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. 2003 Apr-Jun;49(2):109-13.

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

B Gitanjali  1 , R Raveendran, D G Pandian, S Sujindra
Affiliations
  • PMID: 12867683
Free article

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

B Gitanjali et al. J Postgrad Med. 2003 Apr-Jun.
Free article

Abstract

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 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.

Settings and design: A simulated clinical trial in two tertiary health care facilities on in-patients.

Methods and material: 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.

Results: 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.

Conclusions: 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.

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