APPLICATION ID: VERSION: FOR OFFICE USE ONLY

SPORT AND HEALTH SCIENCES College of Life and Environmental Sciences

Ethics Application All applicants must complete all Sections of this form Insert your project details in the spaces provided. Make sure you complete all relevant sections All Undergraduate, MSc and PhD students must submit their application to their Supervisor for

approval prior to submission. In the case of Path A, UG and MSc projects, supervisors should submit the application and ethics

approval will only be provided when supervisors confirm their approval of the participant information sheet and informed consent form.

For PGR applications, participant information sheets and informed consent forms must be submitted with the application (after being reviewed by supervisors).

All staff applications must include participant information sheets and informed consent forms. All Path B applications must include information sheets and consent forms.

Prior to submitting your application please check that you have completed the items listed below by checking the relevant box.

Filled in all relevant sections of the formIf appropriate (all students), asked your supervisor to approve the application and supporting documentation x

Indicated Path A or Path B Entered a word count in the relevant sectionsListed all those involved in the research including their name and position (e.g. PhD student, research fellow, technician)Ensured that those named above have received appropriate training to conduct the proposed research and have read and understood the applicationProvide DBS number or evidence that the university has informed you that a DBS is not required (for those involved in research with children or vulnerable adults)I have read, understood and provided appropriate details of all relevant risk assessments.Included version numbers and dates on Participation Information sheets and Consent Forms (even if not attached with this application)Checked the readability level of the Participation Information Sheets and Consent Forms (provide a readability score – for help go to https://support.office.com/en-us/article/get-your-document-s-readability-and-level-statistics-85b4969e-e80a-4777-8dd3-f7fc3c8b3fd2Flesch reading ease score of PIS (should be 60) – please enter the number hereCollated all your paperwork into 1 pdf file as described in Section V

1SHS ethics application form v8.1_12_2019

Declaration to be signed by the Applicant and the Supervisor in the case of a student project:

I confirm that the research will be undertaken in accordance with the University Ethics Policy, Research Ethics Framework and Code of Good Practice in Research and Misconduct in Research Process http://www.exeter.ac.uk/cgr/researchethics/codesandpolicies/

I shall ensure that any changes in approved research protocols are reported promptly for approval by the relevant University Ethics committee.

I shall ensure that any external permissions necessary for the research to be undertaken are obtained prior to the research taking place.

I am satisfied that the research study is compliant with the Data Protection Act 2018 and the General Data Protection Regulation (GDPR), and that the necessary arrangements have been, or will be, made with regard to the storage and processing of participants’ personal information and generally, to ensure confidentiality of such data supplied and generated in the course of the research. (Note: Where relevant, further advice is available from the University of Exeter Data Protection Officer, by emailing dataprotection@exeter.ac.uk or at www.exeter.ac.uk/dataprotection)

I will ensure that all adverse or unforeseen problems arising from the research project are reported in a timely fashion to the Chair of the relevant University Research Ethics Committee.

I will provide notification when the study is complete and if it fails to start or is abandoned using the end of study declaration form. http://sshs.exeter.ac.uk/students/ethics/

I have met and advised the student (if applicable) on the ethical aspects of the study design and am satisfied that it complies with the current professional (where relevant), discipline and University guidelines.

I have read this application and believe it to be scientifically and ethically sound

Studies involving Human Tissue

I shall ensure that the research study complies with the appropriate regulations and relevant University of Exeter policies on the use of human tissue samples (if applicable) and health and safety.

If applicable, I shall provide notification to the committee and ensure that any stored human tissue samples will be destroyed when the study end date expires/storage end date expires if participants did not agree to their samples being used for future studies or the PIS stated that samples would be destroyed at the end of the study/after analysis.

If applicable, I will submit a new application to the Research Ethics Committee for new use of stored human tissue samples if the PIS and consent form did not specify a storage end date and participants agreed for their samples to be used for future studies

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If applicable, before the study end date, I will submit a substantial amendment form to the Research Ethics Committee for continued use of stored human tissue samples if the PIS and consent form did not specify a storage end date, participants agreed for their samples to be used for future studies and no new analysis is being undertaken.

