HOW TO COMPLETE THE EHS RESEARCH ETHICS APPLICATION FORM PESS APPLICATIONS
HOW TO COMPLETE THE EHS RESEARCH ETHICS APPLICATION FORM PESS APPLICATIONS TABLE OF CONTENTS EHSREC Coversheet Questionnaire……………………………………………………… 3 Chair’s Decision Form …………………………………………………………………………. 4 Guidelines on Completing EHSREC Application Form ………………………….. 4 Submission Process to EHSREC …………………………………………………………… 15 Appendix A (Sample Volunteer Information Sheets) …………………………… 17 Appendix B (Sample Volunteer Consent Forms)………………………………….. 26 Appendix C (Sample Recruitment Documents) …………………………………… 31 2 THE COVERSHEET QUESTIONNAIRE ALL ethic applications must attach the EHSREC Cover Sheet Questionnaire to the application. Applications will not be considered without this. Cover Sheet Questionnaire Guidelines Section 1. Ethical Issues The Cover Sheet Questionnaire should assist you and the EHS research ethics committee members in identifying ethical issues which arise in research with human subjects. Applicants are encouraged to use this cover sheet as an opportunity to consider what ethical issues arise, whether they could be circumvented by using an alternative research design, and, if not, what measures are in place to safeguard participants. Section 2. Approved Procedures Select the appropriate button and provide procedure name and approval number if applicable. If you have indicated that subjects are under 18 in Section 1, it is appropriate to state Child Protection Guidelines in this section. This indicates to the committee that the guidelines have been read and accepted. Ensure that the signed child protection form is submitted with the application. Section 3. Eligibility for Chair's Decision Select the appropriate button. If application is being submitted for Chair’s Decision (i.e. the research is of a similar nature previously approved by a research committee in UL) provide the name and number of the previous Application. Section 4. Who is carrying out the research primarily? Indicate who the research will be the primary work of. Section 5. Supporting Documentation and Signatures Select the appropriate buttons and ensure the principal investigator has signed and dated the Cover Sheet. 3 CHAIR’S DECISION FORM In the event that you are looking to REPLICATE a project that has already been approved previously by a research ethics committee you need to complete the Chair's Decision Form and not the full ethics application form. Please note the Principal Investigator (PI) must be the PI for the previously approved application as well as the new application. In completing the Chair's Decision Form you must refer to the previously approved application code and name. Applications will not be considered without reference to this code. On the Chair’s Decision Form, ensure there is enough information so that a decision can be made in relation to the application. Use the headings provided to guide you in outlining the proposed changes. If the previously approved application was approved by a different research ethics committee to EHSREC, then you must attach a copy of the successful application as well as identify the application number. If the previously approved application was approved by EHSREC you must supply the EHSREC approval code. EHSREC APPLICATION FORM If submitting a proposal for a NEW project, please complete the EHS ethics application form. The form is fully compatible with Windows running Adobe Acrobat 9 (includes all UL builds); full compatibility with Apple Mac is not guaranteed. The following guidelines will assist you in completing the form. Title of Project The title should be as short a possible but still fully reflect the topic and scope of the project. Do not use abbreviated terms in the title Period for which Approval is Sought Start Date of Approval: An ethics committee cannot approve research applications where dates indicated are in the past. Applicants can choose one of two options: (a) ‘Date of Approval’ (choose this option, if you require approval from the date that the ethics committee will approve the research). (b) ‘Specific Date’ (choose this option if you want approval to begin from a specific date). Select Date from drop down Calendar. Regardless of whether you choose option (a) or (b) you must enter a date for when approval will end. Select Date from drop down Calendar. Note: for final year project applications it is important that you indicate a time that allows you sufficient amount of time to gather data and complete the research. 4 Student investigators should discuss this with their supervisor (principal investigator – PI) as the PI may want to include an extended date for up a number of years to allow other students to complete the same research. The EHS Research Ethics Committee processes Undergraduate Research, Taught Postgraduate Research, Research Postgraduate and Staff Research applications. Project Investigators Principal Investigator The principal investigator should be an employee of the University of Limerick. For research carried out in the PESS department the Principal Investigator is usually a PESS faculty member and is always the supervisor of the project. Details of the PI should be included. Position: Junior Lecturer, Lecturer or Professor. Qualifications, telephone number and email addresses can be found on the staff pages of the PESS website. Other Investigators Details of students (undergraduate) who are research investigators in the project must be listed in 'Other Investigators'. Programme of study that the student investigator is enrolled in should be stated. The researchers listed under ‘other investigators’ must sign the hard copy of the application before submitting the application to the committee. Head of Department State the name of the current PESS Head of Department. SECTION 1: Study Design and Conduct of Study (a) Aims of the