(P.4.2) For future applications please delete the first sentence. (F.1.1) The Committee this should be no. The Committee does not accept that some participants who are consented and screened will not become participants if enrolment is filled during screening. Please clarify if participants can be involved in any other kinds of research or does this only mean clinical trials. Amend PIS to clarify. Is separate authorisation to access medical records required in New Zealand? Please clarify this statement in the PIS. Please explain records that are withheld from participants during study? Why is this? The Committee noted that participants can withdraw verbally, written withdrawal is not required. The Committee requested the following changes to the Participant Information Sheet and Consent Form: Please clarify for participants what an supplement’ is. ‘anti-cancer Change investigator to study doctor. Remove flip of coin to explain randomisation. Please explain timeframes in lay language. Please explain study procedures in lay language needs elaboration. – Please explain how study doctors will determine which family member will be called. Please review for American spelling US law, terminology care’. – – ‘comfort Please include severity, duration and management options for side effects / risks. Pg.12 please explain archived tissue to participants. – avoid problems at a later stage’ please reword this (pg.12) make it an open ‘to – – invitation. Pg.13 destroying samples in event of not being able to be destroyed? When would this – – occur? Please address this point. Pg.13 remove by U.S. law’. – ‘required Please use ACC statement from HDEC template. Refer to HDEC NTB on pg.15 Please include short lay language title (PIS/CF). Please review language relating to death of participants. Is insensitive. No need to withdraw in writing verbally is sufficient – Pg.10 please explain what a local label is for participants. – Genetic sub study pg.3 insert Maori support contact details – Decision This application was provisionally approved by consensus, subject to the following information being received. Please provide a separate Participant Information Sheet and Consent Form for the use of tissue for future unspecified research (Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes, para 2).
(P.4.2) For future applications please delete the first sentence. (F.1.1) The Committee this should be no. The Committee does not accept that some participants who are consented and screened will not become participants if enrolment is filled during screening. Please clarify if participants can be involved in any other kinds of research or does this only mean clinical trials. Amend PIS to clarify. Is separate authorisation to access medical records required in New Zealand? Please clarify this statement in the PIS. Please explain records that are withheld from participants during study? Why is this? The Committee noted that participants can withdraw verbally, written withdrawal is not required. The Committee requested the following changes to the Participant Information Sheet and Consent Form: Please clarify for participants what an ‘anti-cancer supplement’ is. Change investigator to study doctor. Remove flip of coin to explain randomisation. Please explain timeframes in lay language. Please explain study procedures in lay language – needs elaboration. Please explain how study doctors will determine which family member will be called. Please review for American spelling – US law, terminology – ‘comfort care’. Please include severity, duration and management options for side effects / risks. Pg.12 – please explain archived tissue to participants. ‘to avoid problems at a later stage’ – please reword this (pg.12) – make it an open invitation. Pg.13 – destroying samples – in event of not being able to be destroyed? When would this occur? Please address this point. Pg.13 – remove ‘required by U.S. law’. Please use ACC statement from HDEC template. Refer to HDEC NTB on pg.15 Please include short lay language title (PIS/CF). Please review language relating to death of participants. Is insensitive. No need to withdraw in writing – verbally is sufficient Pg.10 – please explain what a local label is for participants. Genetic sub study pg.3 – insert Maori support contact details Decision This application was provisionally approved by consensus, subject to the following information being received. Please provide a separate Participant Information Sheet and Consent Form for the use of tissue for future unspecified research (Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes, para 2).
ntb-4-nov-14-meeting-minutes.docx