Contents
1 Introduction
Since the introduction of the research governance framework for health and social care, and its subsequent replacement with the UK framework for health and social care research 2017, it has been necessary to have in place a working policy relating to the way that research is undertaken in Rotherham Doncaster and South Humber NHS Foundation Trust (RDaSH).
When an NHS body is the organisation providing care, it is required to confirm capability and capacity before research can begin to enable the trust to maintain records of and monitor the research taking place. Research is an essential component of developing effective health care but it can also carry elements of risk.
1.1 Definitions and explanation of terms used
| Term | Definition |
|---|---|
| Study wide review | Ensuring that the research complies with all legislative |
| Ethics | Ensuring the dignity, rights, safety and wellbeing of research participants |
| Science | Ensuring that the design and methods of research are subject to independent review by relevant experts |
| Information | Ensuring full and free public access to information on the research and its findings |
| Health and safety | Ensuring at all times the safety of research participants, researchers and other staff or volunteers involved in research |
| Finance | Ensuring financial probity of the research |
| Law | Ensuring compliance with the law in the conduct of research |
These core principles are ensured through robust review of the research by the Health Research Authority (HRA), research ethics committee (REC), study sponsors, funder and oversight of the conduct of the research by the Grounded Research department and researchers in RDaSH.
2 Purpose
This policy aims to ensure that RDaSH has systems in place to develop and maintain a research culture of excellence through consistent application of the principles and requirements of the UK framework for health and social care research. The trust will seek to do this by providing support and guidance for those who wish to undertake research. research This will be done via the Grounded Research department who will enable research to be undertaken to high standards, taking into account ethical implications.
3 Scope
This policy applies to everyone involved with RDaSH and is particularly relevant to those who host, manage, participate in, or undertake research, regardless of their status within RDaSH, including the following:
- trust employed researchers and research support staff
- seconded researchers and research support staff
- researchers not employed by the trust who wish to conduct research in or with the trust under a letter of access or honorary contract or letter of access
- students undertaking research in the trust as part of an academic qualification
4 Responsibilities, accountabilities and duties
4.1 Accountability
Overall accountability for research governance within the trust lies with the chief executive. This responsibility is delegated to the executive medical director or research director. The executive medical director or research director will ensure that research is reviewed and approved in principle by the research panel before it can progress. The executive medical director or research director is supported by the Grounded Research department which has operational responsibilities for research.
4.2 Research panel
The research panel supports the research governance function and reviews, approves and monitors all research projects in the trust. (see appendix A).
4.3 Delegation of responsibilities
Authorisation for all research projects lies with the chief executive and the medical director. Other duties are delegated as follows:
| Task or process | Designated officer(s) |
|---|---|
| Promoting a positive culture of research within the trust | All |
| Functioning as the first point of contact for research within the trust | All |
| Taking action if misconduct or fraud is suspected in line with the RDaSH counter fraud bribery and corruption policy and the disciplinary policy | RD or ARD |
| Alerting the medical director or research director of any complaints received related to research activity and supporting investigation as agreed at the research panel | ARD or HR |
| Supporting access to appropriate expertise in the design of research | HR or RGM |
| Supporting the planning and delivery of research | HR or RGM |
| The management development and implementation of research governance systems and procedures | RGM |
| Highlighting changes to legislation and national processes relating to research and ensuring these changes are implemented across the organisation | RGM |
| Making researchers aware of governance requirements and ensuring they understand their responsibilities | RGM |
| Providing support via access to information on research governance procedures and regulatory requirements | RGM |
| Advising and assisting researchers through the requirements of the research approvals processes including HRA, REC and MHRA as required | RGM |
| Ensuring that all applicable regulatory requirements are adhered to | RGM |
| Ensuring that research is conducted in accordance with good clinical practice (GCP) principles | RGM |
| Reviewing capability and capacity of all research taking place including obtaining internal authorisations | RGM |
| Ensuring that research is well managed, monitored and reported | RGM |
| Ensuring that the conduct of RDaSH sponsored studies are appropriately monitored | RGM |
| Monitoring recruitment to time and target and providing support or advice where appropriate | RGM |
| Communicating research summaries or appropriate reports to a variety of audiences | RGM |
| Alerting the medical director or research director of any complaints and supporting investigation as agreed at the research panel Grounded Research department | ARD or HR |
| Managing research passport validation for RDaSH employed staff conducting research outside of the organisation | RGM |
| Ensuring that honorary research contracts and letters of access are issued for external researchers coming into the organisation | RGM |
| Managing research passport validation for RDaSH employed researchers and research support researchers and research support staff conducting research outside of the organisation. Ensuring that honorary research contracts and letters of access are issued for external researchers coming into the organisation | RGM |
4.4 Researcher responsibilities
Each researcher is accountable for their own practice and for abiding by the UK framework for health and social care research, GCP and other relevant legislation and regulations relating to research that they are involved with.
