Faculty of Business, Law & the Built Environment Guidance Notes for Completing the Ethical Approval Form The following notes have been compiled to act as a guide for applicants pursuing ethical approval for research to be undertaken as part of their taught programme. Each section below refers directly to the sections on the application form and highlights what minimum information is required.
The title of the research project needs to be clear and succinct giving an idea to the reader exactly what the project involves. A title to a study should not contain any acronyms but all words should be explained in full. 2. Project focus and objectives Provide a short overview of the aims of the research study, such as: what are you going to do, who will it involve, what do you hope to achieve. Summarise the main objectives or outcomes expected of the research study, for example: • To generate an understanding of certain issues...
This section provides a summary of the methods you are going to use to perform the research study. Briefly describe the following: • Who will be approached, how many, what will their involvement entail, how often, where are they from/located. You need to describe the sampling frame you have chosen, why you have selected the sample size, and identifyhttp://www.ukassignment.org/yingguozuoye/ying_liu_zuo_dai_/ how the sample represents the wider population, so that results can be generalised. 4. Number of participants to be recruited and rationale for sample size For a study to be ethical, it needs to be performed on sufficient numbers to allow the results to fully represent the wider population and thus to be generalised. It is understood, particularly for student research, that large samples may be unmanageable but the rationale as to how you determined the size of your study sample needs to be explained and what problems a small sample may have on the study findings acknowledged. One method of determining a sample size could be to use similar numbers recruited within previous work/studies that have been shown to be appropriate to substantiate the study findings.#p#分页标题#e# To fully understand the impact of the number of participants you have selected for your study sample it is important to provide a total number of potential participants so a percentage of the total possible sample can be reviewed (for example total number of people on a course compared with the 20 students enrolled in the study). 5. Organisational agreement for the research study to take place If the proposed participants in your study belong to a specific organisation ((eg commercial company, hospital, university, sports club ) you need to ensure that you gain the consent of the organisation before you approach these individuals in the first instance. It is also necessary to seek the express consent of the specific managers of your proosed group of participants. In this section you need to describe the plan of what you intend to do to achieve this consent/agreement to access participants. Any letters to/or from the managers of organisations, both asking for consent from the organisation and the response to the request (see example letter Appendix 1) need to be submitted with the application. It is not appropriate to answer this section as Not Applicable, the response should be Yes or No and the answer explained fully. In the case of an external organisation you need to find out what processes are involved in gaining the consent of the organisations management, such as appropriate committees or management agreement. If the participants are to be recruited from within the University of Salford you will need to find out what processes are involved in gaining the consent/agreement of the management from where the research participants originate (for example the Research Committee /Heads of Departments/ Programme Leaders).
An ethical requirement with respect to recruiting participants for research is that they are fully informed of what the study entails, what their participation will involve, how long the study will take, what difference it will make to them. Once people understand the research study and their involvement then they can make an informed decision about whether to get involved and provide informed consent. Once research participants have decided to be involved in the research study informed consent must be obtained. Written consent should be obtained from all participants where at all possible, and a standard consent form should be used (see Research Participant Consent Form Appendix 3) . For survey research where questionnaires are posted to participants it may be appropriate to presume participants consent to being involved in the research by returning a completed questionnaire, so written consent is not necessarily required.#p#分页标题#e# It is equally as important that research participants understand that they can withdraw from a research study at any time without any consequences, even after data has been collected, as they can ask for their data not to be included and subsequently destroyed. This is stipulated on the written consent form and information sheet but you need to mention it in your description of how informed consent is to be obtained.