Research: Indicate the aims of the research clearly. (b) Provide a description of the study, clearly outlining what is required of all participants. Describe ALL procedures to be used. A list of approved procedures that have been used in PESS research are available on the PESS website. The EHSREC website also provides access to approved procedures. State the name and approval number of procedure(s) being carried out in the study in Section 1 of application form. 5 Describe the different types of data you intend to collect and how data will be analysed. Examples of Study Descriptors Physical Activity: refers to assessment of any type of physical activity in the research project. If participants will be taking part in some form of physical activity, they must complete the PESS Pre Test Questionnaire. If a subject is under 18, the parent/guardian will assist the the child in completing the Pre‐Test Questionnaire or will complete the questionnaire if the child is too young. Questionnaire/Interview: refers to a questionnaire that is being used as part of the research. It does not refer to the PESS pre‐test questionnaire. Ensure that the questionnaire or sample interview questions are included in the application. Note that the approved EHSREC approval number for interview/questionnaires is EHSREC10_RA01. Measure Physical in Nature: refers to the physical procedures that are involved in the research, e.g. height, weight, flexibility, muscular power, strength etc. Observational: refers to research which is only observational, i.e. where there is no intervention involved. SECTION 2: Recruitment of Research Participants (a) Describe the population being recruiting from. Include age, gender, ethnicity (if ethnicity is relevant). Any inclusion or exclusion criteria should be referred to in this section. (b) Describe how participants will be sourced and identified. If recruitment involves recruitment via letter, email, or poster, a copy of this must be submitted with the application. (c) Participant Numbers The maximum number of participants that project intends to recruit must be indicated. Allow for drop‐outs and other losses. (d) Rewards to Participants Indicate any financial remuneration or any other forms of rewards that participants will receive. (e) Location of Research Identify the location(s) of the proposed research project. If research is taking place in UL, indicate in which building, and laboratory or room number(s) if known. If research is taking place at an external location, name the external location if known. 6 SECTION 3: Consent Read the instructions in this section first, before you complete Section 3 of the form. The instructions firstly remind the applicant that: 1. An information sheet and consent form for participants must be submitted with the application 2. If it is not possible to obtain written consent (e.g. telephone interviews, internet based research), the applicant must provide evidence of how consent is being obtained in the application 3. An information sheet and consent form for parents or guardians must be submitted with the application if participants are under 18 or if adults are unable to consent. Sample Consent Forms are provided in Appendix B 4. For research in schools, a copy of the cover letter to the school principal must be submitted with the application Section 3(a) only needs to be answered if the following applies: If the research involves participants (adults or children) who are unable to give consent, explain how consent will be obtained. If the research includes participants who can't read or speak English (or Irish, if the research is aimed at Irish speakers), explain how consent will be obtained. In situations where obtaining free consent may be difficult (e.g. prisons), explain who you will ensure that free consent is given. Enter N/A if none of the above apply to your project SECTION 4: Care and Protection of Research Participants (a) Provide detailed information on any potential risks to the participant or researcher from procedures or techniques to be employed in the research. Risk is defined by the EHS research ethics committee as the potential to cause short or long term discomfort, pain, physical injury or emotional distress (embarrassment, anxiety) that is greater than that which would be experienced in the participant's everyday life. Where substantive risk is identified, provide details on steps that have been taken to minimise this risk. (b) Participation time for each participant Indicate clearly in hours and minutes the total participation time for each participant. Consider the different participant types you have in your study, e.g. coach, athlete, school pupils, teachers etc. (c) Breakdown of time for multiple testing sessions Where there is multiple testing sessions for participants, provide a breakdown detailing how the total participation time is divided over the course of the 7 experiment or research study. (d) Benefits v's Risks of Study Explain why the potential benefits of the study justify any risks to participants and participant time input. If you have identified in Section 4a that the risks are not greater than that which would be experienced in the participant’s everyday life, then you do not have to provide a justification of benefits outweighing risks. State that risks are not greater than that which would be experienced in the participant’s every day life. If you have identified in 4a that there are risks to the participant that are greater than that which would be experience in the participant’s everyday life, then explain why the benefits justify any risks to participant and participant time input. SECTION 5: Protection of Participant Confidentiality (a) Who will have access to the data collected from participants? Will only the investigators named in the application form have access to the