Name of lead applicant:................................................ Email:................................

Signature of applicant: ………………………………….. Date: ………………….

Name of supervisor:……………………………………

Signature of supervisor: …………………......................... Date……………………

Scanned or facsimile e-signatures only please

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Section IDoes your study include any of the following?

Adults unable to consent for themselvesChoose an item.

School children (under 16 years of age)Choose an item.

People with learning or communication difficultiesChoose an item.

Those at risk of psychological distress or otherwise vulnerableChoose an item.

People in custodyChoose an item.

People engaged in illegal activities (e.g. drug taking)Choose an item.

Unhealthy volunteers or people with pre-existing diseaseChoose an item.

The use of existing human tissue (e.g., muscle tissue, whole blood, saliva, urine)? consult the UoE HTA Management Handbook for full list of relevant materials https://universityofexeteruk.sharepoint.com/sites/humantissueact/SitePages/Home.aspx

Choose an item.

The storage of human samples (e.g., muscle tissue, whole blood, saliva, urine (if not centrifuged to render acellular) – consult the UoE HTA Management Handbook for full list of relevant materials

Choose an item.

The use of medicines (including prescription and over the counter)Choose an item.

Invasive procedures (e.g. muscle biopsies)NB. Capillary blood sampling, blood sampling via venipunctureand cannulation are Path A and not regarded as invasive

Choose an item.

IF YOU HAVE TICKED YES TO ANY OF THE QUESTIONS ABOVE YOU MUST SELECT PATH B BELOW.Path (tick 1 box only)

Path A Path B

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Project title (max 25 words)

Type of Project Independent undergraduate project Independent MSc project PhD project Staff/student project Staff project Study already approved by NHS REC

Start date: DMYEnd date of data collection: DMY

End date of data storage: DMY

i. Research data should normally be stored securely for a period of 10 years or as required by the funding body.ii. For PhD studies data should normally be stored securely for a period of 6 years or as required by the funding body.

iii. The period of human sample storage, if relevant, is from commencement of study and should be for a maximum of 5 years following which a request to extend the storage period will be required.

iv. For undergraduate or MSc studies, data should normally be stored securely only until the final degree grade has been awarded.For more information about how to store your research data go to: http://www.exeter.ac.uk/research/researchdatamanagement/about/faqs

Tick one box below to indicate the research group your study falls into

Biomechanics Physiology-performance

Physical activity and health Physiology-nutrition

Psychology-sport/exercise

Lay Summary (max 200 words): Provide a brief summary of your project using language that would be understood by a lay person outside of the sports science community including: Background; Objectives; Methods; Value of Research. Do not cut and paste text from a protocol document or grant application.

Enter word count:

I/We confirm that I/We have financial approval to undertake this study

UG / PGT Student:I confirm that I have discussed the cost implications of this study with my supervisor

FORMCHECKBOX

Staff/PGR:The Cost Code that the study will be charged to is:

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Name(s) and status of all researchers/collaborators not listed as lead applicant

Name EmailStatus

(Staff/Ph.D./MSc/UG)

Role (s) in the study (e.g. taking consent, taking blood etc).

Number each role separately

Appropriate training undertaken

(✓ or N/A)*

Signature 1.

1.2.3.

*Tick the box to confirm that the named person has received all the training necessary to undertake the role in the study. If training is not required for the role, please enter N/A. If in doubt, please contact Garrick Taylor G.F.Taylor@exeter.ac.uk. 1. Each researcher in the list should provide an electronic signature to confirm that they have read and agree with the content of the application.

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Section II1. i. Research questionPlease write in the form of a research question using the PICO model to formulate the question: Population (P), Intervention (I), Control/Comparison condition(s) (C) and Outcomes (O) http://www.gcu.ac.uk/library/pilot/searching/thepicoframework/Example: In middle aged men and women with newly diagnosed type II diabetes (P) what is the effect of walking a mile a day at a brisk/fast pace for 12 weeks (I) on HbA1c (O) compared to habitual daily activity (C)?

