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School of 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. Applications with insufficient information will be returned unapproved to the applicant, and will have to be re-submitted at a later date, resulting in a delay to the start of the research study. Please note that obtaining ethical approval is a requirement for the successful completion of research dissertation module. It is needed for research involving primary or/and secondary data. Ethical approval should be applied after the supervisor has approved your research proposal. Ethical approval is needed prior to collecting primary data. Failure to obtain ethical approval may result in non-approval of the dissertation module result by the board of examiners. 1. Title of proposed research project 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: 3. To generate an understanding of certain issues... To evaluate a particular phenomenon or service To highlight the differences between To describe/understand the experiences of To measure the difference between X and Y To improve the knowledge of

Research methodology

This section provides a summary of the methods you are going to use to perform the research study. Briefly describe the following:

Doc/CBI/18c /1 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 identify how the sample represents the wider population, so that results can be generalised. Identify the research methodology you have adopted (such as phenomenology, action research etc).Whatever you choose, make sure it is clear why this method is important. What method are you using to gather data, data collection tools, interview guides, questionnaires etc. Whatever you use you should include (with the application) a copy of the relevant documents or at least a draft copy of such. Explain how the data will be analysed for example using quantitative data packages such as SPSS, what statistical tests will be applied,and/or any qualitative techniques such as thematic, content, explanation building analysis. Number of participants to be recruited and rationale for sample size

4.

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. 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

Doc/CBI/18c /1 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). 6. Gaining informed consent

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. In this section you need to describe the process by which you are going to ensure that research participants provide informed consent. This must include providing participants with an information sheet in clear easy to understand format (Appendix 2). Research participants should be given a minimum of 24 hours to consider their involvement in a research study and you need to make clear to participants how much time they will be given to consider whether or not they wish to become involved. 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. 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. 7. Data protection issues You need to consider how you can protect sensitive data and ensure that participants personal data remains confidential.

Doc/CBI/18c /1 You need to describe the methods you will use to achieve this and it is recommended that: All research participants will be provided with a research code, known only to the researcher to ensure that their identity remains anonymous and confidential Names and contact details of research participants should be stored on a password protected computer, accessed only by the researcher. All data collected such as questionnaires, interview tapes, transcripts, should be anonymous and coded, hard paper copies of data should be stored in a locked filing cabinet within a locked room, accessed only by the researcher Data stored electronically must be on a password protected computer, accessed only by the researcher. It is recommended that information is stored on a network drive which is password protected. All data transported on computer discs, CDs and USB memory sticks should be anonymous identified only by a code and where possible encrypted to protect against loss. All publications of data should be written in a way so as to disguise the identity of the research participants involved. Data should not be used which can identify an individual unless prior consent has been obtained from the individual involved. Data should be stored and archived for a minimum of 3 years, after the graduate award has been made, to allow verification of data from external sources if necessary, or longer if used for further research.

8. Other ethical issues to consider 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 participants who are blind/deaf and it is important to clearly explain the methods taken to involve all participants, ensure they are adequately informed.

Doc/CBI/18c /1 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.

Doc/CBI/18c /1 Appendix 1

Example of Organisation/Management Letter - consent to approach research participants Use headed paper (from supervisor) identifying your contact details

Date

Dear (title of appropriate person) 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 Name & Title of Researcher Contact email

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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. Study Title Does this explain the study in simple English? One consistent title should appear on all your study documents and be self-explanatory. Any acronyms need to be written out in full. Invitation paragraph You need to explain that you are asking the participant to take part in research. For example: 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 . You might want to add a couple or sentences explaining about the study here. What is the purpose of the study? Purpose is an important consideration for participants, and you should present it clearly and succinctly, in the context of other work in the field. Primarily the purpose may be educational, such as undertaking a research study as part of a course. If this is the case, then this purpose should be made clear. Why have I been invited? 7

Doc/CBI/18c /1 You should explain briefly why and how the participant was chosen and how many others will be in the study. 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. Do I have to take part? You should explain that taking part in the research is entirely voluntary. The following is an example: 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.. What will happen to me if I take part? This section should include: how long the participant will be involved in the research how long the research will last (if different) how often they will need to meet a researcher, how long these visits will be what exactly will happen, for example: access to personal information, questionnaires, interviews, discussion groups,etc Use the most appropriate format to demonstrate their involvement (diagrams/tables). The detail will depend on the complexity of the study. It may help if the information is displayed in a flow chart or grid indicating what will happen at each meeting, where appropriate. 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. Expenses and payments? You should explain if any expenses (for example travel, loss of earning etc.) are available. You should consider whether any gifts or vouchers which you intent as a thank-you should be detailed in the information sheet. What will I have to do?

