The creation of a new National Research Governance Service

(NRGS)

The current process for NhS R&d permissions highlights a fundamental tension between the concept of a ‘single standardised system’

(which is desirable from the point of view of speed and efficiency in trial set-up), and the reality of an NhS structure which devolves responsibility, including the legal duty of care, to individual NhS Trusts. Many of the issues experienced by respondents result from this unresolved tension. The NIhR have previously stated, ‘Lack of standardised systems and processes, as well as the lack of an agreed risk-based approach to granting permissions and managing research projects, has led to inconsistencies when interpreting the principles set in the RGF and relevant legislation, such as the Human Tissue Act.’ ⁶⁴

A new approach needs to be taken to eliminate the heterogeneity of Trust activity and the following sections outline a more streamlined process for NhS R&d permissions.

4.5.1 Roles and responsibilities:

a streamlined system

We recommend that a new National Research governance Service (NRgS) should be established in england. The NRgS would be a core component of the proposed new health Research Agency (hRA) described in chapter 9.

The NRgS would reduce the bureaucracy and increase the speed of NhS R&d permissions by replacing multiple, inconsistent checks by individual NhS Trusts, with a single, consistent, efficient process for obtaining NhS R&d permission (see Recommendation 3). The creation of the NRgS should be a priority to maximise the benefits of changes elsewhere in the regulation pathway and to ensure the NRgS is fully integrated in the new hRA from the outset. The NRgS would:

63 For further information see http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx

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• Perform all study-wide NhS governance checks once, ensuring consistent national standards and clear and consistent

interpretation of requirements for compliance.

• Recommend research projects as suitable for undertaking in the NhS, subject to assessment by Trusts of local feasibility and delivery.

• Maintain up-to-date records on NhS staff that are appropriate to conduct research studies, including whether they have passed criminal Records Bureau (cRB) checks.

• Introduce timelines for providing NhS R&d permission.

• Provide model agreements and agreed costing structures.

Individual NhS Trusts would then need to undertake local checks to assess feasibility and delivery, and to confirm their willingness to participate in a study, within – we propose — 20 working days. By transferring all study-wide checks to the NRgS, the function of Trust R&d offices would evolve to focus on monitoring local capacity, performance and conduct. The publication of metrics on research activity is a key aspect of this shift in approach (see Recommendation 2b and section 4.5.2).

In implementing this new model consideration should be given to the role of regional research

‘representatives’ to build confidence in, and understanding of, the centralised element, and to support Trusts in implementing procedures to streamline local assessment and delivery.

current initiatives designed to improve R&d permissions are progressing through encouragement and consensus, but lack a real driver. The NRgS would provide clear guidance and leadership on a new permission process for studies in england, including NIhR Portfolio and non-Portfolio studies. The NRgS should work with systems in the devolved nations to establish a mechanism to achieve UK wide permissions. To this end, many respondents highlighted the success of NReS

in achieving close working and a memorandum of understanding between the national systems across the UK.

This new model would complement recent investment and allow, for example, clRNs to focus on supporting high-quality research and recruiting patients. Alongside the recommendations made in chapter 9, the creation of the NRgS would clearly separate issues and decisions around:

• Funding and infrastructure (NIhR).

• local capacity, monitoring and delivery (NhS Trusts).

• Study-wide checks and oversight of the NhS permissions process (NRgS).

• Regulation, licences and authorisations (the new hRA, see chapter 9).

4.5.2 Incentives and metrics

The NIhR should develop a system to formally assess the performance of Trusts in approving and carrying out research when allocating funding. The process should be transparent and metrics should be published on Trusts’

research activities, including use of the streamlined NRgS model and timelines for assessment of local feasibility, delivery and recruitment. The failure of Trusts to provide prompt and reasonable local R&d approval should be formally considered when assessing participation in wider NIhR initiatives or providing support to Trusts for research (see Recommendation 4). chief executives of NhS Trusts should be closely involved in the design of the NRgS model to ensure it addresses their concerns and removes some of the existing disincentives to undertaking research.

4.5.3 Indemnity

It is our understanding that the NhS litigation Authority has received no claims relating to research. however, we understand that a fear of litigation persists within the NhS and contributes to a risk-averse approach and a lack of confidence in checks undertaken by others.

The success of our new model is dependent on

individual Trusts having confidence in the NRgS and delegating the responsibility for study-wide checks. Trusts, through providing confirmation of local governance and feasibility, would grant final NhS permission, in line with their legal duty of care for patients.

One of the possible mechanisms for cementing this division of roles would be to ensure clarity on responsibility for different aspects of research indemnity so that there is confidence that:

• If research causes harm due to errors in the permission process this is the responsibility of the regulator (in our proposed model this would be the new health Research Agency).

• If research causes harm through negligence of staff, this is a Trust responsibility (in the same way that clinical negligence is covered by the existing clinical Negligence Scheme for Trusts).

• If research causes harm through poor design or conduct of the study this is the responsibility of the sponsor.

4.5.4 Contracts and costing of research The NRgS would support Trusts in providing an efficient assessment of local feasibility and delivery by providing model agreements, templates and agreed costing structures.

The development of a model clinical Trial Agreement for commercial research has greatly streamlined the processes for industry-sponsored studies and the use of a similar approach for non-commercial research would be of significant benefit.

Many researchers have highlighted the problems faced when attributing costs to non-commercial clinical studies, with various Trusts using different cost tariffs, leading to negotiation and delays. The costs of R&d in the NhS are currently split into three categories:⁶⁵

• Research costs, which: are the costs of R&d itself and ‘include the costs of data collection and analysis…and can include the pay and indirect costs of staff employed to carry out the R&D’.

• NhS Support costs, including the additional patient-related costs associated with the research, which would end once the R&d activity has stopped, even if the patient care continues to be provided.

• Treatment costs, which are the patients’

costs and which would continue to be incurred if the patient care service in question continued to be provided after the R&d activity had stopped. excess treatment costs (eTcs) are the difference (if any) between the total treatment costs and the costs of the standard treatment.

commercial studies pay eTcs but, as highlighted in section 3.3.2, difficulties in accessing funds to cover eTcs are a major barrier to undertaking non-commercial research.

The forthcoming re-organisation of NhS commissioning arrangements provide a timely opportunity to address this (see Recommendation 2d).

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Recommendations

Obtaining NHS permissions was identified as the single greatest barrier to health research and the rate-limiting step in most studies. Changes are needed to reduce bureaucracy and increase the speed of NHS R&D permissions by replacing multiple, inconsistent, slow checks by individual NHS Trusts, with a single, consistent, efficient process for the NHS as a whole. We therefore recommend that: