SCHOOL OF SPORT AND HEALTH SCIENCES ETHICS COMMITTEE MEETING 21 October 2009 A meeting of the Ethics Committee was held on Wednesday 21 October at 2pm in RB02 Richards Building. Present: Dr David Brown (DB) Ms Alison Hume (AH) Dr Vicky Stiles (VS) Prof Adrian Taylor (AT) Dr Daryl Wiklerson (DW) Sociology Representative Committee Administrator Biomechanics Representative Psychology Representative (Acting Chair) Physiology Representative Apologies: Dr Gary O’Donovan (G’OD) Physiology Representative Rev Dr James Theodosius Lay Member Dr Jo Welsman (JW) Chair MINUTES 1. Welcome and Apologies AT, as acting Chair during JW’s absence, welcomed DW to his first meeting. 2. Minutes of Meeting 8/7/09 The minutes of the Ethics Committee meeting held on 8 July 2009 were AGREED and signed as an accurate record. 3. Matters Arising Item 3 – Chair’s Business It was noted that the sample Participant Information Sheet and the Consent Form in the Policy and Procedures document had still to be updated. Action: G’OD to produce sample Participant Information Sheet and Consent Form for the Ethics Policy and Procedures document Item 6 - Consideration of Submitted Proposals (Path B) Proposal 1 (8/7/09) Title: Recovery from non-functional overreaching in a young swimmer: A case study Applicant: Dr Richard Winsley with Associate Professor Craig Williams and Mr Nuno Matos (Research Student) The amendments required had been returned for approval by JW and the proposal had been APPROVED Proposal 2 (8/7/09) Title: Use of perceived exertion to predict maximal oxygen uptake during arm ergometry Applicant: Prof Roger Eston with Mr Harran Al-Rahamneh (Research Student) No amendments had been submitted. Proposal 3 (8/7/09) Title: Effect of fibre-type-specific glycogen depletion on ‘Critical Power’ and W’ Applicant: Prof Andrew Jones with Dr Daryl Wilkerson (Lecturer) and Mr Len Parker Simpson (Research Student) No amendments had been submitted. Proposal 4 (8/7/09) Title: The Effect of N-acetylcysteine on oxygen uptake Kinetics and exercise tolerance Applicant: Prof Andrew Jones with Professor Iain Campbell (Department of Anaesthesia, Wythenshawe Hospital, Manchester), Dr Daryl Wilkerson (Lecturer) and Mr Stephen Bailey (Research Student) The amendments required had been returned for approval by JW and the proposal had been APPROVED 1 Proposal 5 (8/7/09) Title: The effect of dietary nitrate on exercise tolerance and the kinetics of oxygen uptake and phosphocreatine degradation Applicant: Prof Andrew Jones with Dr Daryl Wilkerson (Lecturer), Dr Jonathan Fulford (PCMD) and Mr Stephen Bailey (Research Student) The amendments required had been returned for approval by JW and the proposal had been APPROVED Proposal 6 (8/7/09) Title: Muscle (Phosphocreatine) dynamics following the onset of moderate exercise: the influence of baseline work-rate Applicant: Prof Andrew Jones with Dr Daryl Wilkerson (Lecturer), Dr Jonathan Fulford (PCMD), Dr Anni Vanhatalo (Associate Research Fellow), Mr Fred DiMenna (Research Student) and Mr Stephen Bailey (Research Student) No amendments had been submitted. Proposal 7 (8/7/09) Title: Efficacy of cold water immersions on exercise induced muscle soreness Applicant: Dr Ann Rowlands with Mr Jinu Varghese (MSc Student) The amendments required had been returned for approval by JW and the proposal had been APPROVED Proposal 8 (8/7/09) Title: Mentro Allan – Phase 2 of the Project Applicant: Dr Jacquelyn Allen –Collinson with Dr Aspasia Leledaki (A,,,,), Professor N Curry (Countryside and Community Research Institute - CCRI) and Dr Michael Clark (CCRI) The amendments required had been returned for approval by JW and the proposal had been APPROVED 4. University Ethics Committee There were no new minutes to review. Action: AH to confirm the dates for future meetings for AT, while acting Chair. 5. Chair’s Business 5.1 New Risk Assessment Procedures for exercise in adults It was noted that there are new SSHS risk assessment procedures for exercise in adults and that these were circulated by David Childs on 21 September 2009. 5.2 Letter to the University Ethics Committee regarding research undertaken in early 2002 The letter to the Research and Knowledge Transfer office about the ethics of the data collection methodology which lead to the findings in Professor Ernst’s recent editorial publication ‘Chiropractic Treatment for Asthma’ was noted. In particular the highly delicate nature of deception and retrospective informed consent. 5.3 Chair’s Action for Project 6/5/09#2 It was reported that Mr Medj Nuaman (an undergraduate student) had replaced Mr Brian Street (MSc student) as a researcher on the project 6/5/09#2 and that this changed had been approved by Chair’s action over the summer. 5.4 Path A applications Summaries of the approved Path A staff applications (up to 21 October) and taught student applications received over the summer (previously circulated) were noted. It was requested that the word ‘trialist’ be amended to participant on the summaries. Action: AH to change the word ‘trialist’ to ‘participant’ on the summaries 2 6. Consideration of submitted proposals (path B) Proposal 1 (21/10/09) Title: The effect of dietary nitrate supplementation upon exercise performance and oxygen uptake dynamics Applicant: Prof Andrew Jones with Professor Paul Winyard (PCMD) and Ms Katherine Lansley (Research Student) The proposal (circulated previously) was discussed by the Committee. The Committee advised that the application should be amended as follows: i Ensure that participants are screened using the latest risk assessment procedures (September 2009) – see SSHS/HAZ/0078. ii Confirm that 3 years is a sufficient time to hold the raw data given that some publications require data to be held for 5 years post publication. Ensure that the length of time that the data will be stored is consistent