St Mary’s University
Ethics Sub-Committee
Application for Ethical Approval (Research)
This form must be completed by any undergraduate or postgraduate student, or member of staff at St Mary’s University, who is undertaking research involving contact with, or observation of, human participants.
Undergraduate and postgraduate students should have the form signed by their supervisor, and forwarded to the Faculty Ethics Sub-Committee representative. Staff applications should be forwarded directly to the Faculty Ethics Sub-Committee representative. All supporting documents should be merged into one document (in order of the checklist) and named in the following format: ‘Full Name – Faculty – Supervisor’
Please note that for all undergraduate and taught masters research projects the supervisor is considered to be the Principal Investigator for the study.
If the proposal has been submitted for approval to an external, properly constituted ethics committee (e.g. NHS Ethics), then please submit a copy of the application and approval letter to the Secretary of the Ethics Sub-Committee. Please note that you will also be required to complete the St Mary’s Application for Ethical Approval.
Before completing this form:
- Please refer to the University’s Ethical Guidelines. As the researcher/ supervisor, you are responsible for exercising appropriate professional judgment in this review.
- Please refer to the Ethical Application System (Three Tiers) information sheet.
- Please refer to the Frequently Asked Questions (FAQs) and Commonly Made Mistakes sheet.
- If you are conducting research with children or young people, please ensure that you read the Guidelines for Conducting Research with Children or Young People, and answer the below questions with reference to the guidelines.
Please note:
In line with University Academic Regulations the signed completed Ethics Form must be included as an appendix to the final research project.
If you have any queries when completing this document, please consult your supervisor (for students) or Faculty Ethics Sub-Committee representative (for staff).
St Mary’s Ethics Application Checklist
The checklist below will help you to ensure that all the supporting documents are submitted with your ethics application form. The supporting documents are necessary for the Ethics Sub-Committee to be able to review and approve your application. Please note, if the appropriate documents are not submitted with the application form then the application will be returned directly to the applicant and may need to be re-submitted at a later date.
| Document | Enclosed?* | Version No |
| 1. Application Form | Mandatory | 1 |
| 2. Participant Invitation Letter | ☐ Yes ☐ No ☒ Not applicable | |
| 3. Participant Information Sheet(s) | Mandatory | 1 |
| 4. Participant Consent Form(s) | Mandatory | 1 |
| 5. Parental Consent Form | ☐ Yes ☐ No ☒ Not applicable | |
| 6. Participant Recruitment Material – e.g. copies of posters, newspaper adverts, emails | ☐ Yes ☐ No ☒ Not applicable | |
| 7. Letter from host organisation (granting permission to conduct study on the premises) | ☐ Yes ☐ No ☒ Not applicable | |
| 8. Research instrument, e.g. validated questionnaire, survey, interview schedule | ☐ Yes ☐ No ☒ Not applicable | |
| 9. DBS certificate available (original to be presented separately from this application)* | ☐ Yes ☐ No ☒ Not applicable | |
| 10. Other Research Ethics Committee application (e.g. NHS REC form) | ☐ Yes ☐ No ☒ Not applicable | |
| 11. Certificates of training (required if storing human tissue) | ☐ Yes ☐ No ☒ Not applicable |
I can confirm that all relevant documents are included in order of the list and in one document (any DBS check to be sent separately) named in the following format:
‘Full Name – Faculty – Supervisor’
| Signature of Proposer(s): | Laura Bathe-Taylor; Jacqueline De La Cruz Suarez; Daminiben Patel; Hannah Wiltshire; Ayaman Qazi, Cara Brookes. | Date: 05/02/2020 |
| Signature of Supervisor (for student research projects): | Date: |
Ethics Application Form
| 1. Name of proposer(s) | Laura Bathe-Taylor; Jacqueline De La Cruz Suarez; Daminiben Patel; Hannah Wiltshire; Ayaman Qazi; Cara Brookes. |
| 2. St Mary’s email address | 153026; 190314; 194077; 152062; 193879 @live.stmarys.ac.uk |
| 3. Name of supervisor | Mark Glaister |
| 4. Title of project | The effect of varying thicknesses of adipose tissue on the ability of neuromuscular electrical stimulation to aid recovery from exercise induced muscle damage. |
| 5. Faculty or Service | ☐ EHSS ☒ SHAS ☐ Institute of Theology |
| 6. Programme | ☐ UG ☒ PG (taught) ☐ PG (research) Name of programme: Applied Sport and Exercise Physiology |
| 7. Type of activity | ☐ Staff ☐ UG student ☒ PG student ☐ Visiting ☐ Associate |
| 8. Confidentiality | |
| Will all information remain confidential in line with the Data Protection Act 2018? | ☒ Yes ☐ No |
| 9. Consent | |
| Will written informed consent be obtained from all participants/participants’ representatives? | ☒ Yes ☐ No ☐ Not applicable |
| 10. Pre-approved Protocol | |
| Has the protocol been approved by the Ethics Sub-Committee under a generic application? | ☐ Yes ☒ No ☐ Not applicable Date of approval: |
| 11. Approval from another Ethics Committee | |
| a) Will the research require approval by an ethics committee external to St Mary’s University? | ☒ Yes ☐ No |
| b) Are you working with persons under 18 years of age or vulnerable adults? | ☐ Yes ☒ No |
| 12. Identifiable risks | |
| Is there significant potential for physical or psychological discomfort, harm, stress or burden to participants? | ☒Yes ☐ No |
| Are participants over 65 years of age? | ☐Yes ☒ No |
| Do participants have limited ability to give voluntary consent? This could include cognitively impaired persons, prisoners, persons with a chronic physical or mental condition, or those who live in or are connected to an institutional environment. | ☐Yes ☒ No |
| Are any invasive techniques involved? And/or the collection of body fluids or tissue? | ☐Yes ☒ No |
| Is an extensive degree of exercise or physical exertion involved? | ☒Yes ☐ No |
| Is there manipulation of cognitive or affective human responses which could cause stress or anxiety? | ☐Yes ☒ No |
| Are drugs or other substances (including liquid and food additives) to be administered? | ☐Yes ☒ No |
| Will deception of participants be used in a way which might cause distress, or might reasonably affect their willingness to participate in the research? For example, misleading participants on the purpose of the research, by giving them false information. | ☐Yes ☒ No |
| Will highly personal, intimate or other private and confidential information be sought? For example sexual preferences. | ☐Yes ☒ No |
| Will payment be made to participants? This can include costs for expenses or time. | ☐Yes ☒ No If yes, provide details: |
| Could the relationship between the researcher/ supervisor and the participant be such that a participant might feel pressurised to take part? | ☐Yes ☒ No |
| Are you working under the remit of the Human Tissue Act 2004? | ☐Yes ☒ No |
| Do you have an approved risk assessment form relating to this research? | ☒Yes ☐ No |
| 13. Proposed start and completion date |
| Please indicate: When the study is due to commence. Timetable for data collection. The expected date of completion. Please ensure that your start date is at least four weeks after the submission deadline for the Ethics Sub-Committee meeting. |
| Study is due to commence by the 30th March 2020. Data collection will be collected by the 1st May 2020.The full study completion date is 8th May 2020. |
| 14. Sponsors/collaborators |
| Please give names and details of sponsors or collaborators on the project. This does not include your supervisor(s) or St Mary’s University. Sponsor: An individual or organisation who provides financial resources or some other support for a project. Collaborator: An individual or organisation who works on the project as a recognised contributor by providing advice, data or another form of support. |
| Not applicable. |
| 15. Other Research Ethics Committee Approval |
| Please indicate: Whether additional approval is required or has already been obtained (e.g. an NHS Research Ethics Committee). Whether approval has previously been given for any element of this research by the University Ethics Sub-Committee. Please also note which code of practice / professional body you have consulted for your project. |
| Not applicable. |
| 16. Purpose of the study |
| In lay language, please provide a brief introduction to the background and rationale for your study. |
| Neuromuscular electrical stimulation applied to fatigued skeletal muscle has been found to be somewhat effective in reducing time to recovery, likely due to a decreased perception of pain from a decreased blood lactate concentration and potential increase in creatine kinase (Malone, Blake & Caulfield, 2014). Questions have arisen in interest of the intensity of stimulation, with no current recommended values. Research has suggested that neuromuscular electrical stimulation can be subjective due to a participant’s perception of pain or the amount of adipose tissue at the site of stimulation. Doheny, Cailfield, Minogue and Lowery (2010) suggested that adipose tissue decreases the current of stimulation to the skeletal muscle as it has high electrical resistivity and low blood flow. Therefore, the aim of the current study is to determine the effect of varying thicknesses of adipose tissue on the effectiveness of neuromuscular electrical stimulation (4 Hz) to aid recovery from exercise induced muscle damage. |
| 17. Study design/methodology |
| In lay language, please provide details of: The design of the study (qualitative/quantitative questionnaires etc.) The proposed methods of data collection (what you will do, how you will do this and the nature of tests). The requirement of the participant i.e. the extent of their commitment and the length of time they will be required to attend testing. Details of where the research/testing will take place, including country. Please state whether the materials/procedures you are using are original, or the intellectual property of a third party. If the materials/procedures are original, please describe any pre-testing you have done or will do to ensure that they are effective. |
| This study is a quantitative longitudinal study design. Individuals that are interested in taking part in the study will receive an information sheet. The information sheet will describe the rationale of the study, the criteria of the study, and what they are required to participate in (Appendix 1). During visit 1, participants will arrive at the laboratory and they will have a chance to ask any questions they have relating to the study. Once the participant is comfortable with continuing on with the study, they will complete a physical activity readiness questionnaire and consent form (Appendix 2). Participants will have their height and body mass measured, before having a skinfold measurement taken. The skinfold site will be marked at the mid-point between the greater trochanter and tibial landmark, where the neuromuscular electrical stimulation pads will sit. Adipose tissue will be pinched in between the index finger and the thumb and will be measured by skinfold calipers (Harpenden Skinfold Calliper, Baty International, West Sussex, UK) by the investigator, this will be repeated twice, and the average will be recorded. Participants will then perform 3 counter movement jumps (CMJ) on a jump mat (Jump Mat, FSL Electronics Cookstown, NI). Participants will put their hands on their hips and hold a squatting position before being asked to jump as high as they can, on the verbal command “go”. After a short rest the participant will perform a maximal voluntary