Research Governance Policy
1. Scope and Purpose
2. Need for a research governance policy
To meet the requirements of funding bodies To manage risk
To improve the quality of research To protect the quality of research
To safeguard the public and achieve public confidence in evidence 3. General Principles
Integrity Accountability Openness
Conflicts of interest
4. A framework for Research Governance
Adherence to legal, ethical and procedural requirements Responsibilities and accountabilities
Contractual responsibilities Finance
Intellectual property rights Supervision
5. Monitoring
6. Trust response to non compliance
1. Scope and Purpose
The Trust wishes to commission and undertake high quality research in a way that fosters excellence, effective leadership, openness, accountability and honesty. The Trust has a clear responsibility to develop a culture among staff and with contracted researchers in which attention to governance and ethics in research becomes accepted practice. The purpose of this document is to outline the Trust’s obligations and the requirements of both staff and contracted researchers in Research Governance.1
For the purpose of this policy, research includes:
o original investigation undertaken in order to gain knowledge and understanding2
o the development and interpretation of existing knowledge for specific applications or within a professional setting (for example, within a healthcare setting), including audit and audit-type studies, and service evaluation3
The Research Governance Policy applies to research carried out, funded, commissioned or published by or on behalf of the Trust.
2. Why is a Research Governance Policy required? The research governance policy has five aims:
To improve the quality of research: A Research Governance Policy helps to promote more efficient practices; and a culture of peer review, transparency, open communication and high ethical
standards.
To meet the requirements of funding bodies. Our research sponsors expect the Trust to have published standards of good practice and to have an adequate structure to promote and achieve good research practice.
To manage risk: Research misconduct may adversely affect the Trust’s overall reputation as well as its relationship with research sponsors and research partners. It is considered best practice to have published standards of good research practice which include procedures for the investigation of allegations of research misconduct.4
To protect the researcher. A Research Governance Policy is helpful in clarifying responsibilities, accountabilities and obligations. The Research Governance Policy and associated procedures make explicit many elements within research that were implicit.
1
Related policies include Handling Confidential Information and financial guidelines. 2
Aston Business School Definition of Research available on line at http://www.abs.aston.ac.uk/newweb/research/ethics/recDefinition.asp 3
See appendix 1 for further information 4
Association of Medical Research Charities AMRC Guidelines on Good Research Practice, 2002
To safeguard the public and achieve public confidence in research. The public expects high scientific, ethical and financial standards; transparent decision-making processes; clear allocation of responsibilities and robust monitoring arrangements.
3. General principles Ethical requirements
Researchers must ensure that engagement in non-therapeutic research causes no or only minimal harm to participants. The dignity, rights, safety and well-being of participants must be a primary consideration in any research study.
Researchers should consider the ethical implications of the research and the social, political, cultural and economic consequences of the work for the participants, funders and general public. All research carried out should be to high ethical standards, and comply with all relevant legal requirements for ethical approvals. Researchers 5 must adhere to all relevant policies or codes of good practice. Researchers must address ethical requirements (including sensitivity of participants and information) in the presentation of their project proposals.
Integrity
Researchers should be honest in respect of their own actions in research and in their responses to the actions of other researchers. This must apply to the whole range of research work, including experimental design, generating and analysing data, applying for funding, publishing results and acknowledging the direct and indirect contribution of colleagues, collaborators and others.6
The Trust has a responsibility to encourage the highest possible standards of care, consideration and integrity within all research. The Trust is accountable for:
o the safety of the participants and the researchers o the probity of the financial management of the project o the reliability of the results
o making every best effort to provide value for money invested in the project
Openness
Researchers are expected to be as open as possible in discussing their work, making useful results of their work, including relevant data and materials, available to others as rapidly as possible (consistent with contract requirements, consents and ethical approvals and intellectual property rights). However it is recognised that researchers may need, on occasions, to delay disclosure of details of their work in order to protect their legitimate research interests.
Researcher must also be open about any personal or political interests they have that might impact on the interpretation of results.
