The Joint Academic Plan

Towards a sustainable academic programme in RNOH

There have been two recent presentations to the Board on academic matters, the first of which included the Dean of UCL Faculty of Biomedical Sciences and the Director of the Institute of Orthopaedics and Musculoskeletal Science (IOMS). At a recent Board-to-Board meeting, where the desirability of an academic dimension to the Trust’s vision was under discussion, the request was made for a formal paper bringing together the multiple facets of this question and analysing the challenges of developing a sustainable academic programme (the term ‘academic’ is taken to include both education and research). This paper describes the context and rationale for the Joint Academic Plan (JAP) between RNOH and IOMS, lays out the obstacles that must be overcome and describes the strategy we are pursuing to do so.

The production of this paper has occurred in parallel with the production of a Development Plan for the IOMS, which is being presented to the Dean of the Faculty of Biomedical Sciences and the Provost of UCL. This is presented at appendix 1 for comparison.

1Background

A strong driver for this discussion was the injunction by London SHA, in their letter inviting the full business case for RNOH redevelopment, that the Trust should strengthen its ties with IOMS so that the campus may evolve in the direction of an Academic Health Sciences Centre (AHSC). However, this recent development came on top of profound changes already in motion, concerning NHS R&D funding, research governance and the evolution of UCL’s MedicalSchool.

1.1The Academic Health Sciences Centre concept

The AHSC concept goes beyond the traditional notion of a teaching hospital with its synergy between a NHS provider and a University medical school. It embodies a greater degree of corporate integration between the two entities, based on various models, one of which is complete financial merger as in the recently established Imperial College-based Academic Health Sciences Centre (
The three elements of clinical service, education and research are given equal weight by the combined organisation on the grounds that only by achieving balanced excellence between them can patients benefit from cutting edge medicine as it evolves.

1.1.1UCL Partners

This is UCL’s move in the direction of an AHSC. The first phase is limited to four Trusts (UCH, Royal Free, Moorfields and Great Ormond Street) and eight subject areas (child health, women's health, ophthalmology, diseases of the nervous system, cardiovascular disease, cancer, infection, and transplantation). Their branding is seen at: The term ‘UCL Partners’ is not to be confused with the ‘UCL and Partners Health Sciences Research Deanery’ (see section2.2), in which we participate.

1.1.2Potential for RNOH involvement

Depending on the model adopted, RNOH involvement would require (i) some degree of integration of Trauma & Orthopaedic clinical services and (ii) networked academic activity, both across all the participating Trusts. Although this would be a medium- to long-term prospect, the need to build towards the second of these should inform our academic approach from now. In particular, the desire to be independent as a campus and a Trust must be complemented by a constructive strategy of integration with other (particularly UCL-related) Trusts and other academic departments in UCL whose expertise can benefit our research and educational efforts.

1.2NHS R&D Funding

Up until two years ago, RNOH received around £2m pa in Culyer R&D funding, of which about half was spent on academic activities (the rest was used to support clinical work). This provided a relatively uncontested source of money for research projects in the Trust and the Institute; there is a plausible argument that the ease with which this money could be obtained meant that there was no drive to raise the scientific standard of research proposals. The biggest challenge we face is that this funding has been rapidly phased out and the available R&D funds are now held at national level. Although there is now considerably more R&D funding available in the NHS as a whole, it has to be competed for among all specialities, through the various funding streams of the National Institute for Health Research (NIHR), the Research Councils and the charities. Competition is fierce and only the best-designed studies get funding. Successful applications tend to come from established teams of researchers and funding is deliberately being concentrated in larger centres. Furthermore, musculoskeletal research is not near the top of the national priority list, though this is tending slowly to improve. To stay in the game, the Stanmore campus must develop the skills to put together high quality applications, with robust, randomised study designs and numbers of participants adequate to answer important questions definitively. By combining the capabilities of academic and clinical staff in Stanmore, we can achieve this.

1.3Research Governance

The Research Governance Framework was produced by the government in 2002, in response to various scandals including the Liverpool ‘body parts’. However it also stems from international innovations as represented by the ICH[*] Good Clinical Practice code (GCP) and the European Directive on Clinical Trials. The basic goal is to protect patients who participate as study subjects from possible harm. The introduction of research governance has been paralleled by an overhaul of the research ethics system.

The main consequence is that Trusts who wish to be research active must either have a proper R&D Department or out-source their research governance to another Trust that does. In either case, Trust staff who wish to take part in trials have to abide by the rules as investigators. This includes being trained in ICH-GCP. We have arranged short courses to provide this and the take-up among RNOH staff is gradually rising. We can be inspected at any time to confirm our compliance (see 1.3.3).

