UKCRC Regulatory and Governance Advice Service

UKCRC is leading on the development of a UK-wide advice service for people with queries about regulatory and governance issues and UKCRN is an integral part of that advice service. The UKCRN Regulatory and Governance team are currently working in collaboration with the Medical Research Council to establish this service.

Further information is available on the UKCRC website

The UKCRC R&G Advice Service provides support for local advice providers and a route for handling more complex queries such as those involving more than one regulatory issue. It also provides access to a range of web-based resources including tool kits and a Q&A site

This service is being set up with involvement from the following partners:

• NHS R&D Forum
• Medicines and Healthcare products Regulatory Agency (MHRA) Clinical Trials and Devices sections
• Patient Information Advisory Group (PIAG)
• Human Tissue Authority (HTA)
• National Research Ethics Service (NRES)
• Human Fertilisation and Embryology Authority (HFEA)
• Gene Therapy Advisory Committee (GTAC)
• Department of Health.

Why do we need an advice service?
There are a number of different sources of advice currently available and this can often cause confusion. It is difficult for regulators to advise on interpretation and there is a need to promote consistency across the research community whilst offering sound, authoritative and endorsed advice.

What are we aiming to achieve?

• Clear and accessible advice for all those involved in health research
• Guidance on good practice that complies with requirements
• Recognition and visibility as an authoritative source
• Timely and efficient responses

In time, the service will provide advice to researchers through NHS R&D expert centres in each Health Economy. The new NHS R&D Strategy, "Best Research for Best Health" and National Institute for Health Research website provide further details.

The UKCRN Regulatory Team and the MRC Regulatory Support Centre have developed and piloted the Advice Service for the UKCRC.