isometric contraction (MVIC) which will be measured by a strain gauge (MIE Medical Research Ltd., Leeds, UK) placed 2 cm above the malleoli on the ankle of the dominant leg. MVIC will be measured 3 times for 3s at a knee joint angle of 60°, standardised using a goniometer. Participants will then be asked to squat at 90° and then mark on a visual analogue scale (100mm) how sore the muscle is (0mm= not painful, 100mm= extremely painful) to determine delay onset muscle soreness (DOMS). After the baseline measures are complete, participants will perform a fatiguing protocol consisting of 100 drop jumps (5 sets of 20). Participants will step onto a box 60 cm high before stepping off the box onto the ground and jumping maximally upwards after coming into contact with the floor. The participant will step back onto the box and will have 10s rest to prepare for the next jump. Every 20 repetitions, or 1 set, participants will have a 1 min standing rest. Immediately after the fatiguing protocol participants will re-perform the baseline measures (MVIC, DOMS, CMJ). After measures are taken, a neuromuscular electrical stimulation (NMES) (NeuroTrac Sports Neuromuscular Stimulation, Verity Medical Ltd., Hampshire, UK) intervention will be performed for 20 minutes at 4Hz, while the participant is in a supine position. Self-adhesive gel electrodes will be placed longitudinally over the participant’s distal vastus medialis muscle and the proximal vastus lateralis muscle as suggested by the Surface ElectroMyoGraphy for the non-invasive assessment of muscles (SENIAM) guidelines. When NMES is complete, the stimulation will be stopped, and the electrodes will be removed from the participants skin. Immediately after NMES, 24 hours post-NMES, and 48 hours post-NMES baseline measures will be repeated to establish the participant’s recovery (MVIC, DOMS, CMJ). Participants will be required to attend the laboratory 3 days back to back with 24 hours between sessions. The first session will last a maximum of 90 minutes, and the further 2 sessions will last a maximum of 60 minutes each. In total participants will be required for a maximum of 210 minutes (3.5 hours) over the 3 days of testing. The research will take place in the Human Performance Laboratory at St Mary’s University, Waldegrave Road, Strawberry Hill, Twickenham, United Kingdom, TW1 4SX. The equipment and procedures are property of St Mary’s University, Twickenham. |
| 18. Participants |
| Please mention: The number of participants you are recruiting and why. For example, because of their specific age or sex. How they will be recruited and chosen. The inclusion/exclusion criteria. For internet studies please clarify how you will verify the age of the participants. If the research is taking place in a school or organisation then please include their written agreement for the research to be undertaken. Please state any connection you may have with any organisation you are recruiting from, for example, employment. |
| Based on previous research (Malone et al., 2014), we aim to recruit 15 people for this study. Participants will be recruited from the university by word of mouth. Physically active participants will be of any gender and between the ages of 18 to 55 years old. Participants will be required to avoid strenuous activity 24 hours prior to the fatigue protocol and will be told avoid exercise or any alternative supplementation or pain relief over the 3 sessions. Not applicable. Not applicable. Not applicable. |
| 19. Consent |
| If you have any exclusion criteria, please ensure that your Consent Form and Participant Information Sheet clearly makes participants aware that their data may or may not be used. Are there any incentives/pressures which may make it difficult for participants to refuse to take part? If so, explain and clarify why this needs to be done. Will any of the participants be from any of the following groups? Children under 18 Participants with learning disabilities Participants suffering from dementia Other vulnerable groups. If any of the above apply, state whether the researcher/investigator holds a current DBS certificate (undertaken within the last 3 years). A copy of the DBS must be supplied separately from the application. Provide details on how consent will be obtained. This includes consent from all necessary persons i.e. participants and parents. |
| No No Consent will be obtained from the participant via a physical activity readiness questionnaire and consent form letting the participant know that they are entitled to withdraw from the study at any time without question. |
| 20. Risks and benefits of research/activity |
| Are there any potential risks or adverse effects (e.g. injury, pain, discomfort, distress, changes to lifestyle) associated with this study? If so please provide details, including information on how these will be minimised. Please explain where the risks / effects may arise from (and why), so that it is clear why the risks / effects will be difficult to completely eliminate or minimise. Does the study involve any invasive procedures? If so, please confirm that the researchers or collaborators have appropriate training and are competent to deliver these procedures. Please note that invasive procedures also include the use of deceptive procedures in order to obtain information. Will individual/group interviews/questionnaires include anything that may be sensitive or upsetting? If so, please clarify why this information is necessary (and if applicable, any prior use of the questionnaire/interview). Please describe how you would deal with any adverse reactions participants might experience. Discuss any adverse reaction that might occur and the actions that will be taken in response by you, your supervisor or some third party (explain why a third party is being used for this purpose). Are there any benefits to the participant or for the organisation taking part in the research? |
