Ethical Clearance for Standard Laboratory & Field Procedures
School of Sport & Exercise Sciences (SSES)
University of Kent
The Medway Building
Chatham Maritime
Kent ME4 4AG
VersionMarch2015
Prepared by Steve Meadows (Lecturer)
& Andy Galbraith (Senior Technician / Health & Safety Officer).
1
Contents
Page(s)Introduction / 2
Contact Details / 2
Ethical Considerations / 3
General Restrictions & Limitations / 3
Ethical Review Process / 4
Section 1.0 Staffing / 5
Section 2.0 Timescale of Document / 6
Section 3.0 Location / 6
Section 4.0 SSES Standard Laboratory & Field Procedures & Practices / 6 - 12
Section 5.0 Compliance with Human Tissue Act 2004 / 13
Section 6.0 Complaints / 13
Section 7.0 Type of Participant / 13
Section 8.0 Inclusion & Exclusion Criteria / 13
Section 9.0 Recruitment / 13
Section 10.0 Confidentiality / 13
Section 11.0 Examples of Activities Covered by this Document / 13
Section 12.0 Safety & Risk / 14
Section 13.0 Data Analysis / 14
Section 14.0 Information for Participants / 15
Appendix A BASES Code of Conduct / 16
Appendix BSSES Standard Laboratory & Field Procedures & Practices
Quick Reference Table / 19
Introduction
This document details a range of standard laboratory& field-basedprocedures routinely carried out in the School of Sport & Exercise Science (SSES) at the University of Kent. There are two reasons for compiling this document and seeking general ethical clearance for research work. Firstly, in line with the general requirements of ethical committees, to ensure all aspects of work are subject to ethical scrutiny. Secondly, to prevent the Faculty of Science Research Ethics Advisory Group (REAG) and SSES REAG being unduly burdened with numerous individual proposals associated with experimental work of a similar and routine nature.
Scope of Document
For projects involving procedures detailed in this document the Faculty of Science Ethics Review Checklist for Research with Human Participants needs to be completed and submitted to SSES REAG along with any accompanying documentation being used (e.g. participant information sheets,recruitment advertisements, letters or emails; informed consent forms, questionnaires, interview guides or other instruments or measures to be used).
If a research project involves anything that requires a ‘yes’ response on the Faculty of Science Ethics Review Checklist , then a Full Ethics Application for Research document would also need to be completed.
This proposal clearly delimits the scope of work for which ethics clearance is awarded and this delimitation is deliberately conservative to protect research participants and researchers. Separate and individual clearance will need be sought for all work outside of the limits stated in this document, such as working with clinical groups, older adults (males > 45 years; females > 55 years),children (apart from therapeutic interventions – see section 4.1.23) and all work involving more invasive or novel procedures. Ethical clearance for any such projects should be submitted using the Faculty of Science Full Ethics Application for Research with Human Participants. Advice on ethics submissions can be found on the Faculty of Science website:
Contact Details
Research Ethics & Governance Officer (Nicole Palmer)
Tel. 01227 824797 email: Web:
SSES REAG representative (Steve Meadows)
Tel. 01634 888811 email:
SSES Administration Office: Submission of Ethics Documents (Ruth Cox)
Tel. 01634 888858 email:
SSES Head of School (Professor Louis Passfield)
Tel. 01634 888858 email:
SSES Director of Research (Professor Samuele Marcora)
Tel. 01634 202971 email:
SSES Health & Safety Officer (Dr Andy Galbraith)
Tel. 01634 888812 email:
The broad framework for the way in which staff, postgraduate and undergraduate students act within SSES laboratories, clinics, rehabilitation facilities,or field-based environments fall within the Code of Conduct of the British Association of Sport & Exercise Sciences (BASES, 2009) (see Appendix A). These ethics guidelines are designed to incorporate physiology, biomechanics, psychology, sports therapy and related disciplines using the similar methodology.