The researcher is responsible for:
- notifying the Grounded Research department of research they are planning to undertake by submitting the research registration form (see registering a research project SOP) and submitting the local information pack as defined by the HRA
- adhering to the approved research protocol
- complying with legal requirements and obtaining the prior approval of the relevant dare group or the executive medical director or research director
- provide information to the appropriate managers and clinical staff regarding research being conducted in their service, department or ward. This should include information regarding the conduct of the research and especially anything relevant to the participant’s wellbeing
- safeguarding participants’ welfare whilst in the study
- retain responsibility, where applicable, for research participants’ care
- the dissemination and publication of their work, with the guidance of the Grounded Research department
- adhering to all trust policies and procedures. Reporting any adverse incidents connected to the research in line with the trusts incident management procedures (see incident management policy) and the incident reporting system (IR1). In addition, specific legal requirements exist to report incidents, for example, adverse reactions to medicines to the medicines and healthcare products regulatory agency (MHRA)
- adhering to the Health and Safety at Work Act, (see health and safety at work policy) in respect to themselves and their participants
- all those involved in research with human participants, their organs, tissues or data, must be aware of and implement the basic principles from the UK framework for health and social care research
- the appropriate use and protection of patient information is of paramount importance to the trust. All individuals involved in research must be aware of their legal and ethical duties and particular attention must be given to systems for ensuring confidentiality of personal information and to the security of these systems. All relevant trust policies and procedures must be adhered to for example information governance policy and management framework, which includes data protection, healthcare record keeping policy and corporate records policy and the requirements of the Caldicott guardian
- research material such as questionnaires or raw data must be kept in accordance with NHS guidance (see corporate retention and disposal policy (records management) for retention periods)
- all those carrying out research to which the requirements of the Mental Capacity Act (2005), apply must act in accordance with the provisions of the act
- all those involved in research have a duty to ensure that they and those they manage are appropriately qualified, both by education and experience, for the role they play in relation to any research. They must be aware of and have ready access to sources of information and support in undertaking that role
5 Procedure or implementation
5.1 Confirmation of capability and capacity (CC and C)
All research must follow the procedures outlined below:
- the research protocol must be submitted to the research panel to check that the project fits with the research strategy and is feasible to run in the trust
- research activities must not start at site until the Grounded Research department provides CC and C
Approval is dependent upon:
- all research projects involving human participants, their data or organs, must have Health Research Authority (HRA) approval or appropriate exemption
- research ethics committee favourable opinion is required with the exception of studies deemed exempt by HRA
- appropriate approval(s) from the service or department
- where there is no appropriate band 8 manager (for example they are involved in the research) the approval should be escalated to the next level of management
- for research that requires significant resource to be provided by the trust, approval should be obtained from the relevant director (or equivalent) as well as the service manager (or equivalent manager, band 8 or above)
- support service approval must be obtained where the service is required to support any form of research activity
- any research involving medicines must go through the trust medicines management committee for approval
- researchers wishing to store patient identifiable information for example, patient names, addresses, dates of birth etc. on a database or spreadsheet must apply for permission and obtain sign off from the Caldicott guardian (see information governance policy and management framework). The Caldicott guardian sits on the research panel and this requirement is met part of research panel approval (see appendix D).
5.2 Finance and intellectual property
All researchers must comply with the procedures of RDaSH standing financial instructions (see standing financial instructions SOP) in planning and accounting for all expenditure.
All researchers must be aware of and adhere to the counter fraud bribery and corruption policy (see counter fraud bribery and corruption policy).
