Research Ethics and Governance Committee

Medical School Research Ethics and Governance Committee

The remit of the Swansea University Medical School  (SUMS) Research Ethics and Governance Committee (REG Committee) is to provide a strategic overview of research ethics and governance issues within SUMS and in relation to other Colleges and the University.

Medical School Research Ethics Committee

The SUMS Research Ethics Committee is a sub-committee of the REG Committee and directly reports to it. The remit of the SUMS research Ethics sub- Committee (RESC) is:

To ethically review all *research on human participants and/or data which is not publicly available. (When conducting research outside the UK, ethical permissions should be sought locally as well as through the College ethics committee).

*In respect of students, the term ‘research’ is given a broader definition to encompass service evaluation, where this concerns human participants.

SUMS Staff: To provide ethical review for research on human participants and/or data which is not publicly available when no other system for formal ethical review is available.

Excluded:

  •  Research by staff which requires NHS research ethics scrutiny
  •  Research where no human subjects or personal data are accessed (such as a review of literature)
  •  Research using publicly available data.
  •  Personal reflective practice based work.

Submission:

Your electronic submission should all be contained within 1 document and should be emailed to: sumsresc@swansea.ac.uk

Guidance on applying

Procedure for submission of applications for ethical review
Identify any ethical issues raised by the research and discuss these with your supervisor/research team. Identify the correct pathway for ethics approval by following this decision support tree.
Complete an application on the Standard Ethical Approval pro-forma and send it, with any additional documents as a single document, Word or PDF, electronically to the administrator of the committee. Applications received no later than two weeks before a scheduled meeting will be considered.  Applications will then be made available to committee members.
A committee member will be nominated by the Chair to present the application at the relevant meeting (to summarise the application, and any relevant points).
The application will then be considered by the committee during the meeting. You are not usually required to attend.
A decision will be reached. This will be that the application has been: (a) approved, (b) approved pending chair’s action, (c) judged in need of revision and resubmission, or (d) not approved. The Chair will convey the decision to the applicant within 5 working days.
Do not submit a separate research proposal as this will not be reviewed - all information must be included in the application form.

Frequently Asked Questions

Frequently Asked Questions

Do I need to get ethics approval to do this project?
Ethics review is required for all work, involving human participants that will be made public - for example, undergraduate dissertations, theses for higher degrees, externally funded research and 'unfunded' research (including undergraduate and postgraduate research) which produces reports or other publications.

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.

I want to do a study observing the way children/adolescents and staff members interact during education classes in school. Do I need to tell anyone about this or can I just go ahead and do it?
In this sort of study, you will need permission from both the person in charge of the school and the parents of the children you wish to observe. The person in charge of the school has a duty of care for the children and will need to be convinced that what you are doing is for a worthwhile purpose and that it does not entail any risks to the children. Assent from the child/adolescent should also be sought.

A local school has agreed that we can give questionnaires on alcohol and drug use to their year 9s. Do I need to get permission from their parents as well?
Although the teacher has given his or her assent to the study, you will still need to explain the study to the children and gain their assent to take part. You should also gain consent from parents. As the study is on a sensitive topic, it is particularly important that all those involved - children, parents and teachers - are properly informed about the study and given the option not to participate, or not to have their child asked to participate.

Can I give potential research participants information and ask them to consent at the same time?
Potential participants are usually give 7-14 days to consider agreeing to be part of a research project. To avoid possible coercion (or perceived coercion) it is considered best practice for potential participants to be approached in the first instance by a person not directly involved in the research study. E.g. a lecturer (not involved in the study) hands out information letters to students and the researcher arranges to meet the those interested in participating at a later time.

I would like to send a questionnaire on school meals and healthy eating to all the teachers in three local primary schools. I know people who work at all the schools - can I just ask them to distribute my questionnaire for me?
It is very useful having local contacts in each school who can distribute questionnaires for you. However, if they are going to use the staff pigeon holes or internal post in the school, it would be good practice to get permission from the Head Teacher first.

I want to use focus groups to collect data, what are “ground rules” that people refer to?
The ground rules refer to a series of recommendations that participants agree to before the focus group begins. The rules ensure that all participants have an opportunity to interact within a group discussion which is also safe and productive for all concerned. Some ground rules include:

  • One person speak at a time
  • Speak for yourself, using “I” statements
  • Participate in both talking and listening
  • Be critical of ideas but respect different points of view and different perspectives
  • Stay on the topic and don’t digress too much
  • Maintain the confidentiality of opinions expressed in this discussion
  • Focus on issues that need to be discussed and not individuals
  • Wait for one person to finish speaking and don’t interrupt others

Contact us

Use the links on the side to find further information, or contact the Committee's administrator, sumsresc@swansea.ac.uk

IMPORTANT POINTS TO REMEMBER

IMPORTANT POINTS TO REMEMBER

No research should cause unnecessary harm and preferably it should benefit participants.

Potential participants have the right to receive clearly communicated information from the researcher in advance.

Participants should be free from coercion of any kind and should not be pressured to participate in a study.

The consent of vulnerable participants or their representatives' assent should be actively sought by researchers.

Honesty should be central to the relationship between researcher, participant and institutional representatives.

Application form and guidance notes

Download the application form here:  SUMS Application for Standard Ethical Approval ‌‌‌
Download the guidance notes here:  Guidance notes for standard ethical approval
Download the notes for ethical principles here:  Notes on ethical principles

REG Committee membership

Read our terms of reference for the Research Ethics and Governance Committee .
The committee is comprised of a body of senior staff members within SUMS with relevant responsibilities. Please see Ethics organizational diagram .
To see the current membership and expertise of the committee, click SUMS REG Members .

RESC Committee membership and Terms of Reference

Read our terms of reference for the Research Ethics sub-Committee:  RESC terms of reference

The RESC committee is comprised of a body of staff members within SUMS with relevant expertise (e.g. knowledge of healthcare law, various kinds of research and practice, and healthcare ethics), including the secretary of the committee.
To see the current membership and expertise of the committee, click  Terms of Reference

RESC Meetings

Meetings are held monthly, usually on the first Tuesday of the month. Applications received by 5p.m. two weeks before each meeting will be considered.

To see the dates for the next meeting, please click here: RESC meetings

Research Governance and Research Conduct Complaints

• For queries on Research Governance please contact researchintegrity@swansea.ac.uk
• Participants should be informed of their right to complain about research misconduct and may do so by emailing researchmisconduct@swansea.ac.uk

Contact us

Use the links on the side to find further information, or contact the Committee's administrator, sumsresc@swansea.ac.uk 

Amendments

Amendments are changes made to your research project after the initial approval(s) have been given.

Should you need to request an amendment to a previously submitted RESC application in which you received favourable ethical opinion, please complete the following steps:

  1. Complete and sign the Notice of Amendment to Ethics application request Ethics amendment .

Please note that amendments will need to be re-authorised by supervisors/line managers  where appropriate.

 

  1. Include ANY updated supporting documentation, including consent forms, PIS, protocol etc.

 

  1. Please ensure that any amended documentation has the changes clearly highlighted or in tracked changes. You may wish to include both your original documents as well as the updated version if there have been a large number of changes. If this is the case, please include a list of all the changes in a separate document for reference and list all attachments under the 'List of enclosed documents' on the RESC form.

 

  1. The Amendment form should then be electronically submitted to Medical School Research Ethics Subcommittee [sumsresc@swansea.ac.uk] together with all of the relevant supporting documents.