Ethical Considerations
The ethical nature of the work is ensured by the following:
- the approach embraces the principles of the Helsinki Agreement (see:
- participation as a subject is voluntary and subject to written informed consent;
- procedures and protocols are similar to those practiced nationally by others in the profession;
- all work that is subject to health and safety procedures and risk assessments for procedures should be read (if available) or written (if not available);
- handling of personal information fulfills statutory requirements (Data Protection Act, 1998);
- activities are designed towards experimental research,education or consultancy;
- when activities involve physical activity / exercise subjects will be restricted to healthy, asymptomaticindividuals and pre-screening (PAR-Q+ / health questionnaires / pre-test screening) maximises assurance that they are in a fit condition without contraindications to undertake the activity / exercise.
- Collection of human tissue samples conforms to the Human Tissue Act (HTA) 2004.
- It is acknowledged that risk assessment should form part of the ethical considerations for an activity. Therefore, it may be appropriate to include a risk assessment, or reference to an existing risk assessment (see Appendix B Table 1. SSES Standard Laboratory & Field Procedures and Practices) in an ethics submission.
General Restrictions and Limitations
Subjects are within the age range 18 – 45 years (male) and 18 – 55 years (female)specified in the procedure details, apparently healthy, and are of a physically-active disposition. The only exception is work covered under section 4.1.23.
The activity must be supervised by a member of the academic staff with experience and competence appropriate to the study. Undergraduate and postgraduate students can collect data without an academic member of staff present as long as they are sufficiently trained by a technical and/or academic member of staff and demonstrate competence in the procedure to be used.In accordance with normal laboratory operating procedure anyone conducting research testing should have undergone the laboratory induction which covers health and safety issues and should not work alone, but accompanied by a technician, co-researcher or research assistant.
Common methodologies undertaken that are covered in this document include: observation, interviews, focus groups, video analysis, questionnaires, training or dietary interventions, exercise testing, exercise in altered environments, ethnography, etc.
If the activity is being undertaken outside of normal University operating hours (taken to be 0800 – 1800) an out of hours risk assessment should be completed.
The procedures must be carried out in accordance with the instructions and limitations relevant to each study.
All electrical equipment connected to a participant (e.g. amplifiers, stimulators) must have been manufactured for that purpose and must bear the appropriate symbol to signify this.
All electrical equipment connected to a participant must be in a good state of maintenance with a current electrical test certificate (PAT tested).
The modesty of the participant must be protected, and investigators must be sensitive to gender and cultural issues.
The anonymity of the participant and the confidentiality of the data collected must be ensured.
There must be no humiliation of subjects.
There should be no use of undue payments or any other inducements to recruit or to avoid withdrawal of participants. ‘Out of pocket’ expenses are permitted.
The use of deception or misinformation is only allowed as a component of a placebo control, and where it causes no increased risk of any form to the participant.
Any data indicating possible abnormality must not be bought to the attention of the participant during the collection of data, and should be discussed privately with the participant later, preferably by the academic supervisor. In general, this will include a recommendation to seek medical advice.
Health screening procedures will be used in all appropriate circumstances. These would normally be written and would utilise standard SSES documentation for PAR-Q+, health questionnaire and pre-test screening documents. It is necessary to consider the requirements of the Data Protection Act 1998 in relation to the use of this type of documentation.
The only techniques of blood sampling permissible under this document is capillary and venupuncture sampling and by those who have received appropriate training from a member of academic or technical staff (capillary sampling), or phlebotomy training course with an appropriate provider, e.g. Kent & Canterbury Hospital (for venupuncture sampling).
This document excludes working with the following groups of people:
- Anyone below the age of 18 (apart from section 4.1.23) or above the age of 45for males or 55 for females
- Anyone with a physical or mental disability or unable to give informed consent
- Anyone who is unable to understand procedures provided in a participant information sheet (due to a language barrier)
- A woman who is pregnant, or who believes she may be pregnant
- NHS patients, adults in social care, residential care home residents or prisoners
If there is any doubt about the suitability of a participant, and application of the principles within this document to the participant, independent advice and ethical approval is needed. Please contact the SSES REAG representative or the University Research Ethics & Governance Officer (contact details can be found on page2 of this document).
Ethics approval should be obtained before pilot testing takes place (this is University of Kent policy).