data? If other individuals will have access to non‐anonymised participant data, e.g. coaches, school principals, this must be made clear in the application form and in the participant information form, so that participants are fully informed. (b) How will confidentiality be ensured? Provide information on how a subject's confidentiality will be maintained. Participant data should be made anonymous and should be stored in a format whereby specific subject information cannot be identified. Subject names should be assigned codes or pseudonyms, and only the data linked to these codes should be stored electronically. Indicate where the data be stored. Remember to refer all the types of data that is being collected and think about where each data type will be stored and on what type of device it will be stored. E.g. paper copies of the data (questionnaires, consent forms), audio/digital data, video tapes. If storing data on a USB device, indicate what measures will be taken to ensure that data is stored on such a device for a temporary period (e.g. data should be erased from USB device immediately after data collection and transferred to a computer). The PI will normally be storing hard copies of the data instead of the student investigator. In addition, indicate what appropriate measures the investigators will undertake to ensure that the stored data (electronic and paper copy) is secure at all times (State the measures clearly). After the data collection period, only the principal investigator will retain the subject names and their assigned codes and hard copy data. Computers/electronic storage devices used by the investigators should be password 8 protected and this should be stated. Video and audio recordings are considered impossible to anonymise and contain private and/or confidential information. Great care should be taken when storing video and audio recordings. If using video or audio recordings specify where these will be stored (e.g. specific location (include laboratory name and room number) or Principal Investigator's name and room number). How long will data be kept? How will data be destroyed at the end of the storage period? Note: Currently investigators are obliged to store data for between 7 and 10 years, and ensure that it is effectively destroyed at the end of this period. SECTION 6: Community Considerations In this section you need to describe how the results will be made available to the participants and to the concerned communities (if applicable). The Principal investigator is the gatekeeper of all information and results pertaining to the application. If the investigators are making the results/ outcomes of the study available to participants, this should be carried out by written request to the Principal Investigator and not to the student investigator. Example of wording for Section 6 “The results of the final year project will be available to participants on written request to the Principal Investigator” This wording should be reflected in the participant/parent information sheet under an appropriate heading, e.g. “What happens to the information” or “What happens at the end of the study” SECTION 7: Indemnity All research undertaken by UL employees requires indemnity insurance. UL's insurance policy and exemptions are shown on the University of Limerick's Research Ethics Web Page. If your planned research methodology is substantially different to that which you have obtained ethical approval for before at UL, and has identifiable potential risks to participants or experimenters the principal investigator must contact Cliona Donnellan (cliona.donnellan@ul.ie) to confirm that the research project will be insured. If the planned work requires invasive procedures, Cliona Donnellan should be contacted and informed. UL insurers may need to be contacted and informed of such procedures. Allow several days for a response. 9 Note that UL's current insurance does not cover clinical trials. On the application form, you must indicate either 'YES' or 'NO' as to whether the research project is covered by UL's indemnity policy. DOCUMENT CHECKLIST On the checklist indicate which documents are attached and which documents are not applicable. The following documents may or may not be included with your application: Volunteer Information Sheets Adult Volunteer Information Sheet Child Volunteer Information Sheet Parental Information Sheet Adult Information Sheet The information sheet must include the full title of the study. Please note the following: The information sheet should be written using layman's terms The information sheet should not contain any technical or specialist terms that may not be understood by the potential subjects. Adult subjects should be allowed a sufficient amount of time to read and to consider the contents of the information sheet. The information sheet is retained by the subject/parent/carer and should include the application's EHSREC number on it. (EHSREC number is provided to the Principal Investigator from the ethics committee once the application is approved) The following is a list of items to address when preparing an information sheet. These subheadings can be included on the information sheet. UL Logo and name at top of page Title of project What is the study about? What will I have to do? What are the benefits? What are the risks? What if I do not want to take part? E.g are there alternatives. This is important to consider especially when the research involves recruiting from an intact class or group. Volunteers should not feel that they are forced to take part. What happens to the information? 