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Process & Responsibility Matrix

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Musketeers' Memorandum Process

NIHR CRN Study Support Service

If you need support with setting up your study, the NIHR Clinical Research Network (CRN) can help you to navigate the systems and processes to get your study up and running to deliver high-quality research.
For studies eligible for the NIHR CRN Portfolio, the Study Support Service will work with you, R&D offices, funders, and other stakeholders to deliver your study to time and target, regardless of location, study type, study size, therapy, or research area. They can assist in:
Contact your Local Clinical Research Network Study Support Service team to discuss your support needs.

Musketeers' Memorandum Eligibility Checklist

After reviewing the eligibility requirements for the Musketeers' Memorandum (MM), if the study team believes their study matches the MM criteria, the Chief Investigator (CI) should submit a completed MM Eligibility Checklist. An online version of the Checklist can be found on the Eligibility page, or if you have access issues, you can request a Word version by emailing musketeers@nihr.ac.uk.

The Eligibility Checklist must be returned with a completed Protocol, so that the review process can begin.

The MM team (CRN Cluster E) will review the completed MM Eligibility Checklist and confirm whether the study meets the MM criteria. It may be necessary for the MM team to liaise with the relevant Local Specialty Leads or the Genetics National Specialty Lead for additional advice regarding MM eligibility and confirmation. In some cases, responsibility for assessment and confirmation may be delegated to the Regional Genetics Coordinators by the Local Specialty Leads.

Studies must first be considered eligible for the NIHR CRN Portfolio before MM eligibility can be confirmed. A conditional confirmation of MM eligibility may be provided at this stage until NIHR CRN Portfolio adoption is confirmed.

Submitting Project Application Documents

When MM eligibility is confirmed (or conditionally confirmed), the Study Team should then submit the project application documents to the appropriate bodies for review.
- Health Research Authority (HRA) and Health & Care Research Wales (HCRW) Approval: This is a separate approval process, led by the HRA. Please refer to their website for HRA Approval information and links to the Integrated Research Application System (IRAS) form.
- MM Studies must also be eligible for the NIHR CRN Portfolio. Please visit NIHR CRN Portfolio webpage for information.

It is crucial the Study Team ensures study documentation explicitly states the study falls under the MM agreement. The aim of this is to make it as clear as possible to the four nations coordinating units* that the study is linked to the Musketeers' Memorandum.

References to MM eligibility should be included in the following documents, which should clearly describe the study activities:
- IRAS application form,
- Organisation Information Document,
- Schedule of Events (SoeCAT).

IRAS form recommendations:
- Include the MM eligibility confirmation email with the document set submitted with the IRAS form.
- Add '(...a Musketeers' Memorandum Study)' to the study title and include this in the summary narrative.
- Include the Lead Site only. You can submit a separate spreadsheet of all expected participating MM sites.

MM studies involving adults lacking capacity

Up-to-date information and guidance regarding studies involving adults who cannot consent for themselves can be found on the Health Research Authority (HRA) website. The Mental Capacity Act (2005) applies in England and Wales only. For Northern Ireland, refer to Section 132 provisions of the Mental Capacity Act (Northern Ireland) 2016. For Scotland, refer to the provisions of Section 51 of the Adults with Incapacity (Scotland) Act 2000.

HRA/HCRW Approval and Site Participation Agreement

For sites in England and Wales, once the HRA/HCRW has issued its Initial Assessment Letter or HRA/HCRW Approval, the Study Team should then circulate all study documentation to the following:
- Participating NHS sites’ R&D office
- Participating Genetic Research Centre generic mailbox or Regional Genetics Research Site Coordinators, if a generic mailbox is unavailable.

(Contact details are available on the R&D Forum website or the MM Contact List)

Where a study is being set-up under the MM agreement and this has been made clear in the application to HRA/HCRW, the HRA/HCRW Approval letter will confirm that no formal review of capacity and capability is required at sites that are party to the Musketeers' Memorandum. Participating R&D Departments at the regional genetics centres are expected to agree to their participation in a timely manner. For sites in England and Wales, whilst no formal review of capacity and capability is required for sites set up under the MM, participating NHS organisations should confirm their readiness to host the study, by email to the CI/sponsor, once HRA/HCRW Approval is in place, and record the relevant start-up data points within their Local Portfolio Management System (LPMS). There may be occasions where sites are not practically able to take part in a particular MM study e.g. conflict of research interests. Such instances will be dealt with on a case-by-case basis.

In parallel, the study will be reviewed by the lead nation and/or participating nations according to the UK Wide Agreement, liaising directly with the study team/sponsor to gain further information or documentation as required. The study team/sponsor are responsible for following up on delayed approvals.

It is recommended the Study Team sends an Advance Warning Email to the following, to advise that a MM study and corresponding documentation set is due to be shared:
- Participating NHS sites’ R&D office,
- Participating Genetic Research Centre generic mailbox or Regional Genetics Research Site Coordinators if genetic mailbox unavailable.

(Contact details are available on the R&D Forum website or the MM Contact List)

Here is an example of an Advance Warning Email. If you have any difficulty accessing it, please email musketeers@nihr.ac.uk for a copy.

- *Health and Social Care in Northern Ireland; NHS Research Scotland; Department of Health and the Health Research Authority in England; and Health and Care Research Wales.

Responsibilities of Individuals and Organisations

Sponsors and study teams should refer to the UK Policy Framework for Health and Social Care Research (2017) which describes the responsibilities of individuals and organisations involved in the delivery of research. Once approved, the sponsor is responsible for collating approval letters and sharing them with participating R&D departments/study teams. For the purposes of ease of approval and study management, the study delivery team are also responsible for holding files which demonstrate the suitability of all ‘nominal’ PIs (e.g. CVs and evidence of appropriate training such as Good Clinical Practice training).
The sponsor/study team may then liaise with sites to set up the study and begin recruitment.

Management of MM Studies: Responsibility Matrix

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