In the case of consultancy or research work undertaken for representative squads or groups of individuals, access can be given by a single designated representative of that team or group, on behalf of all participating individuals. As this individual is essentially acting as a gatekeeper to the group, please ensure appropriate gatekeeper safeguards are in place and this is highlighted and explained on the ethics application form. This may require a full ethics submission. This representative would normally be either the Team Doctor, Physiotherapist, coach / instructor, or teacher. Separate informed consent and medical suitability of individuals in the squad or group to undertake the activity should be obtained and protocols of voluntary participation explained. After the assessment, data on all individuals can be provided to the designated representative of the squad or group, following normal data protection processes.
Ethical Review Process
Documentationused for ethical review in SSES is used across the Faculty of Science and comprise a ‘two-tier’ review system. Researchers are required to complete a checklist that is designed to identify those projects that involve more than minimal risk and therefore require a full review, possibly through the NHS National Research Ethics Service Committee. As most activity in SSES involves human participants, more careful scrutiny is normally needed and the more comprehensive full ethics form provides additional details to the REAG.The checklist and full ethics forms are located on the Faculty of Science Research Ethics webpage (please note that these documents are amended periodically; current versions can be downloaded from the Faculty of Science Research Ethics webpage available at:
The process of SSES ethical review is illustrated in Figure 1. below:
Further information concerning Faculty of Science ethics procedures and key documents can be found at:
1.0Staffing
Activities covered in this document are performed by:
- all full-time, part-time or sessional members of academic, visiting researchers and technical staff;
- all postgraduate students registered for an MSc or research degree;
- undergraduate students who undertake a dissertation project.
All SSES academic staff are research active, possess or are working towards a PhD and routinely teach undergraduate and postgraduate students to conduct the procedures detailed in this document.
2.0Timescaleof Document
Initially for a 12 month period to March2016, subject to a satisfactory report received by the Faculty of Science REAG. From March 2016 a 3 year full review should be conducted. It is acknowledged that there may be ongoing minor revisions to respond to changes in practice or for health and safety reasons.
3.0Location
All research activities, both within the Medway Building and Medway Park, and field work fall within the scope of this document in all respects. Technicians will not allow laboratory bookings or equipment loans toundergraduate students without confirmation of ethical approval (copy of ethics approval letter). Postgraduate students should not proceed with on-line laboratory bookings without receiving ethical approval for the planned activity.
3.1Medway Building and Medway Park
The vast majority of work undertaken within the scope of this document will take place within the SSES laboratories based on the Medway Campus, Chatham Maritime, Kent and Medway Park, Mill Road, Gillingham, Kent.
3.2Field Work.
On occasion, activities will take place outside of University premises. Full riskassessments will be performed prior to the activity. When equipment is borrowed from SSES one of thetechnicians will check that a risk assessment and ethical approvalhas been completed before equipment is released.Common methodologies undertaken that are covered in this document include: observation, interviews, focus groups, video analysis, questionnaires, training or dietary interventions, exercise in altered environments, ethnography, etc.
4.0SSES Standard Laboratory & Field Procedures & Practices
Combinations of Procedures
The use of more than one of the following techniques or procedures in any one study is allowed except when scientific knowledge/information suggests that the risk of the combined procedures would be greater than the sum of the risk of the individual procedures.
4.1Procedures. (A quick reference table canbe found in: Appendix B Table 1. SSES Standard Laboratory & Field Procedures & Practices)
4.1.1Indirect Calorimetry
Measurement of oxygen uptake and energy expenditure by the collection of expired air through a mouthpiece or full-face mask. Expired air is collected into Douglas bags for off-line analysis, or sampled using the MetaLyzer cart or Metamax 3B portable system for on-line (breath-by-breath) analysis Subjects may breathe through a facemask or a re-breathing bag, tube or valve box with mouthpiece and nose clip or ventilated hood. There should be suitable filters / one way valves where necessary. Inspiratory and expiratory resistances should be minimal.
Risk assessments: SES80, SES52.
4.1.2Cardiovascular Function
Measurement of heart rate and ECG by a pulse monitor or an ECG monitor. Measurement of cardiac function by Physioflow. Measurement of blood pressure using a manual or automated sphygmomanometer.
