NIHR Research Support Services Framework - Frequently Asked Questions (FAQs)
Questions on implementation
Q1: What is the role of the NIHR and the Department of Health in adopting Research Support Services Framework?
Q2: Is the NIHR responsible for any Research Support Services activity carried out by organisations for studies outside the NIHR portfolio? If not, what happens in those cases?
Q3: The Plan for Growth says that in future funding to providers of NHS services will become conditional on meeting benchmarks, and this will affect new contracts from autumn 2011 and performance will affect funding from 2013.
· How will the NIHR implement this?
· What is the NIHR doing about outcome measures and benchmarks?
Q4: How does the framework fit in with the Research Governance Framework for Health and Social Care?
Q5: How can the framework’s concept of ‘consistent procedures’ be realised across all organisations when they differ so much in terms of size and capability?
Q6: How do the NIHR Research Support Services align with other NIHR/Department of Health initiatives?
Q7: Will the Medicines and Healthcare products Regulatory Agency (MHRA) be aware of the framework when undertaking inspections?
Questions for Trust/Board/Directors/R&D Manager
Q8: Will organisations be able to demonstrate their capability to undertake research?
Q9: What information do I need to include in my organisation’s R&D Operational Capability Statement?
Q10: Can I alter the format of the framework documents/forms?
Q11: How often should the R&D Operational Capability Statement be reviewed and who can do this?
Q12: Can I publish the R&D Operational Capability Statement?
Q13: Given the Government’s proposals for primary care trusts (PCTs), who is responsible for the NIHR Research Support Services and the R&D Operational Capability Statement in primary care?
Q14: What can I do now to show that I have adopted the NIHR Research Support Services Framework in accordance with the Plan for Growth? Can I use Quality Accounts?
Q15: Do I still use the NIHR Co-ordinated System for gaining NHS Permission (CSP)?
Q16: I already have appropriate standard operating procedures (SOPs). Do I have to rewrite them?
Questions for the R&D Manager
Q17: Why should I review study documentation at a participating organisation before the research ethics committee (REC) review as a document may subsequently change?
Q18: What happens when the organisation managing research is an independent organisation with a contract to provide services to the NHS?
Questions on outcome measures
Q19: The Plan for Growth says that trusts and the NIHR will publish metrics. What does this mean in practice? Why not use the measures in the current NIHR Clinical Research Network performance objectives and avoid any duplication?
Q20: What do you mean by a balanced scorecard?
Q21: Are outcome indicators different to targets?
Q22: Why are the published outcomes for clinical trials and the initial benchmark important?
Q23: Are outcome indicators the same as local management information?
Q24: How will the NIHR use the outcome indicators?
Questions for Investigators
Q25: Are investigators aware of the NIHR Research Support Services and the associated framework?
Questions for industry
Q26: Is industry aware of the NIHR Research Support Services and the associated framework?
Questions on funding
Q27: Can NIHR Flexibility and Sustainability Funding (FSF) be used for the cost of training and development in relation to adopting the Research Support Services framework?
General questions
Q28: Whom should I contact if an organisation does not appear to have adopted the NIHR Research Support Services framework?
Q1: What is the role of the NIHR and the Department of Health in adopting the NIHR Research Support Services Framework?
A: The NIHR has adopted the Research Support Services Framework with immediate effect, as standard practice for NIHR portfolio studies. The NIHR CRN will work with CLRNs to embed the Framework’s standards and good practice. The Department of Health will, for the time being retain responsibility for reviewing the policy content of the Framework.
Q2: Is the NIHR responsible for any Research Support Services activity carried out by organisations for studies outside the NIHR portfolio? If not, what happens in those cases?
A: The NIHR is not responsible for the management of non-portfolio studies but there are clear benefits in all organisations applying the same principles of good practice across all of their research management. The NIHR will encourage adoption whenever possible. The NIHR Research Support Services have been developed with significant input from stakeholders including the NHS, industry and regulators. All supported a consistent, proportionate approach to the management of research studies. The Department of Health looks to the NHS to take professional responsibility for adopting streamlined, consistent and transparent practice across all their research activity
Q3: The Plan for Growth says that in future funding to providers of NHS services will become conditional on meeting benchmarks, affecting new contracts from autumn 2011 and performance will affect funding from 2013.
· How will the NIHR implement this?
· What is the NIHR doing about outcome measures and benchmarks?
A: The Plan for Growth points to a serious lack of consistency which affects our reputation as a leader in R&D. It is very important that we all put this right quickly. The NIHR will work with the NHS and others to:
· establish the routine practice of measuring performance against a balanced scorecard (see question 19) of outcome indicators,
· describe and illustrate how NHS organisations are to report performance against these indicators,
· publish how NIHR will use these indicators in dashboards, to measure and compare performance against benchmarks (including a benchmark of 70 days for commencing a clinical trial), and,
· publish NIHR policy on the process by which unacceptable performance will affect NIHR funding.
Q4: How does the framework fit in with the Research Governance Framework for Health and Social Care?
A: It is based on and supports its principles.