5
References to Researchers throughout this document include those contracted to undertake research on behalf of the Trust
6
The Wellcome Trust Guidelines for Good Research Practice, January 2002
Conflicts of Interest
A conflict of interest arises when a researcher’s judgement concerning a primary interest, such as scientific knowledge, could be unduly influenced by a secondary interest, such as financial gain or personal advancement. Conflicts of interest must be disclosed and addressed appropriately. Where the researcher is not fully competent or sufficiently informed to make a fair judgement about the conflict, it is essential that advice is sought.
4. A Framework for Research Governance
Adherence to legal, ethical and procedural requirements
Researchers must comply with all applicable legislation. This includes legislation related to data protection and health and safety.
Researchers should conform to all Trust policies and in particular:
The Health and Safety Policies, which are available here: X:\Staff Material\Staff Guides\Health & Safety Handbook\LIVE Health and Safety Employee Handbook 20 June 2011 JM.docx
The Employee Handbook, which is located: X:\Staff Material\Staff Guides\HR Handbook\Employee Handbook\Employee Handbook v7_Mch2013.docx
Researchers should abide by the code of ethics of any professional body or association of which they are members. Researchers should also be aware of any code of ethics that applies to potential and actual collaborators on the project and/or other participants.
Where necessary, approval from the appropriate Research Ethics Committee must be obtained for research undertaken within the National Health Service. Where research is undertaken outside of the National Health Service, an ad hoc internal ethics committee process may be appropriate. Approvals from local research governance processes should also be sought where these are relevant to the study.
Guidance can be obtained from the website http://www.nres.nhs.uk/
Similarly researchers will conform to national requirements on information governance to protect confidential information in line with proposal arising from the Caldicott7 review and current national guidance from NHS England http://www.england.nhs.uk/ourwork/tsd/data-info/ig/.
Researchers must agree to and sign the Trust policy on handling l information on induction
Considerations should be given to the impact of the research on society
The principles of beneficence and non–maleficence are fundamental to all research activity. Beneficence is the requirement to promote the interests and wellbeing of others. It is the ethical principle of ‘doing good’ in the widest sense. Non-maleficence is the principle of ‘not doing harm’. Both principles must be applied to all entities directly or indirectly affected by the research.
7https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/192572/2900774_InfoGovernance_accv 2.pdf
Researchers have an obligation to attempt to minimise any risk of harm to themselves, the participants and the environment which may result from their research.
Researchers shall give consideration to the value of the research
It is essential that existing sources of research within the same area are considered carefully prior to any research being undertaken. Research that knowingly duplicates other work unnecessarily or which is not of sufficient quality to contribute to existing knowledge is, in itself, unethical.
Consent shall be acquired before any research is undertaken
Consent should be sought from participants in accordance with legal requirements and they should not be under the impression that they are required to participate. They should understand what participation in the study requires and what benefits may arise from the research. For studies where vulnerable participants are involved then it is especially important to consider the specific appropriate ethical protocols. Where there are legitimate reasons not to acquire such consent, prior approval must be sought from the relevant Ethics Committee.
All participants should be genuinely willing to take part in the research
Participants should not be forced into participating in the research and they should not be offered inducements which may lead them to make decisions prejudicial to their welfare. Consideration should be given as to whether legitimate incentives could influence the results of the research. The use of payments to respondents must consequently be subject to ethical scrutiny. Reimbursement of participants’ expenses, for example travelling, is permitted if the terms of the funding permit this. At the outset of the research, researchers should make it clear to the participants that they may withdraw at any time.
Participants shall be fully aware of the aims of the research, what it entails and other relevant information
As a general rule, potential participants have the right to receive clear and detailed information about what the research entails in advance. This should be explained on an information sheet set out in plain English, or other appropriate language, and participants should be given plenty of time to study this sheet and to ask questions. Information that would be likely to affect a participant’s willingness to participate should not be deliberately withheld, since this would remove from participants an important means of protecting their own interests. Where there are legitimate reasons not to fully inform participants prior approval must be sought from the relevant Ethics Committee.
