Chief Legal Counsel Anna Hörnlund, who wrote a letter in this week's The Lancet, says Macchiarini's work needed to obtain ethical approval from one of six
regional ethical review boards, as required by Swedish law — and neither Macchiarini nor his former employer, Karolinska Institutet, did so:
This study was approved by
the regional ethical review board of Gothenburg, Sweden, which issued a waiver regarding the need for patient informed consent.
This study was approved by
the regional ethical review board in Umeå, Sweden, and conformed to the Declaration of Helsinki.28