10 Who else is taking part? What if something goes wrong? What happens at the end of the study? What if I have more questions or do not understand something? What happens if I change my mind during the study? Contact name and number of Project Investigators. The following standard paragraph statement should be included at the end of the of subject information sheet: If you have any concerns about this study and wish to contact someone independent, you may contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick. Tel:(061)234101/Email: ehsresearchethics@ul.ie Children Information Sheets (i.e. volunteers up to age 18) Children require a separate suitably worded information sheet. The information sheet must be written in a language that is age appropriate for the subjects. The information sheet should not contain any technical or specialist terms that may not be understood by the potential subjects. The subheadings listed in the adult volunteer information sheet can also be used on a child information sheet. The last subheading (which refers to EHSREC contact point) is not required as it is unlikely that children will understand it. This information will be included on the parental information sheet. Parent/Carer Information Sheet Parents require a separate suitably worded information sheet. The information sheet for the parent/carer must include the full title of the study. The information sheet should be written using layman's terms, and should not contain any technical or specialist terms that may not be understood by the parents/carers of the subjects. Parent/Carer information sheets should be written with their child or the person whom they care for in mind. Parent/carers of subjects should be allowed a sufficient amount of time to read and to consider the contents of the information sheet. The information sheet is retained by the parent/carer and should include the application's EHSREC number on it. 11 The following is a list of items to address when preparing a Parental information sheet. UL Logo and name at top of page Title of project What is the study about? What will my child have to do? What are the benefits? What are the risks? What if my child does not want to take part? What happens to the information? Who else is taking part? What if something goes wrong? What happens at the end of the study? What if I have more questions or do not understand something? What happens if I change my mind during the study? Contact name and number of Project Investigators. The following standard statement should also be included at the end of the of subject information sheet : If you have any concerns about this study and wish to contact someone independent, you may contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick. Tel: (061) 234101 / Email: ehsresearchethics@ul.ie Sample Information Sheets included in Appendix A Informed Consent Forms Informed Consent Forms for Adult Subjects/Parents/Guardians Informed Consent Forms – Children The title of the project must be included on the form. The EHSREC number must be included on the form. The following statements are examples of the statements that should be included on a consent form: I have read and understood the subject/parent/carer information sheet. I understand what the project is about, and what the results will be used for. I have completed the pre‐test questionnaire (only include if study involves physical activity) I am fully aware of all of the procedures involving myself, and of any risks and benefits associated with the study. I know that my participation is voluntary and that I can withdraw from the project at any stage without giving any reason. 12 I am aware that my results will/will not be kept confidential (delete as appropriate. I consent for the data to be used anonymously in report format and published output. Sometimes with the subjects permission results are provided to another party (e.g. a coach). This should be indicated on the consent form and in the participant information sheet. There should be a place for the subject to sign and date that they have understood fully what will be involved in the research. There should be a place for the Investigator to sign and date the form. The subject should not feel coerced in any way and it must be clear to the subject (or their parent/guardian/carer) that they may decline to take part, or withdraw at any time, without affecting them in any way. In most cases, the decision to participate and give informed consent should take place after an interval (hours or days) allowing the patient time to read the information sheet and discuss further with relatives or friends. Sample Adult/Parent Consent Forms are in Appendix B Informed Consent Form ‐ Children In addition to the child's legal guardians/carers giving consent, children should be given the opportunity to give consent and a suitably worded consent form should be provided. Children have a right to withdraw their consent at any time, regardless of the fact that their legal guardian/carer has given consent. The same statements outlined for the adult consent form or amended/simplified versions of the statements (depending on the age of the subjects) should be used for the child consent form. A Child Consent Form should be separate form to the Parent/Guardian's Consent Form Sample Child Consent Forms is in Appendix B 13 Witnessing Signature A witness signature and PRINTED NAME are required on consent forms, next to the volunteer's signature, in the following circumstances: Children volunteers Potentially vulnerable volunteers Whenever there is a need for a witness, for example, when the freedom to give voluntary consent may be questioned, or a study that includes significant risks. Recruitment Documents (Letter/Email/Poster) If you are using a letter, a poster, an e‐mail or something similar to recruit subjects or to ask for permission to use persons within an institution (e.g. school), then a copy of this document must be attached to the application form. This recruitment document should outline in detail what the project is all about, whom to contact for further information, reference to the fact that the project has been approved by EHSREC, etc. Sample Recruitment Documents are in Appendix C Declaration The declaration must be signed and dated by the Principal Investigator. If the Principal Investigator is not a permanent member of staff, the Head of Department should sign the declaration. 