Human participants in research

Research funded by UKRI and with human participants should always be reviewed by a UK research ethics committee. This may be a research ethics committee for health and social care or of the research organisation, depending on the type of research.

Conducting an ethics review

Guidance for researchers and Research Ethics Committee in research organisations, such as universities, can be found in the Framework for Research Ethics published by the ESRC.

ARMA guidance on ethics review (PDF, 795KB)

Research involving health and social care

If the research involves health and social care, then researchers should consult the UK Policy Framework for Health and Social Care Ethics and other guidance on the Health Research Authority website.

Key principles

The following principles apply to all research which involves human participants.

Research should aim to maximise benefits for individuals and society and minimise risk and harm

Researchers should ensure that their research is beneficial to participants, individuals, science and society, and be realistic about the benefits that it is likely to deliver.

The rights and dignity of individuals and groups should be respected

Research should be designed and conducted in a way that respects the rights, interests, values, dignity and autonomy, if possible, of participants (including individuals, groups and communities). Ethics issues are most likely to arise around privacy, equality, diversity and health and safety.

Wherever possible, participation should be voluntary and appropriately informed

Researchers should inform participants that they have a right to refuse to participate, free of consequences, and can withdraw from the research for any reason.

Research should be conducted with integrity and transparency

Integrity demands that there is a clear fit between what researchers say they will do and how they will conduct their research. Transparency means being clear about the nature of the research and communicating this to those involved.

Lines of responsibility and accountability should be clearly defined

Researchers must exercise self-critical responsibility in the planning and conduct of their research. Research ethics committees and research organisations have a responsibility to guide and support researchers, especially when the research involves difficult ethical decisions.

Maintaining the independence of research

Researchers should maintain the independence of their research and where conflicts of interest cannot be avoided they should be made explicit.

Independence of research is founded on academic credentials, professional standards, expertise and experience. It is free from personal, organisational and political bias, dishonesty, and considerations of gain and should be safeguarded at all times.

Guidance and resources

The list of useful resources below is not exhaustive and inclusion should not imply full endorsement. Where there are differences, the UKRI policy and guidance will take precedence.

Health research authority approval guidelines

This describes the HRA process for assessment of governance and legal compliance that is required for all studies undertaken within the NHS and requiring NHS ethics review.

UK framework for health and social care research

The key framework on ethical review of health and social care research, particularly when this involves NHS patients.

ARMA guidance on ethics review (PDF, 795KB)

Guidance from the Association of Research Managers and Administrators on ethics review provided by research organisations, such as universities, for research not involving the NHS.

Medicines for human use (clinical trials) regulations

The key legislation in the UK for undertaking clinical trials of new medicines.

Access the UK legislation for clinical trials of medicines (PDF, 80KB)

A summary of the original legislation for clinical trials of new medicines in the UK and Europe.

Clinical trials for UK medicines, UK legislation

The MRC guidance on the UK legislation for clinical trials of new medicines.

Clinical trials toolkit

The toolkit provides guidance on interpreting the clinical trials regulations for academic clinical trials of medicines, as well as additional links to relevant resources.

MRC: medical research involving adults who cannot consent (PDF, 480KB)

This document in the MRC Ethics Series describes the legal and ethical frameworks relevant to research involving adults who do not have the capacity to provide informed consent.

Framework on the feedback of health-related findings in research (PDF, 260KB)

This framework developed by the MRC and Wellcome provides guidance for researchers on making decisions about when to provide feedback on health-related findings, including unexpected or incidental findings, to research participants.

A community-based participatory research: a guide to ethical principles and practice (PDF, 2.4MB)

Guidance developed by the National Co-ordinating Centre for Public Engagement.

Common cause: fair and mutual partnerships: 10 principles for community-university partnerships (PDF, 80KB)

10 principles for conducting fair and mutual research partnerships between Universities and Black and Minority Ethnic communities from AHRC-funded Common Cause project

ESRC framework for research ethics

An ethics framework developed by the ESRC for research organisations, including universities. The requirements are mandatory for ESRC-funded research.

MRC ethics series: using information about people in health research

This document provides guidance about the legal and governance frameworks relevant to using personal information in research, including identifiable information.

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