Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

摘要: CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine percentage of patients who agree to participate a trial after receiving either complete or partial information regarding find out whether there were gender educational status-related differences. assess reasons for consenting refusing their depth understanding consent. SETTINGS AND DESIGN: A simulated clinical two tertiary health care facilities on in-patients. METHODS MATERIAL: An form mock drug was prepared. The detailed / procedure explained purposive sample selected in-patients asked for. Patients free list giving withholding Their assessed using questionnaire. Chi-square test used statistical analyses. RESULTS: percentages those full disclosure 29/102 (30%) 15/50 same. There significant (p=0.043) difference with lesser females participation trial. Educational status did alter this percentage. Most withheld because they want give blood take new drug. Understanding poor consented. CONCLUSIONS: fact only one-third subjects are likely needs considered while planning trials large size. Gender but influences number study. Poor elements necessitates evolving better methods implementing procedures India.