This document provides an overview of research ethics and how this can be applied specifically to public health research in non-National Health Service (NHS) settings. The purpose and remit of Research Ethics Committees (RECs) are discussed, with further detail focusing on the Public Health Research Ethics Committee for studies which are taking place outside of the NHS and without an academic partner. 

This document will help researchers to understand the wider benefits of seeking an ethics review of their work. It will also help to clarify the role of RECs in protecting participants and supporting researchers to be confident in addressing ethical issues in their work.

The Wellcome Trust defines research ethics as “the moral principles that govern how researchers should carry out their work.” Various approaches to research ethics have been established over the years.

The Declaration of Helsinki 1964 was developed by the World Medical Association as an international agreement for promoting ethical research, following unethical medical experiments that were conducted during World War II. The statement highlights the importance of distinguishing between clinical care and research. It emphasises the importance of protecting the well-being of human participants involved in medical research and enshrines both informed consent and the right to withdraw from research.

A second influential document is the Belmont Report (1978) that introduced three basic ethical principles for research involving human participants:

• Respect for persons (autonomy): individuals should be free to provide informed consent and those who are unable to are entitled to protection.

• Beneficence (doing good): protecting individuals from harm and maximising the possible benefits to them. 

• Justice: treating all individuals equally.

These ‘Belmont Principles’ were subsequently expanded by adding a fourth principle – avoiding harm (non-maleficence) - and together these four principles have formed the cornerstones of ethical considerations within applied ethics for almost fifty years. They are particularly influential in medical as well as research ethics.

It is important to note that research ethics primarily evolved from the consideration of research involving human participants, for an assumed individual benefit. The earlier principles were therefore developed with a focus on the individual, and did not explicitly consider population level interventions and benefits. 

Organisations have since drawn upon these founding principles to establish their own sets of principles. For example, the Economic and Social Research Council (ESRC) is a UK funder of economic, social, behavioural, and human data science. They list their six principles of ethical research as follows:

• Research should aim to maximise benefit for individuals and society and minimise risk and harm.

• The rights and dignity of individuals and groups should be respected.

• Wherever possible, participation should be voluntary and appropriately informed.

• Research should be conducted with integrity and transparency.

• Lines of responsibility and accountability should be clearly defined.

Independence of research should be maintained and where conflicts of interest cannot be avoided, they should be made explicit.

Principles of research ethics, help organisations to forge processes and policies, which provide researchers with a framework of best practice. This supports researchers to comply with institutional requirements and to maximise ethical acceptability in their research. Organisations undertaking research, are encouraged to develop an ethics policy to guide researchers in undertaking research in an ethical and consistent way. 

The Public Health Skills and Knowledge Framework states that ethics is an integral part of public health decision-making, as local authorities and other decision-makers cannot act to serve population health without considering the ethical arguments. The validity of a particular intervention should not be evaluated without understanding its ethical implications. 

Ethical issues in public health research are not dissimilar from other human research however, what does set it apart, is the population or community focus, rather than that of the individual. The ethical implications for a collective benefit are therefore fundamental to the ethics of public health research. Public health research also has a significant focus on health inequalities, which is not always at the forefront of other research programmes. The ethical implications for reducing health inequalities are a key consideration in public health research but not necessarily in other areas of health research. 

When undertaking public health research, local authorities will often need to consider the ethical implications of the following:

• Engagement with communities: ensuring transparency when approaching members of the public as either a local authority employee or as a researcher, as this can affect the data collected and/or the willingness to participate in the research. 

• Co-production of research: community members having an active role in developing, designing, and delivering services, and engaging with people who have real-life experience to ensure the research is relevant and acceptable to participants. 

• Community research programmes: it is important that those undertaking the research are able to foster a sense of trust, honesty, and openness with participants, and this can be achieved by training local residents as researchers and empowering them to take an active role in research. 

