Israel Medical Association Journal

Background: A thorough informed consent (IC) process is required before in vitro fertilization (IVF) treatments can begin because these treatments are by and large elective and they have expectable and preventable complications, such as ovarian hyper-stimulation syndrome and multi-fetal pregnancies.

Objectives: To empirically examine whether patient knowledge and understanding of potential hazards associated with IVF treatment are better after the IC process compared to before. The authors hypothesized that patients' better understanding of potential complications would be translated and expressed as rational choices of treatment alternatives.

Methods: Responses of 48 IVF patients after IC process (study group) from two IVF units in northern Israel were compared to those of 46 patients before IVF (control group).

Only women undergoing IVF for first time who were older than 18 years of age were eligible for the study.

Results: Socio-demographic parameters were found to be quite similar between the study group and the control group. Contrary to our expectations, in the study group 12 women (25.5%) considered delivery of a single baby as their optimal result, compared to 15 (32.6%) in the control group. Furthermore, preferences shifted toward triplets: eight patients (17%) after IC considered this option as their best result, compared to only five patients (11%) before IC.

Conclusions: IC process goals are not achieved under current practices, at least as far as IVF treatment are concerned. New tools and incentives should be implemented to meet the requirements dictated by the laws regarding patient rights.

Background: Patient protection requires the provision of informed consent for participation in medical research. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) is frequently used for screening the capacity of research subjects to consent to participate in research.

Objectives: To evaluate the utility of the Hebrew translation of the MacCAT-CR for the assessment of capacity of patients with chronic schizophrenia to provide informed consent to participate in clinical trials.

Methods: We evaluated the translated MacCAT-CR by comparing the capacity of patients with chronic schizophrenia to provide informed consent to participate in clinical trials. The following standardized neurocognitive assessment tools were used: Addenbrooke’s Cognitive Examination (ACE) and Frontal Assessment Battery (FAB), as well as the attending doctor’s assessment.

Results: Twenty-one patients participated. Mean MacCAT-CR score was12 ¡À 10.57 (range 0¨C32), mean FAB score was 9.9 ¡À 4.77 (range 1¨C18), mean ACE was 59.14 ¡À 16.6 (range 27¨C86) and mean doctor’s assessment was 5.24 ¡À 1.18 (range 3¨C7).

Conclusions: The Hebrew-version of the MacCAT-CR helped identify patients with the capacity to provide informed consent for participation in research. Patients with FAB scores ¡Ý 12 tended to score higher on the Hebrew-version of the MacCAT-CR, thus confirming the utility of the Hebrew version of the MacCAT-CR. During the screening process for clinical trials it may be practical to administer the concise FAB questionnaire, and then administer the MacCAT-CR only to those who scored ¡Ý 12 on the FAB.

Background: The rate in Israel of in vitro fertilization and embryo transfer procedures is the highest among industrialized countries. The procedure has the potential to make treated patients forever happy, should the desired result occur. It also entails, however, numerous potential complications. Patients who are candidates for the procedure should fully understand potential desired and undesired results, and should give their consent based on this understanding. The question whether currently used informed consent forms for these procedures indeed serve this purpose is, however, open.

Objectives: To explore the usefulness of informed consent forms for IVF&ET[1] that are currently used in Israel to represent the potential benefits and risks of the procedures to the patients.

Methods: Informed consent forms for IVF&ET were scrutinized for accuracy, clarity and relevance, by comparison to relevant medical literature. IVF&ET informed consent forms were also assessed whether they fulfill the requirements of the Israeli Law of Patient's Rights.

Results: Currently used "informed" consent forms for IVF&ET were found to be fundamentally inaccurate and outdated. In some cases (number of embryos to be transferred), the information is grossly obscure. In other cases (alternative management) there are glaring omissions.

Conclusions: Informed consent forms for IVF&ET that are currently used in Israel do not adequately serve their stated purpose. Potential risks and benefits are not presented clearly and alternative management strategies are also missing. Thus, they do not fulfill their social, ethical or legal goals. Updating these forms is urgently needed. New versions should clearly distinguish between common (controllable) and uncommon (uncontrollable) complications.