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NIHR UK Rare Genetic Disease Research Consortium Agreement

NIHR UK Rare Genetic Disease Research Consortium Agreement

Musketeers' Memorandum

There are over 7000 rare diseases, most being the result of a genetic disorder. In the 1980's and 90's great progress was made in understanding the cause and improving the care of patients affected by this group of conditions which collectively affect 1 in 17 people in the UK. Sadly, an unintentional consequence of modern research governance is that small scale projects largely dried up. The common practice of genetics teams joining forces to investigate a particular rare disorder fell foul of the need for individual contracts and material transfer agreements. In most cases, there were more administrative staff involved in the permission process than there were patients in the UK with the disease. The present system is deeply frustrating to families urging research groups to work on their disease. As our capacity to identify the underlying cause increases the disproportionate bureaucracy is shown in stark relief.

At a meeting of NIHR Senior Investigators John Burn and his team were tasked with working with NOCRI to develop a national agreement applicable to non-CTIMP rare disease projects with minimal local hospital costs whereby when one of our regional genetics centres, supported by their NHS Trust, developed a rare disease non-CTIMP project, the R&D team responsible for all the other regional genetics centres would sign off without a full review of protocol and the need for individual negotiations.

In 2012, representatives of most Trusts with regional genetic centres met in London and there was broad agreement to proceed. The agreement has been assembled by a Trust and University lawyer from Cambridge and Southampton, originally selected by the NIHR because of their expertise and involvement on other NIHR agreement initiatives, and who have consulted a few of your R&D leads. The cost to trusts will be minimal and each will benefit from portfolio recruitment funding. The benefits to people with rare disease will be significant. It is hoped that every centre in the UK joins the agreement - the "Musketeers' Memorandum"- all for one and one for all! 

For further information contact Dr Gill Borthwick.

The Agreement was circulated on Tuesday 21st May 2013 for final signature and fully executed on 23rd November 2013.

The first amendment to the Agreement was circulated on 25th July 2014.  This Agreement is now fully executed with the Royal Marsden Hospital now being party to the Agreement.

Musketeers' Memorandum Agreement (Amendment 1, 25th July 2014)

Schedule 1 - Word document

Access Policy 14th April 2014

The Parties who sign up to this agreement and the research studies approved under this agreement will be recorded on this website.

List of NHS organisations who have signed the Agreement

Studies to be approved with the Agreement

Approved Studies

If you are the CI of a study and you would like it to be considered under this Agreement please contact musketeers@nihr.ac.uk.  All studies need to fit the Rare Genetic Disease definition of an illness caused by abnormalities in genes or chromosomes and affecting less than 5 in 10,000 of the general population.

Update 27th April 2016: The last Musketeers study has been circulated today for approval; to date 32 rare genetic disease research studies have gained NHS permissions under the Musketeers' Memorandum. Due to the recent change in the English approval process we are working with the HRA and the NIHR CRN to integrate the Musketeers' Memorandum 3 day approval with the new system. The studies will be guided regionally by the lead site R&D teams and the Regional NIHR CRN genetics lead. There are already studies listed on this website to be approved with the new HRA process. The new process may include standardising the HRA Statement of Activities, and a review of the Musketeers' Memorandum.

For further information please contact Dr Gill Borthwick.