Participants have the right to confidentiality
Participants’ confidentiality shall be maintained at all times. Researchers must sign and adhere to the Trust’s Confidentiality Policy.
Publication of research findings
Subject to the standards set out in the Trust Confidentiality Policy, researchers are required to disseminate and publish all research findings. The terms for publication are included in the grant conditions for externally funded projects – see Schedule 4 of template:X:\Staff Material\Staff Guides\Grant documents\Grant Conditions Template FINAL DRAFT.docx
When publishing research, all reasonable steps must be taken to ensure that published reports, statistics and public statements about research activities and performance are accurate and
unambiguous. The nature of financial support must be acknowledged in all reports of research outcomes, both to acknowledge the support and to enable readers to make their own judgement over any prejudicial influences the financial support may have had upon the direction of the research.
All researchers who have contributed to the development of the results and dissemination must be appropriately acknowledged.
Research Ethics Framework and decision making structure
The research ethics framework (appendix 2) represents the required processes from the initial concept through to output of each piece of research undertaken, commissioned or funded by the Trust.
4.2 Quality Review Process
All proposals for internally funded projects where estimated expenditures exceed £50,000 will require either
a. two external referees (including senior associates) taken from outside of the project team to comment on the plan for the research project. In most instances the Trust will identify an individual with an established reputation in a relevant research field from their group of Senior Associates. In addition the opinion of a suitable referee will be sought on any public reports or papers arising from the project before publication.
b. A steering/advisory group that contains at least two expert advisors
For externally funded research projects the Trust will adhere to the peer review arrangements and research governance requirements of the project sponsor. Wherever possible the research team will actively seek external views on proposed research methodologies and on research findings. For smaller projects the Trust will require approval of the Senior Management Team in establishing new research work and before the publication of any findings. For externally commissioned
projects the Trust will need to ensure that it is content with the quality of work which its name will be associated with. However the Trust recognises that in certain extreme circumstances the research team may disagree and wish to publish independently.
See Appendices three and four for further details of the governance process. 4.3 Responsibilities and accountabilities
Where the Trust is funding the study, it has a key role in scientific quality assurance establishing that the research proposal is worthwhile, of high scientific quality, and that there is a proper use of the funds to secure value for money. This includes evaluating the experience and expertise of the Principal Investigator and other key researchers; and whether there is appropriate research infrastructure for the study, for example:
o management and governance arrangements o access to potential participants/data
o specialised facilities such as equipment o materials or support staff
Where the Principal Investigator is not a member of staff, the relevant SMT lead is responsible for this evaluation. It is good practice for funders to make scientific judgments related to their
responsibilities with expert advice independent of the investigators. In general we would describe the key roles and responsibilities as below. Principal Investigator
A senior individual must be designated as the Principal Investigator. This person takes
responsibility for the conduct of the research and is accountable for this to their employers. The principal investigator shall have responsibility for:
o ensuring the study complies with all legal and ethical requirements and that the Trust’s Research Governance Process is adhered to
o timely monitoring and reporting of the progress and outcomes of the work required by the sponsor, funders or others with a legitimate interest and ensuring they are of an acceptable standard
o the findings of the work being open to critical review through accepted scientific and professional channels
o ensuring arrangements are in place for the management of any intellectual property arising o ensuring procedures are in place to ensure collection of high quality, accurate data and the
integrity and confidentiality of data processing and storage
o ensuring arrangements are in place for the appropriate archiving of data when the research has finished
o ensuring appropriate arrangements for the dissemination of research methods and findings
Principal Investigator responsibilities to staff include:
o ensuring that each member of the research team is qualified by education, training and experience to discharge his/her role in the study
o new researchers receive adequate supervision, support and training and receive appropriate recognition in the authorship of paper/reports
o detecting and preventing research misconduct by adopting the role of guarantor for published outputs
Responsibilities to participants include:
o prioritising the dignity, rights, safety and wellbeing of participants
o ensuring findings from the work are disseminated properly and fed back as appropriate to participants
Where the Principal Investigator is not a member of Trust staff, the SMT lead for the project is responsible for ensuring these actions are undertaken.
