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V1 Informed Consent Form EC2

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Department of Sport, Health & Exercise Science

Participant Letter of Invitation


Project title An investigation into the physiological, biochemical and psychological effects of delayed onset muscle soreness/muscle damage and how this effects maximal incremental exercise performance Name: Dr Adrian Midgley Email address: A.W.Midgley@hull.ac.uk Contact telephone number: 01482 463270 Student investigator (if applicable) Name: Miss Bryna Chrismas Email address: b.chrismas@hull.ac.uk Contact telephone number: 01482 464236

Principal investigator

Click here to enter a date. Dear Sir or Madam This is a letter of invitation to enquire if you would like to take part in a research project at The University of Hull. Before you decide if you would like to take part it is important for you to understand why the project is being done and what it will involve. Please take time to carefully read the Participant Information Sheet on the following pages and discuss it with others if you wish. Ask me if there is anything that is not clear, or if you would like more information. If you would like to take part please complete and return the Informed Consent Declaration form. Please do not hesitate to contact me if you have any questions. Yours faithfully, 1|Page

V1 Informed Consent Form EC2


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Bryna Chrismas

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V1 Informed Consent Form EC2


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Department of Sport, Health & Exercise Science

Participant Information Sheet


1. Project title An investigation into the physiological, biochemical and psychological effects of delayed onset muscle soreness/muscle damage and how this effects maximal incremental exercise performance Name: Dr Adrian Midgley Email address: A.W.Midgley@hull.ac.uk investigator 3. Student investigator (if applicable) Contact telephone number: 01482 463270 Name: Miss Bryna Chrismas Email address: b.chrismas@hull.ac.uk Contact telephone number: 01482 464236

2. Principal

4. What is the purpose of this project? Scientists have investigated what effect performing strenuous exercise has on subsequent exercise performance for over a century. However, we still do not know what happens inside the body after very strenuous exercise and different people react in different ways. The aim of this research is to investigate how people react to strenuous exercise.

5. Why have I been chosen? You have been asked to volunteer as you may fit the study criteria. This project 3|Page

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needs males or females aged between 18 50 years who are apparently healthy, without any illness or injury and are currently physically active (more than 30 min moderate exercise at least 3 times per week). Participants must not be fell runners or anyone who does negative weights, anyone who smokes or regularly takes anti-inflammatory (e.g. paracetamol) drugs, anyone with a pacemaker or a metal plate in the lower body.

6. What happens if I volunteer to take part in this project? First, it is up to you to decide whether or not to take part. If you decide to take part you will be given this Participant Information Sheet to keep and asked to complete the Informed Consent Declaration at the back. You should give the Informed Consent Declaration to the investigator at the earliest opportunity. You will also have the opportunity to ask any questions you may have about the project. If you decide to take part you are still free to withdraw at any time and without needing to give a reason.

7. What will I have to do?

You will complete a pre-exercise medical questionnaire and the details of all the tests will be fully explained to you prior to doing any testing. The medical questionnaire will highlight any pre-existing medical conditions that could put you at increased risk if you performed any of the testing. Secondly, if everything is ok with your medical questionnaire form and you are happy to participate, you will be randomly put in either a Experimental group or a Control group. Everyone will be asked to visit the laboratories at the University Of Hull, Department of Sport, Health and Exercise Science on 6 separate occasions. The only difference between the groups, is that during the 4th visit the Experimental group will complete a downhill run, whereas the control group wont do any exercise. There will be a minimum of 2 days and a maximum of 5 days between visits 1,2 and 3 and then there must be exactly 24 h between visits 4 ,5 and 6. It is very important for the results of the study that these times are strictly adhered to. You will be asked to refrain from participating in any strenuous, unaccustomed exercise for the duration of the study. You may participate in light training or training you are usually accustomed to. Between visits 4 and 6 you are asked to refrain from participating in any form of exercise. You are also asked to refrain from stretching, using a cold compress (e.g. an ice pack) or heat treatment (hot water bottle, bath, deep heat), you cannot have a massage, wear any compression garments (e.g. skins, baselayers, compression socks) or take any anti-inflammatory drugs (e.g paracetamol, ibuprofen, aspirin). 24 h before each visit you must refrain from drinking alcohol, 4 h before each visit you should refrain from eating a large high fat meal. You are asked to drink at least 500 ml water 2 h prior to each visit. It is
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V1 Informed Consent Form EC2


