Delivering clinical research to time and target
Health Research Authority
Integrated Research System (IRAS)
NIHR Portfolio Adoption
R&I Trust Approval
Audit & Monitoring
Research Governance is the name given to the management, standards of conduct, processes and systems related to research. Research Governance is not a single process; many activities and concepts are encompassed within it.
Guidance for standards and processes that constitute good research practice in the NHS were brought together and documented in the 2001 Department of Health publication, "The Research Governance Framework for Health & Social Care". A theme running through Research Governance is the need for the protection of patients’ rights, dignity and safety.
The Centre for Health Research and Innovation is responsible for the operation of a number of systems to ensure that research conducted within the Trust conforms to all necessary legal, regulatory and ethical requirements.
Research Approval covers all activities relating to the setting up and starting of research projects within the Trust. This includes:
- Research notification and approval, including Health Research Authority, Research Ethics Committee and local Confirmation of Capcity and Capability.
- Honorary Research Contracts and Passports
- Quality Assurance
In March 2011, the government published its Plan for Growth which included specific aims and incentives to improve efficiency in the initiation and delivery of clinical research. From 2012, the National Institute for Health research (NIHR) will publish metrics to measure those efficiencies including a benchmark of 62/80 days or less from the time taken for a valid research application to be processed to first patient recruitment. Within the Centre for Health Research and Innovation we have updated our processes with the aim of achieving the targets, but we need your cooperation.
So what does this mean for those working in research and how will it affect current and future research applications?
For those thinking about starting a research project, please contact the Research Access team who can offer advice, support and template documents that will be required for a research application. If you are an investigator of a study or have been asked to head up a study from an external organisation, again please seek advice from the Research Access team.
There must be documentary evidence that a favourable opinion has been obtained before research can commence.
The requirement for a favourable HRA opinion also applies to student research projects and research that has been approved by commercial companies’ ethics committees, even if they do not require review by the National Research Ethics Committees (REC).
Research ethics refers to the protection of individuals involved in research and the quality, validity and relevance of the research itself. NHS Research Ethics Committees are convened to review research projects and to ensure that the rights, wellbeing and dignity of research participants will be protected and that the research itself meets minimum scientific standards. This process now sits within the broader HRA approval.
The permissions or approvals required will depend on the type of research you are undertaking.
Permissions may include:
- HRA approval
- NHS Research Ethics Committee
- NIHR Portfolio Adoption
- Medicines and Healthcare Products Regulatory Authority (MHRA)
- Local R&I acknowledgment - Confirmation of Capacity and Capability
For general information on all of the above permissions see: http://www.hra.nhs.uk/research-community/applying-for-approvals/hra-approval/
The HRA process is accessed via the online integrated research application System (IRAS) – https://www.myresearchproject.org.uk/. For support in completing your IRAS application and for further details of what documents will be required prior to making a submission to ethics and R&I please contact the Research Access team for further information.
Most applications can be made via the (IRAS) http://www.myresearchproject.org.uk.
IRAS was developed to bring all the research regulatory application forms together in one place. By completing a checklist of questions, the system will generate the forms you need to complete based upon your responses including the:
- Portfolio Adoption Form (PAF) – if your research is funded externally it may be eligible for portfolio adoption, which will bring additional funding into the Trust to support the delivery of research.
- IRAS Form
- CAG - Confidential Advisory Group
- MHRA application
If your research study meets the criteria for portfolio adoption, it is important to submit the Portfolio Adoption Form at an early stage (prior to the IRAS) in order to be processed.
On the first page of your IRAS application you can choose to have your project assessed for NIHR Clinical Research Network (CRN) support and inclusion in the NIHR Clinical Research Network (CRN) Portfolio.
Research studies funded by NIHR and NIHR partners are eligible to be adopted on to the NIHR Portfolio.
In the past following ethical approval, local Trust R&D or R&I approval was required. This process of approval has changed, and now following HRA approval, the local Trusts, need to confirm their capacity and capability to carry out the research and provide an email acknowledgement before the Sponsor provides the green-light to recruit.
We ask that you contact the Centre for Health Research and Innovation as early in the process as possible, to provide the team with time to carry out feasibility.
We ask for copies of all documents sent to HRA, plus a copy of the ethics committee approval and GCP certificates. Please contact the Research Access Team for a list of documents required.
Additional approvals may be required for projects involving ionising radiation, devices, drugs, or human tissue. Approval from the Medicines and Healthcare Regulatory Agency (MHRA) is required for studies that are investigating the efficacy or safety of medicines, or research involving medical devices that are not CE marked, or when devices are used outside their intended purpose. Contact the Research Access team to discuss your project in more detail.
To comply with the Research Governance Framework, NHS Trusts are required to ensure all research involving their staff or patients is adequately monitored. The Trust has a Research Audit policy to ensure that informed consent and other procedures in the research protocol approved by the research ethics committee are being adhered to, within Good Clinical Practice guidelines. Currently 10% of all non-commercial projects are randomly selected for audit inspection by the R&I Department each year.
Further details can be found in the document Advice and Guidance for Researchers[pdf] 546KB