2. i. What is already known on this topic? – In just a few sentences summarise the state of scientific knowledge on this topic and why the proposed study needs to be done (provide references where appropriate – ideally from systematic review level evidence. Include findings from unpublished studies if relevant). Be clear and specific.

ii. What will we know as a result of this study that we did not know before? Provide a few sentences that are brief and specific. Use the last sentence to summarise potential implications for practice, research or policy.

8SHS ethics application form v8.1_12_2019

3. i. What are the primary and secondary objectives of your study?Primary Objective Primary Outcome

MeasureMethod used to measure the

outcomeHow will the analysis of the primary outcome be

undertaken? (e.g. independent samples t-test repeated measures ANOVA, linear regression)

e.g. Test for Int v Con differences in glucose control

Glycated haemoglobin (HbA1c)

Fasting venous blood sample The dependent variable in a mixed design ANOVA

Secondary Objectives

Secondary Outcome Measure

Method used to measure the outcome

How will the analysis of the secondary outcome be undertaken? (e.g. independent samples t-test repeated

measures ANOVA, linear regression)1.2.3.4.5.

NB. Red text is an example.

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3. ii. What other variables will you measure that you expect to influence the outcome? (e.g. descriptive variables or potential confounders, moderators, mediators etc)

Any additional measures

Type of variable (descriptive confounder,

moderator, mediator, mechanism)

Method used to measure the variable

How will the variable be included in the statistical analysis?

e.g. Food intake confounder EPIC food diary* As a co-variate in the analysis of the primary and secondary outcomes

e.g. Gender moderator Questionnaire (M/F) ‘Gender x Intervention Group’ interaction term

e.g. Age group descriptive Questionnaire Descriptive variable only

1.2.3.4.5.

NB. Red text is an example. All study variables should appear in sections 3.i and 3.ii. *Provide references for reliability and validity of proposed measures.

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4. i. What type of research design is your study? Cross–sectional Repeated measures Validity

Randomised cross-over trial Uncontrolled before-after Other

Randomised controlled trial Calibration

If ‘Other’ please describe

4. ii. Will you register the study as a clinical trial? Yes No

4. iii. If yes, will you publish the protocol prior to the start of recruitment? Yes No

5. Procedures for selecting participants i. How will participants be sampled? Convenience Purposive Quota Simple random

Stratified random Multi stage random Cluster

ii. What method will be used to invite participants into your study (e.g. flyer, email etc.)? If you are planning to use an advert/flyer please include a copy at the end of the application

iii. How will people be consented (provide details of the process in full including how people will receive the PIS – how, what where etc)?

iv. What are the inclusion and exclusion criteria? Exclusions Inclusions

Please provide a scientific justification for all exclusions and inclusions listed.

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6. Sample size determination i. Are you required to justify your sample size?

i.

ii. Yes vii.

NoIf NO indicate your reason in 6ii. below, or for YES go straight to Q 6.iii & ivii. Reason for not needing to justify the sample size:

This is an independent BSc or MSc project

This is a qualitative study

No hypothesis testing analysis will be carried out on the data (i.e. this is a feasibility or pilot study)

iii. The sample size of your study should be sufficiently powered to address your primary

research question. Does the ‘effect size’ that you have estimated, and used in your sample size calculation, relate directly to the primary research question? Yes No

iv. Justify the ‘effect size’ that you anticipate to obtain/observe in your study in the box below and describe any assumptions you may have made in the absence of any relevant information (include references from which the input data for the ‘effect size’ were taken from – the effect size represents the minimum clinically meaningful difference OR the smallest effect previously observed OR the smallest effect needed for progression to a full trial (in the case of pilot studies)

v. How many people in total will be recruited?

vi. How many groups and conditions will there be? Groups: 1 2 3 4 5 6 7 8 9 10+ Conditions: 1 2 3 4 5 6 7 8 9 10+

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Paste the screenshot of the output from the software (e.g. G*Power) or online calculator that you used to determine the required sample size below.

vii. How will people be allocated to groups (leave blank if 1 group)?Random Non-random

If random please provide details of the randomisation procedure, e.g., simple, block, stratified etc ( if block or stratified give details-see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3136079/ for guidance)OR if Non-random please explain why.

viii. How will the order of conditions be allocated? (if >1 conditions) Counterbalanced Not counterbalanced If counterbalanced please describe procedure OR if not counterbalanced please explain why.