| Yes, the fatiguing protocol and MVIC may cause muscular discomfort of the quadriceps, which should reside within 72 hours. The investigators will minimize the risk of injury by ensuring that the participants are using the correct technique and ensuring that the equipment is safe. The participant will communicate any severe discomfort. Investigators will ensure that participants are fit, healthy and free from injury prior to starting the study. Risks may arise from poor landing technique, slips, trips, and falls. Risks will be minimalized by ensuring the environment is free of any potential hazards. An investigator will demonstrate the correct technique prior to the participant taking part (Appendix 3). Not applicable. Not applicable. Not applicable. Participants will benefit from the study by finding out whether NMES is an effective recovery strategy for them after exercise induced muscle damage. |
| 21. Confidentiality, privacy and data protection |
| Outline what steps will be taken to ensure participants’ confidentiality. Describe how data, particularly personal information, will be stored (please state that all electronic data will be stored on St Mary’s University servers). If there is a possibility of publication, please state that you will keep the data for a period of 10 years. Consider how you will identify participants who request their data be withdrawn, such that you can still maintain the confidentiality of theirs and others’ data. Describe how you will manage data using a data a management plan. You should show how you plan to store the data securely and select the data that will be made publically available once the project has ended. You should also show how you will take account of the relevant legislation including that relating to data protection, freedom of information and intellectual property. Identify all persons who will have access to the data (normally yourself and your supervisor). Will the data results include information which may identify people or places? Explain what information will be identifiable. Whether the persons or places (e.g. organisations) are aware of this. Consent forms should state what information will be identifiable and any likely outputs which will use the information e.g. dissertations, theses and any future publications/presentations. |
| Data will be stored on a password protected server at St Mary’s University, Twickenham. All names will be excluded to prevent identification, and participants will be given an identification code. In case of publication data will be stored for a maximum of 10 years; however, subjects that wish to withdraw from the study will have their data excluded. The following people will have access to the data: Laura Bathe-Taylor, Hannah Wiltshire, Ayaman Qazi, Damini Patel, Cara Brookes, Jacquelin De La Cruz, and Mark Glaister. |
| 22. Feedback to participants |
| Please give details of how feedback will be given to participants: |
| Feedback will be offered to the participants once the study is complete. The feedback will be in an appropriate summary form and would not include any individualised data or breach any confidentiality policies. Study results will be written into a journal article format and will be shared with and module conveyor Mark Glaister. |
The proposer recognises their responsibility in carrying out the project in accordance with the University’s Ethical Guidelines and will ensure that any person(s) assisting in the research/ teaching are also bound by these. The Ethics Sub-Committee must be notified of, and approve, any deviation from the information provided on this form.
| Signature of Proposer(s): | Laura Bathe-Taylor, Hannah Wiltshire, Ayaman Qazi, Damini Patel, Cara Brookes, Jacquelin De La Cruz. | Date: | 05/02/2020 |
| Signature of Supervisor (for student research projects): | Date: |
Approval Sheet
| Name of proposer(s) | Ayaman Qazi, Hannah Wiltshire, Jacquelin De La Cruz, Damini Patel, Laura Bathe-Taylor, Cara Brookes. |
| Name of supervisor | Mark Glaister |
| Programme of study | MSc Applied Sport and Exercise Physiology |
| Title of project | The effect of varying thicknesses of adipose tissue on the ability of neuromuscular electrical stimulation to aid recovery from exercise induced muscle damage. |
Supervisors, please complete section 1. If approved at level 1, please forward a copy of this Approval Sheet to the Faculty Ethics Representative for their records.
| SECTION 1: To be completed by supervisor. | |||
Approved at Level 1. Refer to Faculty Ethics Representative for consideration at Level 2 or Level 3. | |||
| Signature of Supervisor (for student research projects): | Date: |
| SECTION 2: To be completed by Faculty Ethics Representative. | |||
Approved at Level 2. Level 3 consideration is required by Ethics Sub-Committee. | |||
| Signature of Faculty Ethics Representative: | Date: |
Appendix 1
The effect of varying thicknesses of adipose tissue on the ability of neuromuscular electrical stimulation to aid recovery from exercise induced muscle damage.
You are being invited to take part in a research study. Before you decide to take part, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Thank you for your interest in participating in this study.
What is the purpose and aim of our research?
Neuromuscular electrical stimulation (NMES) is an alternative recovery strategy that involves the application of surface electrodes to the quadriceps muscle to enhance blood flow and reduce pain. Research suggests that adipose tissue decreases the current of stimulation to the underlying skeletal muscle as it has high electrical resistivity and low blood flow. The purpose of this research is to determine the effect of varying thicknesses of adipose tissue on the ability of NMES (4 Hz) to aid recovery from exercise induced muscle damage.
Why you have been invited and what will happen if you agree to take part?