14 SUBMISSION PROCESS TO EHSREC For submission to EHSREC, applicants are requested to submit an electronic copy, and ONE typed paper copy (containing original signatures) of the completed application form to Anne OBrien in the EHS Faculty Office. The paper copy can be handed in at faculty office E1004. Electronic submissions must be submitted to anne.obrien@ul.ie ehsresearchethics@ul.ie. When submitting the application by email, please ensure that the email has the following attachments: Completed cover sheet questionnaire form. Completed ethics application OR chair's decision form (as appropriate) Word File containing all the associated documents that relate to the application form, e.g. subject information form (s), subject consent form(s), pre‐test questionnaire, recruitment email/poster/letter etc. All these documents must be pasted into ONE word file, and not attached as individual attachments. Risk assessment forms for procedures being used should be attached as separate PDF files with the electronic submission. If research involves children, a signed copy of the University of Limerick Child Protection Form should be attached to the hard copy of the application. Please note that all material relating to the application should carry the University of Limerick logo e.g. Information Sheets, Consent Forms etc. 15 APPENDICES Appendix A: Sample Information Sheets Appendix B: Sample Consent Forms Appendix C: Sample Recruitment Documents 16 APPENDIX A UNIVERSITY of LIMERICK O L L S CO I L L U I M N I G H VOLUNTEER INFORMATION SHEET ‘Adolescents’ Participation in and Views On Sport and Physical Activity’ Dear Student/Volunteer, As part of my Final Year Project in the University of Limerick, I am conducting research on adolescents’ participation into team sports. This information sheet will inform you about the study. What is the study about? The project aims to develop a greater understanding of what influences adolescents’ participation in team sports. What will I have to do? Your involvement in this project will be during your timetabled school day‐ e.g. lunch time. You will be invited to participate in two forty minute focus group sessions with some of your peers. The focus groups will involve 5‐6 students being asked to answer questions and discuss their participation in sport and physical activity in a group setting. OR Your involvement in this project will take place during your timetabled school day, e.g. during X Class. What are the benefits? This might benefit you in terms of thinking and analysing the reasons for why you participate in sport/physical activity. The findings of the study might help physical education teachers and others to provide more positive and meaningful physical education and physical activity experiences for adolescents so that they might become physically active like you. What are the risks? While some of the questions asked may be sensitive, you will not be required to answer any question you do not wish to. If the research involves participation in physical activity and the risks are not greater than the risks from participation in regular physical education classes, state this clearly. 17 What if I do not want to take part? Participation in this study is voluntary and you can choose not to consent or to withdraw consent and stop participating in this study at any time. Include a statement on alternatives if relevant (e.g. if research is taking place during class time). What happens to the information? The information that is collected will be kept confidential and stored on the researchers’ computer with a protection password. The information will be anonymised and kept for a period of seven years, after which it will be deleted and/or disposed of. Note: if participant information is being passed onto a third party, e.g. a coach, this needs to be stated. Who else is taking part? Adolescents, aged 14‐17 years from your school and other schools will be invited to take part in the research. What if something goes wrong? In the unlikely event that something goes wrong during the focus group session, the interview session will immediately stop until the investigator and participant(s) are ready to resume the session or the session would be stopped completely. What happens at the end of the study? At the end of the study the information will be used to present results but the information will be completely anonymised. All data gathered from the research will be held by the principal investigator for up to 7 years in a password‐protected computer at UL. The results of the final year project will be available to participants on written request to the Principal Investigator. Maybe appropriate to indicate that the request can be made by the parent. What if I have more questions or do not understand something? If you have any questions related to any aspect of the study you may contact either of the researchers. It is important that you feel that all your questions have been answered. What happens if I change my mind during the study? At any stage should you feel that you want to discontinue being a participant, you are free to stop and take no further part. There are no consequences for changing your mind about participating in the study. Contact name and number of Project Investigators. Principal Investigator Faculty Member, PESS Dept. University of Limerick, Tel (061) number Email: staff.name@ul.ie Other investigator Student Name Undergraduate Student PESS Department Contact Number studentidnumber@studentmail.ul.ie 18 Thank you for taking the time to read this. I would be grateful if you would consider participating in this study. Yours sincerely, ______________________ ______________________ Faculty Member Name Student Name If you have any concerns about this study and wish to contact someone independent, you may contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick. Tel: (061) 234101 / Email: ehsresearchethics@ul.ie For young participants, it is not necessary to include the EHSREC statement on the information sheet, as it is unlikely that they will understand it. Ensure that it is included on the Parent Information Sheet. 