Ms Leith Pugmire and Dr Natasha Tassell-Matamua 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 Study The study investigates the effect of an antenatal evidence-based parenting workshop and a sling on the health outcomes and development of newborn infants. Participants will be randomised to a waiting list control or the intervention group. Intervention group participants will participate in a parenting workshop and be given a sling. After one year control participants will participate in a workshop and receive a sling. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried if the researchers will provide the Ministry of Health guidance on bed sharing. The researchers explained that they will. The Committee queried why other methods will be presented if the Ministry of Health guidelines have been presented. The researcher explained that international research shows that not talking about methods of bed sharing and the issues arising from these is correlated with negative outcomes. The committee stated that due stress should be placed on NZ guidelines for both sleeping and feeding and that no sense of blame for birthing interventions be presented. The Committee queried the Quaker grant that was received by the researcher and if the Quakers would have any interaction with the study. The researchers explained that they received a Quakers scholarship but otherwise they have no impact, control, or access to the study. The Committee queried the blinding of the study. The researcher explained that to not blind participants could contaminate the results and would make the control group no longer a control. The Committee queried the age range of mothers. The researcher explained that there is no age range and mothers will be randomised. The Committee queried if low recruitment would have an effect on the powering of the study. The researchers explained that previous studies with low numbers have been powered and that they are prepared to extend the recruitment phase of the study as required. The Committee requested the following changes to the Participant Information Sheet and Consent Form, and Advertisement: Please make sure the information sheet explain that participants may be allocated to the control arm of the study. Please check the language of the information sheet for complexity. The Committee felt that the language was too scientific and not layperson friendly.
Ms Leith Pugmire and Dr Natasha Tassell-Matamua 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 Study The study investigates the effect of an antenatal evidence-based parenting workshop and a sling on the health outcomes and development of newborn infants. Participants will be randomised to a waiting list control or the intervention group. Intervention group participants will participate in a parenting workshop and be given a sling. After one year control participants will participate in a workshop and receive a sling. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried if the researchers will provide the Ministry of Health guidance on bed sharing. The researchers explained that they will. The Committee queried why other methods will be presented if the Ministry of Health guidelines have been presented. The researcher explained that international research shows that not talking about methods of bed sharing and the issues arising from these is correlated with negative outcomes. The committee stated that due stress should be placed on NZ guidelines for both sleeping and feeding and that no sense of blame for birthing interventions be presented. The Committee queried the Quaker grant that was received by the researcher and if the Quakers would have any interaction with the study. The researchers explained that they received a Quakers scholarship but otherwise they have no impact, control, or access to the study. The Committee queried the blinding of the study. The researcher explained that to not blind participants could contaminate the results and would make the control group no longer a control. The Committee queried the age range of mothers. The researcher explained that there is no age range and mothers will be randomised. The Committee queried if low recruitment would have an effect on the powering of the study. The researchers explained that previous studies with low numbers have been powered and that they are prepared to extend the recruitment phase of the study as required. The Committee requested the following changes to the Participant Information Sheet and Consent Form, and Advertisement: Please make sure the information sheet explain that participants may be allocated to the control arm of the study. Please check the language of the information sheet for complexity. The Committee felt that the language was too scientific and not layperson friendly.
sth-22_nov-16-meeting-minutes.docx