Q5: How can the framework’s concept of ‘consistent procedures’ be realised across all organisations when they differ so much in terms of size and capability?
A: The framework is about a consistent and proportionate approach to managing risk and using professional judgement. The purpose of research management procedures should be recognisable from one organisation to another. It does not mean that the management of every study in every organisation has to follow all the same steps. Operational risk is always to be viewed and managed in the same way even if it results in different management actions. You should consider what needs to be done case by case.
Q6: How do the NIHR Research Support Services align with other NIHR/Department of Health initiatives?
A: Adopting streamlined, transparent and risk proportionate research processes is a service wide objective. The NIHR, Department of Health and other organisations are working together to maintain alignment of related initiatives including:
- The NIHR Research Support Services,
- the CSP improvement programme,
- the implementation of the new RDMIS CSP module,
- the MHRA risk stratification pilot, and
- the roll-out of the NIHR CRN North West Exemplar programme,
The CSP improvement programmes and NIHR Research Support Services are nearing alignment. The NIHR CRN will be working with Trusts implementing the NIHR Research Support Services and other partners to embed good practice identified in the NIHR CRN North West Exemplar programme and elsewhere.
Q7: Will the Medicines and Healthcare products Regulatory Agency (MHRA) be aware of the framework when undertaking inspections?
A: Yes. We have worked closely with regulators including the MHRA during the development of the framework. There is general agreement on the principle of proportionate management of operational risks. The MHRA has its own guidelines for inspection based on risks to the safety and integrity of studies. These are consistent with the management of operational risks using the NIHR Research Support Services Framework.
Q8: Will organisations be able to demonstrate their capability to undertake research?
A: Yes. NHS chief executives (and Boards) will be able to show a visible commitment to research within their organisations through the R&D Operational Capability Statement. Normally, the statement will be published and will help research sponsors and the NIHR Networks to identify the most appropriate sites for a study. Publishing this information will encourage sites to make full use of the best facilities, to improve research facilities and to enter into collaborations where appropriate.
Q9: What information do I need to include in my organisation’s R&D Operational Capability Statement?
A: You should tailor the content of the ‘statement’ to local circumstances. An organisation with a large and varied research portfolio will benefit from a more comprehensive R&D Operational Capability Statement than a site with a small and les diverse study portfolio. Whatever the scale of activity there is key information about capability and local responsibilities that will assist the relationship between your organisation and others. You should make use of all the sections in the statement which, are relevant to the types of research and the relationships that are important to your organisation.
Q10: Can I alter the format of the framework documents/forms?
A: The intention is to provide consistent information in a format that anyone can easily recognise across the NHS:
- The R&D Operational Capability Statement should not be altered. It provides consistent information. You complete the parts that are relevant to your organisation.
- We encourage using the Planning Tool as it is but we recognise that some sites already have similar standards. Whichever standard you use we do think it is important that for consistency and data sharing it reflects the principles in the Research Support Services Planning Tool.
- The SOP guidelines can be used in any way that suits local needs, to generate or check the required information.
Q11: How often should the R&D Operational Capability Statement be reviewed and who can do this?
A: The Framework suggests an annual review. You may also decide to reissue it if your circumstances change. The important thing is that the statement reflects current/expected capability. You may decide that some parts of the statement should be reviewed more frequently by members of the R&D team, for example the availability of appropriate equipment. The statement can then be referred to the chief executive/Board for approval annually.
Q12: Can I publish the R&D Operational Capability Statement?
A: Yes. Some Trusts have already done so on their Trust site. Nationally, the NIHR will consider how to link to published statements when it reviews its own website.
Q13: Given the Government’s proposals for primary care trusts (PCTs), who is responsible for the NIHR Research Support Services and the R&D Operational Capability Statement in primary care?
A: The organisational structure of the NHS does not stand still, and R&D continues. All organisations undertaking R&D (as participating organisations or sponsoring organisations) should use the tools and guidelines in the NIHR Research Support Services. The current organisation should use the tools to meet its current needs, and include information that will be useful in any expected reorganisation. The statement can be used to confirm current details prior to any change and this supports effective change management.
Q14: What can I do now to show that I have adopted the NIHR Research Support Services Framework in accordance with the Plan for Growth? Can I use Quality Accounts?
A: Trusts can start to show that they have adopted Research Support Services by:
- Adopting the Research Support Services Framework,
- Publishing in local reports that action has been taken, and,
- Reporting in Quality Accounts that action has been taken.
We do not expect you to be able to show immediate evidence in every area but we do expect you to be able to start to show and continue to show progress. Stakeholders have consistently applauded the development of the framework and this suggests a great willingness for it to be successful.
Q15: Do I still use the NIHR Co-ordinated System for gaining NHS Permission (CSP)?
A: Yes.
Q16: I already have appropriate standard operating procedures (SOPs). Do I have to rewrite them?
A: No. There is no need to change them if they already align with the framework. You can use the framework to check current practice against a consistent national approach. Do use the framework to help fill gaps, streamline processes and adopt consistent practice that others inside and outside your organisation can easily understand.
Q17: Why should I review study documentation at a participating organisation before the research ethics committee (REC) review as a document may subsequently change?
