Q. I’m thinking of putting in an application for ethics review but I’d like to find out a bit more information/ask a question first.
A: There’s lots of useful information on the UREC (University Research Ethics Group) website, You’ll also find the forms you need to fill out here. If you can’t find what you’re looking for or if you have a general question to ask, you should first contact the nominated person for your school.
Q. How much time should I allow for the approval process?
A. The Ethics Review Panel aims for a turnaround of 10 working days from receipt of an application. However, this is for an initial response – quite often the panel will request revisions to be made, or they might ask for clarification or further information. Ideally then, you should aim to submit your application at least three to four weeks before your project is due to begin. You can help speed things up by ensuring that you submit any relevant supporting documentation when you first put your application forward. As a general rule, the panel will want to see any documents (guidance sheets, questionnaires etc.) that you refer to in your application.
Q. I’m not sure if my project comes under research or service evaluation - how do I know if I need to get ethical approval or not?
A. One of the questions asked most frequently is “Do I need to get ethical review for my project?” The best way to answer this is not to try and decide whether your project counts as evaluation or research, since this is often a grey area which can be further confused by the topic your work is covering. A better way to think about it is to ask yourself if your work will touch on any potentially sensitive issues, for example race, religion, gender, sexual orientation, mental or physical health issues, socio/economic issues, or if it will involve vulnerable people. If the answer is yes, then your project may need to be reviewed (as high or low risk will depend on the particular work), and you should seek advice from your nominated person as to how to proceed. If your work involves contact with anyone under 18 years of age, then it MUST be classed as high risk regardless of the topic covered.
Q. Are there legal as well as ethical considerations that I need to know about?
A. The legislation you're most likely to need an awareness of is the Data Protection Act but, depending on the topic of your research, you might also need to be aware of other legislation such as the Mental Capacity Act and Government guidance such as that covering the safeguarding of children. You can also find the University guidance on safeguarding here. As always, if in doubt talk to your nominated person.
Q. My colleague has some interesting data from a project they ran last year. Can I use this information in my own work/project? And can other people use the data from my project for a different purpose?
A. Information, even when anonymised, cannot be used for purposes other than those agreed in the original project unless ALL participants have been asked for, and have given, their consent for this to happen. If you think that there is a possibility that the information gathered in your project may be used for another purpose you must get your participants to agree to this when they sign the consent form. You can do this by including the following wording: I agree for the data collected from me to be used in potential future research conducted by xxxxxxx at the University of Sunderland. The consent form should also include information on confidentiality – please refer to the example form on the UREG website for more detail. If you want to use someone else’s data then you must check that they have got signed consent from all participants for this to happen.
Q. What additional documents and information should I provide with my application form?
A. You should submit any documents or information referred to in your application, or that will be used in the project. This might include: participant consent forms; guidance for interviewers; questionnaires; information sheets for participants; promotional materials used to advertise the project or activities associated with it, etc. If in doubt, check with your nominated person!
Q. I am repeating the same study/survey/focus group as last year. Do I need to go through the full approval process again this year?
A. Activities that are carried out annually don’t generally need to go through the full approval process each time, however, your project or activity must be reviewed each year to make sure there have been no significant changes. Four weeks before starting the annual activity you should contact the Ethics Administrator to discuss this. If there has been a significant change, a new ethics application will need to be submitted. All annual activities must undergo a full ethics review after five years, regardless of whether there have been substantial changes.
Q. My project has changed since ethics approval was granted. Do I need to put in a new application?
A. As above, this is dependent on whether or not the changes are substantial.
Q. My project is developing in phases. Do I need separate reviews for each phase?
A. Some projects develop in phases or stages, with one phase informing the next. In these cases it can be difficult to be precise about the topics the second phase will look at, since that maybe dependent on what happens in the first phase. If you’re planning an application and you think your project falls into this category you should make this clear on your application form, specifying the different stages of the project and stating the general purpose of the focus groups, surveys etc. that will form the first phase. If this is done, then there will be no need for a second review. If your project is already in progress and is developing into areas, activities or topics that were not mentioned on your application form then a second review may be necessary and you should seek advice from the ethics contact within your school.
Q. Can I use my personal email address?
A. No, your University email address must be used at all times during the study.
Q. Can I provide my mobile number to participants?
A. No, please do not share your personal contact details with participants.
Q. What happens if changes are made to the project after ethics approval has been obtained?
A. In this situation, the researcher must consider whether the proposed amendment constitutes a significant change that could have a potential impact on the welfare, dignity and rights of the participants.
A `significant change´ refers to a new research approach or method that, had it been planned at the time, would have been mentioned on the original research ethics approval application.
Examples of this include:
This list is indicative, rather than exhaustive. In such cases, or if there is any other doubt about whether a proposed change is significant, the researcher should contact the Ethics Administrator who will then provide the details to one of the ethics reviewers who originally reviewed the project (ideally the lead reviewer, where relevant). The reviewer should then consider the changes and liaise with the Ethics Administrator to advise the researcher on the appropriate course of action. This could involve re-applying for full ethics approval, if the changes are particularly significant; alternatively, the reviewer may be happy to approve the changes immediately (it is left to the discretion of academic departments to decide departmental procedure in this regard). The Ethics Administrator should keep a record of the proposed changes and the actions that were undertaken as a result.
The requirements of this section do not apply to the routine, everyday adjustments to data gathering plans and activities that researchers must often make in response to the contingencies of research. Nor does it apply to minor corrections in the written information given to participants, such as remedying spelling errors or typos. Discretion, responsibility and common sense are necessary in interpreting this section: researchers are required to reflect upon what they are doing, its relationship to their original ethics approval application, and whether any ongoing adjustments are significant, in the terms outlined above.