Document is current

Article History

Received: 15 November 2018

Accepted: 2 July 2019

First Online: 6 July 2019

Ethics approval and consent to participate

: A copy of the protocol, informed consent forms, additional information to be completed by the participants, such as survey instruments or questionnaires, proposals, and any other advertising/contracting material has been approved by the NIEHS IRB and all participating local IRBs.The investigators are responsible for obtaining approval from the NIEHS IRB and all participating local IRBs of the ongoing continuing review throughout the entire duration of the study. The investigator must notify the NIEHS IRB and all participating local IRBs of serious adverse events and protocol violations per their requirements.This protocol is considered to be of minimal risk. Parents of newborns who fulfill the inclusion criteria are approached for the study by the trained neonatologist who is not the primary care physician. Parents who are interested are provided with written copies of the consent form by the neonatologist and are given ample opportunity to study the consent, process the information in the document, and ask questions about the study in order to make an informed decision about study participation. Individual questions are answered at the end of the consent session. The Associate Investigator, or an authorized designated person, discusses the consent with the participant and answer his/her questions. The participant is informed that study participation is voluntary and that s/he can withdraw from the study at any time and for any reason. All participants, as well as the person obtaining consent, must read, sign, and date two original copies of the consent form before study participation. One copy is maintained in the participant’s study file at the hospital, and a second copy is given to the participants for their records. The consent process is conducted in a private location in order to maintain patient confidentiality. The acquisition of informed consent is documented in the participant’s medical records. All informed consent discussions and written consent forms are delivered in Argentinian Spanish.

: There is no individual person’s data involved in this investigation.

: The authors declare that they have no competing interests.