FSE Research Ethics Committee (REC)

About the Research Integrity, Ethics and Governance sub-committee (REC)

The FSE Research Integrity, Ethics and Governance sub-committee provides a strategic overview of research ethics and governance issues within FSE and in relation to other faculties and the University. The sub-committee reports directly to the University Research Integrity: Ethics and Governance committee.

The committee is represented by members from each school within the FSE. Each department also has a sub-committee who review ethical applications from their respective departments.

The remit of the committee is to ethically screen all research activities within the FSE (when conducting research outside the UK, ethical permissions should be sought locally as well as through the FSE REC).

Why is ethics approval needed?

Upholding Research Integrity: Ethical approval ensures that the research we conduct meets the highest standards of integrity. It is a testament to our commitment to producing reliable, genuine, and trustworthy results.
Protecting Participants: Particularly in human and animal research, ethical clearance is of paramount importance to ensure the well-being, rights, and dignity of participants are not compromised. This is essential not just from a moral standpoint but also to ensure the validity of our data.
Ensuring Data Accuracy: When research protocols are reviewed for ethics, potential flaws or biases in the methodology can be identified and rectified. This leads to better and more accurate results.
Building Public Trust: For our research to have a lasting impact, it must be trusted by both our peers and the public. Adhering to ethical guidelines assures them of our dedication to rigorous and responsible research.
Avoiding Legal and Institutional Repercussions: Collecting data without ethical approval can lead to severe consequences, ranging from retraction of published works to legal actions.

It is therefore paramount that all researchers understand and respect the significance of ethical considerations in their work. Not only is it a reflection of our professionalism, but it also determines the value and impact of our contributions to the academic world.

When is ethics approval needed?

All research activity needs ethical approval. However, the FSE Ethics Committee notes that there is no single accepted definition of “research” as this can vary depending on subject and also context. For example students may be asked to “research” a subject when it is meant to simply gather information and read or consult some sources.

Therefore the operational definition of research that the FSE has adopted to help us screen research projects for research ethics compliance is:

Research is a process of inquiry that entails the collection of data and the use of reasoning to establish facts, reach conclusions and generate knowledge.

Similarly the agreed definition for data in the context of Research ethics is:

Data are materials, facts, and statistics collected together for reference or analysis via research.

Further Information

Terms of Reference

Faculty REC Terms of Reference - ToR

Guidance on applying

The University online ethics system should be used for ALL proposed projects to determine whether further ethical review is required by the FSE REC or AWERB.

The Research Ethics Form is accessed through your MyApps page under the name 'Ethics Application / Healthcare Sponsorship'.

You will need to sign in using your university email and password.

Faculty specific guidance documents are available on the FSE Research Support canvas HUB. Staff can access these and share with relevant students.

There are also more general user guides embedded onto the ethics system under 'Help'.

For further assistance please contact us at fse-ethics@swansea.ac.uk

Ethical review timeline

Applications made to the FSE ethics committee are typically reviewed within six weeks. The committee make every effort to return an application as soon as is possible and reviewers are encouraged to review applications within two weeks.

Once approved, an approval number will be provided via automatic email and you can begin your work. If it is not approved you will be invited to re-submit after addressing the ethical concerns raised by the committee.

You will receive an email when the review is complete.

Committee membership

The committee is comprised of a body of staff members within the FSE with relevant expertise (e.g. knowledge of the use of animals in scientific research, human studies and environmental risks), and the Chair.

Research Integrity, Research Governance and Research Conduct Complaints

Full information and the University's guidelines regarding research integrity can be found here.

For queries on Research Governance please contact researchintegrity@swansea.ac.uk. If you have any specific queries in relation to sponsorship of research, then kindly get in touch with Paola Griffiths (researchgovernance@swansea.ac.uk) who has an updated spreadsheet with information on University sponsored research by School.

Participants should be informed of their right to complain about research misconduct and may do so by emailing researchmisconduct@swansea.ac.uk

Contact FSE Research Ethics Committee

For further information and enquiries related to research ethics please contact: fse-ethics@swansea.ac.uk

Frequently asked questions

Frequently Asked Questions

Do I need to get ethics approval to do this project?

See list of exemptions noted below. If your research activity does not fall within these listed exemptions then, you are required to complete the initial assessment on the university ethics system prior to any data collection. The answers to the questions in the initial assessment will determine if further ethical review is required by the FSE REC. If no further review is required a unique Approval number will be supplied via email.

Research interviews and questionnaires can raise issues which participants find distressing to talk or think about. Does this mean I can't use interviews or questionnaires to do my study?

The possibility that your participants could become upset in the course of your interviews or questionnaires does not mean you cannot use these data collection methods. What you will need to do, however, is to make sure you have the support, knowledge and skills to help someone if they become distressed. This may include both listening skills and written information on services which are available locally to provide longer term support for individuals. In your application for ethics approval, set out your plans for what you will do if a participant becomes upset.

Do I need to ask my participants to sign a consent form? Some people are put off if you ask them to sign something.

You must obtain formal, written consent from participants. There may be exceptions with certain kinds of anonymous questionnaires, where completion of the questionnaire is taken to indicate consent. This may be the case where questionnaires are accessed via a web link (e.g. Survey Monkey) or with postal questionnaires the respondent signifies their consent when they return the questionnaire to you.

Download the University approved template Participant Consent Form from the online ethics system.

Areas which may be exempt from ethical review

The FSE Ethics Committee notes that it is not possible to produce a list of research topics that will always be exempt from ethical screening as this depends very much on context. We strongly recommend that prospective applicants wishing to start a research project undertake an ethics screening assessment using the online ethics system where they will be instructed whether their project requires further ethical review or not.

