INFORMED CONSENT Assist.Prof.Dr. Mehmet KARATAS Dept. of History of Medicine & Ethics
Informing the Patient Informing the patient about every medical procedure that will be carried out by the medical staff in a way that the patient may understand Diagnosis, diagnosis methods Risk and benefits of treatment Alternative treatments Maleficences with treatment
Elements of Informing Explaining the information in a way that the patient can understand Making sure that the patient understands The conscious of patient Volunteer Signed document
Why should the patient be informed? Patients autonomy Physicians safety Patient-Doctor relationship Legal issues
Legal Basis of Informed Consent International Documents The Law on the Practice of Medicine and Medical Sciences Medical Ethics Charter Patients’ Rights Directive Regulations on Clinical Trials
Limiting Factors of Informing Child patients Unconscious patients Psyciatric patients Cancer patients Patients that will be affected by being informed on their medical situation
CONSENT No coercion No guided help Physician can not convince patient Patients ability to comprehend should be sufficient
Hippocrates Approach Paternalistic
Unconsented Situations Emergency Patients Unconscious Patients Supposed Consent (extension of intervention)
Medical Interventions/Limits “Doctors and dentists, except in emergency situations, due to professional or personal reasons, may refuse to treat the patient” (charter) Extension of Intervention "The consent the patient gives for medical treatment, if required by this intervention to include other medical procedures it may be followed through" (regulation)
References F. Başak ÇAKMAK/Bilal GÜNENÇ, İnönü Üniversitesi Tıp Fakültesi, translation Tolga GÜVEN, Marmara Üniversitesi Tıp Tarihi ve Etik AD ders notları Gürkan SERT, Hasta Hakları Robert M VEATCH, Medical Ethics Emine ATABEK, Mebrure DEĞER, Tıbbi Deontoloji Konuları Hasta Hakları Yönetmeliği, 1998 Klinik Araştırmalar Hakkında Yönetmelik, 2011 Çağlar Boyu Tıp, Roche Yayınları