Giard R W
Medisch Centrum Rijnmond-Zuid, locatie Clara, afd. Klinische Pathologie, Postbus 9119, 3007 AC Rotterdam.
Ned Tijdschr Geneeskd. 2001 Mar 17;145(11):512-5.
Five years after its implementation, the Dutch Medical Treatment Act, which regulates the doctor-patient contract, was evaluated. Two subjects were investigated: the right of the patient to be informed and to give informed consent and the way physicians deal with personal information. From a methodological point of view, this appraisal was very disappointing. At best, the evaluation report is descriptive but not evaluative: no comparative study was carried out before and after the law was implemented to ascertain effects. The Act is difficult to evaluate in practice as its goal, improving the legal position of the patient, is dogmatic. Its regulations on informed consent and agreement as well as the rules of law concerning the use of patient data for clinical research, have at times proved to be impractical even though such legal directives appear to be reasonable. The problems addressed by this law should be more widely debated and be subjected to a far more rigorous validation process.
在实施五年后,对规范医患合同的荷兰《医疗法案》进行了评估。调查了两个主题:患者被告知及给予知情同意的权利,以及医生处理个人信息的方式。从方法论的角度来看,此次评估非常令人失望。该评估报告充其量只是描述性的,而非评估性的:在法律实施前后未进行比较研究以确定效果。由于该法案的目标是改善患者的法律地位,比较教条,因此在实践中很难评估。其关于知情同意和协议的规定,以及关于将患者数据用于临床研究的法律规则,有时已被证明不切实际,尽管这些法律指令看似合理。该法律所解决的问题应进行更广泛的辩论,并接受更为严格的验证过程。