Where there is any potential intellectual property identified researchers must comply with the trust’s intellectual property exploitation policy (see intellectual property exploitation policy).
Where the research is externally funded, the findings will be subject to contractual agreement with the research funder or the employing organisation before commencement. The trust must ensure that there are agreements between them and research funders or other care organisations about ownership, exploitation and income from any intellectual property that may arise from research conducted by their employees.
5.3 Involvement of consumers, service users, carer’s and the public in research
Participants, or their representatives, should be involved wherever possible in the design, conduct, and analysis and reporting of research. Social care research has a long tradition of the involvement of participants in research. “Involve”, the consumers in NHS research group, has established the principle that major advisory bodies in NHS R and D programs should normally have at least two consumer representatives.
Once established, findings must be made available to those participating in the research (including the relatives of deceased patients who have consented to the use of organs or tissue in the research) and to all those who could benefit from them, through publication or other appropriate means.
As health and social care research is conducted for the benefit of patients, users, care professionals, and the public in general, there should be free access to information both on the research being conducted and on the findings of the research, once these have been subjected to appropriate scientific review. Reports will be comprehensible and consider language and special requirements
5.4 Complaints and misconduct
Where a complaint is made relating to research taking place in RDaSH, the complaint will be thoroughly investigated by the research panel and, if appropriate, action will be taken in accordance with the HR disciplinary policy (see disciplinary policy).
The research panel will hold an emergency meeting to implement an immediate investigation into the possible research misconduct. Depending on the findings of the investigation actions will be agreed. These may include actions to improve protocol compliance, requiring the research team to complete additional training or introduction of an improvement plan. Where the findings identify a serious protocol breach the research can be suspended or closed at site in line with GCP. Professionals may be subject to disciplinary action in with the event of a serious breach of GCP.
At all times HR polices will be adhered to.
Each professional group is also responsible to their respective regulatory body, such as the GMC, or NMC.
5.5 Indemnity
All research must have a nominated sponsor who will carry non-negligent indemnity.
For clinical trials involving medicines it is a legal requirement that there should be insurance or indemnity to cover the liabilities of sponsors and investigators and if any organisation or sponsor itself offers compensation without proof of negligence, it has made the necessary financial arrangements.
Agreements will be documented that include the responsibilities of all parties involved within the programme.
This may include where there is:
- work at more than one RDaSH site
- RDaSH staff working at another trust
- external staff working at RDaSH under a honorary contract or letter of access
- researchers employed by more than one organisation
- patients, users and care professionals from more than one organisation
- more than one source of funding
For research led by RDaSH employed staff, the trust can act as sponsor and provide full indemnity for that research study, providing the research is not for an academic qualification.
Researchers not employed by RDaSH but accessing the trust resources for the purposes of their research will have to provide evidence of indemnity. This is usually provided as part of the research passport process (see research passport SOP)
Any researcher employed by the trust who does not follow the agreed process for approval of their research will not be entitled to trust indemnity.
Where the approved study protocol is not adhered to RDaSH, as sponsor organisation, can suspend or terminate a study following investigation by the research panel.
5.6 External organisations
Where research is externally funded, the funding organisation has the responsibility for ensuring that the funds are used in the manner that they are intended.
Where research is externally sponsored, the sponsoring organisation has the responsibility for ensuring that sponsorship responsibilities are met, the sponsor being legally responsible for the conduct of the research.
In the event that a participant makes a complaint to the trust, the complaint handling policy should be followed and where appropriate the sponsor should be informed of the event only in a fully in an anonymised report. Research participants should be able to notify the sponsor, trust or both of any complaint they may have. Study specific contact details must be provided.
5.7 External researchers
External researchers, without either a clinical contract or student placement with supervision, who wish to conduct their research on RDaSH premises, access patients, RDaSH facilities and, or patient data must have an honorary contract or a letter of access. The research passport system (see research passport SOP) and associated procedures have been developed to ensure that the interests of all parties are considered and the safety of patients and are maintained. Furthermore, these procedures have been developed in parallel with other arrangements across the UK to streamline the processes for obtaining permission from NHS organisations to undertake research.
A research passport can be used as evidence with which to apply for an honorary contract or letter of access.
National arrangements are outlined within the research in the NHS HR good practice resource pack.
