What Is Research Governance?

Academic Services Directorate Research Services

RESEARCH GOVERNANCE

Information for researchers

of 12 March 08 Version 1 Review date : March 2009 What is Research Governance?

Research Governance is a means by which organisations and individuals ensure the delivery of high quality research. It applies to all research; for research involving human participants or access to NHS resources there are additional more stringent requirements, and, in some cases (such as clinical trials), specific legislation which must be complied with.

Research Governance:-

. Sets out principles, requirements and standards of good research practice.

. Defines mechanisms to deliver them.

. Improves research quality by:- o Enhancing ethical and scientific quality o Promoting good practice o Reducing adverse incidents and ensuring lessons are learned o Preventing poor performance and misconduct.

. Is for all those who:- o Participate in research o Host research within their organisation o Fund research proposals or infrastructure o Manage research o Undertake research.

Standards

Research Governance aims to continuously improve standards and reduce unacceptable variations in research practice. As a

of 12 March 08 Version 1 Review date : March 2009 researcher it is your responsibility to ensure that you are aware of the standards that you are expected to adhere to and maintain.

The minimum standards from five broad domains (Science, Ethics, Information, Health & Safety, Finance) that researchers must adhere to and the relevant mechanisms in place within the University are outlined below.

1. Science; To ensure the validity and quality of research proposals.

. Faculty/Research Institute/School Research Ethics Committees have been established and are charged with reviewing staff/student research projects (for more information please contact your Faculty/Research Institute/ School Research Ethics Committee).

. To support the local research community the Keele Joint Independent Peer Review Committee was established and developed a shared system for independent review of research. For more information please access; http://www.keele.ac.uk/research/research/governance/peerr eview.htm

2. Ethics; To ensure the dignity, rights safety and well being of participants (includes informed consent, use of tissues or organs, use and protection of patient data).

. University Research Ethics Committees

Faculty/Research Institute/School Research Ethics Committees have been established and are charged with reviewing staff/student research projects (for more Page 3 of 12 March 08 Version 1 Review date : March 2009 information please contact your Faculty/Research Institute/ School Research Ethics Committee). Ethical review is mandatory for projects involving human participants.

. NHS Research Ethics Committee (REC)

Approval from an NHS Research Ethics Committee must be obtained for any research project (including student projects) which involves:-

a) Patients and users of the NHS. b) individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above; c) access to data, organs or other bodily material of past and present NHS patients; d) fetal material and IVF involving NHS patients; e) the recently dead in NHS premises or facilities; and f) NHS staff – recruited as research participants by virtue of their professional role.

In the UK, all NHS Research Ethics Committees are managed by the National Research Ethics Service http://www.nres.npsa.nhs.uk/. There is a standard NHS REC application form that must be completed for all ethics applications (available from the above website).

. NHS based research

Approval from the relevant NHS Trust should be sought for any research conducted in the NHS.

of 12 March 08 Version 1 Review date : March 2009 3. Information; To ensure free access to results of any research.

. Proposed Research / Findings

Information about proposed research projects and their conclusions must be presented in a format accessible to research participants and, where appropriate, the general public. The Royal Society provides useful guidance in this area; http://www.royalsoc.ac.uk/document.asp? tip=0&id=5789

. Confidentiality

Confidentiality of personal information is essential. Data used for research purposes should be dealt with in accordance with the Data Protection Act (1998) http://www.opsi.gov.uk/acts/acts1998/19980029.htm.

. Intellectual Property

Consideration must be given to the appropriate exploitation of intellectual property rights derived from research. For further information or advice, please contact the University Intellectual Property team on 01782 584492 or access http://www.keele.ac.uk/research/innovation/index.html

of 12 March 08 Version 1 Review date : March 2009 . Data protection

Anyone processing personal data must comply with The Data Protection Act 1998 and follow the 8 principles of data protection http://www.opsi.gov.uk/acts/acts1998/19980029.htm.

Researchers undertaking research within the Health and Social Care sectors must be aware of and follow the Caldicott principles http://en.wikipedia.org/wiki/Caldicott_Report

4. Health & Safety; To ensure the safety of participants and staff

. Health & Safety at Work Act (1974)

The health and safety of participants, researchers and other staff must be given priority at all times. It is a legal requirement under the Health and Safety at Work Act (1974) that health and safety guidelines must be strictly observed.

