Wouter Leclercq

Chapter 2 24 The fundamentals of today’s practice of SIC gained more structure at the beginning of 20th century, especially after the development of anesthesia and more invasive surgery (Figure 2.1). In Mohr vs. Williams in 1905, a woman agreed to an operation on her right ear. 8 However, during the operation the surgeon found her left ear in the need of a repair. He was subsequently sued and convicted because he had not proceeded according to the preoperative agreement. The judge called this agreement a contract that authorizes the physician to operate only to the extent of the consent given. 9 In Schoendorff vs. Society of New York Hospital in 1914, Justice Benjamin Cardozo (Figure 2.3) became famous for his judgment in the following case. A woman had consented to an abdominal examination under anesthesia but not to an operation. 10 Nevertheless, the surgeon removed a tumor that eventually led the patient to file a law suit. Cardozo’s opinion has become one of the most basic elements in the concept of SIC development: ‘‘Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without the patient’s consent commits an assault for which he is liable in damages’’. 11-13 A patient should be viewed as a person who has the right of bodily self-determination. 5,12 After the Second World War, there was a strong public reaction to the cruelties committed by Nazi concentration camp ‘‘doctors’’ who performed horrible tests on ‘‘patients’’ without prior information or approval. A code was written as a direct result of the Nuremberg trials (U.S.A. vs. Karl Brandt et al.). This ‘‘Nuremberg Code’’ was an important step in the development of the IC process in trials (Figure 2.4). It consisted of ten preconditions any human research study had to fulfill. Interestingly, the first governmental instruction for IC in trials originated in Germany and was written in 1900. 14 Later on in 1964, The World Health Organization set the Declaration of Helsinki with 22 preconditions for human research. The 1957 case Salgo vs. Leland Stanford, Jr. University Board of Trustees introduced the term ‘‘informed consent,’’ and this term was accepted in Natanson vs. Kline in 1960. 12,15,16 At the same time, a development occurred in the domain of ‘‘information.’’ The 1957 UK case Bolam vs. Friern Hospital Management Committee focused on which risks should be discussed with a surgical patient. 17 This doctor-centered view resulted in a reasonable standard: Any surgeon should tell what other surgeons also tell their patients, a principle known as the Bolam principle. 11 However, the 1972 Canterbury vs. Spence case determined that all risks and alternatives of a procedure have to be explained. 18 This trial clearly demonstrated a shift from the doctors’ point of view toward the patients’ point of view as the standard of IC: the ‘‘reasonable patient standard’’. 11,12,19,20 Subsequently, the Australian High Court overruled the Bolam principle in the 1992 Roger vs. Whittaker case of a woman losing sight in her good eye after being operated on her diseased eye. 21 Although