How to guide: Assessing, arranging and confirming capability and capacity

Capacity and capability (C&C) assessment is the method by which sites consider whether they can take on a new study. In some cases this needs to be a formal assessment and confirmation, in other cases an email may suffice, or in others the Health Research Authority (HRA) may state that the study can proceed without C&C unless the site indicates any objection. Regarding C&C for Participant Identification Centre (PIC) activity, please see the ‘Understanding the role of PICs’ guide, and the below PIC section.

This guide outlines the ways in which practices should undertake the appropriate Assess, Arrange and Confirm Capacity and Capability stage of site agreement when setting up a study.

See also HRA guidance on: Assess, arrange and confirm terminology.

Key information you should be aware of:

• West Yorkshire Research & Development (WY R&D) issues an advisory email for studies of which we have had sight, to assist practices with completing their review. Practices can request a copy of this advisory from WY R&D or from the study team.
• Research governance is conducted centrally by the HRA. The HRA issues HRA approval which incorporates ethical review.
• Each participating site must assess, arrange and confirm their capability and capacity to participate, dependent on the requirements of the individual study.
• The decision to participate, and the agreement, should be at the level of the participating organisation, i.e. usually at the level of the practice (as an independent contractor). PCNs are not able to sign a contract unless they have been set up as a company, and neither a PCN nor a federation is not able to sign a contract on behalf of its members unless there is a formal agreement that they can do this. If the research is taking place at the federation level, e.g. in the out of hours service, then this could be signed off by the federation. The ICB cannot sign off on behalf of practices.
• It is important to note that the processes confirmed in the HRA approval letter must be followed as formal confirmation or signing of agreements is legally necessary where indicated in this letter.

Highlights

• What can happen before approval
• Process following approval
• How to assess
• How to arrange
• How to confirm

See also

• Getting your practice ready to do research guide
• Roles and terminology guide
• Principal Investigator guide
• Data guide

Full guide

Pre-HRA approval:

• Sponsors are encouraged to liaise with potential sites as early as possible in the process of developing their study. This may be before HRA approval for the study has been received or even applied for.
• At the pre-approval stage, sites can carry out a feasibility review of the study documents, but should be aware that the documents cannot be considered final until HRA approval is confirmed to the study team.
• A patient could be involved to discuss study feasibility, but no patient recruitment can usually take place until the study is approved.

After HRA approval of the study:

• The next step in the process is that the study team will receive a HRA approval letter.
• When the HRA approval letter is received, it will confirm expectations related to confirmation of capacity and capability (in the ‘Information to support study setup’ table at the end of the letter).
• This will include stating whether formal confirmation of C&C (capability and capacity) is required, and whether the study intends to use the Organisation Information Document (OID) as the site agreement.
• You should ask for a copy of the letter and check this table first to inform what you need to do next.
• WY R&D should also have the opportunity to issue an advisory email which will give advice on next steps in assessing, arranging and confirming C&C.
• If formal confirmation of C&C is required, see below for detail of the steps.

Assess:

Further to any initial feasibility assessment done at the Expression of Interest (EOI) stage, this is the main and formal feasibility assessment. When formally confirming your capacity & capability, and/or confirming the OID or contract, this is where you commit to the study, so this assessment should be more in-depth. Depending on the study commitment, this may be quick (for example if just a staff survey), or may require more consideration.

At this stage, you should have from the study team:

• A copy of the study protocol and local documents (the Local Information Pack).
• A copy of the Organisation Information Document or study contract.

An advisory email will have been sent to the study team from WY R&D, and you can request a copy of this from the study team or from WY R&D.

Other document types

Studies which started a number of years ago may try to use older documents. The SSI (Site specific information) and Statement of Activities are now out of date so can no longer be used for confirming participation. The study team should be directed to https://www.myresearchproject.org.uk/help/hlpsitespecific.aspx#UK-Local-Information-Pack-Transition to replace these documents with the current ones.

Further advice and examples of setting up studies in primary care:

You can read more about study setup in primary care settings, including examples, at https://s3.eu-west-2.amazonaws.com/www.hra.nhs.uk/media/documents/HRA_Approval_in_Primary_Care_Settings__Principles_of_Study_Set-Up_Version_2.0_09Mar17.pdf (note that this document contains some old references but can be taken as the most recent guidance).

Glossary of Acronyms and Terms:

• C&C – Capacity and Capability
• RDN – Research Delivery Network
• HRA – Health Research Authority
• OID – Organisation Information Document
• PI – Principal Investigator
• PIC – Participant Identification Centre
• SSI – Site Specific Information (form)