Ghiyasvandian Sharzad, Bolourchifard Fariba, Parsa Yekta Zohreh
1. School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran 2. School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Glob J Health Sci. 2014 Oct 29;7(3):1-7. doi: 10.5539/gjhs.v7n3p1.
One of the basic issues in clinical studies is to receive the informed consent; that is to say, all the activities applied in patient's involvement in the information, decision-making, ability and volunteering in diagnosis, cure and care. In as much as most cancer patients require information about their individual needs, the present study is conducted to determine the perceived information from the informed consent of clinical studies in cancer patients.
This is a descriptive study. Fifty cancer patients hospitalized for participating in the clinical study was chosen according to the convenience sampling. Tools used in this research included the questionnaire (individual and social features) and the check list about patient's right and cancer patient's information before and after receiving informed consent in clinical studies (10 items on a Likert rating scale). To validate the study, content and formal validation was used. Data in this research were analyzed using descriptive statistics (frequency, mean and standard deviation) and the software of SPSS 16.
In general, the mean of the scores obtained from cancer patients' perceived information before completing the informed consent of the clinical studies was 14 ± 3.5 and after consent of the clinical studies was 16 ± 2.4. The cancer patients' perceived information before and after consent of the clinical studies was weak.
Based on the findings of the present study, the rate of the information the cancer patients received, before completing the informed consent form, was low, but after completing the informed consent form this rate was again low. Therefore, conducting similar and wider studies is recommended to unveil the factors affecting perceiving information and how to promote the quality of the informed consent in other hospitals in Iran.
临床研究中的基本问题之一是获得知情同意；也就是说，患者参与诊断、治疗和护理过程中的信息、决策、能力及自愿参与等所有活动。鉴于大多数癌症患者需要了解与其个人需求相关的信息，本研究旨在确定癌症患者从临床研究知情同意书中获取的信息认知情况。
这是一项描述性研究。采用便利抽样法选取了50名因参与临床研究而住院的癌症患者。本研究使用的工具包括问卷（个人和社会特征）以及临床研究中患者在签署知情同意书前后的权利和癌症患者信息清单（李克特量表上的10个项目）。为验证该研究，采用了内容效度和形式效度。本研究中的数据使用描述性统计（频率、均值和标准差）及SPSS 16软件进行分析。
总体而言，癌症患者在签署临床研究知情同意书之前获得的信息认知得分均值为14±3.5，签署之后为16±2.4。癌症患者在签署临床研究知情同意书前后的信息认知情况较差。
基于本研究结果，癌症患者在签署知情同意书之前所获得的信息比例较低，签署之后这一比例仍然较低。因此，建议开展类似的更广泛研究，以揭示影响信息认知的因素以及如何提高伊朗其他医院知情同意书的质量。