You have been chosen because you are non-injured, a non-smoker and between the age of 18-55. It is up to you to decide whether or not to take part. If you decide to take part, you will be given this information sheet to keep and you will be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time without giving a reason, and without any penalty.
You will be required to attend the Biomechanics Laboratory at St. Mary’s University on three occasions. In session 1 you will be required at the laboratory for a maximum of 90 minutes. You will be required to attend the laboratory 24 hours and 48 hours after session 1 for a maximum of 60 minutes each.
At the 1st session you will have your height and weight recorded followed by a skin fold measurement. For the skinfold measurement we will have to have access to your mid-quadriceps where we will measure the mid-point between your hip and knee. We will then pinch a small section of the skin and underlying fat tissue and use some calipers to measure the thickness of the underlying fat. You will then perform 3 counter movement jumps where you will be asked to put your hands on your hips and bend your knees before jumping as high as you can. You will then perform 3 maximal voluntary isometric contraction (MVIC) where a gauge will be placed on your leg and you will be required to produce a maximal force against resistance. You will then be required to mark your rate of muscle pain on a 0mm (no pain) to 100mm (extreme pain) scale.
You will then perform a fatiguing protocol which consist of 5 sets of 20 drop jumps. You will step onto a box 60 cm high before stepping off the box onto the ground and jumping maximally upwards after coming into contact with the floor. You will step back onto the box and will have 10s rest to prepare for the next jump. Every 20 repetitions, or 1 set, you will have a 1 min standing rest.
Immediately after the drop jumps you will repeat the counter movement jumps, maximal voluntary isometric contractions, and mark on the scale of pain. You will lay on your back while an investigator will place electrode pads on your quadriceps muscle and the muscle will be stimulated at 4Hz for 20 minutes. Immediately after, 24 hours after, and 48 hours after the NMES you will repeat the counter movement jumps, maximal voluntary isometric contractions, and mark on the scale of pain.
Are there any benefits from taking part?
You will find out if NMES helps you to recover from exercise induced muscle damage effectively.
Are there any risks or side effects?
The safety concerns of NMES application have been reviewed in depth (Sachetti, et al., 2018). Two of the primary researchers are trained physiotherapists with experience in handling NMES modalities. The further four primary researchers have undergraduate science degrees.
Agreement to participate in this research should not compromise your legal rights if something goes wrong. Research can carry unforeseen risks and we want you to be informed of your rights in the unlikely event that any harm should occur as a result of taking part in this study. Every care will be taken to ensure that your well-being and safety are not compromised during the course of the study. St Mary’s University also has insurance arrangements in place in the unlikely event that something does go wrong, and you are harmed as a result of taking part in the research study.
Are there any special precautions you must take before, during or after taking part in the study?
You must wear shorts for the skinfold measurement and NMES application. You will be asked to refrain from strenuous exercise for 24 hours prior to the experimental testing session. You will be asked to avoid any supplementation, pain relief medication or exercise between sessions. You will also be asked to refrain from caffeine for 2 hours prior to the experimental testing session.
What will happen to any information/data/samples that are collected from you?
Your identity will not be revealed. All information which is collected about you during the course of the research will be kept strictly confidential. We will keep a record that you have taken part in the study but will not keep any other personal information about you. Professional standards of confidentiality will be adhered, and the handling, processing, storage and destruction of data will be conducted in accordance with the Data Protection Act (1998).
What will happen to the results of the study?
The results of the research will be available within 30 days of all data being collected. You will receive your own individual results if you request so. Your data will be reported in a scientific paper, but it will not be possible to identify you from these reports. If you would like to be sent a copy of the work when it is completed, we can arrange this. Data from this study will be kept on the St Mary’s University servers for a maximum of 10 years.
Contacts for further information:
Primary researchers:
Ayaman Qazi – 193879@live.stmarys.ac.uk
Cara Brookes – 197900@live.stmarys.ac.uk
Damini Patel – 194077@live.stmarys.ac.uk
Hannah Wiltshire – 152062@live.stmarys.ac.uk
Jacqueline De La Cruz – 190314@live.stmarys.ac.uk
Laura Bathe-Taylor – 153026@live.stmarys.ac.uk
Project supervisor:
Mark Glaister – Mark.Glaister@stmarys.ac.uk
YOU WILL BE GIVEN A COPY OF THIS FORM TO KEEP TOGETHER WITH A COPY OF YOUR CONSENT FORM.
Appendix 2
Practical activity consent form
Name of participant: ……………………………………………………………………………..
Title of the practical activity: The effect of varying thicknesses of adipose tissue on the ability of neuromuscular electrical stimulation to aid recovery from exercise induced muscle damage.
Main coordinator and contact details:
Ayaman Qazi – 193879@live.stmarys.ac.uk
Cara Brookes – 197900@live.stmarys.ac.uk
Damini Patel – 194077@live.stmarys.ac.uk
Hannah Wiltshire – 152062@live.stmarys.ac.uk
Jacqueline De La Cruz – 190314@live.stmarys.ac.uk
Laura Bathe-Taylor – 153026@live.stmarys.ac.uk
Participants of the practical activity:
- I agree to take part in the above practical activity.
