research governance meaning

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What is research governance?

This section provides guidance on the responsibilities of the College in relation to research governance and principles of good practice for health and social care research

Research governance can be defined as a broad range of regulations, principles and standards of good practice that exist to achieve and continuously improve research quality across all aspects of healthcare in the UK and worldwide. It can also be defined as regulations, principles and standards for projects outside of healthcare research, including good study conduct.

Who does it apply to?

Research Governance applies to everyone connected to research including Chief Investigators, Researchers, their employer(s) or support staff. For those in healthcare research it can also apply to those in a healthcare role, such as care professionals.

By healthcare research, we mean  any health-related research which involves humans, their tissue and/or data.

Examples of such research would include: 

• Analysis of data from a patient's medical notes
• Observations 
• Conducting surveys
• Using non-invasive imaging
• Using blood or other tissue samples
• Inclusion in trials of drugs, devices, surgical procedures or other treatments

For non-healthcare research, this could include:

• Interviews with study participants
• Use of personal data
• Observations of participants

If you are involved in research of this kind, it is important that you are aware of your obligations to the healthcare or non-healthcare research process and the development of research governance. You must also be aware of the College's research misconduct  procedures.

Why is it needed?

Research Governance is needed to:

• Safeguard participants in research
• Protect researchers/investigators (by providing a clear framework to work within)
• Enhance ethical and scientific quality
• Minimise risk
• Monitor practice and performance
• Promote good practice and ensure lessons are learned

Research governance: where did it come from, what does it mean?

Affiliation.

• 1 Open Learning Unit, Department of Primary Care and Population Sciences, University College London, Holborn Union Building, Highgate Hill, London N19 5LW, UK. [email protected]
• PMID: 16260798
• PMCID: PMC1275997
• DOI: 10.1177/014107680509801110

For a variety of historical and social reasons, research has become increasingly formalized and regulated. This change has potential benefits (reduction in fraud and misconduct, protection of vulnerable groups, financial probity) but also disadvantages (increased paperwork, time delays, constraints on research freedom). The terms 'research' and 'governance' mean different things in different contexts. Even with explicit guidance, ambiguities must be resolved by human judgement. Variation in the nature and outcome of approval decisions is therefore a fact of life. The type of approval needed for a research study depends on the official remit of the approval body, the question to be addressed; the methods to be used; the context in which the work will take place; the level of analysis and interpretation; and the plans for how the findings will be presented and used.

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• What is research governance & why is it important?

Envision a world where there were no policies, processes, rules, or regulations. What do you see? Chaos and confusion? Similarly, conducting research in the absence of clearly defined guidelines and policies may no doubt still yield new findings, however, they may or may not be entirely ethical and of great quality.

Just like all the other industries the research sector too is evolving rapidly. Today winning the funding is just starting point and brings along increased responsibility unlike in the past when the research activities were not heavily regulated by the government and legislation.

Good research governance is essential to protect the interests of participants, researchers, funders, and other stakeholders. It also enables research to be conducted efficiently and effectively, making the most use of available resources.

But what exactly does research governance imply and why is it important? To assist you gain a better understanding of the subject; read the article we have compiled below.

What is research governance?

The government, as well as the research institutions that perform research, establish rules and procedures from time-to-time basis on which research is planned, monitored, and managed. All these frameworks together, constitute research governance. It is a system that ensures that research is conducted ethically and with rigour and that the results are reliable. 

Good research governance protects both the researcher and the participant while also ensuring that research is of the highest quality. And with the growing funding support available not just from the government but also from non-profit organisations for conducting research activities, and research being conducted on such a massive scale around the world, the need for governance is greater than it has ever been.  

Importance of good research governance

Research carries a significant impact on people's lives. The Research Governance framework includes a set of principles and practices that guide and manage the conduct of research. It ensures that research is conducted ethically and with integrity. 

Good research governance is important for several reasons.

It protects the safety and welfare of participants in research studies

The responsible conduct of research is a fundamental ethical obligation for all individuals involved in the design, conduct, and review of research. It is also a regulatory requirement for institutions receiving federal funding for research. Research governance not only promotes the safety and welfare of participants in research studies but also helps to ensure the validity and integrity of the research process is maintained.

