College Ethical Approval Panel for Taught Programmes: College of Health and Social Care, University of Salford Guidance Notes for Completing the College Ethical Approval Panel for Taught Programmes Application Form The following notes have been compiled to act as a guide for applicants pursuing ethical approval from the College Health and Social Care, Ethical Approval Panel for Taught Programmes. Each section below refers directly to the sections on the application form and highlights what minimum information is required. NOTE: It is essential that the reviewers on the ethics committee have sufficient information to be able to make an informed decision regarding the application. Therefore applications with insufficient information will be returned to the applicant and need to be re-submitted at a later date resulting in a delay in obtaining ethical approval and subsequently the start of the research study. Proportionate Review Checklist Please select a response to the questions on the checklist. Projects that indicate that potential risk is involved will be subject to a full review by the ethics panel. Projects that select mainly ‘YES’ or NA will be subject to a proportionate review by an ethics panel member. Each project should be carefully assessed with the supervisor according to the relevant professional regulatory guidelines for research ethics. Please refer to the Appendix to the checklist for information to support your responses. Application Form 1. Title of proposed research project (approx 20 words) 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 then abbreviated. 2. Project focus (approx 100 words) 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. 3. Project objectives (between 3-5 clear bullet points) Summarise the main objectives or outcomes expected of the research study. For example: 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… 4. What is the rationale which led to the study? (approx 300 words) Version 6 (18.10.12) College Ethical Approval Panel for Taught Programmes: College of Health and Social Care, University of Salford Providing a rationale for the study refers to the presentation of a clear comprehensive summary of background research/literature which has informed your study development. In this section you need to generate an argument as to what has been done, what we already know about the phenomenon being researched, what the gaps are in the research knowledge and what your project will contribute to or add to this body of knowledge. All research publications need to be clearly referenced and a full list of references provided in section 12. 5. Is your project linked to any other projects? Linked projects are acceptable, but separate ethical applications must be made by each applicant. In this section you must state which other project yours is linked to; whether it forms part of a larger project or is a joint project with another student. Each applicant must give a clear outline of their particular roles and responsibilities within the project. For example, please make clear your responsibilities. e.g. If researcher A will be undertaking the interviews and researcher B collecting numerical data need to ensure they understand the ethical implications of each activity. In addition, a clear participant information sheet that outlines all the project interventions and expectations of the participants needs to be included. This may mean that the information sheet is the same for the linked projects. 6. Research strategy (approx 300 words) This section provides a summary of the methods you are going to use to perform the research study, the approach which you will take. Briefly describe the following: - Who will be recruited, how many participants, 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 to recruit x amount of people and identify how the sample represents the wider population so the results can be generalised. - Identify the research methodology you have adopted, such as epidemiology, phenomenology, action research, whatever you choose make sure it is clear to the reader why this method is important. - What method are you using to gather data, data collection tools, interview guides, questionnaires etc. whatever you use you must include (in the appendices with the application) a copy of the instrument or at least a draft copy of any instrument or interview guide (this should be version dated and identified on the checklist). - Explain how the data will be analysed – for example using quantitative data packaged such as SPSS, what statistical tests will be applied and/or using qualitative techniques such as thematic, content, explanation building analysis. Please provide an indication of the project duration or project schedule in your research strategy or as an appendix. 7. Number of participants to be recruited and rationale for sample size (approx 100 words) 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 be generalised. You need to provide a clear rationale why you chose the size of sample for your study. Identify whether a power calculation was performed/appropriate and how this was determined. The committee acknowledges 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 Version 6 (18.10.12) College Ethical Approval Panel for Taught Programmes: College of Health and Social Care, University of Salford 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). 8. Organisational agreement for the research study to take place (approx 100 words) Whilst the ethics committee does not advocate approaching and gaining consent from organisations to undertake research prior to ethical approval being granted, it is recommended that the applicant consider how they will obtain agreement and what strategies they have developed to enable this. For example, it is acceptable that applicants approach organisations to seek advice about the process of gaining approval and provisional support for the study, prior to applying for approval. The strategy ensures that the organisation is receptive to the applicant’s project and would be in principle, willing to approve the project once college ethical approval has been obtained. 