19 APPENDIX A UNIVERSITY of LIMERICK O L L S CO I L L U I M N I G H PARENT/CARER INFORMATION SHEET ‘Adolescents’ Participation in and Views On Sport and Physical Activity’ Dear Parent/Carer, As part of my Final Year Project in the University of Limerick, I am conducting research on adolescents’ participation into team sports. This information sheet will inform you about the study. What is the study about? The project aims to develop a greater understanding of what influences adolescents’ participation in team sports. What will your child have to do? Your child’s involvement in this project will be during your timetabled school day‐ e.g. lunch time. He/she will be invited to participate in two forty minute focus group sessions with some of their peers. The focus groups will involve 5‐6 students being asked to answer questions and discuss their participation in sport and physical activity in a group setting. Indicate alternatives if relevant. What are the benefits? This might benefit your child in terms of thinking and analysing the reasons for why they participate in sport/physical activity. The findings of the study might help physical education teachers and others to provide more positive and meaningful physical education and physical activity experiences for adolescents so that they might become physically active like your child. What are the risks? While some of the questions asked may be sensitive, your child will not be required to answer any question they do not wish to. If the research involves participation in physical activity and the risks are not greater than the risks from participation in regular physical education classes, state this clearly to the parent. What if I do not want to take part? Participation in this study is voluntary and your child can choose not to consent or to withdraw consent and stop participating in this study at any time. In addition, you can 20 choose not to consent or to withdraw consent and stop your child participating in this study at any time. What happens to the information? The information that is collected will be kept confidential and stored on the researchers’ computer with a protection password. The information will be anonymised and kept for a period of seven years, after which it will be deleted and/or disposed of. Note: if participant information is being passed onto a third party, e.g. a coach, this needs to be stated. Who else is taking part? Adolescents, aged 14‐17 years from your child’s school and three other schools from the country will be invited to take part in the research. What if something goes wrong? In the unlikely event that something goes wrong during the focus group session, the interview session will immediately stop until the investigator and participant(s) are ready to resume the session or the session would be stopped completely. What happens at the end of the study? At the end of the study the information will be used to present results but the information will be completely anonymised. All data gathered from the research will be held by the principal investigator for up to 7 years in a password‐protected computer at UL. The results of the final year project will be available to participants on written request to the Principal Investigator. What if I have more questions or do not understand something? If you have any questions related to any aspect of the study you may contact either of the researchers. It is important that you feel that all your questions have been answered. What happens if I change my mind during the study? At any stage should you feel that you want your child to discontinue being a participant, your child is free to stop and take no further part. There are no consequences to your child should you change your mind about their participation in the study. Contact name and number of Project Investigators. Principal Investigator Faculty Member, PESS Dept. University of Limerick, Tel (061) number Email: staff.name@ul.ie Other investigator Student Name Undergraduate Student PESS Department Contact Number studentidnumber@studentmail.ul.ie Thank you for taking the time to read this. I would be grateful if you would consider participating in this study. 21 Yours sincerely, ______________________ Faculty Member ______________________ Name Student Name If you have any concerns about this study and wish to contact someone independent, you may contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick. Tel: (061) 234101 / Email: ehsresearchethics@ul.ie 22 APPENDIX A UNIVERSITY of LIMERICK Volunteer Information Sheet Title: A Biomechanical Analysis of the differences in the golf swing between novice and expert golfers using qualitative and quantitative methods. What is the project about? This research aims to investigate the qualitative and quantitative differences between novice and expert golfers performing a golf swing. We will then use this investigation to determine the critical teaching and coaching points of the golf swing. What will you have to do? You will be required to come to the PESS building in the University of Limerick at an agreed suitable time on a single occasion for a maximum of thirty minutes. On the day, you will be