ABSTRACT
It is normal practice to obtain informed consent from parents for research on newborn infants. For consent to be valid parents must be deemed to be mentally competent, have received appropriate information, and be able to understand the information and give consent voluntarily. Between January 1997 and September 1998, semi-structured interviews were performed with the parents of 200 infants and with 107 neonatologists in nine European countries. The interviews were conducted by bi-lingual English/native language speaking research assistants who were unknown to the parents. Translations of interview transcripts were performed in each country by either the interviewer, the study partner or an independent translator. Original transcripts of the interviews were reviewed to perform quality checks. The most common problems reported included that: they were overwhelmed by emotions and thus unable to think clearly; research at the time was a minor concern as they were preoccupied with the welfare of the baby.