9. Recruiting individuals to be involved in the research (approx 200 words) This section needs to clearly explain how and which individuals you propose to recruit for the research study. You need to clearly identify a recruitment plan and add supporting material (copies of Posters, newspaper adverts, website, and letters) which will be used to attract research participants. Where and how will the participants be recruited, using what method? How will research participants communicate that they are interested in being involved? Please also stipulate the age group you plan to recruit. In the majority of research studies research participants should be recruited voluntarily by advert or poster, although be aware this can be a slow process. If you are contacting participants directly by letter then you need to describe where you will get their names and addresses from. Ideally you should not be given a list of names to contact as this information is confidential to the target organisation/participant. It is best that letters are distributed by a third party who is privy to this information and ask participants to reply directly to you providing their own contact details. If you wish to recruit a certain cohort of students undertaking a specific course then you need to have recruitment letters and information sheets distributed by the programme leader in advance to when you want to undertake data collection to give participants time to consider whether to be involved. Organisational agreement will need to be sought from the Programme Leader for permission to recruit participants during class time and once received contact the Module Leader/Lecturer out of courtesy. Please do not approach people directly or use a global email to recruit your participants. If you plan to use posters to recruit participants, please ensure that they include the following details 1. A clear study title 2. An inoffensive image 3. Clear aims of the study Version 6 (18.10.12) College Ethical Approval Panel for Taught Programmes: College of Health and Social Care, University of Salford 4. The University contact details of the researcher and supervisor 5. The current University logo It is essential that you assure research participants that their involvement will be confidential (where at all possible). This means that no other person should know that they are involved in your research study unless they themselves choose to disclose this fact. If you are recruiting participants to a group interview you need to confirm that all group participants agree to keep the identity of other members of the group confidential. 10. Gaining informed consent (approx 200 words) 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 a person understands the research study and their involvement then they can make an informed decision about whether to get involved and provide informed consent (agreement to be involved having been told all the facts about the study). In this section you need to describe the process by which you are going to ensure a research participant provides informed consent. This must include providing the patient with an information sheet in clear, easy to understand format (the committee recommend following the Information Sheet guidelines provided). Sufficient time should be given for potential participants to absorb and consider the information given about the research and what is expected of their participation before they are asked to make a decision regarding participation. You should make it clear who will see the research data you collect and the results, i.e. you, your supervisor and any other people involved in your data collection, for example, technicians or audio transcribers. Once a research participant has decided to be involved in the research study informed consent must be obtained. The committee prefers written consent from research participants (where at all possible) for this a standard consent form (see Research Participant Consent Form) has been devised which the committee would prefer you to use. For research taking place faceface then written consent should always be obtained, this also allows the research participant to ask direct questions. For survey research where questionnaires are posted to participants it is appropriate to presume participants consent to being involved in the research by returning a completed questionnaire, so written consent is not required. Sufficient time should be given for potential participants to absorb and consider the information given about the research and what is expected of their participation before they are asked to make a decision regarding participation It is equally as important that the research participant understands that they can withdraw from a research study at any time without any consequences, even after data has been collected 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. It is essential that a person who is being approached to be involved in a research study is considered mentally competent to provide informed consent. Where this is in question further Version 6 (18.10.12) College Ethical Approval Panel for Taught Programmes: College of Health and Social Care, University of Salford safeguards need to be described and an argument presented as to why it is important for these people to be involved in the study. 11. Data protection issues (approx 100 words) Protecting sensitive data needs to be considered and how you can ensure participants’ data remains confidential, such as the names/contact details of research participants and/or personal information disclosed within a research study. You need to describe the methods you will use to achieve this, the committee recommends 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 recordings, transcripts, should be anonymous and coded, hard paper copies of data, including consent forms 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, preferably the F drive. All data transported on computer discs, CDs and USB memory sticks should be anonymous identified only by a code and 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. 12. Other ethical issues to consider (approx 200 words) There are a number of other ethical issues that you need to consider and explain in this section only if they are relevant to your study. Language Barriers – Participants must be able to understand the study. 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 nonEnglish 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. Version 6 (18.10.12) College Ethical Approval Panel for Taught Programmes: College of Health and Social Care, University of Salford 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. Using a sensitive interview approach, stopping interviewing if participant distressed, providing contact details of an appropriate support service to refer/recommend to the participant to discuss issues further with a professional. Researcher skills and training – If the researcher proposes to carry out a procedure which they have learned as part of their programme of study, for example finger-pricking, the student must submit confirmation that they have undertaken this training to the panel as part of their application. Where relevant to their application, students should also indicate if they have been DBS checked. Failure to consider ethical issues adequately will result in your application being returned for resubmission or amendments. 13. References Provide a Full list of references which support the background argument and rationale in section 4. NOTE: Ensure that all supporting documents such as copies of recruitment material, questionnaires, interview guides, patient information sheets, consent form, risk assessment form are attached to the application form and clearly indicated on the applicant’s checklist. Version 6 (18.10.12)