Project Leader
The project leader shall have responsibility for the delivery and management of a study including: o developing practical plans to implement research proposals
o ensuring adequate staffing for the project to deliver results in a timely fashion and of high quality
o ensuring supporting resources are available and are used in accordance with trust policies o timely reporting of the progress and outcomes of the work required by the sponsor, funders
or others with a legitimate interest
o managing the processes of data collection to ensure high quality, accurate data and the integrity and confidentiality of data processing and storage
o ensuring arrangements are in place for the appropriate archiving of data when the research has finished
Researcher
The Researcher shall have responsibility for:
o undertaking research in line with agreed proposals and to agreed standards
o adhering to relevant Trust policies on research governance ethics, and information handling o undertaking work in ways that are consistent with this code of practice
4.3 Contractual responsibilities
When the Trust undertakes research that is funded externally or is contracting others to undertake research, the terms of research must be agreed in advance. This requirement will be waived only in the most exceptional of circumstances.
Terms will include:
o the specification of the research project
o the roles and responsibilities of the researchers, the employing institution(s), the Trust (whether as funder or employing institution), and the funder(s)
o agreement on the dissemination and exploitation of the research outputs o responsibilities for publication
The need for confidentiality and non-disclosure agreements must be negotiated in advance. Issues of pre-existing rights and other legal issues should also be clarified in advance.
4.4 Finance
The Principal Investigator will be responsible for budget management, though they may choose to delegate that to the Project Lead. The Trust Senior Management Team will scrutinise research proposals in order to establish if the stated funding is adequate and robust. The Trust Financial Director will establish if the level of indemnity cover for negligent harm is suitable for the type of research being proposed.
For new projects (not outlined in the annual business plan) where the estimated cost exceed £75,000, or are assessed as being of high reputational risk, then approval to go ahead will be required from the Finance Committee or Trust Board.
4.5 Intellectual Property Rights
Researchers will adhere to policies (internal and external), agreements (internal and external) and, where appropriate, contractual requirements regarding ownership, exploitation and income from intellectual property.
All external contracts should follow the standard terms for grant conditions see: X:\Staff Material\Staff Guides\Grant documents\Grant Conditions Template FINAL DRAFT.docx
4.6 Supervision
Senior managers will seek to sustain a research culture of mutual co operation within the Trust, where individuals are encouraged to develop their skills and engage in the open exchange of ideas. It will be the responsibility of the SMT leads to ensure that appropriate supervision of researchers is provided. SMT leads will ensure that all staff are informed of the Research Governance Policy as part of their induction.
5 Monitoring
All research within the Trust will be open for scrutiny and all projects shall be open to internal audit in respect of key indicators such as legal requirements, ethical approval, and adherence to
guidelines for financial reporting. For each substantive research project the Senior Management Team will require completion of simple summary documentation outlining the nature of the
projects, the necessary permissions required and potential liabilities for the Trust (appendix four). The document will also identify any high level risks associated with the project. These will be reviewed on a regular basis whilst a project is active.
All Trust policies and procedures, whether existing or subsequently approved, must be adhered to including those for ethical approval of research.
Publication in the form of peer-reviewed public output provides the opportunity for external and public monitoring. It is recommended that there are clear arrangements, made at an early stage in the research, between team members and stakeholders about the projects’ publication and communication strategy.
