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King’s College London (KCL) College Research
Ethics Committees (CREC)
Taught Practical Summary Form
Name of Applicant:
Title of Module/Course:
Name of Review Panel:
Section 1: Activities and Interventions
Please select all activities or interventions that will be incorporated into this
practical from the following:
No. Activity or Intervention
1
2
2.1
2.2
2.3
2.4
2.5
3
4
5
6
6.1
6.2
6.3
7
7.1
7.2
8
9
9.1
9.2
Drinking a litre of water or a litre of isotonic saline
Dietary Restrictions and challenges related to physiology practicals
Version 1 Limited fasting
Version 2 controlled diet
Version 3 true fasting
Version 4 alcohol
Version 5 specific dietary components (e.g.caffeine)
Breath-holding
Hyperventilation
Rebreathing
Postural changes and effects of altered gravity states
Version 1: supine vs standing
Version2: head down tilt vs standing
Version 3: effect of cuff position
Diving Response
Version 1: simple facial submersion with apnoea
Version 2: facial immersion – identification of the factors that trigger the
diving response
Valsalva Manoeuvre
Dynamic Exercise
Version 1: short period of moderate exercise
Version 2: exercise at incremental workloads, total duration 20-30 minutes
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Please
Tick
2
9.3
10
11
Version 3: exercise at incremental work loads up to V02max
Isometric exercise using a handgrip dynamometer
Effect of elevated ambient temperature on physiological functions in
light/medium exercise
Yes
I confirm that that none of the activities or interventions will be
altered from the ethically approved versions.
If no, please provide further details below:
The following amendments have been made: (please reference the activity or
intervention number to which you refer)
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No
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Section 2: Protocols
A: Protocols for Investigating Neuromuscular System Functions
Please select all protocols that will be incorporated into this practical from the
following:
No
Protocol
1
1.1
1.1.1
1.1.2
1.2
1.2.1
1.2.2
1.2.3
1.2.4
2
Nerve conduction studies
Non-invasive measurement of Motor conduction in peripheral nerves
Version 1 for ulnar nerve motor conduction velocity
Version 2 for the median nerve motor conduction velocity
Non-invasive recording of a sensory nerve conduction velocity
Version 1 for Ulnar nerve, orthodromic sensory conduction
Version 2 for Ulnar nerve, antidromic sensory conduction
Version 3 for Median nerve, orthodromic sensory conduction
Version 4 for Median nerve, antidromic sensory conduction
Muscle force regulation and motor unit “recruitment” investigations using
EMG recordings
2.1
Version 1: EMG and recruitment
2.2
Version 2: Grip force and EMG during an isometric contraction
3
Determination of the isometric contractile properties of the triceps surae
using percutaneous stimulation
4
Knee extensor muscle function assessed using isokinetic dynamometry
5
An investigation of factors contributing to muscle fatigue
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Reflexes
6.1
Stretch Reflex
6.2
Hoffman reflex
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Reaction times
8
Gait examined by means of footprint analysis (pedograph) system
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Tests of balance
9.1
Romberg test
9.2
Star excursion balance test (SEBT)
9.3
Measurement of sway
9.3.1 Measurement of lateral sway, using a small laser pointer fixed to the
standing subject
9.3.2 Measurement of anterior-posterior sway using a wire Goniometer or
optical Goniometer attached to the ankle
9.3.3 Measurement of lateral and anterior-posterior sway using a wire
Goniometer or optical goniometer attached to the ankle
9.4
Berg Balance test
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B: Protocols for Cardiovascular Measurements
Please select all protocols that will be incorporated into this practical from the
following:
No
Protocol
Please
Tick
1
1.1
1.2
1.3
Non-invasive methods:
Polar heart rate monitor
Borg perceived exertion scale
Inflatable cuff and stethoscope for auscultation method to measure blood
pressure
1.4
Automatic sphygmomanometer
1.5
The finapres (and subsequent versions such as “finometer”)
1.6
Pulse oximeter
1.7
Electrocardiogram (ECG)
1.7.1 3-lead ECG
1.7.2 The 12-lead ECG
1.8
Skin blood flow recording
2
Invasive methods
2.1
Finger-prick blood sampling for blood glucose and/or lactate
measurements
C: Protocols for Respiratory Meaurements
Please select all protocols that will be incorporated into this practical from the
following:
No
Protocol
1
1.1
1.2
2
Spirometry for lung volumes using pneumotachographs
Version 1: Standard resting spirometry
Version 2: Spirometry measurements during exercise
Use of (Wright) peak flow meters for measurement of peak expiratory
flow rate
Use of Pneumo-trace to record breathing rate
Vitalograph for measuring forced vital capacity and forced expiratory
volume in 1 second
Measurement of alveolar oxygen and carbon dioxide
Version 1: using mixed expired air
Version 2: end-tidal gas measurements
3
4
5
5.1
5.2
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D: Protocols for Recording Skin and Core Body Temperature
Please select all protocols that will be incorporated into this practical from the
following:
No
Protocol
1
2
2.1
2.2
Measuring skin temperature
Measuring body core temperature
Version 1: using a rectal probe
Version 2: using an external auditory canal probe or infra-red
thermometer
Please
Tick
E: Protocols for Renal Physiology Investigations
Please select all protocols that will be incorporated into this practical from the
following:
No
Protocol
1
Measuring urinary flow rate and osmolality
Please
Tick
Yes
No
I confirm that that none of the protocols will be altered from the
ethically approved versions.
If no, please provide further details below:
The following amendments have been made: (please reference the protocol number
to which you refer)
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Section 3: Documentation for Participants
Please confirm that you will provide the following ethically approved documents to
participants:
Yes
Consent form for students taking part in course practicals Version 2 15/07/13
Information Sheet for Students Version 1 24/05/13
PAR-Q form: For Volunteer subjects only Version 1 24/05/13
If you have answered no to any of the above, please state your reasoning:
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No
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Section 4: Data Handling
Please confirm the following in relation to the handling of data:
Yes
No
Will all processing of personal information related to the practical will be in full
compliance with the Data Protection Act 1998 (DPA)?
Will all personal information be anonymised?
Will the raw data generated be securely stored electronically (either password
protected or encrypted device?)
If you have answered no to any of the above, please state your reasoning:
Section 5: Declaration
APPLICANT:
I undertake to abide by accepted ethical principles and appropriate code(s) of
practice in carrying out this module/course. The information supplied above is to the
best of my knowledge accurate. I understand my obligations and the rights of the
participating students, particularly as regards obtaining valid consent. I understand
that I must not commence this module/course until approval has been given by the
Research Ethics Office or BDM RESC (as appropriate) to proceed.
Signature ……………………………………………………………………
Date………………………….
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