept the form until the end of December 2008.

Application amendment process

Applicants wishing to amend any aspect of their application must notify the Secretariat. Typically, the types of changes made are to the data items requested, or extending the purpose of the activity to encompass an aspect not originally envisaged, or changes to the security arrangements. Notification may be made by email in the first instance.

Where changes are minor these will be noted and approved by the Secretariat. For significant changes, a revised application form should be submitted with the changes highlighted for ease of reference.

Supporting documents do not need to be re-submitted other than where they are relevant to the proposed changes. For example, where there are changes to the purpose then a revised protocol should be submitted; where the data is to be moved to another location, details of how the data will be transferred and stored securely as well as the policies for the new site should be submitted, where these are the same as before, this should be indicated.

Changes will be recorded on the Register of approved studies and published as appropriate.

Please contact the Secretariat if you have queries about proposed amendments.

Fast track application process

The fast track application process has been extended and now includes new categories. This document outlines the new process and types of application that are now eligible for consideration.

• in Portable Document Format (updated October 2007)
  
• in Word format (updated October 2007)

Other guidance

Download in Portable Document Format (except where otherwise stated):

• Handling questions of scientific validity (February 2007)
  
• The use of patient information in the Long Term Conditions programme (updated October 2008)
  
• Your health records: A patient information leaflet about the role of PIAG (February 2006)
  
• Information about patients: An information leaflet about the role of PIAG for Healthcare Professionals and Researchers (February 2006)
  
• Reports of inappropriate use of patient identifiable information: PIAG process for response to concerns raised by third parties
  
• Illustrative template (April 2005) for System Level Security Policy (SLSP) in Rich Text Format
  
• Annual review guidance for current approved applications
  
• User involvement guide (February 2006)
  
• Joint guidance with National Diabetic Retinopathy Screening on the use of patient information for the screening programme (July 2005)

UKCRC Regulatory and Governance Advice Service

The UKCRC has established a UK-wide Regulatory and Governance (R&G) Advice Service which provides support for those involved in health research (including non-portfolio studies). The R&G Advice Service aims to provide consistent and authoritative advice on a range of regulatory and governance issues.

The R&G Advice Service does this by providing:

• support for advice providers in NHS and University R&D offices; Medical Research Council employees; Topic-specific and Comprehensive Research Networks staff and Clinical Trial Unit staff without access to local R&D advice.
  
• a route for handling complex queries (via a web based application) e.g. those involving more than one regulatory issue.
• on-line resources such as
  
  
  • Toolkit
  • Question and answers
  • Consultations
  • Best practice guidance
  • Events and training
  • R&G news

The R&G Advice Service is supported by a network of regulatory and governance bodies (including [insert name of your organisation, e.g. MHRA]), which prioritise queries to the Advice Service in order to provide authoritative and timely responses.

The service is jointly coordinated by the UKCRN R&G Team and the MRC Regulatory Support Centre (RSC).

• Further informatikon on the UKCRC Regulatory and Governance Advice Service

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