Research

Strategic Aim One:

Picking research that delivers

Strategic Aim Two:

Research to people

Strategic Aim Three:

Going global

Strategic Aim Four:

Supporting scientists

Regulation, ethics, governance & working with decision-makers

For academic and commercial research to be effectively carried out and translated into patient benefit, we need regulations that are proportionate to risks and harmonised across organisations. We also need to ensure that researchers have appropriate access to healthcare systems and related safe datasets and that the public has trust in research governance.

Working with partners, the MRC plays an important role in influencing regulation and governance in a way that facilitates research while maintaining the highest ethical standards.

Objective

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

Now

The MRC supports the recent establishment of the Health Research Authority (HRA) and is building close working relationships with the HRA and other organisations involved in research governance across the UK —through secondments to projects on the delivery of guidance and training for researchers, for example.

  • We are working in partnership with other funders, academics and industry to influence the direction of EU legislation relating to clinical trials and data protection with the aim of facilitating clinical research regulation.
  • The MRC aims to ensure that innovative developments in research are aligned with best practice in the ethical conduct of research — for example, we are working with the Wellcome Trust on a joint framework on how health-related findings in research should be addressed.
  • We are working, as part of the UK Bioscience Sector Coalition, to ensure that implementing the changes to animal research regulation resulting from EU directive 2010/63 leads to a reduction in unnecessary bureaucracy while maintaining high welfare standards.
  • The MRC is a signatory of the 2012 UK Research Integrity Concordat and is working in partnership with other research councils to strengthen the culture of research integrity via improved guidance, training and accountability.

Future

  • Through effective partnerships we aim to ensure that the UK regulatory landscape, linked to the EU framework, is risk proportionate and harmonised — allowing research to be delivered in a more timely, less resource-intensive environment.
  • We aim to increase opportunities to deliver on the rich potential of UK (and global) patient and population data, and associated biological samples, while ensuring the highest standards of ethics and governance to promote public confidence in this key area.
  • By engaging with the HRA, the Medicines and Healthcare products Regulatory Authority (MHRA) and oversight bodies across the UK and EU, we aim to support the development of a harmonised system of approval in the UK and EU; ensuring clear consistent guidance is easily available to researchers navigating this system.
  • We aim to provide effective systems and guidance to researchers to promote transparency of outcomes and sharing of data from MRC-funded research.

How

  • We will work in partnership with others to effectively bridge between researchers and regulators/policy-makers to ensure legal and regulatory frameworks are developed with a clear understanding of the medical research landscape.
  • The MRC will work with others to increase communication, engagement and the involvement of the public in approaches to regulation and governance involving people and animals.
  • We will facilitate access to patient and population data and biological samples, whilst maintaining the highest standards of safety and security for data use - We will lead on the concept of "safe" data.
  • We will ensure that researchers can access up-to-date and clear guidance on the conduct of research and will work across the sector to strengthen the integrity of research.
  • We will continue to promote a culture of openness about the use of animals in research and dialogue with the public about this issue.