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UPPER SOUTH A REGIONAL ETHICS COMMITTEE Minutes of the meeting of 28 May 2007, 16:00hrs Meeting held in the Boardroom on level 4, Charles Luney House, 250 Oxford Terrace, Christchurch APOLOGIES Ellen McCrae, Jane Kerr, Liz Richards PRESENT Carolyn Mason (Chair), Alison Luckey (Deputy Chair), Carolynn Bull, John Horwood, Tom Marshall, Edie Moke, Nicky Murray, Russell Scott, Alieke Dierckx (Administrator) Sharon English attended as expert advisor. Meeting commenced at 16:10hrs. NEW PROTOCOLS 1. Investigating cortical contribution to pre-motor planning of volitional and naive swallows using the Bereitschafspotential Investigators: P Macrae, Dr ML Huckabee (Supervisor), Prof R Jones Ethics ref: URA/07/05/035 Spokesperson: Edie Moke Approved subject to amendments Edie Moke to review. Requests - The application form indicates consultation has taken place with Dr Gail Gillon. Information sheet - P2 paragraph 2: Please explain or re-word “the influence of arousal and attention on swallowing”. - Clarify how many visits are involved, and the duration of the visits. The information given in response to question B1 of the application form does not correlate with what is stated in the information sheet. - P3 section 7. What is the likelihood of further data being required? If participants are required to return for a second visit, how long will this visit be? Will participants then receive extra reimbursements? - P3 Risks and benefits: Please rewrite the second sentence to read, “There are no direct benefits to you as an individual. You will be paid $150 to reimburse your time and travel expenses. - In other studies offering payments to participants, the Committee has noted that participants’ benefits have been affected. WINZ has regarded the entire time of participant involvement in the study (even for example one visit per week over 6 weeks) as being a period of paid employment, and benefits have been stopped URA Minutes 28 May 2007 1 over this period of time. It is suggested to investigate whether participants in this study will be affected in this way, and if so, the Information Sheet should state that benefits may be affected by the reimbursements paid for participation. Please contact the Administrator for details. - State that this is student research. Questionnaire - Please reword the first question to read, “Which ethnic groups do you belong to?” - Reword the first sentence to read, “Please complete the following questionnaire by ticking the boxes that are most applicable to you.” - Please remove the phrase ‘suffer from’. Does this question refer to current or past problems, or both? Clarify. - Clarify how much detail is required about current medications (eg name/dosage etc). Advertisement - Paragraph 1: Please reword the last sentence to read, “There are no known risks associated with any procedures used in this study.” - Is it expected that participants will experience any discomfort during the study? If so, this should be stated. General - The committee wishes to compliment the researcher on their clear application and information sheet. 2. Coming to terms with serious mental illness Investigator: Dr A Scott Ethics ref: URA/07/05/036 Spokesperson: Tom Marshall Dr Scott attended the meeting. Approved subject to amendments Tom Marshall and Edie Moke to review Requests - Written evidence of Maori consultation is required. - A locality assessment is required from MHERC, Pacific Trust and Te Awa o te Ora Information sheet - The information sheet and consent form must be printed on letterhead. - P1 What research?: Clarify ‘living process’. - P1 Who may take part?: State that participants over the age of 18 are sought. - Some participants may become distressed and/or unwell during the interviews. Explain how this will be dealt with and include this information in the information sheet. - State in the information sheet what topics will be covered in the interview. - State that a person who is happy to have the interview audiotaped may be chosen to participate in preference over someone who is not. - The footers of the information sheet and consent form must contain the full study title, a version number and/or date. URA Minutes 28 May 2007 2 - Include the following information: If you have any questions or concerns about your rights as a participant in this research study you can contact an independent health and disability advocate. This is a free service provided under the Health and Disability Commissioner Act. Telephone: (NZ wide) 0800 555 050 Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT) Email (NZ wide): [email protected] - Include the following statement: “This study has received ethical approval from the Upper South A Regional Ethics Committee.” - P1 Risks and benefits: Please find an alternative for ‘sufferers’. - P2 Confidentiality: Please amend the last sentence to read, “You may choose to have the tapes either returned to you or destroyed at the end of the study, and transcripts will be deleted.” - P2 Who am I?: Please reverse the order of the two sentences in this section. Consent form - How will transcripts and audiotapes be returned to participants? It may be necessary to make an arrangement with the participant individually. This should be registered on the consent form. - If anyone other than the researcher transcribes the interview tapes, the transcriber will need to sign a confidentiality agreement. State in the information sheet who will transcribe the tapes. General - With regard to offering karakia before/during the interviews, further discussion with the Maori advisor is recommended. Clarify how this will be made available (ie who will carry this out), and explain this in the information sheet and consent form. Suggestions - It is suggested to focus on thoughts rather than feelings, because people generally find it easier to put their thoughts into words. - Questionnaire: The questions about support groups and resources could be extended to include family/friends/whanau. - Information sheet: It is suggested to put the text of the ‘results’ section under ‘what research’ on page 1. 