Guidance on Preparing an Application for the School Research Ethics Committee (SREC)
These notes seek to help you to produce an application that addresses those aspects of your project that the SREC needs to consider. If your application is not clearly written or omits matters of relevance to its ethical status, then further clarification may be needed, so possibly delaying the start of your project. The SREC has produced these notes in an attempt to make the process more transparent, and more straightforward for all concerned.
Please note that the SREC web pages contain a number of examples of applications and associated documentation that the Committee found particularly clear and effective.
Is your project appropriate for submission to the SREC?
If you are a member of staff, researcher or student working at SOCSI, and your project involves the collection and/or analysis of data and/or material from human subjects then it needs to be considered by the SREC. Projects of a clinical nature need to be considered by an appropriate medical ethics committee rather than by the SREC. Certain clinical-related projects that are described by medical ethics committees as ‘evaluation’ studies, and which are not considered by those committees, do need to be considered by the SREC. Areas of research involving people who lack capacity to consent can only be approved by a medical ethics committee.
The light touch review and Committee review
All applications to the SREC first undergo a ‘light touch’ review. This process is conducted by the Chair of the Committee. It seeks to identify those projects where the possibility of harm or disadvantage to participants and others is minimal. The key dimensions of possible risk are identified in the Ethical Approval Form. In essence, these aspects are concerned with:
- Children and other vulnerable groups
- Illegal activities
- Your professional independence
- Language issues
- Voluntary participation and informed consent
- Possible threats of physical or psychological distress to you or your participants
- Data protection
There are two Ethical Approval Forms, one for students and the other for Staff and MPhil/PhD research, available to download as Word documents (see Related Resources at the top of this page).
You will note that some of the boxes on these forms are shaded. If you need to enter a tick in any of these shaded boxes, then your application will almost certainly be passed to the Committee for further consideration. If you do not enter ticks in these boxes, your project may be approved at the light touch stage. Please note that the contents of all Ethical Approval Forms must be justified by a separate document, your Project Description, which sets out the details of your proposed project. The Ethical Approval Form and Project Description therefore need to be consistent. The following section provides guidance on the preparation of a Project Description.
Preparing a Project Description
The Project Description should be a concise document. Typically, it should be no longer than three to four pages in length. It should be clearly written in ordinary language, and jargon should be avoided. In essence, the Committee is interested in the nature of the human data that you propose to collect (and/or analyse), the sources and circumstances of its collection, and what you propose to do with it. The potential harms associated with the research may also need to be considered carefully, and you will need to explain how you propose to control any associated risks.It is not necessary to provide an extended account of the conceptual background to the project.
The following matters should be addressed. You may wish to use this list as headings when you come to write the document.
- The research. Please provide a concise description of the nature of the research. What is the title of the project? What type of research is being proposed (e.g. PhD research, pilot study, funded research study etc.)? What are the aims and questions of the research?
- Participant details. From whom do you propose to collect data? Profile of sample (e.g. occupation group, socio-economic status, gender, location etc.)? How many? How will they be recruited?
- Methodology and data handling. What methods do you propose to use in collecting data? How will data be stored? Security of data? How will you protect the anonymity of respondents? What are you dissemination plans for project findings? It should be noted that following the completion of your project your data will need to securely stored for a period of no less than five years or for at least two years post-publication.
- Shaded box considerations. If you have ticked any shaded boxes in the Ethical Approval Form, then you should describe what measures you propose to adopt to mitigate any possible harms arising from these considerations. If there are any other ethical issues that are specific to your project then you should describe these, and discuss how you propose to deal with them.
- Information and consent. What will you tell your respondents about the project? How will their consent to provide data be obtained? Please note that although the SREC no longer makes the submission of information sheets and consent forms a requirement, it would be helpful if copies were appended to your application. Examples of both types of document are available elsewhere on the SREC web pages. The information sheet should contain the following details:
- Outline the aim of the research, and its source of funding
- Your identity and why you are doing this research
- Who can participate, and why they have been selected
- What they can expect to happen
- Will tape/video recording be involved?
- Details of confidentiality and anonymity
- How will the data be stored? How will it be used and by whom?
- Right to decline/opt out
- In is important that your information sheet should contain your contact details (together with that of your supervisor, if appropriate) and contact details for the SREC.
