Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?
BACKGROUND
Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread.


OBJECTIVE
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.


METHODS
A simulated clinical trial in two tertiary health care facilities on in-patients.


METHODS
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.
Gitanjali
B
B
Department of Pharmacology, JIPMER, Pondicherry - 605006, India. gitanjali@jipmer.edu
Raveendran
R
R
Pandian
D G
DG
Sujindra
S
S
D000328:Adult; D002986:Clinical Trials as Topic; D004522:Educational Status; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D018579:Patient Selection; D012737:Sex Factors