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7.i. Schedule of screening, consent, interventions and assessments for each participant

Procedures Time to complete (mins)

Location (e.g. lab, home,

field)

No. of times intervention or

measurement will occur in total

Timing of intervention/measurement(e.g. every 15 minutes, every hour, once a week, baseline and follow up, day 1,5,9,11, week 1,5, 9,

11)Eligibility screen 5 Lab 1 1 week prior to baselineInformed consent 10 Lab 1 1 week prior to baselineFamiliarisation 5 Lab 1 1 week prior to baselineInterventions 1. Supplementation 5 Home 14 Twice per day on days 1-72. Cycle training 30 Home 20 5 days per week for weeks 2-53 4 5 Assessments/measures 1. Time to exhaustion 40 Lab 2 Baseline and week 62 3 4 5

NB: All measures in 3.i and 3.ii should appear here

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Insert schematic to show schedule of procedures listed above. Remove example below and replace with a version for your study.

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7.ii. Will the study participants receive a dietary or pharmacological intervention?

Yes No If yes, please provide brand names and manufacturer information. Specify the doses for the active and placebo supplement/drug. For dietary manipulations, provide general description of foods, total daily calorie intake and proportions of macronutrients. State the duration of the intervention, and for cross-over designs, the duration of wash-out. Please provide reference(s) to justify the chosen doses and supplementation regimes.

8. Data management?

i. How will confidential personal data be protected? (See note 1)

ii. How will research data be anonymised? (See note 2)

iii. Will data be transferred on mobile devices (memory stick etc)? Yes No If yes explain method of transfer and secure storage (encryption etc)

iv. How will research data be stored securely?

v. How will PIS and consent forms be stored securely? (See note 3)

vi. Who has access to which data during and after the study?

vii. Do

your consent forms permit you to share data with the people named in vi? Yes No

viii. Who will be responsible for the security and disposal of stored data?

See this guidance on storing personal datahttps://www.exeter.ac.uk/research/researchdatamanagement/

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The University’s Open Access Research and Research Data Management Policy states that all research proposals (staff and PhD) must include a Data Management Plan. DMP Online (https://dmponline.exeter.ac.uk/ ) contains data management plan templates.

Note 1. Confidentiality means that the participants can be identified, but their identities are not revealed to anyone outside of the study. In other words, only the researcher knows the identities of the participants, and measures are put in place to ensure that participants’ identities are not revealed to anyone else. Participants’ personally-identifying information can be linked to their data using ID numbers (pseudonymised). Personally-identifying information should be stored separately from the data. Confidential information (including personal data) must be destroyed and disposed of securely once it is no longer required.

Note 2. Anonymity means that there is no way for anyone (including the researcher) to personally identify participants in the study. This means that no personally-identifying information can be collected in an anonymous study. Personally-identifying information includes, but is not limited to, names, addresses, e-mail addresses, phone numbers, video or audio files etc. This also means that any study conducted face-to-face or over the phone cannot be considered anonymous. Online surveys are the most common method of anonymous data collection, but this does not mean that all online survey research is anonymous. For instance, if the researcher knows the e-mail addresses or IP addresses of the individuals who participated in the survey, the study cannot be considered anonymous.

Note 3. Paper copies should be scanned and stored electronically on an encrypted device or university server after which paper copies should be destroyed.