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very important you drink plenty of water / fluids during all testing so please bring a water bottle with you each time you visit. It is also very important that you closely stick to these pre-test guidelines, otherwise the results of the project may not be valid. Each visit will take 60 - 120 min, during which time you will complete a variety of tests (described below). Some of these tests require maximum effort and are very physically demanding, especially when performed on the same day. You will need to be prepared to push yourself and give a maximum effort. There is also a risk of muscle injury and in extreme cases a heart attack. However, the likelihood of this happening is very small and is greatly reduced with all the safety measures that will be put in place. You will be given a steady warm up prior to any test and all safety procedures will be strictly followed. The investigator conducting the testing is fully first aid trained and will be there at all times. When you come in for each visit you will need to be wearing trainers suitable for running, shorts (short enough so that the upper thigh can be accessed) and a t-shirt. Please wear the same clothes and trainers each time you come in. The first time you visit your height and weight will be measured. Blood pressure will be measured each time you come in and involves a cuff being placed on your upper arm and inflated using an automated machine. It may feel quite tight and uncomfortable as it inflates but it will automatically deflate. There is a very small chance you can faint from having your blood pressure taken but this is very rare. You will then be asked to perform the following tests (in the same order detailed below) during visits 1, 2, 3, 5 and 6 (Please also see the attached diagram which shows you each test you are required to complete during each visit). 1) Your skin temperature will be measured. You will be asked to lie down on a padded bed and an electrode will be placed on your thigh which has a thermometer on it. 2) Blood will be collected from your finger and from a vein in your arm. To take blood from your finger it will first be cleaned with a sterile wipe. A small needle will then be used to puncture the skin (this may hurt a little bit), and blood will be gently squeezed and collected into a little tube. Blood will then be collected from a vein in your arm (in line with your elbow) using a needle. Again the area will be cleaned and then a needle will be inserted into your vein. This may also hurt a bit and feel a little bit uncomfortable. With any blood sampling there is a risk of infection, bruising and you may feel faint. Blood will be taken while you are lying down so if you do feel dizzy at any point the investigator will put your legs up. The investigator will wear protective clothing (e.g. gloves) to reduce the risk of spreading infection. The investigator is also full trained in taking blood and will follow the correct procedures at all times. 3) Following the blood collection once you feel OK you will be asked to stand up to have the circumference of both of your thighs measured. The investigator will make a small dot with a pen (used to mark the skin for surgery) on your thigh to mark the area for tape measure placement. 4) You will then lay back down and the investigator will measure the range of motion in your knee. Firstly you will lay face down on the bench and you will be asked to fully extend your knee (bring your heel towards your bum). You will then lay on your back and will be asked
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to extend your knee by keeping the back of your knee on the bed while raising your heel off the bed. The investigator will demonstrate these actions for you. A goniometer (metal ruler used to measure angles) will be used to measure the angle of your knee and the investigator will need to make 3 dots on your leg to know where to place the goniometer. 5) Next your pressure pain threshold will be measured using a small hand held force measurer. Your pressure pain threshold will be measured at three places on your upper leg and calf. These places will be marked using a pen. The investigator will then say the following I am going to measure your pressure pain threshold on a number of different muscles using a force device. I will apply pressure to each site marked and slowly increase this pressure. As soon as the pressure changes from slightly discomforting to pain I want you to say Now. Pain would be the point at which you feel it hurting and think ouch, I dont like that. It is very important that you understand this is a test of sensitivity and not of endurance, therefore, you must say now as soon as the sensation changes from discomfort to pain. The investigator will then place the flat head of the force measurer on your muscle and will increase the pressure until you say Now. 6) Your perceived muscle soreness will be measured next using a visual analogue scale (VAS). A VAS is a continuous horizontal line which ranges from no pain to worst pain imaginable . This will be measured when you are running on the treadmill. You will be asked to perform a 5 min warm-up on a treadmill at a speed 0.5 km.h-1 above your walk-run transition speed. Your walk- run transition speed is the speed at which you go