• Data management: ensuring that accessing, using and storing public data is in line with data protection legislation (e.g. the Data Protection Act 2018), protecting privacy and confidentiality.  

• Conflicts of interest: managing potential conflicts of interest with stakeholders who may have a vested interest in the research.

• Public resources: making decisions on the allocation of resources for undertaking research, especially when those resources are limited, and local authorities are under financial constraint. 

• Underserved communities: ensuring that communities which are underrepresented and/or experiencing health inequalities are encouraged to participate in research.

• Equity: applying public health interventions fairly across communities and ensuring participation in research is accessible. 

• Health inequalities: there is an obligation that interventions should aim to reduce health inequalities or show a commitment to not increase them. 

• Availability of research results or benefits: ensuring the results are available to those who participated in the research, and communities who may potentially benefit from the research.

Occasionally, despite best intentions, an intervention within a study may inadvertently increase health inequalities due to unforeseen reasons. This could potentially lead to a public health research study needing to halt on the basis of public health research ethics principles. 

An independent ethics review of research is mandated by law for clinical trials of medicinal products or devices, and by National Health Service (NHS) policy for studies involving NHS patients or being conducted in NHS settings. These statutory reviews are managed by the Health Research Authority (HRA) through the Research Ethics Service’s seventy Research Ethics Committees (RECs), and also the Ministry of Defence’s Research Ethics Committee (MODREC). Universities often require an ethics review if research is being conducted by their staff or students as part of their commitment to national research ethics and integrity requirements made by research funders. The HRA also has Social Care RECs for the review of studies involving social care service users as participants, particularly if the research involves participants who may not have the capacity to consent (or have fluctuating consent).

Public health research can operate outside of the NHS, without a university being involved, and not under the HRA Social Care REC remit. As a consequence, it may not require review through these pathways. However, an independent ethics review of the research would promote good research practice and provide assurance to the host organisation for governance approvals, journals when submitting articles for publication, and society more widely that the research has been conducted ethically and can be trusted.

An independent ethics review helps to ensure that research will be undertaken with ethical integrity, and that the rights, dignity, and welfare of participants will be carefully considered. RECs provide a forum to discuss the ethical acceptability of the research proposed, collectively bringing together expertise in science and ethical concepts of research, as well as non-expert public contributors. Recommendations are provided on how to improve the design, conduct and reporting of the research where appropriate, which can provide researchers with a learning opportunity, enabling them to address ethical issues more confidently in their work. RECs can help to provide a consensus in areas of contention, either from different stakeholders of the research or with complex ethical dilemmas. They also help to foster public trust in research by promoting ethical practices and the adherence to recognised standards. The World Health Organization advises that “all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld.”

It can sometimes be quite difficult to distinguish between research needing a REC review and other ‘business as usual’ activities that have different accountability mechanisms (such as clinical/healthcare practice, or the everyday work of social workers who are accountable to their professions). UK wide guidance has been co-produced by the Health Research Authority, UK Health Security Agency and Ministry of Defence (Kolstoe et al. (2025)), including classification tables that can be used to help determine whether an ethics review is required. However, it is important to note that an ethics review would also be encouraged if the researcher or host organisation considers there to be any ethical issues in the study that would benefit from an independent expert review, especially when there are no clear lines of accountability for the proposed activity. 

The UK Research Integrity Office (UKRIO) and the Association of Research Managers and Administrators (ARMA) have also published guidance on research ethics support and review in research organisations, that can be used to support the function of RECs. The guidance includes four core principles:

• Independence: processes operating free from conflicts of interest so that the application of ethics is not compromised.

• Competence: processes being well-informed, consistent, and coherent. 

• Facilitation: prioritising the facilitation of high quality and safe research, evidenced by positive engagement with the processes. 

• Transparency and accountability: transparency of the opinions and advice provided by the REC and being open to public scrutiny. 