RDaSH internal arrangements between human resources and the Grounded Research department and allow the Grounded Research department to manage the processes
6 Training implications
As a trust policy, all staff needs to be aware of the key points that the policy covers. Line managers are responsible for all staff they manage being aware of how they can access copies of this policy.
There are no specific training needs in relation to this policy; however anyone involved in research will need to be familiar with its contents.
Staff involved in research delivery may need to have current GCP training (within the last three years). The Grounded Research department can confirm if required, and the level of training, required and provide details of providers.
Researchers and research support staff will be made aware through one to one meetings or supervision and as part of the CC and C process which highlights the need to adhere to trust policies.
7 Monitoring arrangements
Grounded Research is responsible for informing the board of directors of all significant developments, risks, and progress. Bi-annual updates are submitted to the quality committee (QC), which is a sub-committee of the trust’s board of directors. Reporting is managed by the research panel. The medical director or research director provides the quality committee with an annual end of year report (November) and a six month assurance report (May) each year. Any other issues are recorded via exception reporting.
7.1 Research projects
- How: Use of audit tool. A minimum of 10% of open research projects.
- Who by: Grounded Research team.
- Reported to: Research panel.
- Frequency: Annually.
7.2 Portfolio studies
- How: EDGE database, and open data platform reports.
- Who by: Grounded Research team.
- Reported to: Research panel, and Yorkshire and Humber LCRN.
- Frequency: Monthly.
7.3 Register of research
- How: EDGE database, and open data platform reports.
- Who by: Grounded Research team.
- Reported to: Research panel.
- Frequency: Monthly.
7.4 Research study activity
- How: Recruitment reports, and regular contact with local and central study teams.
- Who by: Grounded Research team.
- Reported to: Research panel.
- Frequency: Monthly.
7.5 Research activity in trust
- How: Annual end of year report and six month assurance report.
- Who by: Research director.
- Reported to: Quality committee.
- Frequency: Bi-annually.
8 Equality impact assessment screening
The completed equality impact assessment for this policy has been published on this policy’s webpage on the trust policy library or archive website. Link to overarching EIA.
8.1 Privacy, dignity and respect
The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’.
As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).
8.1.1 How this will be met
No issues have been identified in relation to this policy.
8.2 Mental Capacity Act 2005
Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.
Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005)to ensure for that the rights of individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.
8.2.1 How this will be met
All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act (2005) (section 1).
9 Links to any other associated documents
- Complaints handling policy
- Corporate records policy
- Counter fraud bribery and corruption policy
- Data protection act and research SOP
- Delegation of study duties SOP
- Disciplinary policy
- Document version control and research SOP
- Healthcare record keeping policy
- Health and safety at work policy
- Incident management policy
- Information governance handbook
- Information governance policy and management framework
- Intellectual property exploitation policy
- Investigator site file SOP
- Performance management (capability) policy
- Registering a research project SOP
- Retention and disposal policy (records management)
- Research passport: Honorary collaboration contract, honorary research contract, letter of access SOP
- Standing financial instructions SOP
10 References
- UK framework for health and social care research (HRA and Department of Health published October 2017) (opens in new window).
- National institute for health research (2010) research in the NHS. HR good practice resource pack. HR good practice: information for researchers, R and D and HR at higher education institutions and the NHS (opens in new window).
- Mental Capacity Act, health research authority (opens in new window).
11 Appendices
11.1 Appendix A Definitions and explanation of terms used
| Acronyms | Long form |
|---|---|
| ARD | Assistant research director |
| CC and C | Confirmation of capability and capacity |
| CRN | Clinical research network |
| DBS | Disclosure and barring service |
| RD | Research director |
| DHSC | Department of health and social care |
| GCP | Good clinical practice |
| HR | Head of research |
| HRA | Health research authority |
| IM and T | Information management and technology |
| IRAS | Integrated research application system |
| LIP | Local information pack (trial documents) |
| MHRA | Medicines and healthcare products regulatory agency |
| NIHR | National institute for health research |
| NMC | Nursing and midwifery council |
| NRES | National research ethics service |
| R and D | Research and development |
| REC | Research ethics committee |
| RMG | Research governance manager |
11.2 Appendix B Research panel composition
- Executive medical director or research director (chair).