The Health and Safety at Work Act can be accessed via http://www.hse.gov.uk/legislation/hswa.pdf

. Keele University Health & Safety Policy Statement

The University’s Health and Safety Policy Statement can be accessed via http://www.keele.ac.uk/admin/hr/ohsu/HSpolicy.htm

of 12 March 08 Version 1 Review date : March 2009 . Lone Working

The University’s Lone Worker Policy can be accessed via http://www.keele.ac.uk/research/research/governance/lone workin.htm

. Overseas Working

UCEA Health and Safety Guidance when working overseas can be accessed via http://www.ucea.ac.uk/objects_store/UCEA%20H&S %20Guidelines%20for%20Working%20Overseas.pdf

5. Finance; to ensure financial probity and compliance with the law

. Research proposals should set out the funding arrangements for the research. Costings for proposals must be made in consultation with the Research Institute Manager, with approvals from Research and Enterprise Services, Research Finance and from the Research Institute Director.

. Research contracts must be signed by the Research grants and contracts Manager and contracts of none standard exposure should be signed by the University’s Secretary and Registrar. Without these signatures the University will not undertake responsibility for upholding contracts and providing insurance.

. Costs in relation to research projects must not be incurred until a fully signed contract is in place. Page 7 of 12 March 08 Version 1 Review date : March 2009 . Public funds used for research must comply with the requirements of the funding body and the policies of the organisation administering the grant.

. To safeguard against any non compliance the University has a Fraud Response Plan, a Risk Management Policy, and University Financial Regulations which can be viewed at http://www.keele.ac.uk/depts/fi/director/finregs/Keele_Fin ancial_Regulations.pdf

of 12 March 08 Version 1 Review date : March 2009 Key responsibilities of the Principal Investigator and Research Team

. Developing research proposals that are scientifically sound and ethical.

. Conducting the research to the agreed protocol and in accordance with legal requirements and guidance and accepted standards of good practice. The University Code of Good Research Practice can be accessed via http://www.keele.ac.uk/research/Governance/Approved %20Code%20of%20Good%20Research%20Practice %20May%20071.doc

. Ensuring participants’ welfare whilst in the study.

. Feeding back the results of the research to participants (sponsors, funders, and host organisations).

Key responsibilities of the Employing Organisation

. Promoting a quality research culture.

. Ensuring researchers understand and discharge their responsibilities.

. Ensuring studies are properly designed and submitted for review as necessary.

. Ensuring studies are managed, monitored and reported as agreed, according to the protocol.

. Taking action if misconduct or fraud is suspected. Page 9 of 12 March 08 Version 1 Review date : March 2009 Useful sources of information

Caldicott Principles http://en.wikipedia.org/wiki/Caldicott_Report.

Code of Good Research Practice (Keele University) http://www.keele.ac.uk/research/Governance/Approved%20Code%20of%20Good %20Research%20Practice%20May%20071.doc

Data protection Act (1998) http://www.opsi.gov.uk/acts/acts1998/19980029.htm.

DoH Research Governance Framework for Health & Social Care http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962

Freedom of Information Act (2000) http://www.opsi.gov.uk/acts/acts2000/20000036.htm

Human Tissue Act (2004) http://www.opsi.gov.uk/acts/acts2004/20040030.htm

Keele Joint Independent Peer Review Committee http://www.keele.ac.uk/research/research/governance/peerreview.htm

Keele University Financial Regulations http://www.keele.ac.uk/depts/fi/director/finregs/Keele_Financial_Regulations.pdf

Keele University Health and Safety Policy Statement http://www.keele.ac.uk/admin/hr/ohsu/HSpolicy.htm

Lone Worker Policy (Keele University) http://www.keele.ac.uk/research/research/governance/loneworking.htm

Medicines for Human Use (Clinical Trials) Amendment Regulations (2006) http://www.opsi.gov.uk/si/si2006/20061928.htm

Mental Capacity Act (2005) http://www.opsi.gov.uk/acts/acts2005/20050009.htm

of 12 March 08 Version 1 Review date : March 2009 National Research Ethics Service http://www.nres.npsa.nhs.uk/

NHS R&D Forum http://www.rdforum.nhs.uk/

The Health and Safety at Work Act (1974) http://www.hse.gov.uk/legislation/hswa.pdf

The Royal Society http://www.royalsoc.ac.uk/document.asp?tip=0&id=5789

UCEA Health and Safety Guidance when working overseas http://www.ucea.ac.uk/objects_store/UCEA%20H&S%20Guidelines%20for %20Working%20Overseas.pdf

of 12 March 08 Version 1 Review date : March 2009 Academic Services Directorate Research Services

If you require any further information regarding Research Governance please contact;-

Nicola Leighton Research Governance Officer Research Services Dorothy Hodgkin Building Keele Univesity ST5 5BG

Tel : 01782 583306 E-mail : [email protected]

of 12 March 08 Version 1 Review date : March 2009