What is research governance?
Research governance refers to ensuring research follows good practice guidelines, in that it is:
- Scientifically and ethically sound
- Has the relevant approvals from both a regulatory and governance perspective
The principles of good practice in the management and conduct of health and social care research in the UK is given in the UK Policy Framework for Health and Social Care Research, published by the Health Research Authority (HRA). This has 19 principles that apply to health and social care research, and gives the responsibilities for those involved in research, including employers, funders and research teams. The policy framework applies to health and social care research involving patients, service users or their relatives or carers. This includes research involving them indirectly, for example using information that the NHS or social care services have collected about them.
The HRA gives guidance on what approvals are necessary, dependent on the type of study.
Please note this is in addition to any approvals needed from academic institutions for university staff and students.
There is a single system for applying for approvals for health and social care / community care research in the UK, called the Integrated Research Application System (IRAS). There is an excellent IRAS help guide, and the HRA also gives guidance on preparation prior to applying for approval via IRAS.
Once formal approval has been gained, there may need to be assessments to check that local services have the capability and capacity to carry out the research. There may also need to be HR processes completed to ensure research staff who are not employed by the service involved in the research have the appropriate skills and experience.
As a researcher, what do I need to let the NECS Research and Evidence team know about?
Researchers are responsible for informing the NECS Research and Evidence team of any non-portfolio research that is planned to take place in CCGs or primary care in the region, before it starts. Non-portfolio research refers to non-commercial studies which are not supported by the NIHR Clinical Research Network (CRN) Portfolio. These tend to be smaller studies, but this is not necessarily the case.
This information enables our team to monitor the type and quantity of studies taking place across the region. This is important as our team advise the CCGs if there is capacity to get involved in studies.
In some cases researchers will also need to apply to the NECS Research and Evidence team for a Letter of Access, or for a formal Capability and Capacity assessment, prior to a study starting (see formal governance processes section below).
What advice and guidance can be provided by the NECS Research and Evidence team?
NECS Research and Evidence team are able to provide general advice and guidance about research governance at any stage of a project, from concept through to delivery. This can be for those working in CCGs or primary care, or for those who wish to carry out research in these areas. We can also provide advice if a CCG or GP practice has been approached about taking part in a project, and would like to discuss this with someone prior to making a decision.
For those leading or involved in projects, we are able to offer advice as to whether a project is defined as research and therefore what approvals and permissions must be sought prior to commencement. We can also provide guidance in completing the relevant approval applications.
In addition, we provide advice and guidance about how to apply for access to carry out research within a CCG or primary care, in terms of the HR process, if the researcher(s) is not an employee of the service in which the research will take place or recruit from (see next section).
What formal research governance processes are provided by the NECS Research and Evidence team?
The NECS Research and Evidence team provide two specific formal research governance processes for North East, North Cumbria and some North Yorkshire CCGs. In practice, this means the team ensure that research carried out in CCG, primary care and other community settings is planned in a way that follows relevant guidelines and seeks appropriate permissions before it can commence.
Firstly, the team carry out for formal Capability and Capacity assessments for non-portfolio studies based in CCGs or primary care. The HRA will state if this is a requirement in their approval letter. If this is required, the researcher should send a copy of the Site Specific information to the team, which includes the local information pack. The Local Information Pack is included in the IRAS application, which needs to be tailored to each participating NHS organisation research site prior to submission for assessment. For further details about this process please contact our team.
The second is the main HR process required for a researcher who wants to carry out research in or recruit from a local CCG or one of their member practices for whom they are not an employee. The researcher needs to apply for a ‘Letter of Access’ by either submitting a ‘Research Passport’ if not an NHS employee, or an ‘NHS to NHS’ letter if an NHS employee, but employed by a different NHS organisation.
Where can I find more information?
There are two key sources of information about research governance; the Health Research Authority (HRA) and the Integrated Research Application System (IRAS).
The HRA is an arm’s length body of the Department of Health and Social Care (DHSC), and one of a number of organisations that work together to regulate health and social care research. The primary aim of the HRA is to protect and promote the interests of patients and the public in health research, and to streamline the regulation of research. The HRA website contains a wealth of information to include planning research, what approvals are needed, the General Data Protection Regulations (GDPR) and how to gain approval. The HRA also have a number of training modules available from their website https://www.hra.nhs.uk/
For specific guidance about applying for approval via the Integrated Research Application System (IRAS), a training module about the application system, and applying online, please see: https://www.myresearchproject.org.uk/
If planning on carrying out research involving CCGs and / or primary care from outside the area supported by the NECS Research and Evidence team, details of other teams supporting research governance in particular areas can be found on the Research and Development Forum website, see https://rdforum.nhs.uk/rd-contacts-directory/