The Academy of Medical Sciences (AMS) has recommended setting up a new independent Health Research Agency, drawing together existing systems for research governance (including NHS R&D permissions) and ethics approvals (both general and specialist), as part of its report on the regulation and governance of health research in the UK.
The AMS’ proposals for streamlining and co-ordinating regulatory and governance
processes for health research in the UK were generally welcomed by government, medical research charities and industry, although the BioIndustry Association (BIA) sounded a cautionary note.
The association “continues to believe that it would be more efficient and effective to build upon and expand existing competencies within MHRA rather than create a new body to oversee the regulation and governance of health research”, it stated.
The BIA had previously suggested that folding discrete agencies such as the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) into a single regulator – i.e., the Medicines and Healthcare products Regulatory Agency (MHRA) – under the UK Department of Health would be “a step in the right direction”.
Responding last October to the Cabinet Office’s formal announcement of plans to overhaul 481 non-departmental public and other bodies, though, the association argued that the ethical and scientific/regulatory review of medical research “should continue to be performed by separate and distinctive bodies”.
A report on the future of ‘arm’s-length bodies’, published under the new Conservative-Liberal coalition by the Department of Health (DoH) in July 2010, had already claimed a “strong argument” in favour of consolidating responsibility for different aspects of medical research, including the activities of the HFEA, the HTA and the National Research Ethics Service (NRES), within a single, arm’s-length research regulator.
However, the BIA had insisted that the NRES – the umbrella body for ethics committees in the National Health Service – was “well managed and is performing an efficient independent review of research through the NHS Research Ethics Committees”.
Following the publication of the Department of Health’s report on arm’s-length bodies, the Academy of Medical Sciences launched a second call for evidence in its review of the regulation and governance of medical research in the UK, specifically to consider the possibility of bringing all aspects of medical research under a single regulatory umbrella.
The AMS report recommends creating, within the framework of a new independent Health Research Agency (HRA), a single system for ethics approvals encompassing both the current responsibilities of the NRES as well as specialist approvals and licences for studies involving patient data, human tissue, gene therapy, human stem cells, etc.
It also envisages a new National Research Governance Service (NRGS) for England – constituting the other main function of the HRA – that would facilitate more timely approvals of research studies conducted at single or multiple NHS sites by assuming responsibility for all study-wide checks currently duplicated across participating NHS Trusts.
The proposed NRGS, the report suggests, would:
• Eliminate inefficiency and support NHS Trusts and researchers through one-shot research governance checks. This would also ensure common standards and consistent interpretation of governance requirements.
• Oversee new arrangements enabling NHS Trusts to determine local research feasibility within agree timelines.
• Allow Trusts to focus on monitoring local capacity, conduct and performance.
According to Professor Sir Michael Rawlins, chair of the National Institute for Health and Clinical Excellence and of the AMS working group that prepared the report commissioned by then Health Secretary Andy Burnham in March 2010, delays in obtaining NHS permissions are “a major failure of the current pathway” and “the biggest single barrier to all types of health research studies” in the UK.
“There is a highly inefficient emphasis on process rather than outcomes, which has led to delays of over a year to gain permissions for simple studies,” he commented.
Rawlins said it was vital the HRA was established “as soon as possible to start making necessary changes right away and then confirmed in primary legislation in due course”. Moreover, to achieve its objectives the Agency would need to be “a genuine single regulator and not a mere façade hiding the continuation of many separate existing bodies”.
Complex and burdensome
Overall, the AMS working group found “unequivocal evidence” that health research in the UK was being “jeopardised by a regulatory and governance framework that has become unnecessarily complex and burdensome”, Sir Michael noted. It received no evidence to suggest “that this increased regulatory and governance burden has led to enhanced safeguards for participants in research”.
With recent data showing a decline in the UK’s global share of clinical research activity, a fertile research environment was essential to the health and wealth of the nation, Sir Michael declared.
“The current system of regulation is making it increasingly difficult to initiate health research in the UK and is preventing patients from participating in studies,” he added. “This is ultimately denying patients early access to new drugs and hindering improvements to public health for the wider society.”
The other key recommendations in the AMS report revolve around:
• Improving the UK environment for clinical trials. In this respect, the AMS working group proposes, the DoH and the Department for Business, Innovation and Skills – supported by the MHRA and other UK stakeholders – should seek to ensure the European Clinical Trials Directive is revised so that:
- The scope of the Directive is reduced.
- Approval and monitoring requirements are proportionate to risk.
- The requirements for safety reporting are simplified to improve the quality of drug safety data and monitoring.
The relationship between the new HRA and the MHRA “will be crucial in improving the current system and should be enshrined in a duty of consultation between the two organisations”, the report says. This should be geared to:
- Ensuring a more proportionate approach to clinical trials regulation.
- Providing “consistent and clear” guidance on the interpretation of the scope of the Clinical Trials Directive.
- Improving “the approach and process of Good Clinical Practice monitoring inspections so that they form a proportionate and constructive part of the regulatory process”.
• Providing access to patient data that protects individual interests and allows approved research to proceed effectively. To this end, the working group urges the government to evaluate progress in implementing the recommendations of the 2008 Data Sharing Review.
Specifically, it recommends that:
- ‘Safe havens’ are established “as a matter of urgency” to allow access to data for approved research.
- Accredited investigators and research team members should be “considered part of a clinical care team to enable identifying patients eligible for approvedstudies”.
- The UK Data Protection Act should be reviewed to identify and amend aspects that need clarifying and to inform proposed revisions to the EU Data Directive.
• Embedding a culture that values research within the NHS. To support improvements in the regulation and governance environment, “a cultural change is required within the NHS to embed health research as a core function, to foster a more facilitative approach to research governance and to promote public and patient engagement in research”, the report says.
It recommends that:
- The core role of health research in the delivery and improvement of the NHS should be more widely communicated to healthcare staff at all levels.
- Heath research should be “formally and irreversibly” embedded into NHS leadership and governance processes through use of appropriate metrics and incentives; training the NHS workforce to ensure it can support health research; and making sure there is an executive director within each NHS Trust with specific responsibilities to promote health research.
Other than its reservations about the proposed single Health Research Agency, the BIA felt the AMS report included “recommendations which are a step in the right direction towards improving the governance framework and creating a better environment for health research in the UK”, noted Alan Morrison, chair of the association’s Regulatory Affairs Advisory Committee.
The Association of the British Pharmaceutical Industry (ABPI) was particularly enthused by “key recommendations that focus on streamlining the processes around clinical trials and address the cultural issues that still exist within some parts of the NHS, which represent a significant hurdle in conducting clinical research”.
The “timely endorsement and implementation of this report by all stakeholders is vital if the UK is to be seen as a serious player in clinical research in an increasingly competitive arena”, urged Allison Jeynes-Ellis, the ABPI’s medical and innovation director.
Speaking for the government, Secretary of State for Health Andrew Lansley said: “National regulation and local governance of health research are too complex and scattered across too many different bodies. The Academy's report makes the case for simplification under a health research agency that will streamline and co-ordinate regulatory and governance processes”.
The government “welcomes the report and will consider carefully how to implement its recommendations”, Lansley added.