The following two cases are areas where, based on past experiences, ethical screening might not be required. If in doubt, we strongly advise applicants to log into the system and seek advice from the FSE Ethics Committee.

1. Literature review and meta-analysis that make use of data or information already in the public domain¹

2. Student practicals and demonstrations of competence that do not involve the collection of data from/about living organisms² or human subjects.

Notes:

¹When researchers wish to make use of data not yet in the public domain, the onus is on them to show the data has been ethically obtained, hence the need for ethical screening.

²For student practicals and demonstrations of competence that make use of living vertebrates and cephalopods, the Animals (Scientific Procedures) Act may still apply. Please contact erp@swansea.ac.uk if in doubt.

Other exemptions from FSE ethical review

The following types of research may not require ethical review by FSE but must have external ethical review prior to undertaking the research activity:

NHS – If you are required to complete the online NHS ethics application then you do not need to seek SU ethics approval

If you are working with the NHS (including nursing homes) involving patients, drugs, medical devices, ionising radiation, or social care then please check the NHS Ethics approval toolkit and student research toolkit to see if you need to complete an application with the NHS.

NHS toolkit - Do I need NHS Ethics approval?

Student research Toolkit

Student research - Health Research Authority (hra.nhs.uk)

HTA - If you are storing purchased or collected relevant material under the Human Tissue Act then you need to check if you require either an NHS ethics review or a Swansea University Ethics review and approval to store the samples under the University Human Tissue Authority (HTA) licence. Please use the decision tree here. For Human Tissue Act enquiries, process or licence applications please contact the HTA Governance Officer or check out the website.

Ministry of Defence - If you are working with the MoD, they have their own ethics review procedure therefore, you do not need to seek SU ethics approval. Please use their system to gain your ethics approval.

Ministry of Defence Research Ethics Committee - GOV.UK (www.gov.uk)

Animals (Scientific Procedures) Act – If the work you propose to do on animals (as defined by ASPA) requires Home Office licencing then you do not need to seek SU ethics approval (note, any project licence submissions will go to the SU AWERB for endorsement prior to being submitted to ASRU). Please contact erp@swansea.ac.uk

Animal Welfare and Ethical Review Body (AWERB)

For work which involves interventions with live animals* on Swansea University campus and in the field the University Animal Welfare and Ethical Review Body (AWERB) will carry out an ethical review.

The AWERB may be contacted via erp@swansea.ac.uk

(*=As defined by ASPA 2012)

Note: To submit an application to the AWERB, please use the Online ethics system.

Resources

Training for researchers

The Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) present The Research Clinic. The interactive training video educates clinical and social researchers on the importance of appropriately protecting research participants and avoiding research misconduct. The Research Clinic allows the viewer to assume the role of one of four characters and determines the outcome of the storyline by selecting decision-making choices for each “playable” character.

Collection of HTA relevant human samples

Where research involves the collection of HTA relevant human samples (https://www.hta.gov.uk/policies/list-materials-considered-be-‘relevant-material’-under-human-tissue-act-2004) from non-NHS patients and storage of material for any period of time either NHS REC approval is required or samples must be held under the University HTA licence (https://www.swansea.ac.uk/research/research-integrity-ethics-governance/research-governance/human-tissue-act/).

Additionally, where researchers wish to use ionising radiation techniques (i.e. DEXA, X-ray etc.), the FSE REC cannot grant approval and NHS must be sought.

See Swansea University guidelines on collection of human tissue and ionising radiation https://www.swansea.ac.uk/research/research-integrity-ethics-governance/research-governance/sponsor-categories/.

Health Research Authority

The HRA protects and promotes the interests of patients and the public in health and social care research.

Guidance on the Operation of ASPA

The Guidance on the operation of ASPA explains how the act is administered and enforced and provides detailed guidance to licence holders and applicants.

The ARRIVE Guidelines

The ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines were developed as part of an NC3Rs initiative to improve the design, analysis and reporting of research using animals – maximising information published and minimising unnecessary studies. The guidelines were published in the online journal PLOS Biology in June 2010 and are currently endorsed by scientific journals, major funding bodies and learned societies.

The Nagoya Protocol

What is the Nagoya Protocol and what is its objective?

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity is a supplementary agreement to the Convention on Biological Diversity. It provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources.

The Nagoya Protocol on ABS was adopted on 29 October 2010 in Nagoya, Japan and entered into force on 12 October 2014, 90 days after the deposit of the fiftieth instrument of ratification. Its objective is the fair and equitable sharing of benefits arising from the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity.

Why is the Nagoya Protocol important?

The Nagoya Protocol will create greater legal certainty and transparency for both providers and users of genetic resources by:

Establishing more predictable conditions for access to genetic resources.
Helping to ensure benefit-sharing when genetic resources leave the country providing the genetic resources

By helping to ensure benefit-sharing, the Nagoya Protocol creates incentives to conserve and sustainably use genetic resources, and therefore enhances the contribution of biodiversity to development and human well-being.

What does the Nagoya Protocol cover?

The Nagoya Protocol applies to genetic resources that are covered by the CBD, and to the benefits arising from their utilization. The Nagoya Protocol also covers traditional knowledge (TK) associated with genetic resources that are covered by the CBD and the benefits arising from its utilization.

Ethical Framework for Obtaining Material from Sentient Animals

This Ethical Framework presents considerations for organisations obtaining material from sentient animals and describes a set of benchmarked, standard requirements which may complete an appropriate ethical assessment. Recipient organisations are encouraged to complete the assessment ahead of receiving materials, however, for archived materials already obtained and held in storage at an organisation, the ethical assessment may be carried out at removal from storage ahead of use.