Ethical standards for research are essential. They ensure that the rights, dignity and wellbeing of participants, researchers and the public are protected.
As well as being the right thing to do, making sure a research project meets ethical standards, or has undergone appropriate, independent ethical review is often a funder, institutional, or legal requirement. It is a key consideration of research integrity* and research governance*. It is also frequently needed for publication of research in peer reviewed journals.
Sometimes the term ‘ethical approval’ is used when talking about research ethics review. However, it may be more helpful to think about meeting ethical standards or seeking an ethical opinion (if required) rather than obtaining an ‘approval’. Approval is more likely to be associated with fixed governance or regulatory requirements, whereas a review on whether ethical standards have been met demonstrates that an ongoing, reflective approach has been adopted.
*Further information on research integrity and research governance is available in the About Research Integrity and About Research Governance Explainers
Research should be designed, conducted, managed, overseen and reported ethically. Basic ethical standards that should be considered include:
Respect for those involved including respecting their dignity, privacy and their right to make their own decisions, free from interference or undue influence
Ensuring that individuals who cannot make their own decisions are appropriately protected
Ensuring that the research is worthwhile (e.g. has a clear public benefit), able to answer a relevant question or address a relevant need and is scientifically robust
Ensuring that the research activities offer the maximum benefit for individuals and society whilst also minimising possible harms
Ensuing that the research activities have consideration for justice and equity
Reviewing the study design, plans for engaging with participants about the research and any information aimed at/provided to potential or actual participants (e.g. information sheets, consent forms). It also includes looking at plans for reporting on and disseminating the results of the research.
Ethical review is an ongoing process. During the conduct of the research ethical issues may arise which require a change to study design or updates to the information for participants.
*Further information on research integrity and research governance is available in the About Research Integrity and About Research Governance Explainers.
The following is not an exhaustive list, ethical considerations will vary depending upon the type or research, participant population and setting:
Are potential participants being provided with clear information about the research that is appropriate, easy to understand and objective.
Based on the information provided will they be able to make a free and informed choice about whether to participate?
Has it been made clear that participation is voluntary and are any risks and disadvantages clearly explained
Are the research aims clear, relevant and useful (e.g. will the research findings be beneficial to society)?
Is the research designed in a way that is appropriate and will be able to achieve the research aims?
Will the privacy of participants and confidentiality be respected?
Are there any potential risks to the safety and wellbeing of participants from the research, and if so, have these been adequately addressed?
Does the research offer an intervention or change in practice, if so, what is the plan for this after the research stops?
Has the design and development of the research involved the relevant participant population or their representatives?
Does the research involve any particularly sensitive subjects or involve any participants who maybe particularly vulnerable (e.g. children)- if so how will this be managed?
Will the opportunity to participate be equally offered to all who may be eligible to participate and has consideration been given to maximising inclusivity?
Will participants be offered any reimbursement for taking part? If so, is the level, type of reimbursement appropriate and has this been explained to participants in an appropriate way?
UK Research & Innovation (UKRI) Ethical Research and Innovation
Economic and Social Research Council (ESRC) Framework for Research Ethics
Social Research Association Research Ethics Guidance
AMRA Research Ethics Support and Review in Research Organisations