Consenting
Philipp Bonhoeffer broke the standards of medical consenting.
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He encouraged the patient to bring relatives or friends to the consenting process. He proposed to make a filmed document of the consenting procedure to be handed to the patient after the consenting process. This served a double purpose. On the one hand it was meant to give the patient full trust that the consenting was complete and appropriate because the possibility to go back to this document should provide him security that everything was dealt with in full and honestly. The other purpose was that Philipp Bonhoeffer could discuss the approach to consenting for new procedures in the academic environment and develop more appropriate consenting procedures for the introduction of innovations.
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The patient agreed to have the consenting procedure filmed and decided to bring two relatives along. On the tape Philipp Bonhoeffer made almost provocative opening statements. He said that if this procedure was going to be a success he would eventually become a rich man. He informed that he would be receiving royalties and that therefore he was biased and that his opinion of the procedure needed to be interpreted as an opinion of somebody who had a genuine bias. Then he went on to tell the patient what he did to mitigate his personal bias in the decision making (he encouraged the patient to go to search for different opinions, informed about colleagues who had different views and why….).
First patient after the procedure holding part of his medical file.
Further he stated that in his earlier experience with the Melody Valve he had had unforeseen events. He said that he expected unforeseen events again and therefore could not fully consent the patient. In his Melody experience he said that after unforeseen events had happen he could usually understand them in full and avoid for them to happen again. He therefore concluded that he had made mistakes and later was able to correct them. He went on to tell the patient that he expected to make mistakes again in the application of this new technology. He differentiated between negligence and mistakes and said that his patient had to understand that medical error of Philipp Bonhoeffer could happen in the procedure and could have devastating outcome. This full exposure of facts to the patient created a relationship of trust between the patient and Philipp Bonhoeffer which was an outstanding basis to perform the procedure. The procedure was a success with major clinical benefit for the patient.
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The tape of the consenting procedure was largely discussed in academic circles and parts of the film were presented in the main arena at EuroPCR as a challenge to standard consenting procedures