from a walk to a run. In order to measure this you will start walking on the treadmill and it will slowly increase in speed. You will be instructed to start jogging when it feels most natural to do so. You will be asked to rate the amount of soreness felt while running by drawing a line along the horizontal VAS. 7) Your vertical jump ability will be measured by doing two different types of jump. You will be asked to perform 3 repetitions of each the jumps. You will first perform 3 squat jumps. You will start in a squat position (knees bent, back straight), with your hands on your hips and knees bent to 90 degrees. Keeping your hands on your hips you will jump up into the air as high as you can keeping your legs straight while in the air. You will then perform the 3 countermovement jumps. You will begin standing fully erect, and following a verbal command (e.g. Go), you will bend your knees and jump into the air as high as you can. You must keep your legs straight whilst airborne and your hands on your hips during the jump. You will be given 1 min rest in between each jump. 8) Next, you will perform 3 maximum 10 m sprints. You will start standing, and in your own time you will sprint along the 10 m marked track as fast as you can. You will be given a 1 min rest in between each sprint. 9) You will then be asked to sit in a special chair in order to measure the maximum force the muscles that extend your knee can produce. You will be sat upright and will be fastened in (a bit like a rollercoaster seat). Your right leg will be tested first and then your left. You will be asked to perform 3 repetitions on each leg and will get a 3 min rest in between each of the reps. You will be asked to push your leg out as hard as you can against the machine (the machine will not move) for approximately 5 seconds. While you are pushing out a small
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electrical current will be passed into your thigh muscle which may feel a bit uncomfortable. You will then be told to relax and a second electrical current will be passed into your thigh muscle. This may jolt your leg and may feel uncomfortable. The electrical current feels a bit like getting a static shock. There is a risk associated with electrical stimulation and in extreme circumstances it can cause electrocution or a heart attack. If you have a pace maker or any metal plates in your body you would not be able to complete the electrical stimulation. This procedure is only carried out by a trained professional who knows where to safely place the electrodes. Any metal objects, jewellery or mobile phones must be removed prior to electrical stimulation. 10) Before the maximal oxygen uptake test you will be asked to rate you perceived readiness on two separate VAS consisting of a continuous horizontal line ranging from 0 (completely disagree) to 100 (completely agree) how much you agree with the following statements: 1) I feel totally mentally ready to provide a maximum effort during the treadmill running test I am about to undertake, 2) I feel totally physically ready to provide a maximum effort during the treadmill running test I am about to undertake. 11) Your maximum oxygen uptake (VO2max) will then be measured. You will be asked to run on a treadmill whilst wearing a face mask (which covers your nose and mouth) and a harness, for as long as you can. You will start off at a comfortable speed at 1% gradient and the speed will increase by 0.1 km.h every 6 seconds until you stop the test. You can still breathe normally with the face mask on and the harness is attached to you for safety. You will wear a heart rate monitor so that your heart rate can be monitored continuously. During this test you will be asked to rate your preception of overall effort, leg pain and breathlessness using 3 seperate scales. At the end of each minute the investigator will hold up each of these 3 scales and ask you to rate your feelings using a number provided on the scale. These scales will be fully explained to you prior to you starting the test. At the end of the test, you will have another fingerprick blood sample which will be taken in the same way as described above. This is a maximum exercise test and you are asked to run until you are exhausted. This may feel uncomfortable and you could feel dizzy/sick. In extreme cases this test could cause a heart attack or a muscle injury. However, this is very rare and you will perform a gradual warm up to reduce this risk. You could also trip/fall off the treadmill so you need to wear good trainers and make sure your laces are tied tightly. A crash mat will be placed at the end of the treadmill for your safety. If you feel sick, get chest pain or need to stop the test for any other reason there is an emergency stop button and the investigator will be there at all times. 12) Downhill run ( Experimental group only) will be performed on the 4th visit. You will be asked to run on the treadmill for 30 min at a decline of 12%. The speed you will run at will be 70% of the maximum speed you got to during the maximum oxygen uptake test. You will wear a safety harness to reduce the risk of tripping/falling and a crash mat will be placed at the end of the treadmill. There will be an emergency stop button if you need to use it and the investigator will closely monitor you at all times.