throughout the documentation. iii Clarify whether recreationally active or highly trained individuals will participate – there are contradictions between page 4 and page 6 of the application form. iv Information Sheet – include the stated aims; information about what is being tested; how long each visit is likely to last; and the digestive implications. v Consent Form – reword point 4 so that it is clear how many occasions participants are required to attend. Decision: the Committee AGREED to provisionally approve the proposal until June 2010, but required the amendments outlined above (i-v). The amendments need to be returned to AH for approval by AT prior to the commencement of the study. Proposal 2 (21/10/09) Title: Calibration and validation of accelerometers with children Applicant: Dr Ann Rowlands and Associate Professor Gaynor Parfitt with Ms Lisa Phillips (Research Student) and Ms Charlotte Benjamin (Research Student) The proposal (circulated previously) was discussed by the Committee. The Committee advised that the application should be amended as follows: i Confirm that all researchers have an enhanced CRB disclosure obtained via the University of Exeter. ii Clarify the start and end dates of the project. iii Question 21 – confirm who will retain the data. iv Question 22 – provide details of all the SSHS risk assessments which will be used for the study, e.g. Exercise testing of children (SSHS/HAZ/0076). v Clarify that a period of familiarisation will be undertaken before data collection. vi Provide further details about a representative sample being asked to return – where will the activities take place, what will they do and for how long? vii . Information Sheet for Pupils – change the word ‘gadget’ (possibly use ‘activity monitor’ and include a picture); amend the last sentence on the first page as this is a little confusing; include details about how strenuous the maximal physical activity test will be; amend Gaynor Parfitt’s title to ‘Associate Prof’; include inclusion/exclusion information; and state how long the data will be stored for. viii Information Sheet for Parents – remove the first paragraph about the School; include Gaynor Parfitt’s details; clarify whether parents are allowed to stay; include details about how strenuous the maximal physical activity test will be; state how long the data will be stored for; include inclusion/exclusion information. Decision: the Committee AGREED to provisionally approve the proposal but required the amendments outlined above (i-viii). The amendments need to be returned to AH for approval by AT prior to the commencement of the study. Proposal 3 (21/10/09) Title: An observational study of involvement and enjoyment in under 12 and under 14 rugby union games Applicant: Dr Mark Wilson with Dr Chris Byrne and two MSc Students (yet to be identified) The proposal (circulated previously) was discussed by the Committee. The Committee advised that the application should be amended as follows: i Confirmation of all researchers be provided and that they have an enhanced CRB disclosure obtained via the University of Exeter. 3 ii Provide further details on the safety of the device from manufacturers – the Committee was particularly concerned about it’s use in competitive matches and safety of the child wearing it and of other children. iii Provide further information about the technique which will be used to video the games, who will be doing it and who will have access to the video. Provide details of RFU guidelines on using video. iv Player Information Sheet – please remove reference to ‘gadget’ – call it activity monitor; Highlight that the data will not be used by the Club or the Team; and state how long the data/video will be kept and who will have access to it. v Parent Information Sheet – please remove the first paragraph and state how long the data/video will be kept and who will have access to it. vi Produce an information sheet and consent forms for the players and parents of the players who will not be wearing the activity device, and the Referee so that they are aware that a modified piece of kit is being worn (the Committee was concerned that it might injure another player). Decision: the Committee AGREED to request that the application be amended taking into consideration (i-vi) and submitted for consideration by the next Committee or a mini Committee if a decision is required sooner. 7. Any Other Business 7.1 Terms of reference and membership The 2009/10 terms of reference and membership (circulated with the agenda) were considered and confirmed. 7.2 Review of applications by the Committee It was reported that G’OD had suggested that a summary of the review of applications by each Committee member be provided to AH at least 24 hours before the Committee meeting so that those applications with major concerns could be prioritised in the meeting, and those with minor concerns considered more quickly. The Committee discussed the suggestion but given that some Colleagues review the applications on the morning of the Committee and have other ways of noting their comments it was agreed not to adopt this suggestion. However, it was agreed that it would be useful if Reviewers could classify their concerns as ‘major’ or ‘minor’ and that AH would circulate the grid should Colleagues wish to use it. Action: AH to circulate the grid for reviewing applications It was noted that Melitta Winlove would be assisting JW’s undergraduate dissertation students during her absence and it was queried whether the ethics applications for these students should be signed off by a staff member. It was agreed that this should be the case and DW volunteered to offer assistance to these students and sign their ethics application forms. 8. Date of the Next Meeting The next Ethics Committee meeting was scheduled for 9 December 2009 4