It ensures that research is compliant with regulations

Good research governance is founded on a system of organisational structures, policies, and procedures that are designed to promote ethical and responsible practices. These include: a code of ethics for researchers, a process for reviewing and approving research proposals, mechanisms for monitoring and supervising research, and procedures for responding to misconduct.

It promotes responsible use of data and results

Research data and findings can be used by government to make important decisions about health, safety, and the environment and/ or by companies to make informed decisions towards improving existing or launching new products or and services. 

But who is responsible for ensuring that the data is used responsibly? The principles and guidelines laid out in the research governance frameworks paves the way for responsible and ethical use of data and research results. It covers all aspects of data management, from how data is collected and stored, to how it is used and shared.

It helps to maintain public trust in research

The role of research governance is to ensure that all research is conducted ethically, and that the public can trust in the results. It helps to maintain public trust in research, by ensuring that experiments are conducted properly, and that any data or findings are made available for public scrutiny.

It ensures that research is conducted ethically and with integrity

Research governance includes policies and procedures that are put in place to protect the validity and integrity of the research and to ensure that research is conducted in an appropriate and responsible manner and in compliance with relevant laws and regulations.

It promotes transparency and accountability in the research process

Research governance plays a huge role in ensuring that researchers are held accountable for their actions. This includes both individual researchers, and research institutions. Misconduct in research can carry a negative impact over an institution's standing and can even result in criminal charges.

How can research governance be improved?

Improved research governance can aid in ensuring research is reliable and of high quality. But how can one improve research governance within their organisation? Here are some tips to get you started:

• establish clear guidelines and procedures for conducting research and ensure everyone involved in the research process understands and follows the same guidelines,
• create and enforce standard operating procedures for all phases of the research process,
• have a system in place for monitoring and reporting research misconduct to ensure researchers understand their obligation to perform their work in line with the ethical standards.
• funding agencies could play an important role in improving research governance by providing more support to researchers and ensuring that their work is carried out in a safe and responsible manner,
• finally, research organisations should consider fostering two-way communication to ensure that all stakeholders are aware of and understand their responsibilities.

While there is no one-size-fits-all answer to research governance. Each institution must develop and continually improve a system that meets the specific needs of its researchers, administrators, and governing board.

Solve your ethics and governance challenges with OmniStar Ethics

Adhering to the revisions in research regulations and guidelines from time to time is something all parties involved in the research must comply with. This process could be simplified if research institutions leveraged technology to their advantage.

To comply with local and government policies and regulations you need reliable processes and information you can trust. With OmniStar’s in-built compliance controls, you can save your applicants' time, researchers' time by streamlining and automating ethics and governance processes within your organisation.

Contact an OmniStar expert today to discuss how we can help solve your ethics and governance challenges with OmniStar Ethics.

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What is research governance?

The standards and principles of the Research Governance Framework currently apply to all research that relates to the responsibilities of the Secretary of State for Health. This includes any research undertaken by academic or independent bodies/ individuals, in or with social care agencies, as well as research undertaken by those agencies themselves.

The purpose of Research Governance is to ensure the highest standards of quality in research. This covers scientific quality and standards of ethics, and all related management aspects in the setting up, conduct, reporting and progression to healthcare improvements.

The Research Governance Framework sets out responsibilities for all involved in research: researchers (including students and their supervisors), care professionals, funding bodies, hosts, employers, and sponsors of research.

Acting as a Sponsor

The Sponsor is an individual, organisation or group taking responsibility for securing the arrangements to initiate, manage, monitor and finance a study. For any research that takes place in the context of the NHS or Social Care services, it is necessary that a Sponsor is identified. The Sponsor is normally expected to be the lead employer of the research team, the lead health or social care organisation, or the main funder.

Main responsibilities

The Sponsor has the responsibility for ensuring that all the necessary arrangements are in place before the study can proceed, including:

• Assure that research study has obtained scientific quality approval from the necessary bodies;
• Ensure that the study has obtained ethical approval;
• Ensure arrangements are in place for the monitoring and reporting of research;
• Ensure the research team have access to resources and support to deliver the research as proposed.

If you wish the University to act as the Research Sponsor of a project, under the terms of the  Department of Health's Research Governance Framework , please download a  copy of this form , complete and get agreement from your Faculty’s Dean. A copy of the form must then be sent to Sarah Taylor in RBDO.