Risk assessments: SES43, SES44, SES45, SES50.
4.1.3Respiratory Procedures / Pulmonary Function
Measurement of lung volume and airflow using a Micro Spirometer, Peak flow meter, Lunglife lung age monitor or the MicroLab ML3500 spirometer.
Risk assessment: SES80.
4.1.4Inspiration of gas mixtures other than air
Including re-breathing from a closed system with, or without, a CO2 absorber in the line. The inspired mixture will not contain gases other than those found in room air. Gas mixtures will be of a quality suitable for inhalation, free from contamination.
Risk assessment: SES84
4.1.5 Respiratory Manoeuvres
Voluntary breath-holding may be studied providing subjects have immediate access to room air and can make adequate respiratory movement should they so wish. Subjects may be asked to make forced expirations or similar actions and hyperventilate. Paced breathing is also permitted. Close observationpresent during these procedures.
Subjects may be asked to make maximal forced expiratory and inspiratory efforts against an occluded airway to measure respiratory muscle strength. Subjects may also be asked to breathe against a progressively increasing external inspiratory or expiratory resistance until volitional fatigue of their respiratory muscles. In all cases, subjects should be able to remove the obstruction or resistance themselves.
The measurement of haemoglobin-oxygen saturation using finger pulse oximetry.
Risk Assessment: SES80
4.1.6Thermoregulatory Studies
The recording of physiological and biochemical responses to increased environmental temperatures. Theincreased temperature will not exceed 45C.Overall heat stress should be considered where there are manipulations of temperature and humidity, as a relative humidity of 90% at 40oC would be more challenging than a 45oC ambient temperature with lower humidity.
The recording of physiological and biochemical responses to decreased environmental temperatures. The temperature will not be lower than -10C. Prior cooling of the body is also practised where subjects are cooled by passive immersion in cold water (>10 OC) prior to beginning exercise.
Comprehensive health screening must be used and researcher safety should be considered in risk assessment.
Risk assessments: SES82, SES49.
4.1.7Hypoxia Studies / Environmental Manipulation
Altered inspired oxygen concentration must be limited (FIO215%). Physiological tests can be performed in a purpose built environmental chamber within temperature range of 15C to +35C and humidity range of 25% to 75% Specific criteria for the termination of exercise testing under environmental stress is given in the risk assessment documentation. Subjects must be removed if core temperature rises by 1.5C to 38.5C (aural measurement) or 2.0C to 39C (rectal measurement). Subjects must be removed if core temperature drops by 1.5C to 35.5C (aural measurement) or 2.0C to 35C (rectal measurement).
Any exercise at increased or decreased temperatures must be physiologically monitored and overall heat or cold stress should be considered where there are manipulations of temperature and humidity. Post-test monitoring should take place to ensure temperature returns to within 0.5C of resting value before participant is discharged from the laboratory.
Comprehensive health screening must be used and researcher safety should be considered in risk assessment.
Risk assessments: SES49, SES82.
Methods of body temperature measurement that are allowed under this protocol are:
4.1.8Measurement of Rectal Temperatures Using Thermistor Probes
Detailed instructions should be given to participants concerning insertion. Precautions should be taken to treat potential shock and check for contraindications, e.g. anal fissures, rectal bleeding, etc. Privacy of participant should be respected.
Risk assessment: SES82
4.1.9Measurement of Aural Temperatures Using Infra-red Equipment
Subjects must be told to stop exercising and removed if core temperature rises by 1.5C to 38.5C or falls by 1.5C to 35.5C(aural measurement).
4.1.10Measurement of Skin Temperatures Using Non-invasive Equipment
Subjects must stop exercising and removed if core temperature rises by 1.5C to 38.5C or falls by 1.5C to 35.5C(skin temperature).
4.1.11Measurement of Limb Blood Flow
By venous occlusion plethsymography using strain gauges, or limb immersion to measure circumference or volume of the limb. Occluding cuffs, when used, to be inflated to a maximum of systolic pressure 100mmHg for up to 10 minutes. Measurement by photoelectric pulse sensor is also permitted.