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An introduction to research governance

What is research governance? Why does it exist and what organisations are involved. Find out more in this article.
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© Midlands Partnership NHS Foundation Trust

In this section we will learn about research governance, which essentially means the processes and means by which research activity is assessed, recorded and monitored. Research governance is there to ensure high standards in research are maintained.

To provide context, we start this section by examining a key policy document: the UK Policy Framework for Health and Social Care Research. This document helps us to understand what counts as ‘good’ research and how we can achieve this.

The UK Policy Framework for Health and Social Care Research

The UK Policy Framework for Health and Social Care Research was produced by the Health Research Authority, NHS Research Scotland, Health and Care Research Wales and Health and Social Care Northern Ireland. The policy framework therefore applies to research conducted in all four of the devolved nations of the UK.

This policy framework helps to establish a set of guiding principles for research in health and social care settings. These principles seek to achieve the following, as described in the document:

‘These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.’ (pg4)

The following short animation helps to introduce the policy framework:

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

The policy framework outlines fifteen principles that apply to all health and social care research conducted in the UK:

  1. Safety
  2. Competence
  3. Scientific and ethical conduct
  4. Patient, service user and public involvement
  5. Integrity, quality and transparency
  6. Protocol
  7. Legality
  8. Benefits and risks
  9. Approval
  10. Information about the research
  11. Accessible findings
  12. Choice
  13. Insurance and indemnity
  14. Respect for privacy
  15. Compliance – A further four principles are described for research that involves interventions i.e. changes to the treatment or services received by service users.
  16. Justified intervention
  17. Ongoing provision of treatment
  18. Integrity of the care received
  19. Duty of care

For further information relating to each of these principles, refer to pages 10-12 of the policy framework document.

In addition to establishing a set of guiding principles, the policy framework outlines roles and responsibilities for key stakeholders involved in research: chief investigators, research teams, funders, sponsors, contract research organisations, research sites, regulators, employers and health and social care providers. Refer to pages 15-28 of the policy for further information.

Good Clinical Practice

If you are planning on conducting research in health and social care settings you should complete the Good Clinical Practice (GCP) training, which is informed by the principles described above. Although the name of the training includes the term ‘clinical’ it is relevant to all types of health and social care research. In completing this training, you will obtain a certificate to demonstrate your understanding of the key principles.

Good Clinical Practice (GCP): https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm

The role of the Health Research Authority

The Health Research Authority (HRA) is one of the regulatory organisations that oversees health and social care research in England, as an example. The HRA co-ordinates and standardises research regulatory practice and provides independent recommendations on the processing of patient data. If you are conducting health and social care research in the UK, then you may need approval from an authority such as the HRA.

To understand whether your project requires approval from the HRA, there is a useful decision aid that you can follow called the ‘Is my project research?’. This decision aid helps you to define whether the study that you are looking to conduct should be categorised as research or whether it may be a service evaluation or audit (refer to Week 1 for an overview of the key differences between these types of approach). This has implications for the level and type of approvals that you will need to obtain before you can commence your research.

Is my study research? https://www.hra-decisiontools.org.uk/research/

TASK: Explore the decision aid, run through the questions a few times giving different responses to help familiarise yourself with the different options and outcomes.

The outcome of the decision aid will guide your decision about whether your project is research and also direct you to a second decision aid that will help you to answer ‘Do I need research ethics approval?’. We will discuss this second decision aid below.

If your research is going to involve collecting data on NHS sites or through NHS services, then it is likely that your project will need to apply for approval from the HRA before you can commence your study and you may also require research ethics approval.

You can apply for HRA approval via the Integrated Research Application System (IRAS). You can do this at the same time as applying for research ethics approval, if required, or separately if you are applying for research ethics approval from a non-NHS committee. We will discuss research ethics in more detail below.

Other Organisational Approvals and Permissions

Health and social care research projects cover a broad spectrum of topics and settings. Some research may require separate or additional approvals to those obtained through the HRA depending on who you intend to include as your participants (if any at all) and where you are planning on conducting your research.

Individual organisations will have their own local governance structures and policies that you will need to identify and design you research around. If you are conducting research within a specific non-NHS organisation, then liaise with the organisation research office (if the organisation has one) or senior members to discuss governance requirements.

If you are a social worker working within a Local Authority, private or charitable organisation, you need to consider carefully how to ensure your project follows the correct guidelines. First, speak with your line manager and establish whether your employer has developed their own local social care governance framework for you to follow. In the absence of a national social care framework, Local Authorities are now developing their own guidance. Should your Local Authority have implemented their own guidance, this should be followed.

See below an example of a local research governance framework developed by East Sussex Council: https://www.eastsussex.gov.uk/social-care/providers/research-governance

In the absence of any guidance, which is the case for many local authorities and will be more likely should you work for a private organisation, for example, a private fostering agency, you should contact your local university social work department who would be happy to guide and support you through your research design.

A Brief Word About Research Sponsorship

Research sponsorship often gets confused with the provision of research funding. Sponsorship in this sense is not related to funding. A research sponsor is an organisation that takes on overall responsibility for ensuring appropriate arrangements are in place to set up, run and report on a research project. Any research in health and social care that involves patients, their tissue or information should have a sponsor.

Who can act as a research sponsor?
The sponsor is usually the employer of the chief investigator (the research project lead). Universities will often assume responsibilities as the research sponsor. Your local university research governance team will be able to advise on sponsorship whether you are an internal or external member of staff. In some cases, NHS organisations may be able to act as sponsor. If you work for an NHS organisation, check with your local Research and Development office about sponsorship.

In the next step we will introduce you to research ethics.

In the comments below, write two reasons why research governance is important. Look to see which reasons other learners have put.

Links referred to in this article

UK Policy Framework for Health and Social Care Research https://s3.eu-west-2.amazonaws.com/www.hra.nhs.uk/media/documents/Final_Accessibility_uk-policy-framework-health-social-care-research_.pdf

Good Clinical Practice (GCP): https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm

Integrated Research Application System (IRAS): https://www.myresearchproject.org.uk/

Health Research Authority (HRA): https://www.hra.nhs.uk/

Is my project research? http://www.hra-decisiontools.org.uk/research/

CRN Study Support: https://www.nihr.ac.uk/explore-nihr/support/study-support-service.htm/

© Midlands Partnership NHS Foundation Trust
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