3. Why are skin cancers more aggressive in renal transplant patients? Investigators: Dr K Mackenzie, Prof J Roake (Supervisor), A/Prof B Robinson, Dr M Currie, Dr G Dachs, Dr S Langley, A/Prof J Stanek Ethics ref: URA/07/05/037 Spokesperson: John Horwood Approved subject to amendments John Horwood to review Requests - A locality assessment from the School of Medicine is required. General - Are these tissues being tissue-banked? If so, a consent process should be put into place. - Where possible, consent for the use of the tissue samples for this study should be obtained. URA Minutes 28 May 2007 3 - The data must be kept for 10 years. 4. Differences in patient's results and perception of the effort required while performing spirometry using different manoeuvres Investigators: Dr M Swanney, LE Beckert, C Frampton, J Stanton, K Wilson Ethics ref: URA/07/05/038 Spokesperson: Nicky Murray Approved subject to amendments Nicky Murray to review Application form - For future reference, it should be noted that the summary of page 3 (section 17) must be in lay language. Information sheet - In order to allow ample time to consider whether to take part, the information sheet should be sent with a covering letter at the same time as appointment confirmation letters are sent. - Consider a lay alternative for ‘vital capacity measurements’ in the title. - P2 Compensation: The updated text for this section is as follows: “In the unlikely event of a physical injury as a result of your participation in this study, you may be covered by ACC under the Injury Prevention, Rehabilitation and Compensation Act. ACC cover is not automatic and your case will need to be assessed by ACC according to the provisions of the 2002 Injury Prevention Rehabilitation and Compensation Act. If your claim is accepted by ACC, you still might not get any compensation. This depends on a number of factors such as whether you are an earner or non-earner. ACC usually provides only partial reimbursement of costs and expenses and there may be no lump sum compensation payable. There is no cover for mental injury unless it is a result of physical injury. If you have ACC cover, generally this will affect your right to sue the investigators. If you have any questions about ACC, contact your nearest ACC office or the investigator.” - P3 Advocacy: The updated text for this section is as follows: ”If you have any questions or concerns about your rights as a participant in this research study you can contact an independent health and disability advocate. This is a free service provided under the Health and Disability Commissioner Act. Telephone: (NZ wide) 0800 555 050 Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT) Email (NZ wide): [email protected] - Please remove the section “I understand that if I have any complaints or concerns about this research” (including the administrator’s contact details) from both the information sheet and consent form. It is more appropriate for participants to contact researchers. - Please refer to the committee as the Upper South A Regional Ethics Committee. - The footers of the information sheet and consent form should contain the full study title, a version number and/or date. General - Will the 192 participants include the 10 control group participants? URA Minutes 28 May 2007 4 5. PROTECT-PACE STUDY - The protection of the left ventricular function during right ventricular placing. Does right ventricular high-septal pacing improve outcome compared with right ventricular apical pacing. Protocol version 1.10 dated 25/11/2006 Investigators: Dr I Crozier, Dr I Melton, Dr R Park, Dr R Troughton Ethics ref: URA/07/05/039 Spokesperson: Russell Scott Approved subject to conditions Russell Scott to review Requests - Please forward the NRL certificate as soon as it is available. - A Part 5 Human Tissue declaration is required. - The committee would like to view the standard pacemaking information pamphlet that is handed out to these patients. Application form - P7 QA8.1: It is noted that this section has not been completed accurately. - P10 QB16: Please complete this section. - P11 QC3: The compensation offered must be at least equal to what ACC would offer. Information sheet - Provide a meaningful lay title - The information sheet and consent form must be written in lay language. Please check both documents. - State that this is a sponsored trial and identify the sponsor. - P2 Procedure: The second paragraph mentions that data will be saved on a diskette. Please clarify what will happen to this diskette. - Include a ‘confidentiality’ paragraph that explains whether data will be anonymised, how it will be stored and destroyed etc. - Specify where the blood samples will be sent for analysis, and explain how they will be disposed of. - P2 Purpose: Please amend the first sentence to read, “You are invited to participate in a clinical study