Untangling the costs of clinical research

Posted on May 4, 2012 by

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Many AMRC charities support research in the NHS, but the money they have raised must go directly to what it was donated for – funding research projects that lead to better health outcomes for patients. They cannot pay for the indirect costs associated with research projects including the care costs patients would normally receive from the NHS, or the hospital infrastructure itself. This makes working out which costs are ‘research’ and should be paid by the charity, and which are associated with standard patient treatment, or with the NHS infrastructure more tricky.

After much discussion, the Department of Health has now recognised this. On 4 May, they published newly agreed guidelines called AcoRD (Attributing the costs of health and social care Research and Development). AcoRD explicitly states that  AMRC charities will NOT be expected to pay some of the research costs (such as data collection or preparing for regulatory approval), where these activities are being carried out by staff employed by the NHS/NIHR Clinical Research Network.

This exception will only be made available to AMRC member charities. The full list of exempted costs is:

  1. Local study trial co-ordination and management.
  2. Data collection needed to answer the questions that the research study is addressing (including collecting data for and completing the report).
  3. Regulatory preparation and compliance including obtaining ethical approval and complying with the Medicine for Human Use (Clinical Trials) Regulations 2004.
  4. The time taken by chief and principal investigators (CI and PI) to explain the study to professional colleagues, and to understand, the research elements of a study. For example the time taken to explain the criteria for patient eligibility or to explain the randomisation protocol.
  5. Sponsorship fees such as MHRA fees, and CTA annual renewal fees.

Why is this important?

The NHS has undergone a major change in the past five years, increasing the number of staff involved in supporting clinical research, and streamlining the approach taken by NHS Trusts to ensure that good quality research can take place.

At the same time, a NIHR Clinical Research Network has been developed, first in topic areas like cancer, and then across the whole of England. The Network is set up to ‘provide the infrastructure that allows high-quality clinical research to take place in the NHS’.

Charities have been frustrated that they have been expected to pay for this research ‘infrastructure’, rather than focus their funds on the direct costs of research. Through the AcoRD guidance the Department of Health has recognised that charities are a special case because their funds come from donations by patients and the public. Section 2.2 says:

In particular, the Department of Health’s support for research infrastructure for charity-funded research now has similarities with the charity Research Funding Stream of Quality-Related funding that supports the full economic cost of charity research in universities.

This new guidance was welcomed by Sharmila Nebhrajani, chief executive of AMRC:

We polled nearly 1,000 adults last year; 92 per cent told us they believe it’s important for the NHS to support research funded by charities. We welcome the helpful approach of AcoRD which does just that. This Department of Health support will maximise the impact of charity investment in NHS research by ensuring that the money goes directly to funding research projects that lead to better health outcomes for patients.’

What do I need to know?

If you are an AMRC charity funding research in the NHS, this will impact on the research you fund – giving clarity on the costs you are responsible for covering. You will need to look at the guidance and refer to it in your application guidance notes. We have produced a detailed briefing to guide you.

You should also encourage your researchers to talk to their local NHS R&D departments and local clinical research networks to ensure the costs are attributed correctly.

What next?

The guidance will come into force for all applications in England that use NHS resources submitted to any funder after 1 October 2012. Ahead of this,over the summer, a small group of research funders and the NIHR Clinical Research Network will meet to oversee the implementation of this guidance and ensure that everything runs smoothly. AMRC will also be closely monitoring three areas of continuing concern:

  • where trusts are recovering the research time of employed clinicians
  •  pharmacy costs
  •  any examples of the guidance increasing bureaucracy.

We are planning a workshop for our members – more details to come. And we’ll continue to keep you updated – please get in touch with me with your experiences, particularly if you encounter problems of increased bureaucracy or inappropriate costs which we can follow up.

Posted in: Policy, Research