asked to sign a consent form and then do a 5 minute warm‐up. You will be asked to perform five practice golf swings before you will be recorded by video performing five golf swings at your own pace. What are the benefits to you? Video analysis and biomechanical assessment has become an essential component in coaching across a wide variety of sports. It is extremely useful for identifying technical errors and providing information to individuals in order for them to improve at their chosen sport. After your recording has been analysed you will be provided with a qualitative biomechanical checklist of the movement patterns you performed, if you would like it. What are the risks? Muscle soreness and fatigue are possibilities as a result of taking part in this study. However, these risks are no greater than that which might result from your normal exercise or training session. You may experience slight embarrassment as a result of being video recorded. If risks are not greater than usual participation in the activity (e.g. golf in this case), state this. What if I do not want to take part? You can discontinue your participation in the research study at any time. Should you feel at any stage that you want to discontinue being a participant in the study, then this is dealt with in an unhesitating and confidential manner where you have the option of pulling out without the risk of information being disclosed. What happens to the information? The information retrieved will be dealt with and handled in complete confidence whereby results of the participants as well as their confidentiality are the first priority of the 23 researchers carrying out the study. The study will be video recorded with all recordings kept strictly confidential and will be used exclusively by the researchers of the study. After the completion of the study, information will be kept electronically on the principal investigator’s password‐protected computer. Note: if participant information is being passed onto a third party, e.g. a coach, this needs to be stated. Who else is taking part? There will be eight novice and eight expert golfers taking part primarily sourced from students and staff at the University of Limerick. What if something goes wrong? In the unlikely event that something goes wrong, the testing procedure will immediately cease and the PESS department emergency procedures will be followed. What happens at the end of the study? At the end of the study the information will be used to present results but the information here will be completely anonymised. All video, subject detail/information and data will be held by the principal investigator for up to 7 years in a password‐protected computer at UL. The results of the final year project will be available to participants on written request to the Principal Investigator. What if I have more questions or do not understand something. If you do not understand any aspect of the experiment we would urge you to come forward to either of the researchers and discuss any questions that you might have. It is important that participants feel completely at ease throughout the experiment. What if I change my mind during the study? Should the you feel at any stage that you want to discontinue being a participant then you are free to stop and take no further part. Project Investigator Contact Details: Principal Investigator Staff Member, PESS Dept. University of Limerick, Tel (061) number Email: staff.name@ul.ie Other investigators Student Name Undergraduate Student PESS Department Contact Number student id number@studentmail.ul.ie If you have any concerns about this study and wish to contact someone independent, you may contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick. Tel: (061) 234101 / Email: ehsresearchethics@ul.ie 24 APPENDIX B: Informed Consent Form (Adult Volunteer) Informed Consent Form Title of study: A Biomechanical analysis of the differences in the golf swing between novice and expert golfers using qualitative and quantitative methods. I have read and understood the subject information sheet. I understand what the project is about, and what the results will be used for. I consent for the data to be used anonymously in report format and published output. I have completed the pre‐test questionnaire. I am fully aware of all of the procedures involving myself, and of any risks and benefits associated with the study. I know that my participation is voluntary and that I can withdraw from the project at any stage without giving any reason. I am aware that my results and video footage will be kept confidential. I understand that my coach will receive a copy of my results (if appropriate) Volunteer’s name ___________________________ Volunteer’s signature ___________________________ Date ___________________________ Investigator’s signature ___________________________ Date ___________________________ 25 Appendix B: Informed Consent Form (Child) UNIVERSITY of LIMERICK O L L S CO I L L U I M N I G H INFORMED CONSENT FORM Title of Project: Adolescents’ participation in and views on sport and physical activity Should you agree to participate in this study please read the statements below and if you agree to them, please sign the consent form. I have read and understood the participant information sheet. I understand what the project is about, and what the results will be used for. I understand that what the researchers find out in this study may be shared with others but that my name will not be given to anyone in any written material developed. I am fully aware of all of the procedures involving myself, and of any risks and benefits associated with the study. I know that my participation is voluntary and that I can withdraw from the project at any stage without giving any reason. I consent (or agree) to my involvement in this research project after agreeing to all the above statements. Name: (please print): __________________________ Signature: ___________________________________ Date: ____________ Witness Signature _____________________________ Date: ____________ Investigator’s Signature _________________________ Date: _____________ For very young participants, simplify the statements further. 