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8. Will I receive any financial reward or travel expenses for taking part?

Yes you will receive 36 . This wil be paid to you after you complete the six visits. If for any reason you cannot complete the testing, unfortunately you will not receive payment. However, it is very important that you do not put yourself in danger just to complete the testing.

9. Are there any other benefits of taking part? Yes, you will receive a report of your maximum oxygen consumption test (VO2max). This will tell you lots of interesting information such as your maximum heart rate, the maximum speed you got to on the treadmill. You will also receive a report of your body fat percentage, height, weight and resting blood pressure. These results can be used to help you with your training. In the report you will be given your value and also information will be provided on how your value compared to other individuals and athletes of a similar age so you can see if you are doing well. You can use this information to set targets for your training.

10.Will participation involve any physical discomfort or harm? Yes, the nature of the project requires you to perform several physically demanding tests during 6 visits. These tests are strenuous and require maximal effort. You could suffer some pain and discomfort during the jumping, 10 m sprint, knee extension test, maximum oxygen uptake test and the downhill run. You may feel dizzy or sick from the exercise . In very extreme circumstances these tests could cause muscle injury, a heart attack or kidney failure. You will perform a warm-up prior to any test which reduces the risk of pulling a muscle or having a heart attack. You can also stop the tests at any point if you feel unwell. The treadmill and the chair used for knee extension are fitted with emergency stop buttons which you can use if required. Blood taking may also make you feel sick or dizzy and can cause some pain and discomfort. You may get a bruise and the arm / finger may feel quite tender. There is also a risk of infection and spreading of blood borne viruses. This would only occur on a very rare occasion and there are a number of safety measures in place that reduce the likelihood of this risk. The electrical stimulation is quite uncomfortable and feels like a small static shock. If the electrodes are not correctly placed there is a risk of a heart attack or electrocution. The investigator is fully trained in this procedure and will ensure the electrodes are only placed on the thigh muscle, a safe distance apart. Furthermore, risk assessments have been carried out for each of the tests you 8|Page

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are asked to perform. The investigator will also check your pre-exercise medical questionnaire to ensure you dont have any pre-existing conditions that would stop you from completing any of the testing or put you in any danger. The investigator is a trained professional and will follow safe operating procedures at all times. The Departmental Health and Safety policy will be adhered to at all times. The investigator is fully first aid trained and will carry a mobile at all times. The laboratories are fitted with first aid kits and telephones.

11.Will I have to provide any bodily samples (e.g. blood or saliva)? Yes as detailed above you will have a finger blood sample and some blood will be obtained from a vein in your arm using a needle. Only persons who are trained to take blood from your finger or vein will collect your blood. They will all have received training in these procedures and have all taken a minimum of 20 blood samples. Blood from the finger will be sampled immediately. Blood from the vein will be stored in a freezer and later sampled at Manchester General Infirmary by a trained professional. The samples will be anonymous. You will be assigned a participant number and only the student investigator will know which number is which individual.

12.Will participation involve any embarrassment or other psychological stress? For some of the measures the investigator is required to palpate (feel) a landmark on the body and will need direct contact with your skin. This may cause some people embarrassment. Privacy will be ensured and a screen will be used if required and all measures will take place in laboratories with either with frosted glass or blinds so people cannot see in. Before the investigator locates a landmark on the skin you will be asked if it is ok.

13.What will happen once I have completed all that is asked of me? You will be emailed with the results of the maximum oxygen consumption test and some feedback will be provided in relation to the values you got compared to the population and other similar athletes.

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14.How will my taking part in this project be kept confidential? You will be allocated a anonymous participant number that will be used to identify any data you provide. Your name and other personal details will not be associated with your data. Your consent form and personal details will be stored separately from your data. All paper records will be stored in a file in a locked draw in a locked office that only the student investigator has a key to the draw. All electronic data will be stored on a password protected computer and on a password protected USB stick. All information and data gathered during this research will be stored in line with the 1988 Data Protection Act and will be destroyed 5 years following conclusion of this study. During this time the data may be used by the student and principal investigator for the purpose of the research question but at no point will your personal information or data be revealed.

