Research Governance concerns setting standards to improve research quality and safeguard the public. It involves enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring lessons are learned and preventing poor performance and misconduct.

model Clinical Investigations Agreement (mCIA) The model Clinical Investigation Agreement (mCIA) is designed to be used without modification for company-sponsored commercial research involving medical devices in patients in hospitals throughout the UK Health Service.

Versions of the mCIA have been developed to ensure compliance with the law in the relevant jurisdiction and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all versions of the Agreement.

The UKCRC recognises that ensuring efficient regulatory processes is a fundamental part of building a first class clinical research environment. The development of the model Clinical Investigation Agreement is another important step in this process, reflecting the breadth of issues that the UKCRC partners tackle together. The UKCRC Partners strongly advocate its use without modification. Useful links:

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The Research Governance Framework for Health and Social Care in Northern Ireland offers an opportunity to ensure that the research undertaken and supported is done so properly and sensitively; respecting the rights, dignity, safety and wellbeing of patients and clients. The document identifies the responsibilities that fall to research sponsors, funders, researchers, employing organisations, care organisations, care professionals and participants. Each have a part to play to ensure that any research undertaken in the area of health and social care meet these standards. It replaces an earlier draft document and takes account of a number of developments. Principal amongst these are the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Human Tissue Act 2004.

Research Governance Framework For Health & Social Care

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A new model Clinical Trial Agreement for industry-sponsored clinical trials of investigational medicinal products managed by Cinical Research Organisations (CROs) is available now for use by HSC Trusts. The new agreement known as the CRO mCTA should reduce the start-up time of clinical trials allowing patients faster access to effective drugs and treatments and providing a more streamlined system. The CRO mCTA is designed to be used without modification and should be acceptable to all parties.

Full details of the Northern Ireland version of the CRO mCTA and guidance can be accessed here.

EU Directive 2001/20/EC of the European Parliament and of the Council on the approximation of laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use heralds significant implications for various aspects of research governance. EU Directive 2001/20/EC was published in the Official Journal of the European Communities on 1 May 2001 and aims to: * Simplify and harmonise administrative provisions governing clinical trials * Clear transparent procedure * Create conditions productive to an effective co-ordination of clinical trials in the EU facilitating the internal market in medicinal products whilst maintaining appropriate levels of protection for public health All member states are required to transpose the Directive 2001/20/EC into national law by May 2004. Under article 8 of the Directive the European Commission is required to publish a series of 11 guidelines. The full text of the EU Directive is available from the link below and further information on, and a link to, the guidelines is also given below.

EU Directive 2001/20/EC/ EU Commission Guidelines/ Full Text