Ethics review processes outside of the HRA’s remit are not nationally controlled and can take place in a wide range of organisations. The UKRIO and ARMA guidance seeks to ensure broad uptake of the principles by being flexible and enabling them to be implemented in ways which are appropriate for the host organisation. 

It is important to note that RECs can provide an ‘opinion’ on the ethics of a research proposal however, formal approval for the research resides within governance processes overseen by the host organisation. 

The Public Health Research Ethics Committee (PHREC) has been established to provide an independent ethics review of public health research within and around the south-central region of England. The entity creating the PHREC is the Research Support Service Specialist Centre for Public Health (RSS SCPH), delivered by the University of Southampton and Partners (USP). The remit for the committee is to review research which is taking place outside of the NHS and does not have an academic partner, therefore, not meeting the requirements for review by either an NHS REC or a university REC.

The PHREC will provide an advisory function which serves as an optional independent review and support for public health research. The committee will provide an independent ethics opinion on the research being conducted along with recommendations for improving the ethical acceptability of the work. Researchers will be able to cite the ethics review by the committee and the opinion provided, to use as assurance for governance processes within their host organisation and for journal publication requirements.

The committee is comprised of a broad range of expertise with representation from public health consultants based in both academia and local authorities, along with ethicists, chairs/members of RECs (e.g. NHS, the Ministry of Defence, and university RECs), and public contributors with strong community research links. It will operate in accordance with the UKRIO and ARMA ethics framework, focusing on the core principles of independence, competency, facilitation, and transparency/accountability.

In order to facilitate research and not provide a barrier to this taking place, applications for ethics review will be assessed by the committee at monthly meetings, with the aim to provide feedback to researchers within fourteen days of the meeting taking place. The process is aiming to help upskill researchers to consider ethics throughout their research, with the provision of constructive and supportive feedback, and an overall ethics opinion of the work.

Further information on the committee including meeting dates and application deadlines can be viewed on this website. For further information on the process or to submit an application, please contact phethics@soton.ac.uk. 

1. Governance assurances

• Is there appropriate expertise and competency in the team to conduct all stages of the study?

• Has a sponsor been identified for the study?

• Is appropriate insurance or indemnity applicable to the study in place?

• Is the study team acting transparently and with integrity?

• Have any conflicts of interest from the study team or stakeholders in the research been disclosed?

2. Assurances that risks have been considered

• Is there potential for the intervention to cause harm or discomfort to individuals or groups of participants?

• Have the risks for harm or discomfort to participants or groups of participants been minimised as much as possible?

• Are children or other potential vulnerable groups involved in the study, and have they been prevented from harm or discomfort?

• Have the benefits and harm produced by the intervention been assessed and, if so, which one outweighs the other (benefit-risk ratio)? 

• Has the reputational risk to the host organisation/sponsor been assessed and minimised?

• Have the risks to the researchers and any third parties been assessed and minimised?

3. Study design and intervention assurance

• Has existing research evidence and research in progress been considered in the design of the study?

• Has there been public involvement or co-production to ensure that the research and its design, are relevant to the needs of the public?

• Will the study determine the effectiveness of the intervention and help support evidence-based decision making? 

• Does the intervention assess an improvement in population health as opposed to the health of individuals?

• Does the intervention help to address health inequalities?

• Will it be assessed whether the intervention has a sustainable, long-term effect on the health of the population?

• Is the intervention the least infringing of possible alternatives?

• Has the environmental impact of the intervention been considered and any sustainability measures put in place?

• If the intervention is paternalistic and restricts decision making in any way for those participating, has this been justified?

4. Recruitment and ongoing participation

• Is there ‘informed consent’ to take part in the study?

• Do participants have the ability to make their own decisions?

• Does participation in the research foster free choice, without coercion?

• Does the study promote a fair and equal opportunity to participate?

• Are the inclusion and exclusion criteria for recruitment transparent and justifiable?

• Are the rights, dignity and well-being of participants protected in the study?