1.3.1What is research and what is audit?

Research Governance does not cover Clinical Audit – that comes under Clinical Governance. Some studies referred to as ‘research’ are in fact audit and do not need to meet the requirements of research governance. (Equally however, they will not be funded by the NIHR). Research, which always requires ethical approval, involves the creation of new knowledge which is generalisable beyond the clinical unit in which it was created.Clinical audit aims to compare process and outcomes in a particular unit with standards that are in the literature, to inform local practice. When this is achieved by reviewing existing notes or X-rays, ethical permission is not required but, if extra X-rays or questionnaires have to be administered then it may be.

1.3.2The Trust as sponsor

A key stipulation of research governance is that every project has to have a sponsor. This is not about funding; it is a legal entity that takes scientific and clinical responsibility for what happens to participants during the study. A particular issue is non-negligent harm (where a new treatment has unexpected bad effects), for which indemnity has to be provided. Many research funding bodies will not sponsor the studies they support, so then either the Trust or the University has to. This means that the R&D Department has to have a robust system for reviewing research proposals, so we can decide (through the Research Committee on behalf of the Trust) whether we wish to act as sponsor. We have to strike the right balance to encourage the discipline among RNOH staff of always contacting the R&D at the earliest possible stage in planning a research project, without putting them off with bureaucracy.

1.3.3The Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA oversees the conduct of clinical research in the NHS and has the duty to inspect sites where it takes place, to check that the organisation has systems in place to ensure that all investigators are acting in accordance with Good Clinical Practice. They come with very little notice and, if they do not find that the Trust R&D management has documentary evidence to show that all investigators are GCP-trained and that every study on the site has an up-to-date Trial Masterfile confirming compliance with all ethical and governance requirements etc, they can close down the entire campus as a research site. Involvement of a patient in a clinical trial without such conformity is a criminal offence, in much the same way that operating on a patient without informed consent is regarded as assault.

For Stanmore to continue as a research-active site, we must either invest in sufficient research management resource to achieve these standards or accept that all local studies will be managed by the R&D Unit at UniversityCollegeHospital. Our present view is that out-sourcing research management would inhibit Trust staff from being research-active and that we should make every effort to provide it in-house, taking our staff along with us in its philosophy and implementation. However we have agreed to accept assistance with research management from UCH for certain classes of study that are funded by the Comprehensive Local Research Network (see 2.2).

1.4Developments in UCL’s policy towards the IOMS.

The MedicalSchool would like to see a successful Institute of Orthopaedics and Musculoskeletal Science: they do see musculoskeletal disease as an important area. The rheumatology strength in UCH and RF is more concerned with systemic inflammatory manifestations and the related immunology; there is no other obvious focus in UCL for addressing the high burden musculoskeletal diseases such as osteoarthritis and osteoporosis, let alone the complex subspecialties such as spinal, revision arthroplasty or bone tumours.

However the MedicalSchool is dissatisfied with the IOMS' performance, particularly its financial viability as measured by key performance indicators such as research and teaching income, space and personnel costs per HEFCE-funded staff. The Institute has been instructed to present a recovery plan to the Provost in January 2009, defining a strategy for achieving financial balance in three years. The submitted IOMS plan is at appendix 1. One consequence of this is that careful attention must be paid to an accounting structure that allows income from teaching and research to benefit both parties to the Joint Academic Plan (see section 2.1.1).

1.5RNOH’s current research culture

A large number of publications have come from RNOH staff. With significant exceptions, they are mainly uncontrolled series of difficult or unusual cases. This is a highly important professional activity, good for training, providing professional leadership and for raising standards. However it was adapted to the previous circumstances of easily available funding from Culyer and from industry and is not the sort of research that can be funded nowadays through peer-reviewed sources such as the NIHR (see 1.3.1). Ithas tended to be organised by consultants on an individual basis, without IOMS involvement. As funding has become scarce and the demands of research governance have tightened up, the rate of applications to the Stanmore Research Ethics Committee has fallen, to the point where its continued existence is under threat.

A new culture is needed, based on the construction of teams involving both consultants and scientists, capable of generating the high quality grant applications we now have to produce. Each application involves hundreds of man-hours of work, so it is important to focus on the research questions that are most important and where we have the greatest strengths.

2The Joint Academic Plan

The research culture, described above, needs to evolve into a more integrated, translational tradition. Quite apart from the academic necessity for this, the new funding and research governance conditions make this unavoidable. On the teaching front, while it is right and proper that clinical staff take the lead on postgraduate training and IOMS staff take the lead on undergraduate education, we need to expand those activities which are more collaborative, such as Mastership courses and the Continental Surgeons course.

