Document Type
Journal Article
Publication Date
11-6-2014
Journal
BMC Public Health
Volume
Volume 14
Inclusive Pages
Article number 1156
Abstract
Background
In order for Informed Consent to be ethical and valid each clinical trial participant must be able to make a voluntary decision to participate, free from pressure or coercion. Nonetheless, many factors may influence the decision reached, and such influences may be different for male and female volunteers. Being aware of these differences may help researches develop better processes for obtaining consent that safeguard the right of autonomy for all participants. The goal of this study was to evaluate potential gender-based differences in the factors influencing clinical trial participation.
Methods
This cross-sectional study was conducted in the Northeast region of Minas Gerais, Brazil, in October 2011. A structured questionnaire was administered to 143 volunteers (48 male, 95 female) screened for participation in a clinical study of an investigational functional food with potential anthelminthic properties. Answers regarding their decision to participate in the study were compared, by gender, using chi-square and Mann Whitney tests. Odds ratios (OR) was used to measure association.
Results
A majority of subjects (58% of males, 59% of females) listed the desire to collaborate with the development of a product against parasitic worms as their main reason for participation. Females were significantly more likely to report a decision influenced by friends, family, or researchers (OR 3.14, 3.45, and 3.46 respectively, p < 0.005). Females were also significantly more likely to report a decision influenced by general altruistic considerations (OR 8.45, p < 0.005). There was no difference, by gender, in the report of decisions influenced by informational meetings, understanding of the disease, or the availability of medical treatments or exams. There was also no difference in knowledge of the rights of research participants.
Conclusion
Study results indicate that there is a strong difference between male and female participants regarding social influences on the decision to participate in clinical research. Further research into the impact this may have on autonomy is warranted.
APA Citation
Lobato, L., Bethony, J.M., Pereira, F.B., Grahek, S.L., Diemert, D. et al. (2014). Impact of gender on the decision to participate in a clinical trial: a cross-sectional study. BMC Public Health, 4:1156.
Peer Reviewed
1
Open Access
1
Comments
Reproduced with permission of BioMed Central. BMC Public Health.