15.How will my data be used? Any information and data gathered during this research project will only be available to the student and principal investigator. Results from this project will be written up as part of a PhD thesis. This thesis will be made available to the public in the British Library once completed. The project may also be written up as a paper and published in a Journal or presented at a conference. You will not be identifiable in any of these.

16.Who has reviewed this study? This project has undergone full ethical scrutiny and all procedures have been risk assessed and approved by the Department of Sport, Health and Exercise Science Ethics Committee at the University of Hull.

17.What if I am unhappy during my participation in the project? You are free to withdraw from the project at any time. During the study itself, if you decide that you do not wish to take any further part then please inform the person named in Section 18 and they will facilitate your withdrawal. You do not have to give a reason for your withdrawal. Any personal information or data that you have provided (both paper and electronic) will be destroyed or deleted as soon as possible after your withdrawal. After you have completed the research 10 | P a g e

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you can still withdraw your personal information and data by contacting the person named in Section 18. If you are concerned that regulations are being infringed, or that your interests are otherwise being ignored, neglected or denied, you should inform Dr Adrian Midgley, Chair of the Department of Sport, Health and Exercise Research Ethics Committee, who will investigate your complaint (Tel: 01482 463270; Email: a.w.midgley@hull.ac.uk).

18.How do I take part? Contact the investigator using the contact details given below. He or she will answer any queries and explain how you can get involved. Name: Miss Bryna Chrismas Email: b.chrismas@hull.ac.uk Phone: 01482 464236

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Department of Sport, Health & Exercise Science

Informed Consent Declaration


Project title An investigation into the physiological, biochemical and psychological effects of delayed onset muscle soreness / muscle damage and how this effects maximal incremental exercise performance. Name: Dr Adrian Midgley Email address: A.W.Midgley@hull.ac.uk Contact telephone number: 01482 464236 Student investigator (if applicable) Name: Miss Bryna Chrismas Email address: b.chrismas@hull.ac.uk Contact telephone number: 01482 464236 Please Initial I confirm that I have read and understood all the information provided in the Informed Consent Form (EC2) relating to the above project and I have had the opportunity to ask questions. I understand this project is designed to further scientific knowledge and that all procedures have been risk assessed and approved by the Department of Sport, Health and Exercise Science Research Ethics Committee at the University of Hull. Any questions I have about my participation in this project have been answered to my satisfaction. I fully understand my participation is voluntary and that I am free to withdraw from this project at any time and at any stage, without giving any reason. I have read and fully understand this consent form. I agree to take part in this project.

Principal investigator

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................................................ ............ Name of participant ................................................ ............. Person taking consent

.................... Date .................... Date

.................................... Signature .................................... Signature

Click here to enter text.

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Guidance Notes for Completing Form EC2 Please note that this section of the form should NOT be printed out and submitted with your ethics application, or given to any potential research participant.
General Guidance Notes The purpose of the Informed Consent Form is to provide sufficient information to a prospective research volunteer in participant friendly language so that they can later give their informed consent. Scientific terms can be used if necessary, but they must be explained. Ethics applications that include a Participant Information Sheet that is too technical for some prospective research volunteers to understand will not be approved by the Ethics Committee. The information provided also should be sufficiently comprehensive that any prospective research volunteer can properly evaluate any psychological or physical harm that might arise from participation, as well as the time commitment and any other burdens. In addition, it is the responsibility of the person taking consent to ensure that the participant is competent to provide consent, able to comprehend the information given to him or her, and is providing voluntary consent free from undue influence. If any sections of the Participation Information Sheet are not applicable to your project write Not applicable in the box. Return to the top of page 1 (Press and hold Ctrl and double click)

Guidance Note for Participant Letter of Invitation You should enter the date and your name in the boxes provided. Where possible the informed consent form should be printed out and the letter signed by hand by the principal investigator. If the ethics application is related to a project that is part of undergraduate or postgraduate study then the student should sign it. Return to Participant Letter of Invitation

Guidance Note for Section 1 The title of your study or dissertation should be included here. Return to Section 1

Guidance Note for Section 2 The principal investigator is the person who will have overall responsibility for the project and should always be a member of staff within the Department of Sport, Health and Exercise Science at the University of Hull (or Doncaster College, as appropriate). Where the project is to be conducted as part of undergraduate or postgraduate study, the principal investigator is always the academic supervisor. This is also true for full-time members of staff (academic or 14 | P a g e