The inclusive structure now established, of a Joint Academic Committee, with Research and Education subcommittees (see appendix 2), is an important vehicle for integration. However, these bodies play a predominantly strategic role and they must be supplemented by working bodies in the form of the Translational Teams (TT), whose focus is the generation of grant proposals. The point of a translational team is to bring together scientists, clinicians and biostatisticians relevant to a particular translational area, ie a field in which biotechnological advances offer the prospect of benefit to patients and where that benefit needs to be demonstrated formally in a controlled trial. The clinical academic staff are primarily responsible for organising this but we need the commitment of all IOMS staff to succeed. We need to engender a culture in which clinicians readily approach IOMS to explore ideas, and design studies, at an early stage. The requirements of research governance are a potential driver for this, which is why the R&D office has been moved into the Institute and the Roles of Clinical Professor and R&D Director have been merged. The availability of epidemiological/biostatistical advice in the IOMS also helps. However we need the Trust Board and executive officers overtly to encourage this evolution by making it clear that it is vital for their development vision. The Integrated Academic Training Programme (see 2.3) is a great resource and we need the Trust representatives in the Regional Training scheme to back it strongly.

Under pressure from the SHA and the MedicalSchool, the options appraisal for location of the RNOH, between Stanmore and the Royal Free, laid great weight on the clinical-academic link. Two academic plans were devised, one for each site, and the Dean pronounced them of equal academic value, leaving the decision free to be made on clinical grounds. The Stanmore plan has evolved into the JAP. Subsequently, rather brief mention was made of the academic plan in the OBC; it is likely that more substance will be required in the FBC.

2.1UCL as the Trust’s primary academic partner

With Europe’s largest MedicalSchool, and excellent performance in the recent Research Assessment Exercise, UCL is clearly the best academic partner for RNOH. Equally, there is no realistic alternative to RNOH as the preferred partner for UCL if they are to have any presence in the musculoskeletal field. Threats to this partnership come from historical suspicion in the Trust that UCL tries to financially exploit the relationship and, from the UCL viewpoint, the relatively low contribution of research and teaching income from IOMS. A key aim of the JAP is to overcome these threats.

2.1.1Departments with whom we should collaborate

UCL has many elements within it producing ideas and techniques that could be of value to patients with musculoskeletal disease. Many remain to be discovered, but some of the relationships that are already developing are:

Institute for Healthy Ageing. Since so much of musculoskeletal disease is age-related, collaboration with this well-respected unit exploring the biology of ageing is obviously advantageous. Discussions are already underway about the issues surrounding the age of donors of sources of stem cells for therapy.
Centre for Molecular Cell Biology. This centre will give us access to state-of-the-art techniques for characterising the cells we use to treat patients in clinical trials of cell therapy.
Professor Robert Brown of the IOMS Tissue Engineering Centre co-directs a collaboration with the Eastman Dental Institute to coordinate UCL’s translational work in tissue engineering and cell-based therapies (the above three links are highly relevant to our second research theme, described in 3.2).
The IOMS Centre for Biomedical Engineering collaborates with the Faculty of Engineering, including the advanced imaging work in Medical Physics (our first theme, see 3.1).
UCL’s PAMELA Institute, which studies the built environment in terms of its friendliness towards people with disabilities, is an obvious partner for our Rehabilitation Centre (our third theme, see 3.3).
The Cancer Institute is one of many centres in UCL with whom we collaborate in the complex orthopaedic conditions in our fourth theme (see 3.4).

These are only a selection of the internationally-renowned units within UCL, with whom we can potentially make co-application for research funding, with vastly improved chances of success, compared to going it alone or in partnership with less-respected institutions.

2.1.2Funding arrangements with UCL

The funds brought in by the educational and research grant efforts of the Joint Academic Plan have to satisfy the needs of both UCL (in bringing the IOMS into financial balance within the Medical School) and RNOHT (in replacing the part of the lost Culyer money that was spent on academic activities), as well as financing an expansion of academic activity that will take us closer to a viable Academic Health Sciences Centre model. This income will be made up of several elements:

Full economic costing of projects, including part of the salary of staff already employed, in recognition of their contribution to a given project
Overheads on National Institute for Health Research funding to the Trust and commercially-funded projects
Profit made on educational activities, both MScs and national courses

The benefit to UCL and RNOHT respectively will vary between projects. The goal must be to make the share equitable across the academic portfolio as a whole. It will be one of the tasks of the Joint Academic Committee to ensure that this happens.