Research governance/ethics
Research ethics and governance are playing an increasingly important role in all aspects of nursing research and practice development.
UK wide
Governance arrangements for research ethics committees: a harmonised edition
This document is the policy of the UK Health Departments describing what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Department's responsibility. It also explains when review by these committees is required.
The policy covers the principles, requirements and standards for research ethics committees, including their remit, composition, functions, management and accountability. It also describes the Research Ethics Service in which the research ethics committees operate and the review they provide.
This harmonised edition comes into effect on 1 September 2011. It revises and replaces editions of the policy previously issued separately in England and Scotland in 2001. It also applies in Wales and Northern Ireland.
Website: Governance arrangements for research ethics committees: a harmonised edition
Integrated Research Application System (IRAS)
IRAS Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK. It enables you to enter the information about your project once instead of duplicating information in separate application forms. IRAS captures the information needed for the relevant approvals from many review bodies, including:
- Medicines and Healthcare products Regulatory Agency (MHRA)
- NHS / HSC R&D offices
- NRES/ NHS / HSC Research Ethics Committees
Contact: IRAS
Email: iras@nres.npsa.nhs.uk
Website: https://www.myresearchproject.org.uk
thinkmca.
thinkmca. distils the main elements of the Mental Capacity Act (MCA) 2005 and the accompanying Code of Practice and presents these in ways with which you can quickly familiarise yourself. Improving our understanding of the MCA 2005 and the Code of Practice makes us feel more confident about using the MCA 2005 and has tangible benefits for those vulnerable adults we treat and care for. There is a helpful research section on the website.
Website: http://www.thinkmca.co.uk/
England wide
National Research Ethics Service (NRES)
NRES works with colleagues across the UK to maintain a UK-wide system of ethical review that protects the safety, dignity and well being of research participants, whilst facilitating and promoting ethical research within the NHS. NRES comprises the Head Office function (formerly COREC) and NHS RECs in England. NRES will continue to work with colleagues in Scotland, Wales and Northern Ireland to maintain the established UK-wide framework for ethical review of research.
Website: www.nres.npsa.nhs.uk/
Department of Health Research Governance Framework for Health and Social Care
The Research Governance Framework for Health and Social Care sets out the broad principles of good research governance. The first edition was issued in March 2001. The second edition was issued in April 2005.
Website: http://www.dh.gov.uk/en/Researchanddevelopment/A-Z/Researchgovernance/DH_4002112
Northern Ireland
Office for Research Ethics Committees Northern Ireland (ORECNI)
HSC Research Ethics Committees have been established by the DHSSPS. These committees will be generalist (that is, capable of considering the ethics of all proposed research projects which involve human subjects, their tissue or data in relation to biomedical and social care research). Each will have a remit covering the whole of Northern Ireland, and will meet monthly. This will create a system where a committee will meet most weeks of the year, capable of reviewing any research proposal.
Website: www.orecni.org.uk/display/home
Research Governance Framework for Northern Ireland
Website: http://www.dh.gov.uk/en/Researchanddevelopment/A-Z/Researchgovernance/DH_4002112
Scotland
Scotland Multi-Centre Research Ethics Committee (MREC)
Any research involving NHS patients, service users, care professionals or volunteers, or their organs, tissue or data must have approval from an NHS Research Ethics Committee (REC) before it can begin. RECs provide independent advice on the extent to which proposals for research comply with ethical standards. In reviewing the proposed study, the REC must give primary consideration to protecting the dignity, rights, safety and well being of all actual or potential research subjects (a role shared with others under Research Governance). In addition, informed consent to participate must be obtained from an individual participating in a study - this is the heart of ethical research in health. CSO works closely with the the National Research Ethics Service in England.
Contact: Craig Gilbert
Tel: 0131 244 2655
Email: craig.gilbert@scotland.gsi.gov.uk
Website: http://www.scotland.gov.uk/Topics/Research/by-topic/health-community-care/chief-scientist-office/6864/6866
Research Governance Framework for Scotland
The first edition was issued in 2001. The second edition was issued in February 2006
Website: http://www.dh.gov.uk/en/Researchanddevelopment/A-Z/Researchgovernance/DH_4002112
Wales
Office of Research Ethics Committees (OREC) for Wales
The National Research Ethics Service works with colleagues across the UK to maintain a UK-wide system of ethical review that protects the safety, dignity and well being of research participants, whilst facilitating and promoting ethical research within the NHS. NRES works with colleagues in Scotland, Wales and Northern Ireland to maintain the established UK-wide framework for ethical review of research.
Contact: Corinne Scott, OREC Manager for Wales
Email: corinne.scott@bsc.wales.nhs.uk
Website: http://www.nres.npsa.nhs.uk/contacts/nres-staff-regional-offices/
Research Governance Framework for Wales
The Research Governance Framework second edition was published in September 2009.
Website: http://wales.gov.uk/topics/health/research/word/publications/researchgovernance/?lang=en
Publications
Research Ethics: RCN guidance for nurses (2009)
The RCN Research Society is delighted to announce the publication of the booklet Research Ethics: RCN guidance for nurses [publication code 003 138]. This booklet is in its 5th revision since its original 1977 publication. Please note this publication is only available as a download.
Website: Research Ethics: RCN guidance for nurses (PDF, 885KB)
Long, T. & Johnson, M. (2007), "Research ethics in the real world: issues and solutions for health and social care". Elsevier: Churchill Livingstone
This book, to which four members of the RCN Research Society Steering Committee (at the time) contributed, departs from the usual principles-based approach and instead takes a predominantly consequentialist (harms and benefits) approach. It aims to be free of abstract philosophy, but will use the analysis of cases and a reasoned approach to examine alternative arguments. Whilst the book deals with issues in some depth it uses plain language and many clear examples of good and less good practice to illustrate points. It is at a level useful to both beginning and more experienced researchers. RCN members can request this book from the RCN library.
Website: http://www.rcn.org.uk/development/library
Fontenla, M. & Rycroft-Malone, J. (2006), "Research governance and ethics: a resource for novice researchers". Nursing Standard. 20, 23, 41-46.
This article provides an overview of the research governance framework and ethical review. Issues surrounding new procedures are clarified and practical advice is provided for those embarking on research projects. The article discusses limitations and highlights possible future changes to research governance in the United Kingdom. RCN members can access this article via the RCN e-library.
Website: http://www.rcn.org.uk/development/library/elibrary
NIHR Health Technology Assessment Programme
The NIHR HTA programme have published the following monographs
- Ethical issues in the design and conduct of randomised controlled trials: a review (Edwards) Vol 2, Number 15
- Implications of socio-cultural contexts for the ethics of clinical trials: a review (Ashcroft) Vol 1, Number 9
Website: http://www.ncchta.org/project/htapubs.asp
Social Research Association (SRA) UK "Ethical Guidelines"
These guidelines (2003) are intended to be educative and discursive, aimed at raising ethical awareness and ethical thinking. The SRA has also established an 'ethics forum' aimed at offering advice and guidance with research ethics queries.