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otherwise) who are undertaking postgraduate study. Please note that the email addresses should be the principal investigators University email address. Personal telephone numbers (as opposed to work numbers), other than mobile phone numbers, should not be given. Return to Section 2

Guidance Note for Section 3 Student investigator is defined here as anyone who is undertaking the research project as part of pursuing an undergraduate or postgraduate qualification. This includes full-time members of staff (academic or otherwise) who are undertaking postgraduate study. Please note that the email addresses should be the students University email address. Personal telephone numbers (as opposed to work numbers), other than mobile phone numbers, should not be given. Return to Section 3

Guidance Note for Section 4 You should provide sufficient information, but you might want to keep it slightly vague so you do not give away the true nature of your research. We have to inform the person, but if we tell them exactly what we are looking for, and what we are expecting to find, then this might create participant bias. For example, if conducting a study assessing possible sex differences in a spatial task this statement could be used to outline the nature of the study in simple nontechnical language: Psychologists have long been interested in how people perform on certain problem-solving tasks. In such tasks it has been discovered that some people perform very well, while other people perform less well. The aim of this study is to examine how different people perform on a commonly used test of problem-solving and reasoning called the Mental Rotation Task. Return to Section 4

Guidance Note for Section 5 You should clarify the inclusion criteria. For example, you might state: We are looking for 18-40 year old men who have no existing medical conditions, are not currently taking prescription drugs, and are not suffering from any injuries. You have been sent this information because we believe you might fit these requirements. Return to Section 5

Guidance Note for Section 6 A standard statement, outlining the initial procedure to participants, has already been included and you should not add any further information. Return to Section 6 15 | P a g e

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Guidance Note for Section 7 You must give the participant ALL the information they need in order to make an informed choice as to whether or not to participate in the project. For example, where and when the research will take place, what will be required, and how long it is expected to take. An example is as follows: You will be asked to attend one testing session held in room 007 of The Don Building at the University Of Hull during November 2011. Please bring and wear comfortable sports clothing and sport shoes. You will be asked to refrain from engaging in any strenuous or unaccustomed exercise 24 hours before your visit and to avoid ingesting food 4 hours before your visit. On arrival you will be met by the investigator who will brief you on the testing procedures and answer any questions or concerns that you might have. After signing a consent form, the investigator will ask you to complete a pre-exercise medical questionnaire requesting some information on your present state of health. The investigator will then give you a booklet containing a psychological test and ask you to begin the test. The investigator will time how long it takes you to complete the test. The investigator will then help you prepare for a VO2max test. You will perform the VO2max test on a motorised treadmill. The treadmill speed will stay at 6 km/h for 5 minutes for you to warm-up, and then will increase by 1 km/h every minute until you decide you are too tired to run any longer. During the VO2max test you will be asked to wear a rubber mask on your face, which is used to measure how much oxygen your body is consuming. After you have completed the test the investigator will give you a debrief sheet explaining the nature of the research, how you can find out about the results, and how you can withdraw your data if you wish. Water will be available for you to drink throughout your visit, although you will not be able to drink during the time you are performing the VO2max test. It is estimated that the total time to complete this study will be 60 minutes. There will be private changing and shower facilities available, situated next to the laboratory, if you wish to use them. Return to Section 7

Guidance Note for Section 8 If there is no financial reward or travel expenses then state No. If there is a financial reward or travel expenses you should state very clearly what the financial reward or travel expenses will be and how they can be claimed. For example, are they paid in cash or do they have to be claimed back? Return to Section 8

Guidance Note for Section 9 You should outline any non-financial benefits that participants may gain from participating in the study. For example, laboratory test results are often useful for helping athletes design their training programs, or help an individual evaluate his or her current fitness levels. Return to Section 9 16 | P a g e

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Guidance Note for Section 10 You should make absolutely clear any reasonably foreseeable discomfort or risk of physical harm to the participant, even if it might seem trivial. For example, if you are getting someone to complete a computer-based test that takes an hour to complete, then sitting in front of a monitor for such a lengthy period of time might make them feel uncomfortable, or cause eye strain. It is a good idea to refer to your Risk Assessment Form for help in completing this section, although remember to keep the language non-technical. Return to Section 10

