Research Ethics and Governance

Does your research involve human subject or tissue and or non-public data?

Yes - my research involves human subjects and/or non-public data

Yes - my research involves human subjects Human Tissue in Research and/or non-public data

 (ACTION - Proceed to Step 2)

No - my research ONLY involves access to literature

No - my research ONLY involves access to data in the public domain and/or open websites without an identifiable gatekeeper

(ACTION - It seems likely that your research does not require ethical approval. If you are unsure, then please check with your supervisor or contact the ethics committee.)

You will need to apply for ethical approval.

This step will help you find which committee you need to go to and what actions need to be taken.

Does your research involve NHS patients, patient data or NHS staff?

Yes - my research involves NHS patients, patient data or NHS staff

(ACTION - Proceed to step 3)

No - my research involves human subjects or personal data but is not NHS based and does not use NHS resources.

(ACTION - You will need to submit Standard Ethical Approval Pro-Forma to Swansea University Medical School Research Ethics Sub-Committee.)

Use the guidance notes to help you complete the form - Guidance notes for standard ethical approval

(IMPORTANT - If your research is based in healthcare outside the UK, then you should seek ethical approval in the country/institution involved where possible in addition to seeking approval from the Swansea University Medical School Research Ethics Sub-Committee).

It is likely that your research proposal is subject to NHS research ethics approval.

Some NHS research may fall outside the remit of the local research ethics committee and  in the first instance, it is recommended that you contact the appropriate local research ethics committee organiser. Some research may be considered as audit or service evaluation under their terms of reference and be exempt from their scrutiny. If this is the case, ask for a letter confirming this and apply to the SUMS Research Ethics Sub-Committee.Swansea University Medical School Research Ethics Sub-Committee

If an application to the local research ethics committee is required, then it can be done via IRAS (Integrated Research Application System). If you are a student of the Medical School, then you should apply via the Medical School's Research Ethics Sub-Committee prior to making an application to the NHS system.

If you are conducting research as part of a Masters programme, then the NHS system requires that your supervisor is named as the principle investigator and you will also need to apply to the University for a letter of indemnity.

You will also need to get permission from your Trust Research and Development group. An IRAS application should also be completed.

(IMPORTANT - Where you are conducting research outside the UK, ethical permission should be sought locally as well as through the Swansea University Medical School Research Ethics Sub-Committee.)

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. 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.

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.

If you are observing the way children/adolescents and staff members interact during education classes in school 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.

Even if a 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.

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.

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.

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