- I have had the practical activity explained to me and understand what my role will be. All of my questions have been answered to my satisfaction.
- I understand that I am free to withdraw from the practical activity at any time, for any reason and without prejudice.
- I have been informed that the confidentiality of the information I provide will be safeguarded.
- I am free to ask any questions at any time before and during the practical activity.
- I am aware that I can obtain a copy of this form, and the relevant Confidential Medical History and/or Physical Activity Readiness Questionnaire (PAR-Q) Form.
Data Protection: I agree to the University College processing personal data which I have supplied. I agree to the processing of such data for any purposes connected with the teaching activity as outlined to me.
Name of participant (print)………………………….Signed………………..….Date………………
Name of witness (print)……………………………..Signed………………..….Date………………
If you wish to withdraw from the practical activity, please advise the practical activity coordinator, and complete the form below.
Title of Project: The effect of varying thicknesses of adipose tissue on the ability of neuromuscular electrical stimulation to aid recovery from exercise induced muscle damage.
I WISH TO WITHDRAW FROM THIS PRACTICAL ACTIVITY
Name: ………………………………………
Signed: ……………………………………………Date: …………………………………
SCHOOL OF Sport, health and applied science
CONFIDENTIAL Medical History / Physical Activity Readiness Questionnaire (PAR-Q) FORM
This screening form must be used in conjunction with an agreed Consent Form.
Full Name: Date of Birth:
Height (cm): Weight (kg):
Have you ever suffered from any of the following medical conditions? If yes please give details:
Yes No Details
Heart Disease or attack o o ______________________________________
High or low blood pressure o o ______________________________________
Stroke o o ______________________________________
Cancer o o ______________________________________
Diabetes o o ______________________________________
Asthma o o ______________________________________
High cholesterol o o ______________________________________
Epilepsy o o ______________________________________
Allergies o o ______________________________________
Other, please give details o o ______________________________________
Do you suffer from any blood borne diseases? If yes please give details;
Please give details of any medication you are currently taking or have taken regularly within the last year:
Please give details of any musculoskeletal injuries you have had in the past 6 months which have affected your capacity to exercise or caused you to take time off work or seek medical advice:
Other Important Information
During a typical week approximately how many hours would you spend exercising?
If you smoke please indicate how many per day:
If you drink alcohol please indicate how many units per week:
Are you currently taking any supplements or medication? Please give details:
Is there any reason not prompted above that would prevent you from participating within the relevant activity?
By signing this document I agree to inform the relevant individual(s) of any change(s) to my circumstances that would prevent me from participating in specific activities.
Signature (Participant): Date:
Signature (Test Coordinator*): Date:
*Test coordinator: The individual responsible for administering the test(s)/session and subsequent data collection
| Appendix 3 Risk Assessment Section 1 – Activity and Coordinator details: | |||
| Activity coordinator name: | Laura Bathe-Taylor; Jacqueline De La Cruz Suarez; Daminiben Patel; Hannah Wiltshire; Ayaman Qazi; Cara Brookes. | Tutor / supervisor: | Mark Glaister |
| Phone number: | 07840170267 | Email address: | 153026@live.stmarys.ac.uk |
| Activity title: | The effect of varying thicknesses of adipose tissue on the ability of neuromuscular electrical stimulation to aid recovery from exercise induced muscle damage. | ||
| Activity location(s) full details: | St Mary’s University, Twickenham, London | ||
| Outline of activity (please specify the type of activity being undertaken): | No | Yes | If yes, please provide details: |
| Use of Human Subjects: demographic type, requirements, age/young persons? | X | 15 healthy trained males and females between 18 to 55 years old, which are non-smokers. | |
| Use of an intervention (either solely or in combination) including dosage or application: E.g. ingestion of food, liquids or supplement, diet, massage, occlusion, environmental exposure, physical activity or other. Outline of specific dosage or application where relevant E.g. mg per kilo of body weight | x | Neuromuscular electrical stimulation will be used for 20 minutes at 4Hz to stimulate the quadriceps in the dominant leg. | |