- Possible harms. You will note that the application form asks you to identify and list any harms (to you and your fellow researchers or to research respondents) that might conceivably arise from the research. You also need to list the measures you will put in place to control associated risks. In the Project Description, you need to demonstrate that you have taken these requirements seriously. Evidence needs to be provided that a realistic assessment of possible harms has been undertaken. You also need to provide evidence that the measures put in place to control possible harms are appropriate. Ideally these measures will eliminate the possibility of harm. If this is not possible, then you need to show how the measures are proportionate to the level of risk, and will be effective in lessening adverse effects, should they occur. See notes below on risks associated with research.
Managing the risks associated with SOCSI research
The management of various sorts of risk now plays a central role in the management of most public and private sector organisations, including Cardiff University. It is important to ensure that risks associated with research work are managed effectively. The review of projects conducted by the SREC is closely related to part of this risk management activity, but a number of important distinctions need to be made.
First, the SREC is concerned with the avoidance and control of possible harms to researchers and/or those being researched. These harms might include physical or psychological damage, or possibly financial, career or other detriments. The SREC is not concerned with risks associated with technical aspects of how the project is run, its potential to fail for various reasons, or to run out of funding. In other words, from a risk management point of view, the SREC is exclusively focused on questions of harm, not wider issues concerned with project management. Also the SREC’s interest in harm includes, but goes beyond, the issues of health and safety.
Second, harm and risk are not the same thing, although the words are sometimes used interchangeably in everyday talk. A formal analysis of risk would consider the potential severity and the likelihood of a range of possible risk issues. The most basic risk assessment tries to quantify potential severity (perhaps on a scale 0-5) and then to quantify likelihood (0-5), with the measure of risk being the product of these two numbers. This procedure forms the basis for the sort of risk assessment that many researchers (mostly scientists who do experiments) in Cardiff University are required to carry out before being allowed to start their projects. You can learn more about these procedures at these links:
Research carried out in SOCSI rarely includes possible harms that can be reliably identified and quantified in this manner. However, this does not mean that it is impossible to be systematic about identifying and controlling possible harms. The messy nature of the real world means that attempts to apply formal risk assessment to SOCSI projects is unlikely to be time well spent. Indeed, there is a real danger of making decisions on the basis of assessments that appear ‘scientific’ but amount in practice to little more than guesswork.
The SREC wishes to see evidence that you have a realistic and professional grasp of the nature of possible harms that could be produced by your research. In other words, the Committee is primarily interested in the quality of the risks associated with your work, rather than trying to reduce them to numbers. Just because a possible harm is very unlikely (for example a respondent getting upset during an interview) doesn’t mean that you don’t need to be fully prepared to cope, if it happens.
Most research in SOCSI is concerned with better understanding, and appreciating, the nature of people’s everyday lives, whether in organisational or family settings, or elsewhere. It may involve investigating and discussing sensitive matters. It often involves researchers being in a range of settings which, whilst being ‘everyday’ for the people they meet there, perhaps present a greater potential for harm than, for example walking in the park. But of course, in some circumstances, walking in the park can be a hazardous business. The key point here is that everyday life is not without risk. The SREC assumes that you will take your common sense into the field with you, and take reasonable measures to protect yourself and those with whom you interact. Clearly some research settings – perhaps overseas, in certain workplaces, or in the company of some social groups or individuals – are likely to be more challenging in terms of looking after yourself. The SREC needs to see evidence that you have considered the range of conceivable harms very carefully, and made your plans accordingly.
The SREC requires you to undertake a structured analysis of possible harms associated with your project. From an ethical point of view, the main reason for this procedure is to ensure that you have very carefully considered the implications for you and your respondents of what you propose to do. The SREC needs to see evidence that your analysis of possible harms is realistic, and the measures you plan to put in place to eliminate the possibility of harms, or to lessen their adverse effects, are appropriate and proportionate to the nature and level of potential harm. The SREC recognises that attempting to quantify these harms will almost certainly not be feasible in the case of SOCSI research. The main purpose of the harm analysis is to arrive at a realistic assessment of what you might encounter, and how you will behave in a professional, responsible and ethically appropriate fashion.
NHS Ethics: Guidance on how and where to apply
For guidance on how and where to apply for ethical approval for NHS / NHS related projects, please click here.