You need to consider how you can protect sensitive data and ensure that participants’ personal data remains confidential. • All research participants will be provided with a research code, known only to the researcher to ensure that their identity remains anonymous and confidential
There are a number of other ethical issues that you need to consider and explain in this section if they are relevant to your study. Examples include: • Language Barriers . It is unethical to exclude participants who do not speak English as their first language, unless your study is particularly focusing on English speaking individuals. Therefore you must identify whether non-English speaking people could be part of your sample and what steps you will take to make sure they can participate in the study, understand the information provided and be able to provide informed consent. • Minority Groups. It is important to ensure that minority groups are considered and where appropriate equally represented within a research study sample. You need to identify how you will make sure that your sample is representative of the wider population, that there are sufficient numbers of minority group participants to ensure that findings can fully represent a particular group. This may involve participant’s who are blind/deaf and it is important to clearly explain the methods taken to involve all participants, ensure they are adequately informed.#p#分页标题#e# • Addressing Sensitive Issues. The researcher needs to demonstrate that they are aware that when participants recollect/describe bad experiences, discuss sensitive information/feelings, that this could impact negatively upon the research participant. A clear explanation should be provided which describes how this impact will be minimised or prevented. Appendix 1
Example of Organisation/Management Letter - consent to approach research participants Use headed paper (from supervisor) identifying your contact details
I am a student undertaking (add appropriate course title and qualification) at the University of Salford. As part of my course I am undertaking a research study titled: add full title of the study. Briefly explain the purpose of the study. Prior to undertaking the study I need your agreement/consent to approach the following (add in the people who you wish to recruit) within your organisation to take part in the study. I will recruit people to the study using (add here the method you have selected such as poster, letter, email etc attach copy of method used and information sheet). I hope to recruit X number of participants. I can assure you that the study will not disrupt the working environment in any way and any data collected will remain confidential. I am applying (or have gained) ethical approval for the study from the University of Salford, Faculty of Business, law & the Built Environment My research is supervised by (add name and qualifications of supervisor). Yours sincerely
Appendix 2 Example : participant information sheet Overview of the participant information sheet The information sheet should provide brief and clear information on the essential elements of the specific study; what the research is about, the condition or treatment under study, the voluntary nature of involvement, what will happen during and after the research has taken place, what treatment (if applicable) will be withheld, the participants responsibilities, the potential risks, inconvenience or restrictions balanced against any possible benefits and the alternatives. It should allow the participant to decide whether the study is of interest to them and whether they wish to read and discuss it further. It is recommended that researchers follow the structure below to guide them in developing an appropriate information sheet.
I would like to invite you to take part in a research study. Before you decide, you need to understand why the research is being done and what it would involve for you. Please take time to read the following information carefully. Ask questions if anything you read is not clear or if you would like more information. Take time to decide whether or not to take part. #p#分页标题#e# You might want to add a couple or sentences explaining about the study here.
For example explain clearly why you have chosen to recruit participants within a particular ethnic group, or age group, healthy volunteers, students on a particularprogramme, males or females and why you are studying this particular population group.
It is up to you to decide. We will describe the study and go through the information sheet, which we will give to you. We will then ask you to sign a consent form to show you agreed to take part. You are free to withdraw at any time, without giving a reason..
If the study will involve video/audio-taping, you should explain what is intended, including any confidentiality issues. Specific consent will be needed if material of any sort will be published that identifies the subject. You should set out simply the research methods you intend to use.
For example if you are discussing or exploring sensitive issues with a participant that could upset them then you need to identify this so the participant is fully aware. After the research is completed make appropriate support services available for the participant to access if further support is required.
We cannot promise the study will help you but the information we get from the study will help to increase the understanding of (name the focus of the research)
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (contact number). If you remain unhappy and wish to complain formally you can do this through… (add appropriate contact details of NHS, Private facility, University complaints procedure). You need to identify the appropriate complaints procedure and provide the contact details/location of where this can found, for example: NHS Complaints Procedure (or Private Institution), University Complaints Procedure, Supervisors name and contact details etc. Will my taking part in the study be kept confidential? The participant should be told:
All information which is collected about you during the course of the research will be kept strictly confidential, and any information about you which leaves your organisation will have your name and address removed so that you cannot be recognised. What will happen if I don’t carry on with the study? If you withdraw from the study all the information and data collected from you, to date, will be destroyed and you name removed from all the study files. What will happen to the results of the research study?
1. General information about research (e.g. list relevant documents or websites) A minimum prerequisite in this section is that the contact details of the researcher (email address) should be clearly identified. Appendix 3 Research Participant Consent Form Title of Project: Name of Researcher:
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