| Use of data and/or sample collection (solely or in combination): E.g. questionnaire/survey, human tissue sampling (blood / urine / saliva / sweat or other), respiratory analysis, body composition, performance tests or other. | x | Combination of quadriceps skinfolds, performance test (drop jumps 5 sets of 20 repetitions), muscle damage protocol (counter movement jump, maximal isometric voluntary contraction). | |
| Use of chemicals/gas cylinders: Type(s), hazardous or not, MSDS available? | x | ||
| Equipment to be used: | |||
| Skinfold callipers (Harpenden Skinfold Calliper, Baty International, West Sussex, UK), Neuromuscular electrical stimulation machine (NeuroTrac Sports Neuromuscular Stimulation, Verity Medical Ltd., Hampshire, UK), jump mat (FSL Electronics Cookstown, NI), strain gauge (MIE Medical Research Ltd., Leeds, UK), visual analogue scale (100mm). |
SECTION 2: Risk Controls – For each hazard identified in Section 1, complete Section 2. Please refer to the Risk Assessment Guidance notes on simmsCAPital folder for Risk Matrix. Please note that L refers to Likelihood; S refers to Severity and RS refers to Risk Score (L times S equals RS)
| Outcome due to Hazard description (Substance / equipment / procedure) | Initial Risk Level High(13-25) Med (5-12) Low (0-4) | Necessary controls to eliminate or adequately reduce the Initial Risk Level of an associated hazard to a suitable Remaining risk level. | Remaining Risk Level High(13-25) Med (5-12) Low (0-4) | ||
| 1 | Access and usage of designated facility, site or location, including private or public. | High | Written approval to access and make use of the designated facility, site or location must be sought from the relevant owner, keeper or manager, where appropriate. Terms & conditions, qualifications, notification, booking requests, reporting, statements of intent or other formal agreement must be confirmed in advance of access and use. A separate assessment of local hazards should be undertaken to ensure safe working practice. Gauge which person(s) will be responsible for dealing with any potential emergency incident, including use of First Aiders, Security or other individual. | Low | |
| 2 | Fire management and evacuation | High | Ensure appropriate responsibilities of relevant individuals or parties are established ensuring fire prevention, evacuation and individual roles are established prior to activity commencing. Please refer to University policy. | Low | |
| 3 | Environmental exposure (internal and external) including temperature, humidity, lighting ventilation or relative weather conditions | High | Ensure suitable local working conditions including regulating temperature, lighting, and humidity where possible. Prepare relevant individuals to manage uncontrollable/unavoidable conditions including instruction on use of personal protective equipment, clothing, shelter, rehydration, rest periods/breaks or other relevant means to maintain suitable comfort and function. Brief individuals on managing experience of deliberate exposure to stressful conditions, including adequate avoidance of visual/physical exposure to sources of high level lighting and associated heat. Ensure low lighting allows participant to still work safely including avoiding injury or subsequent strain/pathology. | Low | |
| 4 | Risks relating to layout , storage, space, obstructions including fall of objects, spillages, slips, trips & falls | High | Ensure all equipment layouts maintain a safe working environment. Ensure measures are in place to manage trip hazards including suitable form(s) of cable covers, excess cabling, objects or equipment do not affect walkway routes. Highlight visually and by instruction unavoidable trip hazards. Manage liquids to avoid spillages. Establish equipment available to manage spillages and who is responsible to address an incident. Ensure the avoidance of any falling object, or safe management processes for any item likely to or intended fall. | Low | |
| 5 | Manual handling, repetitive movements and working at heights | High | Ensure users have received adequate training, adhering to the HSE and University manual handling guideline found on the staff H&S portal page. Identify and avoid or adequately reduce repetitive movements that may cause harm. Any individual working with ladders must receive appropriate training and qualification. | Low | |
| 6 | Use of Equipment including electrical | High | Ensure users have received adequate competency training as specified on Section E) of the Student Research Approval Form to use the equipment. Check electrical items are Pat tested annually, no faults are present. No fluids near the equipment. Check wires for damage during setup and prior to use. Switch off equipment when not in use or in the event of an incident. | Low | |
| 7 | Mechanical (machinery) and use of portable tools / equipment | High | Staff and students may only use equipment that is permitted and training has been provided for. | Low |
SECTION 2: Risk Controls (continued) – For each hazard identified in Section 1, complete Section 2. Please refer to the Risk Assessment Guidance notes on simmsCAPital folder for Risk Matrix.
