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Introduction: According to the law, patients must give informed consent to treatment. The information given to the patient and the consent to treatment must be documented in the patient record. The purpose of this study was to evaluate the documentation of informed consent and to determine the reasons for omission of this information. Materials and methods: 150 patient records from seven general practices and three hospital wards were assessed by external, criteria-based audit. Doctors filled in a questionnaire with the purpose of disclosing reasons for omitted recording. Results: 41 doctors (84%) completed the questionnaire, revealing possible explanations as to omission of information, e.g., a lack of knowledge of the law and lack of compliance. Of 150 patient records, three fulfilled the obligations under the law by recording the information given about the patient's disease, treatment, side effects and consent. In general practice, 13% of the records documented at least one of the above-mentioned points, while 12% of those from medical wards, 49% of those from surgical wards and 85% of those from gynaecological ward included the information. Discussion: The recording of informed consent varied, and doctors should be provided with further instruction. The present structure of medical records makes it difficult to evaluate the documentation, and it is recommended that a standardized form be used.

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