The purpose of a research ethics review is to protect the dignity, rights, safety and well-being of the participant(s), the researcher(s) and the reputation of the University. An ethics review confirms, amongst other things, that any research participants have provided informed consent to participate in a given research project, without inappropriate inducement, and are free to opt out at any time without redress.
Ethical practice in the management of such work requires a body that is independent of the research team to examine the research design. There are three important obligations placed on the ethics committee.
Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information which can be easily understood, and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research.
Secondly, the research ethics committee and its sub-committees have an obligation to society, which provides the resources for research and which will ultimately be affected by the results.
Thirdly, the research ethics committees have an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committees should strive to meet each of these obligations.
It is therefore important that:
(a) the University and its Faculty Ethics Sub-Committees operate in accordance with ethical principles which are explicitly communicated.
(b) the University and its Faculty Ethics Sub-Committees operate in accordance with ethical practices which are followed.
(c) ethics reviewers understand their role and are guided by policies and regulations.
A robust ethics review:
- must be well-reasoned, structured, supportive, and balanced.
- must be consistent, coherent, and well-informed, so that the benefit of the research outweighs any associated risks.
- should provide appropriate positive feedback as well as any necessary constructive criticisms. Such an approach would allow researchers to improve the quality of the project. Ethics review and other supporting processes must make the facilitation of ethically sound research a priority. This will be evidenced by researchers viewing engagement with institutional research ethics processes as positive and valuable for all phases of their research.
- should be clear and defensible, and should comment on methodology only if it raises ethical issues of the research.
- must, in respect of its decisions and advice, be open to public scrutiny, and responsibilities must be recognised and discharged consistently. The reviews must always justify opinions, providing clear rationales.
- must acknowledge that some ground-breaking, highly innovative research may necessarily contain risks and/or could be considered intrusive and should suggest how it can be best accomplished.
- should be risk-aware without being risk-averse.
An ethics review should not:
- focus on matters of methodology and design unless they raise ethical issues, such as exposing participants to avoidable risks and burdens.
- prevent sound research from taking place.
- be overly or inappropriately critical.
- provide legal or policy review. For example, matters such as lawful processing and storage of data should lie within the purview of research data governance.
- provide a proof-reading service; a review should comment on matters of language and layout only if participant documents are so badly constructed that they don’t serve the purpose for which they are designed. Otherwise, the ethical review should avoid reference to matters of spelling, grammar, and syntax.
- check compliance with internal or external policy; this is a matter for research integrity and governance.
General principles of research ethics applications and reviews:
(Documents to consult: University Policy on Assessing Ethical Risks of Research & UKRIO Checklist for Researchers)
- Researchers are responsible for identifying potential ethics issues that may arise within a project and ensuring that it receives an appropriate level of ethical scrutiny.
- A researcher should be guided by the standards set by their professional societies, disciplinary bodies, and the University research policies.
- Research Ethics applications, submitted via the online system, should be considered in relation to the nature and context of the outlined research.
- An ethics review must be proportionate to the potential risk or harm that the research imposes.
- Risks should be balanced against benefits and, where possible minimised.
- A light-touch review is justified in cases where there is a minimal risk of serious harm.
- Research involving individuals or groups who come under the remit of the Mental Capacity Act 2005 should be reviewed by the appropriate Research Ethics Committee (REC). Normally this will be a REC recognised by the Secretary of State and Welsh Ministers and operating under Governance Arrangements for Research Ethics Committees (GAfREC).
- Research conducted in Scotland should be reviewed by the Scotland ‘A’ REC which is operating under the Adults with Incapacity (Scotland) Act 2000.
- Researchers should avoid duplication of an ethics review.
- In collaborative research involving more than one organisation or multidisciplinary research, a single review process as agreed by the University should be used. (Appendix 1)
- The principal investigator must ensure that participating organisations and collaborative researchers are satisfied that the research proposal has received adequate ethics review, and that regular monitoring of the conduct of the research takes place and is promptly reported to all organisations and researchers involved.
- All Research proposals involving human participants will require ethical screening through the online Infonetica application. Research proposals involving human participants AND personal data will require a full review by the appropriate Research Ethics Committees (REC) that operate in accordance with the principles and guidelines set out in the University Research Integrity Policy Framework. All data collection and analysis involving human participants or personal data should receive a ‘Research Ethics Approval’ before the research can commence.
- The research ethics review must be conducted in a manner that is independent, competent, and timely. The ethics review should strive to notify researchers of their decision within a month of receiving a submission, and researchers and the research process should not be disadvantaged by RECs which are not sufficiently resourced to comply.
- Ethics review timeframe should not exceed 60 days maximum unless there are circumstances beyond the control of the University.
- Research Councils expect research on a funded project to commence within three months following the formal notification of funding to allow for recruitment of staff and ethics review. In the majority of cases research proposals should be submitted for an ethics review immediately after notification of funding, but it could also be prior to a pilot study so that participants’ interests are protected, and prior to seeking the agreement of potential research sites and gatekeepers, so they can be assured of its good standing, or prior to the main data collection.
The online ethics review system at Swansea University
The online ethics review system introduced in 2022/23 is designed to facilitate ethics reviews by implicitly addressing all the above issues. The questions and guidance were developed by administrators and academics from across the institution, with the aim of accommodating to the greatest degree possible the cultures and conventions of all constituent Faculties and research areas while providing one unified system for assessing and recording research ethics applications from all researchers, staff and students of the University. Applicants and reviewers/assessors should refer to the templates and guidance provided as part of the system, under ‘Help’ and in the requisite information bubbles.
Reviewing an approved application where the research has been led by another organisation.
All research led by a third party needs to go through a committee and is subject to review and an approval by a Chair.
The reviewer should have the approval letter from the lead organisation, the application, and the supporting documents.
The review is slightly different in that it is addresses the following 2 questions:
- Is the review process as rigorous as /equivalent to that of Swansea University?
- Is there a significant risk of non-trivial harm or moderate or high reputational risk to Swansea?
No – go to 2
Yes – recommend application approval
No - recommend application approval
Yes - recommend reject the application.
Once the review is complete and the reviewer is satisfied with the ethical review undertaken by the lead organisation, the reviewer will allocate a risk level.
The application will then be sent to the Chair/delegate chair to finalise the risk level and generate the approval /rejection letter.
The same approval/rejection letter will be provided to the applicant as for all applications.
If further information is required, the application would be sent back to the applicant to supply clarification of minor points by using the general comments box on the application.
If the application is deemed to be unacceptable, the risk will be accessed by the reviewer and a timeline note added to reject the application.
The chair will comment on the application in general comments, finalise the risk, and reject the application.