26 Appendix B: Informed Consent Form (Parent/Carer) UNIVERSITY of LIMERICK O L L S CO I L L U I M N I G H PARENTAL/CARER CONSENT Title of Study: Adolescents’ participation in and views on sport and physical activity I have read and understood the parent/carer information sheet. I understand what the study is about, and what the results will be used for. I consent for the data to be used anonymously in report format and published output. I am fully aware of all of the procedures involving my child, and of any risks and benefits associated with the study. I know that my child’s participation is voluntary and that I can withdraw my child’s participation in the study at any stage without giving any reason. For the parent/carer I permit consent for ______________________ (name of child) to participate in the above study. Name of child: (please print): _________________________ Name of parent/carer: (please print): ___________________ Parent Signature : __________________________________ Date: ____________ Investigator’s Signature ______________________________ Date: _____________ 27 Appendix C: Recruitment Letter UNIVERSITY of LIMERICK O L L S CO I L L U I M N I G H PRINCIPAL LETTER Adolescents’ Participation In and Views On Sport And Physical Activity Date TBC Dear Principal, I am an undergraduate physical education student who will be on teaching practice in your school in Autumn 2010. As part of a Final Year Project (FYP) in the University of Limerick, I am currently conducting researching on adolescents’ socialisation into individual and team sport. The project aims to develop a greater understanding of what influences adolescents’ participation in team and individual sports. I would be grateful if you would consider allowing me to seek consent from students in your school and their parents to allow them to participate in this study. The pupils’ involvement in this project would be primarily during their timetabled school day‐ e.g. lunch time. The participating pupils would be invited to be involved in two forty minute focus group sessions with some of their peers. The pupils would be asked to answer some questions in these focus group sessions regarding their participation into team and individual sports and physical activity. This participation may benefit the participating pupils in terms of thinking and analysing the reasons for their participation in sport/physical activity. The findings of the study might also help physical education teachers and others to provide more positive and meaningful physical education and physical activity experiences for more adolescents. If participation is during class time, indicate to the principal what your suggestions for alternatives will be for those who do not want to take part in the study. While some of the questions asked may be sensitive, the participating pupils would not be required to answer any question they do not wish to. The information they do give would be kept confidential and stored on the researcher’s computer with a protection password. The information will be anonymised and kept for a period of seven years, after which it will be deleted and/or disposed of sensitively. The same project is also being carried out in three other schools in the country. Participation in this study would be entirely voluntary and the pupils and/or their parents/carers may chose not to consent or to withdraw consent and discontinue participation in this study at any time. If you have any concerns or questions about the project as you come to arrive at your decision about whether or not to allow me to undertake this study in your school, either myself or my project supervisor (Faculty Member) would be happy to assist you. Thank you for your time and consideration. Yours sincerely, 28 ________________________ Student Name Project Investigator Contact Details: Principal Investigator Staff Member, PESS Dept. University of Limerick, Tel (061) number Email: staff.name@ul.ie Other investigator Student Name Undergraduate Student PESS Department Contact Number studentidnumber@studentmail.ul.ie If you have any concerns about this study and wish to contact someone independent, you may contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick. Tel: (061) 234101 / Email: ehsresearchethics@ul.ie 29 Appendix C: Recruitment Email RECRUITMENT EMAIL Golf Biomechanics Research Project I am a fourth year Physical Education student seeking participants for my final year project entitled “A Biomechanical Analysis of the differences in the golf swing between novice and expert golfers using qualitative and quantitative methods” Project: Using biomechanical video analysis we are aiming to investigate the qualitative and quantitative differences between novice and expert golfers performing a golf swing. We will then use this investigation to determine the critical teaching/coaching points of the golf swing. Who are we looking for? Advanced golfers (play more than two times a week) AND novice golfers, with little or no experience of golf. Where: PESS Sports Hall, University of Limerick Further Information: Researcher: Student Name Student number@studentmail.ul.ie Contact Number Supervisor: Staff Name, PESS Department, staff.name @ul.ie, 061 number If you have any concerns about this study and wish to contact someone independent, you may contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick. Tel: (061) 234101 / Email: ehsresearchethics@ul.ie 30
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