• Are participants able to withdraw from the study and has the withdrawal process been considered?

• Do participants have a named and accessible contact for support and to raise concerns?

5. Data management assurance (please note the legal responsibility sits with the sponsoring organisation)

• Will special category (sensitive personal data) or data relating to a person’s criminal convictions be processed?

• Will participant anonymity and confidentiality be maintained?

• Will data linkage allow participants to be identified?

• Will data be stored and managed securely during/after the study?

• Will data be managed in accordance with the host organisation’s Data Management Policy?

• Will the organisation’s Data Protection Officer or Caldicott Guardian, be consulted on the lawful access and use of the data?

• Will the data be made available for reuse after the study has finished?

6. Research inclusion

• Has the potential diversity of people and communities been taken into account in the design of the study?

• Have provisions been made for those with communication needs such as assistance with language barriers or disabilities?

• Does the intervention consider and support vulnerable communities (e.g. children under 18 years of age, older persons, those who are homeless or living in sheltered accommodation, and those who are under the influence of drugs or alcohol etc.)?

• Are communities at risk of being excluded from public health interventions or services due to taking part in the study? 

• Will community engagement take place to manage unintended stigma and discrimination of defined communities in the study?

• Does the study promote a sense of social cohesion and collective responsibility for public health?

• Is there a community added value to taking part in the research e.g. improving the environment, boosting the local economy, or improving access to local resources or services?

7. Finances

• Will cost-effectiveness of the proposed intervention be considered in the study?

• Is there an awareness of maximising the value of public money?

• Has the priority of the research been considered and justified in relation to other community needs?

• Are costs and resource allocation appropriate for the study?

• Are any incentives for participants taking part in the study appropriate and fair e.g. payment, vouchers, or reimbursement of expenses?

8. Publication and dissemination plans

• Will the research be registered on an appropriate and accessible registry?

• Might publications inadvertently identify people through places or personal characteristics?

• Will any of the published data be sensitive or have the potential to cause harm or upset to participants or their families?

• Will all contributors to the study be appropriately acknowledged and all sources of information referenced?

• Is the plan for results to be published in an open and accessible format (ideally as open access outputs)?

• Is there a plan of how to inform participants of the study results?

For further information, the links below offer additional context to the information contained within this guidance document:

• Ethics review pathways decision tool

• Public Health Research Ethics Committee 

Belmont Report: A document produced in 1978 that introduces three basic ethical principles for research involving human participants. 

Chief Investigator: The person who has overall responsibility for the design, conduct, and reporting of a study. 

Co-production: Researchers, practitioners, and the public working together on a research study with equal power and responsibility.

Declaration of Helsinki: A statement produced in 1964 promoting ethical research in human participants and protecting the well-being of participants. 

Ethics: A set of moral principles, regarding what is good for individuals and society. 

Funder: An organisation providing the funding for a research study, usually through defined contracts, agreements, or grants. 

Health Research Authority (HRA): An executive non-departmental public body, sponsored by the Department of Health and Social Care, which protects and promotes the interests of patients and the public in health research.

Host Organisation: The organisation which provides the resources for the research study and holds the main contract with the funder. It is often the employer of the chief investigator. 

National Health Service (NHS): The publicly funded healthcare system for the UK established in 1948. 

National Institute for Health and Care Research (NIHR): The UK’s largest funder of research funded by the Department of Health and Social Care.

Intervention: A process or action in a research study such as administering a treatment or a procedure to participants, in order to evaluate the outcome(s).

Open Access: Findings being immediately available online with free-of-charge access for all users.

Participant: An individual who consents to take part in a research study.

Public Health Research Ethics Committee (PHREC): A bespoke ethics committee to review public health research taking place outside of the NHS and without a university partner. 

Sponsor: An individual or organisation which has the overall responsibility for a research study, including the initiation, management, and financial arrangements of the study.