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Section III9. Risk Assessments for project procedures

Procedure: 1) List all the procedures you will use in this study that could potentially affect the participant (do include procedures where the participant may not be present but could be potentially harmed if the procedure is carried out incorrectly – such as infusion preparation)

2) Review the list of risk assessments (https://universityofexeteruk.sharepoint.com/sites/sportHS) to see if any of them apply to the procedures that you ticked ‘Yes’ to. If a procedure is not covered by an appropriate risk assessment then you will need to complete a new risk assessment (see link above and go to Risk Assessments folder ).

Are there any hazards affecting the participant associated with this procedure? (include any potential risks of injury, discomfort, fatigue, vomiting, psychological harm)

If ‘yes’ hazards state the risk assessment reference for the procedure

Has the Risk Assessment been reviewed at the interval stated within it? (normally annually or biennially)If not the assessment will need to be reviewed before the study commences (liaise with the risk assessor or manager of the procedure)

Example: Muscle biopsy Yes No SSHS/HAZ/0136

Yes No

Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No

Tick the box to confirm that you have read and understood the risk assessment(s) relevant to this application and will comply with the requirements detailed in them. (Do not attach the risk assessments to this application).

Fieldwork Risk Assessment (for off-campus studies only)If your project involves any practical work at a site not under University of Exeter control you must complete a fieldwork risk assessment and e-mail it to shs-healthandsafety@exeter.ac.ukRisk assessment form and guidance can be found at: http://www.exeter.ac.uk/staff/wellbeing/safety/formssignsandtemplates/Tick the box to confirm that you have completed and submitted a fieldwork risk assessment for this study and will comply with the requirements detailed therein (leave blank if N/A).

FORMCHECKB

OX

19SHS ethics application form v8.1_12_2019

Risk Assessment of a Planned & Supervised Activity for Children & Young People (or Vulnerable Adults). If your project involves any planned and supervised activity for children and young people (or vulnerable adults) you must complete either a Children in SHS Labs or Children in Satellite Labs risk assessment, as appropriate, and e-mail it to shs-healthandsafety@exeter.ac.uk

Tick yes or no to confirm whether you have completed and submitted a risk assessment of a planned & supervised activity for children & young people (or vulnerable adults) for this study and will comply with the requirements detailed therein (leave blank if N/A).

Yes No

If ‘No’ is ticked then by submitting this application you agree to complete and submit the risk assessment before the project takes place

If your study involves contact with children or vulnerable adults, please provide a DBS number, the institution that obtained the check and date of issue for each researcher, or give reasons why DBS checks are not required

Name and organisation requesting check Date of issue

Reason why DBS not required:Are you intending to store human samples; Yes No If ‘Yes please complete the application to store form and append it as a separate Word document to this application.https://universityofexeteruk.sharepoint.com/sites/humantissueact/SitePages/Home.aspx (and select form library and application to store form)

Please provide a clear but concise statement of ALL of the ethical considerations raised by the project and how you intend to manage them. This should include any potential harm to participants. Put each consideration on a new line. Do not leave blank

Consideration Action/Management

10. Are there any potential conflicts of interest arising from the project, deriving from relationships with collaborators/sponsors/funders/participants/interest groups? Yes No

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Please disclose all relevant personal and commercial interests.

Section IVAttachmentsProvide a list of attachments that you will submit in support of your application. UG and MSc students who are submitting Path A applications do not need to submit Participant Information and Consent forms as part of their application but these must be approved by the relevant Supervisor in order to obtain ethics approval and in advance of any participants being recruited. All Path B applications: if you intend to use recruitment posters or other media for participant recruitment these must be submitted as attachments.

Indicate which attachments you have included by placing a cross in each box (double click the box)

I. Ethics application form

II. Participant information sheet*

III. Consent/Assent form(s)*

IV. Additional documents as required (please list these)

V. Application to store human samples (attach separately as a Word document)

*Ensure these documents have correct version numbers and dates

Prior to submission please collate all the documents you intend to submit (apart from the human tissue form) to the committee in one pdf file in the order they appear in the list above and save the file with your full name and the date, e.g. melvyn_hillsdon_dd_mm_yy. The ethics committee will only accept pdf files in this format.

21SHS ethics application form v8.1_12_2019