The Case: A Full IRB Committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers intera
ct with their learning disabled child. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. The Committee determined that the mother's required task may upset the child. The IRB approved the study with appropriate language in the parental permission form regarding the possibility that children might become upset. The Question: After the start of the study, the PI reports to the IRB that, as expected, one of the children became upset. The incident was handled according to the protocol and the child is fine. What should the IRB do with regard to this report?
IRB means Institutional Review Board. It is also known as an independent ethics committee whose main purpose is to protect the rights and welfare of human subjects used in research under its institution and making sure that research methods used are ethical. Since the incident has been handled according to protocol and the child is no longer upset then there is nothing left for the IRB to do as regards the report as long as the research was ethical and approved and got parental permission.