UK Health Security Agency (UKHSA): A government agency responsible for health security in England and public health protection across the UK. 

Voluntary, Community and Social Enterprise (VCSE) organisations: Entities which are often non-profit and operate to serve community interests e.g. charities, community groups, and faith-based organisations. 

Beauchamp, Tom L. (2019). Principles of biomedical ethics. New York: Oxford University Press. Edited by James F. Childress.

Data Protection Act (2018). Available at: https://www.legislation.gov.uk/ukpga/2018/12/contents. (Accessed 09 May 2025).

Faculty of Public Health (2024). Good Public Health Practice Framework. Available at: https://www.fph.org.uk/professional-development/good-public-health-practice-2024/. (Accessed 09 May 2025).

GOV.UK (2017). Public health ethics in practice. Available at: https://www.gov.uk/government/publications/public-health-ethics-in-practice. (Accessed 09 May 2025).

GOV.UK (2023). Public Health Skills and Knowledge Framework (PHSKF). Available at: https://www.gov.uk/government/publications/public-health-skills-and-knowledge-framework-phskf. (Accessed 09 May 2025).

Hickey G. (2018). The potential for coproduction to add value to research. Health Expectations. 21(4):693. https://doi.org/10.1111/hex.12821. 

Kolstoe, S. E., & Pugh, J. (2023). The trinity of good research: Distinguishing between research integrity, ethics, and governance. Accountability in Research, 31(8), 1222–1241. https://doi.org/10.1080/08989621.2023.2239712

Kolstoe, S. E., Sözüdoğru, E., Messer, J., Coates, E., & Tobin, E. (2025). Is my project research? Determining which projects require review by a research ethics committee. Accountability in Research, 1–21. https://doi.org/10.1080/08989621.2025.2460521. 

NIHR (2020). Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project. Available at: https://www.nihr.ac.uk/improving-inclusion-under-served-groups-clinical-research-guidance-include-project#:~:text=There%20are%20several%20reasons%20why,in%20health%20and%20care%20research.&text=Successful%20delivery%20of%20intervention%20to,differences%20all%20having%20an%20impact. (Accessed 09 May 2025).

NIHR Funding and Awards (2025). Available at: https://fundingawards.nihr.ac.uk/. (Accessed 09 May 2025).

NIHR RSS Specialist Centre for Public Health delivered by the University of Southampton and Partners. Available at: https://www.nihr-rss-public-health-soton.org/home. (Accessed 25 June 2025). 

Schröder-Bäck, P., Duncan, P., Sherlaw, W. et al. Teaching seven principles for public health ethics: towards a curriculum for a short course on ethics in public health programmes. BMC Med Ethics 15, 73 (2014). https://doi.org/10.1186/1472-6939-15-73.

Taylor H.A. and Moore C.M, (2017) The Ethics of Public Health Research: Moral Obligations to Communities. International Encyclopedia of Public Health, Volume 7, 2025, Pages 199-204 DOI: 10.1016/B978-0-323-99967-0.00113-7

The Wellcome Trust (2014). Ensuring your research is ethical: A guide for Extended Project Qualification students. Available at: https://wellcome.org/sites/default/files/wtp057673_0.pdf. (Accessed 09 May 2025).

UK ARMA. Research Ethics Support and Review in Research Organisations. Available at: https://arma.ac.uk/new-research-ethics-guide-from-arma-ukrio/. (Accessed 14 May 2025).

U.S. Department of Health and Human Services (2015). The Belmont Report 1978. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. (Accessed 09 May 2025).

World Health Organization (2025). Ensuring ethical standards and procedures for research with human beings. Available at: https://www.who.int/activities/ensuring-ethical-standards-and-procedures-for-research-with-human-beings. (Accessed 09 May 2025).

World Medical Association. Declaration of Helsinki – Ethical principles for medical research involving human participants. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki/. (Accessed 09 May 2025).