Centre for Research Ethics & Bioethics (CRB)

Debate: Macchiarini scandal - speech of grey-zone lacks foundation

2016-03-10

After the scandal with experimental surgeries at Karolinska Institutet where surgeon Paolo Macchiarini used synthetic windpipes, there has been talk of grey-zones in Swedish legislation. Today, a number of Swedish ethics researchers publish a debate article claiming this is not true.

The scandals surrounding Paolo Macchiarini’s trachea surgeries and subsequent debacle at Karolinska Institutet and the Karolinska University Hospital raises both ethical and legal questions. Several medical doctors and ethicists have stated that these surgeries were possible because of a so called “grey-zone” between regular hospital care and the legislation surrounding ethical review of research and approval of drugs and new medicinal products. The Swedish government have promised to review the current ethical review legislation and two parallel inquiries into this grey-zone have been advertised.

A group of ethics researchers from six Swedish universities published a debate article in Svenska Dagbladet today. They claim this speech of grey-zone lacks foundation. It seems there are rumors in Swedish research institutions regarding what is permitted according to current regulation. This is becoming clear in the light of Macchiarinis surgeries at the Karolinska University Hospital and recently noted procedures performed at the Sahlgrenska University Hospital in Gothenburg.

Ulrik Kihlbom, Senior lecturer in Medical Ethics, and Stefan Eriksson, Senior Lecturer in Research Ethics, both at CRB, are among the authors.

Read article (in Swedish)

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