Please note that L refers to Likelihood; S refers to Severity and RS refers to Risk Score (L times S equals RS)
| Hazard No. | Outcome due to Hazard description (Substance / equipment / procedure) | Initial Risk Level High (13-25) Med (5-12) Low (0-4) | Controls needed to eliminate or adequately reduce risks | Remaining Risk Level High(13-25) Med (5-12) Low (0-4) |
| 8 | Exposure to sharps – use of razors, lancets or other sharp object | High | Ensure users wear separate PPE per human subject. Ensure different (disposable only) razor, lancet or other invasive equipment used per human subject. Do not reuse disposable item more than once. Discard in suitable biohazard sharps container. | Low |
| 9 | Human subject physical activity, manipulation, treatment or other including use of equipment where relevant. | High | Prior to commencing any activity, ensure the practical activity coordinator(s) has completed all necessary competency training as specified on Section E) of the Student Research Approval Form. Adhere to the University Ethics procedures ensuring all human subjects have received a relevant information sheet, completed an Informed consent form and (Physical Activity Readiness Questionnaire (PARQ)/Medical History Form under the relevant Health and Safety procedures. Note any young person must have Consent and Screening completed by a parent or legal guardian/carer. Ensure documents are countersigned and dated at the same time (witness process) by the relevant research coordinator. Ensure documents are retained during the testing period, and then returned to the University for data protected archiving when testing has been completed This may vary where members of the public are approached on an ‘at the time’ basis under typical survey work. All ingestion interventions must address maximum safe dosage fit for the relevant human participant (s). | Low |
| 10 | Exposure and reaction to use of food, drinks or supplements | High | Low | |
| 11 | Biological hazards | High | Ensure Practical Activity Coordinators (PACs) students have received Human Tissue sampling training and the relevant competency forms signed off by the trainer, considering all aspects of the School’s use of Human Tissue (HT) Guideline (available in MyModule student information folder) for the management of biological hazards. | Low |
| 12 | Working at heights | High | Students and Human subjects not to work at heights. Only suitably qualified staff may assist. | Low |
| 13 | Lone working, including out of hours | High | Students not to undertake unsupervised out of hours activity within University facilities. Field testing locations should be assessed for safe exposure and co-worker or check in systems should be adopted where deemed appropriate. Ensure University Security is notified of any supervised work taking place outside of normal weekday hours (Monday-Friday 9am-5pm) | Low |
| 14 | Use of chemicals | High | Ensure suppliers are appropriately registered and provide adequate Material Safety Data Sheet (MSDS). Refer and adhere to all instructed practice as detailed by the relevant MSDS for all chemicals used. See HSE CLP and REACH regulations. | Low |
| 15 | Other (Please specify and attach a copy of the relevant methodology with associated safety notes): | High | Please specify: | Low |
SECTION 3: Arrangement for supervision and/or monitoring effectiveness of control
Monitoring achieved through pre and post checks, continual test supervision and/or a separately recruited individual where further supervision or monitoring is required. Even where students demonstrate high levels of competency, regular checks should be made by supervising staff that should also be readily available to assist with any questions or problems students might have. Any practice should be amended or stopped if an emerging hazard dictates such a response. This option should be adopted where any uncertainty occurs, seeking advice from suitable staff.
SECTION 4: Referral guidelines relevant to the intended activity (scanned PDF of hard copy, listed web link or other source):
Please ensure that all relevant reliable sources of information can be easily referred to at any time both during the preparation phase and period of activity. Please note some of the relevant University links will include:
| Information source | Location | Areas of information |
| Student Information Folder | MyModules | Student Research Approval Form Laboratory specific guidelines and consumable costs School of SHAS Use of Human Tissue Guideline (new) |
| University Ethics Committee | Student portal | Ethics Application process and associated forms Example Human Subject Consent Form |
| University Health and Safety portal | Student portal | Health and Safety Policy guidelines including Risk Management, Loan working, Manual lifting, Display Screen Equipment and COSHH |
| The Health and Safety Executive | Website found through any web search engine | Well-presented sources of legally approved regulation and legislation covering COSSH, CLP, RIDDOR, DSE and many other areas of health and safety at work |
| Further discipline specific sources of information may be relevant to the area of activity including accreditation bodies such as BASES, BASRAT, SENR, AfN, BPS, UKSCA, REPS, HTA, ITEC etc |
SECTION 5: Emergency response procedures
In the event of an emerging incident, engage the individual(s) who have been previously agreed as responsible for addressing an emergency incident. Assess and eliminate (where safe) hazards that might place the individual(s) needing care or carer(s) at risk. Apply up to date first aid and/or seek medical assistance where appropriate. Contact the University security team for assistance with any incident on or off campus. Contact relevant staff (tutor, Technical team or other) where relevant. Complete relevant reporting form (accident, medical emergency or near miss) available to staff on the University H&S portal page, passing to the Technical Services team for processing. Complete HSE RIDDOR form where relevant, which can be found on the HSE website.
Important contact details (including where activities are undertaken off campus):
- St Mary’s University Security – 0208 240 4335 or 4060 (advise in the event of calling the emergency services)
- St Marys University main reception – 0208 240 4000
- Health and Safety Executive (HSE) Information line – 0845 345 0055 / www.HSE.gov.uk
Please make note of any other relevant contacts here:
SECTION 7: Period of cover – If a more complex assessment is required, continue below:
| PERIOD OF COVER FOR TASK/EVENT | PRINT NAME OF TASK/EVENT LEADER(S) | SIGNATURE | DATE SIGNED | HAZARDS IDENTIFIED (mark with a tick or a cross) | |
| FROM | TO | ||||
SECTION 8: Student liability declaration:
By signing this risk assessment I confirm that I have read and understood the above information that is relevant to my activity, and will ensure adherence to appropriate practice at all times, based on completing formal competency training relevant to the activity I am planning to undertake. I understand that the above statements are intended to be generalised, being applicable to all forms of activity. Not all parts may apply to a specific activity, but it is my responsibility to outline any possible/further detail of necessary hazard management procedures as safety notes within the relevant activity methodology, as statements of intent within the associated Ethics Application Form and as associated Human Subject Consent Form and Information sheet.
| SIGNATURE: | PRINT NAME: | Laura Bathe-Taylor; Jacqueline De La Cruz Suarez; Daminiben Patel; Hannah Wiltshire; Ayaman Qazi; Cara Brookes. | DATE COMPLETED: | 05/02/2020 |
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