Guidance Note for Section 11 If no bodily samples are to be taken then state No. If bodily samples are to be taken then you should outline to the participant how this procedure will be conducted and who will undertake it. For example, if you are taking blood samples state what method you will be using, such as finger prick versus venous sampling, who will be taking the blood samples, and state the persons qualifications, training, and experience in relation to the blood sampling procedure. You also need to state whether the bodily samples are to be analysed immediately, or whether they will be stored. If they are to be stored you should provide details of where they will be stored, who will have access to them, and how long they will be stored. You should also detail how you will anonymise the stored samples. Return to Section 11

Guidance Note for Section 12 You should provide clear details about the content of the testing in relation to whether or not the participant could experience embarrassment or other psychological stress due to participation in the project, even it seems trivial to you. For example, you must state if your testing involves exposing body parts such as during weight or skin fold measurements, or if your interview schedule or questionnaire contains any questions of a personal nature, such as medical, psychiatric, or relationship history, sexuality, or questions about experiences that the person might have encountered, such as relationship breakdown, suicide, or parental abuse. Return to Section 12

Guidance Note for Section 13 You should state when participants will receive any feedback relating to their participation. For example, will this be given to them by the investigator during any part of the investigation, or sometime after all the data are collected. If the participant is being given feedback you should also state how they will receive it, such as by post or email. You might also state that after their participation has finished you are available to answer any queries they might have regarding their 17 | P a g e

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feedback, or any other aspect of the project and that they should use the contact details in Section 18. Interview-based studies must indicate an approximate length of time after which participants can expect to receive the typed transcript of their interview for checking. If deception was involved, participants must be debriefed as soon as is practicably possible after the investigation has been completed (ensure you submit a debrief sheet with your ethics application). Outline how they will be debriefed on the full nature of the study (e.g. only verbally by the researcher, or will they also receive a debrief sheet) and any opportunities they have to ask questions or discuss the research. Return to Section 13

Guidance Note for Section 14 Clarify to participants that their personal information and data will remain confidential at all times during and after the research. An example statement is as follows: You will be allocated an anonymous participant code that will always be used to identify any data that you provide. Your name or other personal details will not be associated with your data. Your consent form and personal details will be stored separately from your data. All paper records will be stored in a locked filing cabinet, accessible only to the research team, and all electronic information will be stored on a password-protected computer and passwordprotected USB memory stick. All information and data gathered during this research will be stored in line with the 1988 Data Protection Act and will be destroyed 5 years following the conclusion of the study. During that time the data may be used by members of the research team only for purposes appropriate to the research question, but at no point will your personal information or data be revealed. Return to Section 14

Guidance Note for Section 15 Indicate how the data will be used and whether participants will be able to find out more about the overall research if they wish. Reassure the participants that they will not be identifiable in any way, regardless of how the data will be used. An example statement is as follows: Any information and data gathered during this project will only be available to the research team. Results from this study will be written up part of an undergraduate dissertation project. If you would like a copy of the dissertation we can arrange for you to receive it as soon as it becomes possible. Should the dissertation be presented or published in any form, you will not be identifiable. Return to Section 15

Guidance Note for Section 16

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V1 Informed Consent Form EC2


This form is periodically updated so please download the latest version from ebridge before completing

A standard statement has already been included and you should not add any further information. Return to Section 16

Guidance Note for Section 17 A standard statement has already been included and you should not add any further information. Return to Section 17

Guidance Note for Section 18 You should type your name and contact details in the text boxes. Please note that the email address should be your University email address. Personal telephone numbers (as opposed to work numbers), other than mobile phone numbers, should not be given. Return to Section 18

Guidance Note for the Informed Consent Declaration You should type your name and contact details in the text boxes. Please note that the email address should be your University email address. Personal telephone numbers (as opposed to work numbers), other than mobile phone numbers, should not be given. In the text box at the bottom of the page you should give details of how the participant should return the Informed Consent Declaration form. This might be a name and address that the form should be posted to, or you might state that the form should be given to the investigator on the participants first visit to the laboratory. Return to the Informed Consent Declaration

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