Gitanjali B, Raveendran R, Pandian D G, Sujindra S
Department of Pharmacology, JIPMER, Pondicherry - 605006, India.
J Postgrad Med. 2003 Apr-Jun;49(2):109-13.
Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread.
To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent.
A simulated clinical trial in two tertiary health care facilities on in-patients.
An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses.
The percentages of those consenting after full disclosure 29/102 (30%) and after partial disclosure 15/50 (30%) were the same. There was a significant (p=0.043) gender difference with a lesser percentage of females (30%) consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented.
The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.
研究人员认为，在文盲现象普遍的发展中国家，可能无法获得完全知情的书面同意。
确定在收到关于试验的完整或部分信息后同意参与试验的患者百分比，并找出是否存在与性别或教育状况相关的差异。评估同意或拒绝的原因以及他们对知情同意的理解深度。
在两家三级医疗保健机构对住院患者进行模拟临床试验。
准备了一份关于药物模拟临床试验的知情同意书。向选定的住院患者的目标样本解释详细/部分程序，并征求他们的同意。要求患者自由列出同意或拒绝的原因。使用问卷评估他们的理解深度。采用卡方检验进行统计分析。
完全披露信息后同意的比例为29/102（30%），部分披露信息后同意的比例为15/50（30%），两者相同。存在显著的性别差异（p = 0.043），同意参与试验的女性比例较低（30%）。教育状况并未改变这一比例。大多数患者拒绝同意是因为他们不想献血或服用新药。同意的患者对知情同意的理解较差。
在规划大样本临床试验时，需要考虑只有三分之一的受试者可能同意参与试验这一事实。性别而非教育状况会影响同意参与研究的受试者数量。患者对知情同意要素的理解较差，因此有必要在印度改进实施同意程序的更好方法。
