The following changes were requested to the PIS and consent form: Please insert name and contact details for study staff (page 6 of the PIS). Please provide a separate optional PIS and consent form for future unspecified research. Please include contact details for Māori cultural support. Please amend the PIS to state have read or had read to me”. ““I Please include an approximate figure on the PIS for reimbursement of expenses. Decision This application was provisionally approved by consensus subject to the following information being received. Please amend the PIS and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies, para 6.22). The response from the researcher will be reviewed, and a final decision made on the application, by Mrs Sandy Gill and Mrs Gael Donoghue. 8 Ethics ref: 13/CEN/183 Title: Transfer from Methadone to Buprenorphine Principal Investigator: Dr David Newcombe Sponsor: South EAstern Sydney Local Health District (SESLHD Clock Start Date: 14 November 2013 Dr David Newcombe, Associate Professor Nicholas Lintzeris, Dr Susanna Galea, Dr Stefanie Leung and Ms Carina Walters were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of ethical issues The main ethical issues considered by the Committee were as follows. The Committee congratulated the researcher on a well put together and thorough application and noted that the purpose of this application was to evaluate a standardised procedure of transferring patients from methadone to suboxone to identify best practice. The Committee advised that in order to have informed consent, a summary of inclusion and exclusion criteria for participants should be included in the PIS. The Committee asked whether the researchers were intending to store and use tissue for future research. The researchers advised that they would not and agreed to remove this paragraph from the PIS (page 5). The Committee asked why participants had one week to decide whether to participate in the study. The researcher explained that this was just to give them enough time to make a decision and so that participants could discuss this with their case worker.
The following changes were requested to the PIS and consent form: Please insert name and contact details for study staff (page 6 of the PIS). Please provide a separate optional PIS and consent form for future unspecified research. Please include contact details for Māori cultural support. Please amend the PIS to state ““I have read or had read to me”. Please include an approximate figure on the PIS for reimbursement of expenses. Decision This application was provisionally approved by consensus subject to the following information being received. Please amend the PIS and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies, para 6.22). The response from the researcher will be reviewed, and a final decision made on the application, by Mrs Sandy Gill and Mrs Gael Donoghue. 8 Ethics ref: 13/CEN/183 Title: Transfer from Methadone to Buprenorphine Principal Investigator: Dr David Newcombe Sponsor: South EAstern Sydney Local Health District (SESLHD Clock Start Date: 14 November 2013 Dr David Newcombe, Associate Professor Nicholas Lintzeris, Dr Susanna Galea, Dr Stefanie Leung and Ms Carina Walters were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of ethical issues The main ethical issues considered by the Committee were as follows. The Committee congratulated the researcher on a well put together and thorough application and noted that the purpose of this application was to evaluate a standardised procedure of transferring patients from methadone to suboxone to identify best practice. The Committee advised that in order to have informed consent, a summary of inclusion and exclusion criteria for participants should be included in the PIS. The Committee asked whether the researchers were intending to store and use tissue for future research. The researchers advised that they would not and agreed to remove this paragraph from the PIS (page 5). The Committee asked why participants had one week to decide whether to participate in the study. The researcher explained that this was just to give them enough time to make a decision and so that participants could discuss this with their case worker.
cen-minutes-26-nov-13.docx