6 Trust response to non–compliance
Non compliance with this policy, whether deliberate, reckless or negligent, may be deemed as research misconduct. For the purposes of this policy, research misconduct includes the following (though is not limited to):
o failure to obtain appropriate permission to conduct research o deception in relation to research proposals
o unethical behaviour in the conduct of research, for example in relation to research participants
o unauthorised use of confidential information
o deviation from good research practice, where this results in unreasonable risk to participants
o fabrication, falsification or corruption of research data
o distortion of research outcomes, by distortion or omission of data that do not fit expected results
o dishonest misinterpretation of results
o publication of data known or believed to be false or misleading o plagiarism or dishonest use of unacknowledged sources o misquotation or misrepresentation of results
o inappropriate attribution of authorship
o fraud or other misuse of research funds or research equipment
o attempting, planning or conspiring to be involved in research misconduct o inciting others to be involved in research misconduct
Cases of research misconduct by staff of the Trust will be dealt with under the Trust’s disciplinary policy. For those undertaking research on behalf of the Trust, compliance with this policy will be required through conditions of the research contract.
All members of staff are encouraged to report, in a reasonable manner, any suspected cases of such misconduct. This should be done directly to the appropriate head of department or the Trust’s Chief Executive.
7 Research Governance Policy Review
The Research Governance Policy will be subject to regular review and amended accordingly to reflect any such changes in national and local policies, as well as professional and agency guidelines. Any such amendment will require approval from the Board of Trustees.
Updated: September 2013
Approved: presented to the Chairman’s Committee October 2013 Review Date: September 2015
Appendix 1 – Definitions of research from National Research Ethics Service http://www.nres.nhs.uk/applications/is-your-project-research/
Appendix 2 – Research Ethics Framework
Proposal
Internal Review Panel review against national definitions
NHS Ethical Approval required
PI submits application to NREC
Approval gained Approval
declined NHS Ethical Approval not required*
Project commences, monitored by PI for compliance with research ethics policy
Project subject to ongoing performance and risk monitoring
PI ensures appropriate dissemination and reporting. Team assist in dissemination, ensure confidentiality maintained and contractual terms adhered to
PI revise and
resubmit application
Appendix 3 – Governance of Research Projects
Develop research idea into plan (including outline of resources and timeframes) Idea for research project SMT consider plan Resource requirement greater than £50k, or enhanced risk? Internal funding* Sponsor’s peer review approval process External funding
Receive comments from two external peer reviewers
Give comments and plan to SMT yes Group Head to approve no
Complete project proposal
SMT decision whether or not to proceed
Project delivery
PI and Comms lead agree communications plan
Internal team producing paper for peer reviewed journal?
Produce internal reports/outputs?
Peer review then SMT approve report prior to publication Agree other
outputs eg web media
SMT – Senior Management Team
*includes projects undertaken by contractors on behalf of the Trust
If project has high risk/impact on financial reserves or budget exceeds £75k, then Trust Board approval reqd
External team produce peer reviewed paper
Draft sent to SMT before publication
Agree contract details/specs
Appendix four – Project Proposal Form
Schedule 1
This form will be used as Schedule 1 to the contractual Grant Conditions which all Grantholders are required to sign.
Project Proposal Form
SMT lead
Project lead
External leads (if applicable)
Project Funder
1. Project Title:
2. What are its aims and objectives?
3. Brief outline of methods
4. Key Project Deliverables – please identify key project deliverables within each phase throughout the lifetime of the project. Please attach dates.
Reference (if any) Description of Key Project Deliverable Date
Please state all teams that will be involved with this project:
Research Policy Economics Communications Resources
5. Funding - What is the level of funding required for this project?
£5-15k £5-75k
£75k +
Is this an externally funded project? If yes, please say how much
6. What are the cost elements of the project?
Staff:
External Grants:
Comms:
Other:
7. Duration - What is the duration of the project?
Start date: Project length:
8. Risk Analysis
Risk type Degree of Exposure (High, Med, Low) Control Method(s) Proposed
Ethical
Governance
Data Handling and Storage
Intellectual Property rights
Financial
Operational
Reputational
9. Communication - What are the expected outputs from the project?
10. Please add here, any other relevant information for SMT to consider
11. Key dates Event Date Submitted to SMT Resubmitted to SMT Passed by SMT
Passed by Finance Committee / Board
Grant letter issued by NT
Grant letter received back
Project start date
Projected end date (research phase) Projected launch date for all outputs