Doc/CBI/18c /1 Set down briefly and clearly what you will expect from the research subjects, such as attending scheduled meetings, keeping diaries, filling out questionnaires etc. What are the possible disadvantages and risks of taking part? Any risks or inconvenience should be briefly outlined. You should consider carefully how to explain any risks involved in your study, as this can be difficult. 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. What are the possible benefits of taking part? Explain these, but where there is no intended benefit for the participant, this should be stated clearly. It is important to not exaggerate the possible benefits. It would be reasonable to say something similar to: 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) What if there is a problem? You should inform participants who to go to if they have a complaint about the research study, their experience, and/or the researcher. A contact number should be given. This may be the researcher in the first instance, who can try to resolve the problem. However a participant may not wish to complain to the researcher if he/she is the object of the complaint, and may wish to make a more formal complaint for example: 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.

Doc/CBI/18c /1 In addition to identifying a clear complaints procedure you need to identify appropriate redress and/or compensation that would be available if the research participant came to any harm as a result of the research study. Will my taking part in the study be kept confidential? You should tell the participant how their confidentiality will be safeguarded during and after the study. You may wish to tell the participants how your procedures for handling, processing, storage and destruction of their data match the principles in the Data Protection Act 1998. The participant should be told: how their data will be collected. that it will be stored safely, giving the custodian and level of identification, for example: o individual participant research data, such questionnaires/interviews o a master list identifying participants to the research codes data will be held on a password protected computer accessed only by the researcher o hard paper/taped data will be stored in a locked cabinet, within locked office, accessed only by researcher o electronic data will be stored on a password protected computer known only by researcher What it will be used for. For example it must be clear if the data is to be used for future studies and whether further ethical approval will be sought. Who will access to view identifiable data (authorised persons such as researchers within the team, supervisors, sponsors How long will it be retained and that is will be disposed of securely (the Faculty recommends a minimum of 3 years) Example introductory statement includes: 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 dont carry on with the study? There are different positions to take on what will happen if a participant withdraws from a study and it up to the researcher to determine what is applicable to their study and ensure that this is clearly communicated to the participant prior to them agreeing to take part. Three possible scenarios include: 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.

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Doc/CBI/18c /1 What will happen to the results of the research study? Participants often want to know the results of the study in which they were involved. You should tell participants what will happen to the results, whether they will be published and how the results will be made available to them. You should add that they will not be identified in any report/publication unless they have given their consent. Who is organising or sponsoring the research? The answer should include the organisation or company sponsoring the research and funding the research if these are different (e.g. Research Charity, academic institution,). Further information and contact details: The additional information that participants require can sometimes be divided into the following four categories. You need to identify where to locate additional information or who to contact to address the different enquires. 1. General information about research (e.g. list relevant documents or websites) 2. Specific information about this research project (e.g. contact details of researcher) 3. Advice as to whether they should participate (e.g. contact details of a different health care professional who can provide impartial advice) 4. Who they should approach if unhappy with the study (e.g. contact details of complaints procedure if not listed earlier) A minimum prerequisite in this section is that the contact details of the researcher (email address) should be clearly identified.

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Appendix 3 Research Participant Consent Form Title of Project: Name of Researcher: Name of Supervisor:
(Delete as appropriate)

I confirm that I have read and understood the information sheet for the above study and what my contribution will be. I have been given the opportunity to ask questions (face to face, via telephone and e-mail) I agree to take part in the interview I agree to the interview being tape recorded I agree to digital images being taken during the research exercises I understand that my participation is voluntary and that I can withdraw from the research at any time without giving any reason I agree to take part in the above study Name of participant Signature Date Name of researcher Researchers e-mail address

Yes

No

Yes

No

Yes Yes Yes

No No No

NA NA NA

Yes

No

Yes

No

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