Compliance & Governance Guidance
Guidance on governance, compliance & other considerations for setting up & opening research studies in Primary Care
CRN East Midlands can provide advice and sign-post general practices to the right information sources, but they cannot undertake the governance and compliance checks on behalf of sites. This responsibility lies with individual Primary Care Site.
The guidance presented below will be reviewed at least annually or when there are any changes to national directives within the 12 month review period.
Last Updated October 2022
Confirmation of Capacity and Capability
Research taking place on NHS premises (in this case general practice) and/or involves NHS patients, patient data or staff, will usually require the general practice to formally confirm they have the capacity and capability to undertake the study.
The HRA Approval letter will state what is expected of the site in relation to this. The general practice also needs to ensure adequate contracts are in place and that any cost implications are covered. The NHS Health Research Authority (HRA) refers to this process as "Assess, Arrange and Confirm".
The protocol should be reviewed and consideration given to a potential Principal Investigator (PI), where required, and whether there are the right facilities and staff on site, and that patient/participant types are available. A review will cover the following:
● ASSESS - Assessing whether or not the general practice has the capacity and capability to participate in the study.
● ARRANGE - Putting practical arrangements in place to provide the capacity and capability to deliver the study.
● CONFIRM - Confirming that the general practice has the capacity and capability in place to deliver the study and will deliver it. The confirmation is usually given through a formal agreement with the Sponsor.
Visit the HRA website for guidance on setting up and delivering a study in primary care settings.
The UK Policy Framework for Health and Social Care Research sets out principles of good practice in the management and conduct of health and social care research in the UK.
UK Local Information Pack
The ‘UK Local Information Pack’ is the UK-wide mechanism for setting up participating NHS organisations (including general practices).
It provides a consistent package of documents to support study set-up and delivery across the UK and should be used by study Sponsors for all studies.
Further information is available here.
Patient Identification Centre (PIC) Agreement
PICs are general practices that identify potential research participants for research studies that are conducted at another NHS organisation (e.g a hospital trust).
They are not research sites and should not be treated in the same way as research sites. General practices acting as PICs cannot be set up through the UK Local Information Pack. They should be set up through a sub-contracting arrangement with the participating NHS organisation that the PIC supports. Appropriate data processing arrangements should be put in place by using the appropriate model agreement (current non-commercial and commercial agreement templates are located here).
HRA Approval Letter
The Health Research Authority (HRA) approval letter, which all studies will have, provides clarification and confirmation about important information regarding the set-up of the study, including:
Types of participating NHS Organisation
This will specify if there are multiple types of site (e.g. recruiting, PIC etc), and what documents should be shared by the study team with the local research team (and research support function, if this is in place).
Expectations related to confirmation of capacity and capability
This will set out expectations for the site in confirming capacity and capability. Where formal confirmation of capacity and capability to deliver the study is required, research activities should not commence at participating NHS organisations in England or Wales prior to this being given.
Agreement to be used (including GDPR requirements)
This specifies what type of agreement needs to be put in place between the Sponsor and the general practice (Commercial Model Clinical Trial Agreement, model Non Commercial Agreement or Organisation Information Document). These should be provided as non-modified versions - more information about model agreements is found here. It is important that general practices familiarise themselves with the provisions set out in any agreement and also ensure that the appropriate agreement is being used for a research study.
Funding Arrangements
Refer to CRN East Midlands Primary Care website for details of funding arrangements for studies where the general practice is acting as a research site or PIC.
Oversight Expectations
This will indicate what role (e.g. a Principal Investigator,
Local Collaborator or other) needs to be appointed at study sites. More information about roles and responsibilities is found here.
HR Good Practice Resource Pack Expectations
This will specify what arrangements need to be in place for external staff undertaking any research activities at a general practice. In some CCG areas, these checks are undertaken by a centralR&D team who will issue the appropriate document e.g. a Letter of Access based on standard/enhanced DBS checks and occupational health clearance. More information is available here.
The General Data Protection Regulation (GDPR)
The General Data Protection Regulation (GDPR) came into force on 25 May 2018.
The HRA has produced operational guidance on the implications of the GDPR for the delivery of research in the UK. Non-modified agreements (see section 4 above) contain provisions relating to data protection and data processing.
A useful resource can be found at UK Data protection law and the common law of confidentiality - Research - Medical Research Council (ukri.org).
General practices will also need to include research in their practice privacy notice (PPN). The BMA has a template PPN for medical research and clinical audit that can be used for this purpose.
National Data Opt-Out & Research
NHS Digital has produced guidance on national data-opt out and research.
The national data opt-out is a facility via which patients can object to their confidential patient information (CPI) being used for research and planning.
Where a patient has set a national data opt-out it does not stop that patient from giving their consent for a specific use of their data. It is important that patients continue to be offered the opportunity to participate in medical research studies, provided this is done in a way that does not breach their confidentiality, i.e. it addresses the Common Law Duty of Confidentiality.
GP Indemnity for Research - New Guidance
Phil Evans, Former NIHR CRN National Specialty Lead for Primary Care, worked with the HRA and in collaboration with NHS Resolution to develop a set of FAQs relating to the state-backed indemnity scheme for general practices in England.
This includes information about how this provides cover for the conduct of research in general practice in the NHS.
Contact Details for Further Information
If you have any questions about this guidance please contact CRN East Midlands via your Local CRN Primary Care Research Team or email primarycareresearch-eastmidlands@nihr.ac.uk