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Strategic Aim Two - Regulation, ethics, governance and working with decision-makers

The MRC is recognised by regulatory authorities as a key stakeholder and plays an important role in influencing UK and European policy-makers.

Objective

To uphold and guide ethical research practice and the highest standards of research governance; to enhance the regulatory process by providing innovative approaches.

Now

The MRC has played a central role in the development of policy and legislation relating to the regulation of medical research. This is helped by detailed discussions between Parliament, Government, regulators and researchers.

  • We have worked with decision-makers in the Department of Health and the National Institute of Health and Clinical Excellence, to identify and address key methodological research needs.

All MRC units must adhere to the high standards of the MRC guidance on ethics and governance as must MRC grantholders, in accordance with terms and conditions of funding. Internationally, the MRC has a strong reputation regarding its guidance on research ethics, regulation and governance.

In early 2006, we set up the MRC Regulatory Support Centre (RSC) to help the MRC and wider scientific community to implement legislative and good practice requirements relating to research involving human participants, their tissues or data.

  • The RSC provides training and advice on regulatory matters across the spectrum of MRC-funded research involving humans.
  • In collaboration with NIHR Clinical Research Network, the centre provides an advice service, available across the UK to researchers and research and development managers, and training on the use and storage of human tissue and data, consent and confidentiality.

In May 2008, we led a workshop dealing with regulation and its impact on research. The conclusions were:

  • Regulation of medical research is necessary but complex.
  • There are difficult balances between public benefit and participants, patient and consumer risk, and many stakeholders making competing demands on regulators.
  • Developing regulations for medical research has tended to be piecemeal leading to duplication of requirements from different regulators. Consequently scientists experience delays that hold up their research.

The MRC works with the other research councils through RCUK to address governance issues and to develop policies that cut across the research base. Current issues include open access publishing and good research conduct.

  • In 2008, RCUK commissioned a report on open access to research outputs. The purpose of the study was to identify the effects and impacts of open access on publishing models and institutional repositories in light of national and international trends.
  • In April 2008, RCUK jointly sponsored a workshop at Keele University on ‘Promoting Good Research Conduct’.

Future

We aim to reduce the bureaucracy involved in regulatory approval while ensuring that the UK retains its high standards of research ethics and integrity.

  • We aim to aspire to achieve clarification and – if appropriate – simplification of regulations, as well as improvement in communication and engagement with all concerned.
  • We aim to ensure that European Union (EU) and UK regulations, such as those set out by the EU Directive on Clinical Trials and NHS Research Governance, and interpretation of these regulations do not present unnecessary barriers to producing evidence about the safety and efficacy of treatments.
  • We aim to pay attention to research regulation, ethics, governance and working with decision-makers in developing countries as well as in the UK.

How

  • We will engage with policy groups considering uses of health and Human Fertilisation and Embryology Authority data in research.
  • We will develop new guidance for stem cell researchers, in the light of the new Human Fertilisation and Embryology Bill, the review of the role of the Global Forum on Bioethics in Research and developments in international discussions in the area.
  • We aim to take a leading role in the development of policy and regulatory framework on the use of the electronic healthcare records in research.
  • We will work with other stakeholders to ensure that European legislation concerning the use of animals in research maintains appropriate standards of animal welfare, and balances the need for appropriate regulation with the resources needed for world class research.
  • We will continue to work with the Human Tissue Authority and other regulators with the aim that processes and guidance for researchers are as simple and efficient as possible.
  • We will continue to work through RCUK and other partners to develop policies and appropriate governance arrangements that foster UK research and maintain its integrity.
  • Through RCUK, we will work with Universities UK and others to establish a common approach to good research conduct across the UK.