comparing…”. - P4 General Information: Please provide the departmental telephone number rather than the main switchboard number. - P4 General Information: Please update the Advocacy Service information as follows: If you have any questions or concerns about your rights as a participant in this research study you can contact an independent health and disability advocate. This is a free service provided under the Health and Disability Commissioner Act. Telephone: (NZ wide) 0800 555 050 Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT) Email (NZ wide): [email protected] - Please refer to the committee as the Upper South A Regional Ethics Committee Suggestions - To clarify the procedure, it is suggested to include a diagram in the information sheet. URA Minutes 28 May 2007 5 Consent form - P6: Please provide the departmental telephone number rather than the main switchboard number. 6. SPIRIT V - A clinical evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the treatment of patients with de novo coronary artery lesions - protocol 05-369, version 6.0 dated 22/11/2006 Investigators: Dr D McClean, Dr D Smyth, A/Prof J Elliot, Prof M Richards, Dr A Moynagh Ethics ref: URA/07/05/040 Spokesperson: Alison Luckey Approved subject to amendments Alison Luckey to review Requests - Form B: The sixth bullet point (“Relationship of proposed research…”) has not been answered fully. - As extra blood will be taken for CK and CK-MB analysis, a Part 5 Human Tissue declaration is required. - Please forward written evidence of Maori consultation as soon as it is available. Application form - P8 QA8.1: It is noted that this section has not been completed accurately. - P11 QC3: The compensation offered must be at least equal to what ACC would offer. Information Sheet - Provide a more meaningful lay title. - Pease ensure lay language is used throughout the information sheet and consent form. - P1 Introduction: State that 50 participants are sought in Christchurch. - P5: The information about Advocacy services should read, “If you have any questions or concerns about your rights as a participant in this research study you can contact an independent health and disability advocate. This is a free service provided under the Health and Disability Commissioner Act. Telephone: (NZ wide) 0800 555 050 Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT) Email (NZ wide): [email protected] Consent form - P7 3rd statement: Please change ‘NZ Multi-Region Ethics Committee’ to ‘Upper South A Regional Ethics Committee’. General - Clarify who is paying for the stents. Suggestions - P5, first statement: It is suggested to remove ‘unbiased’. URA Minutes 28 May 2007 6 7. Residual hearing levels post-surgery for the Southern Cochlear Implant Program baseline levels Investigators: G Vraich, Dr V Looi (Supervisor), P Bird Ethics ref: URA/07/05/041 Spokesperson: Edie Moke G Vraich and Dr V Looi attended the meeting Approved subject to amendments Edie Moke, Carolynn Bull, John Horwood to review Requests - A locality assessment is required from the University of Canterbury. Application form - P13 QF3.1: The committee is unsure what the answer to this question means. The researcher is encouraged to discuss further with their Maori advisor and forward a comment to the committee. Information sheet - Please provide a clearer lay title. - The committee should be referred to as the ‘Upper South A Regional Ethics Committee’. - The footers of the information sheet and consent form should contain the full study title, a version number and/or date. - Please avoid the use of abbreviations such as CI. - Please simplify the language of the information sheet and introduction letter. General - The study data must be stored for 10 years 8. A multicenter, randomised, double-blind, placebo-controlled, parallel-group study of intravenous Methylnaltrexone (MOA-728) for the treatment of post operative Ileus. Protocol 6.0 01/03/2007 Investigators: Prof F Frizelle, Dr G Robertson, Dr J Frye Ethics ref: URA/07/05/042 Spokesperson: Sharon English Approved subject to amendments Nicky Murray, Alison Luckey and Sharon English to review Requests - Please forward a Part 4 declaration signed by Professor Frizelle as soon as it is available. - A Form B is required. Application form - P12 Section C: This study is a clinical trial. Please complete section C. Information sheet - Provide a meaningful lay title. - Please ensure lay language is used throughout the information sheet and consent form. - Ensure the information is appropriate for New Zealand – for instance, attention is required where drugs are mentioned that are not available in New Zealand. URA Minutes 28 May 2007 7 The information sheet refers to the ‘study doctor’s office’. This is generally known as the ‘research office’. - P1 Introduction: Please remove the third paragraph in this section. - P1 Introduction: State how many participants are sought in Christchurch. - P2 first paragraph: This information may be better placed at the beginning of the first paragraph in the introduction section. - P2 second paragraph: This information is repeated elsewhere in the information sheet. - P2 Test article: Please amend the first sentence of the second paragraph to read, “The medication will be given to you through a vein in your arm…). - P6 Risks to unborn children: The committee raised a query regarding the period of time that a male participant in the study should continue to use birth control after completing the study. It is thought that this may be 72 days