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What is governance.

Research governance can be defined as the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.

The framework is of direct relevance to all those who host, conduct, participate in, fund and manage health and social care research.  It is not just for investigators, managers or any one professional group. All service and academic staff have a role to play in the conduct of research.  Participants in research and the public in general can also help to ensure that standards are understood and met.

Examples of such research would include:

• Analysis of data from a patient’s medical notes
• Observations
• Conducting surveys
• Using non-invasive imaging
• Using blood or other tissue samples
• Inclusion in trials of drugs, devices, surgical procedures or other treatments

Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, high-quality research in health and social care.  The public has a right to expect scientific, ethical and financial standards are applied and that transparent decision-making processes with clear allocation of responsibilities and robust monitoring arrangements are in place.

Research governance is needed to:

• Safeguard participants in research
• Protect researchers/investigators (by providing a clear framework to work within)
• Enhance ethical and scientific quality
• Minimise risk
• Monitor practice and performance
• Promote good practice and ensure lessons are learned

The framework aims to forestall poor performance, adverse incidents, research misconduct and fraud, and to ensure that lessons are learned and shared when poor practice is identified.  Learning from adverse events will promote good practice, enhance the ethical and scientific quality of research, and safeguard the public.

The Department of Health (DoH) launched the Research Governance Framework (RGF) to complement existing governance arrangements in clinical practice and financial management in the National Health Service.

Research governance was intended to prevent poor performance, adverse incidents, misconduct or fraud and promote public confidence in research. There has been considerable progress in implementing this Framework to provide clear national standards, a system through which these are applied and managed via local screening committees, training and education in the management and conduct of research and national monitoring.

Moving forward: replacing the Research Governance Framework

Upon becoming a Non-Departmental Public Body (NDPB) on 1 January 2015, the HRA took responsibility for issuing guidance for research in England, which will replace the  Research Governance Framework  (RGF).

The HRA and Devolved Administrations undertook a review and produced a draft revision to the framework which was issued for comment in spring 2015.  They are now reviewing responses received from across the UK and will issue a final version of the policy framework for publication later in 2016.

A core standard for health care organisations is that they have systems to ensure the principles and requirements of this research governance framework are consistently applied.  Health care organisations have to take this standard into account in discharging their duty of care under the Health and Social Care Act 2003.

The Health Research Authority: National Research Ethics Service (NRES) ensures that research ethics committees (RECs) operate in the same way within a set timescale.

Find out more about committees and services

Each NHS Trust is served by an R&D department which ensures that all necessary approvals are set in place before a project begins and that researchers are appropriately qualified and trained.

If you are researching in the NHS, you should seek guidance from the Oxford Health NHS Foundation Trust R&D office, or the appropriate alternate office where the research will take place. The R&D office will provide advice about what you need to do as far as the Trust is concerned.

Email the Research and Development Governance team .

The Research Governance Framework has five elements:

• ethics and patient information
• information
• health & safety & employment
• finance & intellectual property rights

See more for details on the Research Governance Framework

Page last reviewed: 20 March, 2024

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Research Governance concerns setting standards to improve research quality and safeguard the public. It involves enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring lessons are learned and preventing poor performance and misconduct.

A broad range of regulations, principles and standards of good practice exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.

Research governance applies to everyone connected to healthcare research including Chief investigators, health care professionals, researchers, and support staff.

Principles GCP

The following principles are based on Articles 2 to 5 of the EU GCP Directive 2005/28/EC and include 2 new principles, no’s 7 and 8, that are included in the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006.

• The rights, safety and well-being of the trial subjects shall prevail over the interests of science and society
• Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks
• Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects
• The necessary procedures to secure the quality of every aspect of the trial shall be complied with
• The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial
• Clinical trials shall be conducted in accordance with the principles of the Declaration of Helsinki
• The protocol shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy
• The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial
• All clinical information shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.

Conditions based on Article 3 of the GCP Directive

• Before the trial is initiated, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks
• The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified doctor or, when appropriate, of a qualified dentist
• A trial shall be initiated only if an ethics committee and the licensing authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored
• The rights of each subject to physical and mental integrity, to privacy and to the protection of the data concerning him in accordance with the Data Protection Act 1998 are safeguarded
• Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial.
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