Research governance can be defined as the broad range of principles, standards, and regulations of good practice. It ensures high quality research and it is relevant to all staff involved in research.
Adhering to these standards helps ensure patient safety and high quality research leading to the best evidence-based practice for our Service Users, they remain front and centre of what we do as a Trust.
The principles of good practice are set out in the UK Policy Framework for Health and Social Care Research. This framework comprises 19 principles that all health and social care research in the UK are expected to meet.
The type of approvals required depends on the type of research you are doing (The WHAT and to WHOM).
Any research project that involves recruitment of NHS patients, staff, premises, resources such as pharmacy, radiology or laboratories, or data / tissue in England must go through the HRA approval process. HRA approval reviews the governance and legal compliance of a project, with the independent opinion provided through the NHS Research Ethics Committee (NHS REC). It applies where the NHS organisation has a duty of care to participants, either as patients / service users or NHS staff / volunteers.
The REC process is to review participant involvement and whether the research is ethical, this can be completed by either a University Ethics Committee or a NHS Research Ethics Committee. A Non-NHS Research Ethics Committee would be completed by a University Ethics Committee, this is an internal higher education institution review and is not part of the National Research Ethics Service. There will be an application process specific to your institution, so please contact the relevant department or your supervisor to ascertain what is needed for this.
The Health Research Authority - Research Ethics Committee reviews health and social care research where patients or NHS staff are involved. It reviews research applications and provides an opinion about whether the research is ethical and whether it can take place in the NHS, this review forms part of the overall HRA Approval and is accessed via the Integrated Research Application System (IRAS).
There are other approvals that certain types of research have to have from specialist review bodies. For example:
- a clinical trial of an investigational product (CTIMP) would need Medicines and Healthcare products Regulatory Agency (MHRA) approval
- access to patient records without consent would require approval from the Confidentiality Advisory Group
The IRAS application system is used to submit your research to the Health Research Authority as well as other regulatory bodies. To help support the process of what approval is required from the HRA there is an online decision tool. The Research Support Service can provide support with all of these processed.
In terms of the timescales are involved, there is not one answer as there are certain variables to bear in mind and can be dependent on the approvals your project requires as well as any amendments required post-review of your project. If your project requires NHS Ethics Review it may be eligible for Proportionate Review which is an accelerated review of projects, which raise no material ethical issues e.g. anonymous questionnaire based project.
NHS Confirmation of Capacity and Capability
At the initial stage of developing the research study it is advisable to start introductory discussions with the NHS Trust to ensure the research is appropriate and deliverable. Once the organisation agrees it can take part it can be listed in part C of the IRAS form.
Local NHS Trust governance set up revolves around the receipt of the 'local information pack', guidance for this pack is provided in IRAS Help. The Trust requires copies of all study documentation that are part of the research study, to allow them to review.
The three stages of NHS Trust governance process are:
- Assess. The NHS Trust assesses whether they have the capacity and capability to participate in the study as a site
- Arrange. The NHS Trust arrange for put practical provisions in place to enable them to deliver the study
- Confirm. The NHS Trust provides NHS Confirmation of Capacity and Capability. This is the final agreement to start the research in the NHS Trust.
There may be some studies that do not officially require NHS Confirmation of Capacity and Capability, The NHS Trust would still need to review to ensure 'no objection' is required.
We can provide help and support on all approvals through our Research support department.
Throughout the study lifecycle there may be changes needed to the study, this could be changes to the data collection methods to extending the recruitment window. The sponsor for the study will decide if the amendment is substantial or non-substantial. The amendments help section in the Integrated Research Application System (IRAS) can help to support this process, the link is below. As a Research Support Services we can also support you with this process so please get in touch.
The amendment tool on the IRAS system will need to be completed, dependent on the tool outcome you may need to submit to regulatory bodies then send to the NHS Trust or send straight to the NHS trust.
All changes to the study will need to have continued confirmation of capability and capacity from the NHS trust. Your amendments cannot be implemented until the relevant approvals are in place, from the NHS Trust and the regulatory bodies if applicable, with the exception of urgent safety measures.
What is insurance & indemnity?
The GCP Directive advises a clinical trial can be undertaken if ‘provision has made for insurance and indemnity to cover the liability of the investigator and sponsor’.
Insurance ensures that the potential legal liability of harm arising to a participant of a research study is covered whereas an indemnity is contractual obligation by one party to recompense the loss incurred to the other party.
It is the responsibility of the sponsor organisation to insure and indemnify the project over the lifecycle of the research study. If the project is sponsored by a higher education institution or another organisation, you would need to ensure that adequate cover is in place from them. NHS insurance and indemnity will apply if the research is sponsored by an NHS Trust.
It is advisable to get in touch with your sponsor as some may have standard responses on these sections for your IRAS application form.
- UK Policy Framework Health Social Care Research
- The Medicines for Human Use (Clinical Trials) Regulations 2004
- Human Tissue Act 2004
- The EU Clinical Trials Directive (EUCTD - 2001/20/EC)
- The Good Clinical Practice (GCP) Directive (2005/28/EC)
- World Medical Association Declaration of Helsinki
- Data Protection Act 2018
- IRAS Amendment help