- Assistant research director (deputy chair).
- Director of psychological therapies research.
- Head of research.
- Clinical research consultant.
- Principal clinical psychologist.
- Research nurses.
- Clinical studies officers.
- Research assistants.
- Post doctoral research assistant.
- Research governance manager.
- Chief or senior pharmacist.
- Clinical effectiveness lead investigator, nursing and quality directorate.
- Management accountant.
- Research administrator.
- Guests may attend by invitation.
11.3 Appendix C UK framework for health and social care research
The UK framework for health and social care research mandate states that the following core principles apply to all health and social care research.
11.3.1 Principle 1, safety
The safety and well-being of the individual prevail over the interests of science and society.
11.3.2 Principle 2, competence
All the people involved in managing and conducting a research project are qualified by education, training and experience, or otherwise competent under the supervision of a suitably qualified person, to perform their tasks.
11.3.3 Principle 3, scientific and ethical conduct
Research projects are scientifically sound and guided by ethical principles in all their aspects.
11.3.4 Principle 4, patient, service user and public involvement
Patients, service users and the public are involved in the design, management, conduct and dissemination of research, unless otherwise justified.
11.3.5 Principle 5, Integrity, quality and transparency
Research is designed, reviewed, managed and undertaken in a way that ensures integrity, quality and transparency.
11.3.6 Principle 6, protocol
The design and procedure of the research are clearly described and justified in a research proposal or protocol, where applicable conforming to a standard template or specified contents 27.
11.3.7 Principle 7, legality
The researchers and sponsor familiarise themselves with relevant legislation and guidance in respect of managing and conducting the research.
11.3.8 Principle 8, benefits and risks
Before the research project is started, any anticipated benefit for the individual participant and other present and future recipients of the health or social care in question is weighed against the foreseeable risks and inconveniences once they have been mitigated.
11.3.9 Principle 9, approval
A research project is started only if a research ethics committee and any other relevant approval body have favourably reviewed the research proposal or protocol and related information, where their review is expected or required.
11.3.10 Principle 10, information about the research
In order to avoid waste, information about research projects (other than those for educational purposes) is made publicly available before they start (unless a deferral is agreed by or on behalf of the research ethics committee).
11.3.12 Principle 11, accessible findings
Other than research for educational purposes and early phase trials, the findings, whether positive or negative, are made accessible, with adequate consent and privacy safeguards, in a timely manner after they have finished, in compliance with any applicable regulatory standards, for example, legal requirements or expectations of regulators. In addition, where appropriate, information about the findings of the research is available, in a suitable format and timely manner, to those who took part in it, unless otherwise justified.
11.3.12 Principle 12, choice
Research participants are afforded respect and autonomy, taking account of their capacity to understand. Where there is a difference between the research and the standard practice that they might otherwise experience, research participants are given information to understand the distinction and make a choice, unless a research ethics committee agrees otherwise. Where participants’ explicit consent is sought, it is voluntary and informed. Where consent is refused or withdrawn, this is done without reprisal.
11.4 Appendix D RDaSH research study approvals process
- Is your project a research project?
- if no, follow trust guidance for project type
- If yes, HRA approval category, follow either step 11.4.1 or step 11.4.2.
11.4.1 HRA deem CC and C not required
- Submit LIP:
- if objected, research cannot go ahead
- if no objection, research can start
11.4.2 HRA deem CC and C required
- Discuss feasibility with GR and submit LIP.
- Research panel approved?
- if no, research cannot go ahead
- If yes, are internal approvals required?
- if no, all approvals obtained and CC and C checks completed and issued
- If yes, have you got approval of drug trial CTIMP (medicine management), funding (finance), trust resources or capacity (care group) and trust sponsorship (research director)?
- if yes to all, all approvals obtained and CC and C checks completed and issued
- if no, research cannot go ahead
Document control
- Version: 7.2.
- Unique reference number: 335.
- Approved by: Corporate assurance approval group.
- Date approved: 29 January 2024.
- Name of originator or author: Research governance manager.
- Name of responsible individual: Executive medical director and research director.
- Date issued: 13 February 2024.
- Review date: June 2024.
- Target audience: Everyone involved in RDaSH.
Page last reviewed: April 16, 2024
Next review due: April 16, 2025