2 What is research governance? Research governance is the means by which organisations ensure that all research is carried out within the law and following good practice guidance.It is based upon a set of regulations and guidelines which all determine the legal and ethical framework in which research should be conducted to help ensure that the safety of participants and researchers is upheld.
3 Why is research governance important? Historically there have been serious abuses of patient’s rights and well-being, all carried out in the name of scientific research. (Nuremberg, Tuskegee, Alder Hey etc)It clearly sets out the requirements and standards to be met and provides mechanisms to deliver these.Protecting both participants and researchers, by promoting ethical and high quality scientific research.
4 Which legislation and guidance documents are involved? Data Protection Act (1998)Human rights Act (1998)Declaration of Helsinki (2000)Health and Social Care Act (2001)EU Directive (2001/20/EC)Medicines for Human Use Act (2004)Research Governance Framework (2005)Good Clinical Practice (ICHGCP) (2006)Human Tissue Act (2006)Mental Capacity Act (2008)
5 What does the process of research governance involve? Applying to a set of authorities for permission to undertake your research.The number of authorities you will need to apply to will be related to the risk, scale and complexity of your research.Once you have gained permission to start your research the governance process continues following a set of requirements to continually monitor and report on the progress your research.
6 Where do I start?Once you have a research idea you will need to develop a protocol, find someone to financially support the work (funder) and find an organisation to take overall responsibility for its conduct (sponsor).FunderThe research funder is responsible for supplying the financial support for the work. SponsorThe research sponsor is the organisation who takes responsibility for ensuring that the design, conduct and reporting of the study all meet appropriate standards.
7 ApprovalsThe number of bodies you will require approval from will vary depending on the type of research being undertaken.The primary approvals required for almost all studies in health care will be: a) review by institution and/or external ethics committee and approval from the Research and Development department of the hosting NHS Trust.In general, the greater the number of sites you use and the more complex the procedures, the more approvals you will require.
8 Application OrderThere is no fixed order in which you should apply for the relevant authorisations. Once you have a funder and sponsor you can apply to ethics, research and development and other bodies in parallel.
9 Ethics approvalEthics approval for all research involving the NHS (broadly covering patients, premises, resources or facilities) is obtained via the National Research Ethics Service (NRES).For research not involving the NHS then ethics approval should be directed by the sponsor and may involve a University or Social Services ethics committee.The committee will review all the study documents and may meet prior to giving an opinion. It is usual for the committee to request some changes prior to giving a favourable opinion.
10 Research Governance Approval Site management approval will be required from the organisation in which the research is being undertaken. This is often an NHS, Social Services and/or University Research Governance department.This normally involves submitting a series of documents and obtaining sign off from departments participating in the research.This will invariably include data protection, insurance, peer review, site management, financial arrangements and may require legal agreements (between different organisations) if the study has multiple sites and parties are being contracted to perform research related duties.If your project has multiple sites you will need to obtain approval at each of the sites – this may take a long time and may not therefore be practical in some cases (student projects).
11 Additional ApprovalIf your work involves any of the following you may require further approval from other governance authorities:Research InvolvingGovernance AuthorityInvestigational Medicinal Product (IMP)Medicines & Healthcare products Regulatory Authority (MHRA)Medical DeviceMedicines & Healthcare products Regulatory Authority (MHRA) devices DivisionGene TherapyGene Therapy Advisory Committee (GTAC)If you are using gene therapy than you should submit to this research ethics committee instead of the normal NHS REC.Using identifiable data but without participant consentNational Information Governance Board for Health and Social Care (NIGB)Human embryos and/or stem cells.Human Fertilisation and Embryology Authority (HFEA)Radioactive Substances used in research which results in exposure additional to routine diagnostic or therapeutic exposures.Administration of Radioactive Substances Advisory Committee (ARSAC)Each participating centre must apply for its own certificate.Prison or Young Offender InstitutionsMinistry of Justice (National Offender Management Service) through the NRES system
12 Integrated Research Application Service (IRAS) This is a web based database which allows you to input all the information regarding your study by answering a series of questions.This information can then be used to create the individual application forms for many of the governance organisations, including Research Ethics Committees and NHS Trusts.You initially complete a set of filter questions, which will disable those questions not relevant to your research and then work your way through the questions using the question specific help if required.You can save and return to your project within IRAS any number of times, allowing you to complete it gradually as your project evolves.
13 Once you get startedOnce you start gathering data, don’t forget that research governance continues:Adhere to your original protocol/ethics approval or submit an amendment if changes are required e.g. new methods, more participants, more sites;Comply with any conditions e.g. provide an annual report, report any adverse incidents, comply with Sponsor or funder request to monitor and/or inspect.Feedback results to participants and publish responsibly without fraud or fabrication.
14 Practical Tips: Go on ethics and/or GCP training Seek guidance from support departmentsGet advice from those who have done it beforeRead the instructions and guidelines carefullyAllow plenty of timeRemember it is a process to aid the quality of your research and is not just a ‘tick box’ exercise!
15 References Health and Social Care Act (2001) International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) (1996)Data Protection Act (1998)Human rights Act (1998)Declaration of Helsinki (2000 and subsequent versions)European Union Clinical Trial Directive (EUCTD) 2001/20/ECHealth and Social Care Act (2001)Human Tissue Act (2004)Directive 2005/28/EC Good Clinical Practice DirectiveMental Capacity Act (2005)Research Governance Framework for Health and Social Care (2005)
16 Useful Links Integrated Research application System (IRAS) Medicines & Healthcare products Regulatory Authority (MHRA) – Clinical trials pages.Gene Therapy Advisory Committee (GTAC)National Information Governance Board for Health and Social Care (NIGB)Human Fertilisation and Embryology Authority (HFEA)Ministry of Justice (National Offender Management Service)Integrated Research application System (IRAS)NHS Research & Development ForumDepartment of Health – Research and developmentNational Research Ethics Service (NRES)Human Tissue Authority (HTA)