Effect of home-based "Kangaroo Mother Care” on infant intake of breast milk, intestinal inflammation, and signs of mothers’ birth depression and stressSaksnr. NEM 2019/114, REK Vest 2019/31 [Complaint]
Appeal against the decision by Feb.19th 2019 where REC West rejected application for post-approval of the subproject. The subproject was submitted for approval at first, but REC found that the project was started in 2017 and the application had to be considered as an application for post- approval.
This is a subproject of a project that has been evaluated and approved by REC in 2015 (2015/1486). The main project was approved as a randomized controlled trial of the effect of kangaroo mother care method on early child deaths in India. In the subproject the aim is to explore the effect of (KMC; skin-to-skin contact and exclusive breast feeding) on intake of breast milk, infant gut inflammation and postpartum depressive symptoms.
REC West found that the conditions for post-approval was not fulfilled and denied approval of the study.
The Principal Investigator appealed the decision on March 3rd 2019. The main reasons for appeal are as follows:
The protocol for the main project states that sub-studies will be applied for to a local REC. In case of a discrepancy, the wording in the protocol has priority over the wording in the application form. In accordance with wording in the protocol, the project has received approval from at local Indian REC.
REC considered the study to be of interest and had no remarks to the quality of the project, but still considered that the conditions were not met. REC forwarded the case for considerations to The National Committee.
With some doubt, The National Committee considers that the condition of “good faith” is met. The committee considers that the study should be approved.
The appeal on REC west’s decision not to give an afterwards approval of the sub-study “Effect of home-based «Kangaroo Mother Care” on infant intake of breast milk, intestinal inflammation, and signs of mothers’ birth depression and stress”, is accepted.
The project is approved according to the health research act § 10.
According to the new personal information act and GDPR article 24, the controller, i.e. the head of the institution, must be able to demonstrate that the processing of information in the project is performed in accordance with the Regulation.
If substantial changes in the project are to be made, an application must be submitted to the REC that has granted the prior approval.
The project manager must submit a final report to the regional committee for medical and health research ethics when the research project is finished. The final report must present the findings objectively and methodically, ensuring that both positive and negative findings are presented.
The approval is valid until December 31st 2023. The project manager must submit a final report to the regional committee for medical and health research ethics within six months after the research project is finished. Information that are necessary for auditing the project can be kept until 2028.
The Committee’s decision is final and cannot be appealed.