The principal investigator decides to immediately cease the process of discarding selected data.
The principal investigator has decided to stop the process of discarding portions of the data due to the future possibility of identifying these infants in case a treatment or cure could be found for their ailments in the future and argue that case. These are some possible outcomes:
|  | The principal investigator fails to notify the IRB about the change in protocol.
|  | The principal investigator notifies the IRB about the change in protocol, yet does not feel the need to report this in the article he submits for publication.
|  | The principal investigator notifies the IRB about the change in protocol. In addition, he decides to write at some length about the need to consider this issue in the article he submits for publication.