A: In many cases, it is possible for management actions and routine preparations to go ahead in parallel with the REC and regulatory review so that some parts of CSP are completed early. The framework encourages NHS sites not to ignore a study until everything else is complete. The guidelines encourage consideration of key facts that will drive a proportionate approach to managing a study. Considering these may also help to prepare you for conditions or changes arising from REC review. An early assessment with the planning tool can identify whether there could be disruptive or demanding changes to the study or non-approval (based on experience of this type of study and those involved etc).
Q18: What happens when the organisation managing research is an independent organisation with a contract to provide services to the NHS?
A: The framework describes good practice intended to cover all organisations that work with the NHS to deliver studies involving NHS patients etc hence the use of the term ’organisations’ rather than ‘Trusts’ in the guidelines. If the organisation is managing research as part of the NHS it is expected to manage it under the guidelines within the framework.
Q19: The Plan for Growth says that trusts and the NIHR will publish metrics. What does this mean in practice? Why not use the measures in the current NIHR Clinical Research Network performance objectives and avoid any duplication?
A: The NIHR Research Support Services will use five outcome indicators to measure performance. They are measures of quality, speed and volume that will be used as a balanced scorecard. These indicators are consistent with the NIHR Clinical Research Network performance objectives
but describe activity in broader terms. The Plan for Growth announces financial incentives. These will not be based on simple process targets, but on a balanced overview of professional behaviour and performance in initiating and delivering studies within the national system of research governance. The NIHR will test the outcome indicators to ensure that they are appropriate and further information will be available in due course.
Q20: What do you mean by a balanced scorecard?
A: The NIHR’s outcome indicators are measures of performance that we intend will demonstrate the outcomes of good research management practice along the research pathway. A ‘balanced scorecard’ approach uses a small number of outcome indicators in combination to provide evidence of success in different aspects of the R&D processes. This overall combination of evidence of success will be used to assess eligibility for NIHR funding. The NIHR does not intend to link funding rigidly to timelines or other process targets.
Q21: Are outcome indicators different to targets?
A: Yes. Targets are used to support performance management of different processes in the research pathway. They enable organisations to assess progress towards success in particular components of the research pathway. The NIHR’s balanced scorecard is not intended to create targets
Q22: Why are the published outcomes for clinical trials and the initial benchmark important?
A: They will make performance in the initiation and delivery of health research transparent and accountable, routinely enabling comparisons of research sites with one another, and against international benchmarks. This will allow people to hold the NHS to account for improved performance. NHS organisations will provide evidence that they meet the performance standards defined by the NIHR with regard to research initiation and delivery. The NIHR will make this a condition of new contracts from autumn 2011; and performance will affect funding from 2013.
Q23: Are outcome indicators the same as local management information?
A: No. The outcome indicators measure overall performance when using the Framework. This is different to the management information, which is used routinely to detect delays, initiate actions and solve problems affecting individual studies.
Q24: How will the NIHR use the outcome indicators?
A: The indicators provide a view of how well an organisation is performing in its initiation, start-up and delivery of studies. The NIHR will use valid comparative data and benchmarks. Where organisations are clearly outside the expected range of performance against benchmarks then the NIHR will want to understand why. In the first instance, the NIHR will expect organisations to be adopting good practice within the framework, and to be able to evidence that it is following the approaches in the framework.
Q25: Are investigators aware of the NIHR Research Support Services and associated framework?
A: Yes, but their understanding at the practical level will need further communication and effort. Investigators have been involved in the development of the framework and have representation on the NIHR External Reference Group that oversees the work. Please do engage with local investigators to explain how the collaborative approach in the framework will help support quicker and more effective research management procedure.
Q26: Is industry aware of the NIHR Research Support Services and associated framework?
A: Yes. Industry representatives have been involved in the development of the framework. Do be prepared to explain to your industry contacts how you are implementing the framework, and direct them to the NIHR website for information.
Q27: Can NIHR Flexibility and Sustainability Funding (FSF) be used for the cost of training and development in relation to adopting the Research Support Services framework?
A: Network and standard FSF can be used for the cost of training and development in relation to implementing the Research Support Services. The NIHR view is that this is more likely to be an issue for organisations with their own FSF, rather than for organisations hosting networks.
FSF can be used to pay the costs of training and to reimburse the NHS for the cost of staff time spent undergoing training. FSF can be used to pay for internally and externally provided training. The NIHR would not normally expect FSF to be used to support training for HEI administrative staff. FSF cannot be used to pay for the additional time required for the development of SOPs. It remains the responsibility of the organisation to fund its local research management.
Q28: Whom should I contact if an organisation does not appear to have adopted the NIHR Research Support Services framework?
A: Research Support Services advocates early local discussion and collaboration by the relevant parties to identify risks and management actions. Any query that relates to either a specific study in an organisation or the organisation's approach to research should be directed to that organisation in the first instance. Where a query relates to a study supported by the NIHR, local network staff can also assist in resolving and escalating any issues, if required. The R&D Operational Capability Statement does enable an organisation to set out its escalation route for risks and issues arising.