I-19: Informed Consent of Infertile Couples in Iran: Legal Controversies

s:3020:"1. Medical Ethics and History of Medicine Research Center, Tehran University of Medical Science, Tehran Iran 2. Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute, ACECR, Tehran Iran Informed consent is considered the most important step in clinical interventions. According to the Beauchamp’s definition the consent is: “...an autonomous act by a patient or research subject to expressly permit a professional person to perform a medical action on the patient or to include a person in a research project...”. This definition is widely accepted, but recently, the position of the consent is changed to a legal document which is necessary to protect the physician or researcher. For obtaining a good consent, it must be ensured that the patient understands the nature of their condition and the risks and benefits of the treatment procedure and its alternatives, and agrees to it voluntarily. In Iran due to current penal code, the consent is in controversy. There are 3 expressions related to the informed consent in penal code of Iran: 1. Permission "Persian: EZN" article 318 of penal code, 2. Consent "Persian: REZAYAT" article 59 of penal code and 3. Disculpation "Persian: BARAAT" article 60 of penal code. It seems that all the 3 articles can be summarized in "informed consent" with the following conditions: 1. Full information about the disease and treatment procedure including duration, possible pain, complication and … which should be presented both verbally and written in the consent. 2. Informed consent is not a contract but it is the process of making decision between patient and physician which means "the patient knows what is going on". 3. Informed consent cannot disculpate any body; the malpractice can be evaluated if the patient claims. If the physician makes a mistake, he will be punished regardless of presence of an informed consent signed by the patient. 4. There is no need for husband consent in the case of wife's treatment, but as having a baby cannot be considered as "a treatment", the consent for assisted reproduction must be given by both. 5. Informed consent can be taken back in any time, but it seems that the consent in assisted reproduction can be taken back just by wife or husband. 6. According to the law, the consent for therapeutic abortion can be given only by the pregnant woman and there is no need for the husband's consent. This includes the consent for pregnancy termination. 7. One of the most important issues in informed consent is the patient's capacity. Before getting the consent the physician must be confident that the patient understands the situation and can communicate with the doctor. As using assisted reproductive technique is an intentional act for a couple, so, the capacity is not an issue in this regard. Therefore, no patient without capacity can participate in assisted reproduction programs.";