rather than 15 days. - Include the information that 50% of people taking the study drug experience abdominal pain. - Please provide the contact details of the Principal Investigator rather than Dr Dobbs on the information sheet. General - Please clarify why epidural pain relief is not available to participants post surgery. Explain what the standard practice is. - Please clarify why participants taking placebo are not permitted to take laxatives. - Explain how screening for Hepatitis and HIV will be carried out. Suggestions - It is suggested to use ‘medication’ rather than ‘test article’. - It is not necessary to state in the information sheet that a mobile or home phone is required as this can be determined at screening. - 9. Pre-to-post cochlear implant surgery comparisons for speech and environmental sound perception Investigators: J Arnephy, Dr V Looi (Supervisor) Ethics ref: URA/07/05/043 Spokesperson: John Horwood J Arnephy and Dr V Looi attended the meeting. Approved subject to amendments John Horwood, Edie Moke and Carolynn Bull to review Requests - Please submit the invitation letter for ethical approval. - P12 QE2: The ‘statement of rights’ was not included in the application. Please submit this document. - A locality assessment from the University of Canterbury is required. Application form - P13 QF3.1: The committee is unsure what the answer to this question means. The researcher is encouraged to discuss further with their Maori advisor and forward a comment to the committee. URA Minutes 28 May 2007 8 Information sheet - The information sheet is not appropriate for the control group. Please submit a suitable sheet for review. - Please simplify the language of the information sheet. - The term ‘participants’ is preferred to ‘subjects’. - The footers of the information sheet and consent form must contain the full study title, a version number and/or date. - Please refer to the committee as the ‘Upper South A Regional Ethics Committee’. Consent form - The consent form should be rewritten according to the guidelines. General - Please clarify how the control group will be recruited. MATTERS ARISING 1. Is CNP/NTproCNP better than PSA as a marker of prostate cancer? Investigators: Prof G Nicholls, Prof T Yandle, Dr T Prickett, Mr F Kueppers, Mr P Davidson Ethics ref: URA/07/04/028 Spokesperson: Sharon English Approved subject to conditions Sharon English, Alison Luckey and Edie Moke to review Requests - A locality assessment from the Christchurch School of Medicine is required. - A Part 5 Human Tissue declaration is required. - Please provide evidence of Maori consultation. Information sheet - If it is intended to use the data from this study in future research, this must be included in the information sheet and consent form. - Repeat the departmental telephone number at the end of the information sheet. - Include the full study title, a version number and/or date in the footer of the information sheet and consent form. General - Please explain whether in going through medical records, cardiovascular information will be used and linked to cardioendocrine information, for additional studies. If so, this must be included in the information sheet. CORRESPONDENCE 1. Letter from G Witte, Secretary of the Human Ethics Committee, University of Otago The committee is unsure what Mr Witte means. Please clarify. URA Minutes 28 May 2007 9 MINUTES OF LAST MEETING Minutes of meeting 28 April 2007 Approved. PROTOCOLS GIVEN FINAL ETHICAL APPROVAL UNDER DELEGATED AUTHORITY 1. Comparison of late-night salivary cortisol levels with standard screening tests for Cushing’s Syndrome in obese patients with type 2 Diabetes Investigators: Dr E Ellis, Dr S Soule, Dr P Hunt, Dr H Lunt Locality: Christchurch Hospital Ethics ref: URA/07/03/018 The Committee is satisfied that this study is not being conducted principally for the benefit of the manufacturer or distributor of the medicine or item in respect of which the trial is being carried out. 2. Endometrial sampling and receptivity study Investigators: G Evans, Mr G Phillipson, Dr P Benny Localities: Christchurch Women’s Hospital, St George’s Hospital Ethics ref: URA/07/03/021 The Committee is satisfied that this study is not being conducted principally for the benefit of the manufacturer or distributor of the medicine or item in respect of which the trial is being carried out. PROGRESS REPORTS SUBMITTED 1. Genes, Behaviour, Personality and Anorexia Nervosa Investigator: Prof P Joyce Ethics ref: CTY/02/10/158 Allocated to: Tom Marshall 2. Low-dose Cytotoxics as “Anti-angiogenesis Treatment” following Adjuvant Induction Chemotherapy for Patients with ER-negative and PgR-negative Investigator: Prof B Robinson Ethics ref: CTY/02/10/163 Allocated to: Alison Luckey FINAL REPORTS SUBMITTED 1. Neurodevelopmental outcomes of Very Low Birth Weight Infants at Age 4 years: Role of Neuroanatomical and Socio-Environmental Factors Investigator: Dr L Woodward Ethics ref: CTY/02/10/174 Allocated to: Nicky Murray URA Minutes 28 May 2007 10 2. Quality of drinking-water and its relation to gastrointestinal disease in children Investigator: A Ball Ethics ref: CTY/01/03/026 Allocated to: Sharon English SUMMARIES OF RESULTS RECEIVED 1. Neurodevelopmental outcomes of Very Low Birth Weight Infants at Age 4 years: Role of Neuroanatomical and Socio-Environmental Factors Investigator: Dr L Woodward SERIOUS ADVERSE EVENTS SAEs 16 April 2007 – 14 May 2007 (see separate listing) Meeting concluded at 19:50hrs URA Minutes 28 May 2007 11