Home⇛Health Sciences Journal⇛vol. 14 no. 1 (2025)

Enhancing awareness of research participants’ bill of rights: a study in a rural municipality in the Philippines

Maria Milagros U. Magat | Jennifer M. Nailes

Discipline: medicine by specialism

 

Abstract:

Introduction Documenting a research participant’s awareness of the bill of rights is achieved with an informed consent. In recent years, the informed consent document has increasingly become confounding to research participants in its complexity. As such, the awareness of research participants’ bill of rights has emerged as a lingering issue since studies that test awareness of research participants’ bill of rights are limited. Hence, this study aimed to determine the participants’ awareness of the bill of rights after an educational intervention. Methods A quasi-experimental study was done where participants’ awareness of clinical trial participants’ bill of rights was determined after an educational intervention. Results There was a significant difference (p <0.001) in awareness of the elements of the bill of rights (including voluntary participation, being told about the benefits and risks of participating in the study and right to withdraw from the study) after the intervention except for the element which asked about the details describing clinical trial objectives and activities. A significant difference was observed before and after intervention among females, middle aged participants and older, among those who did not complete high school and among those unemployed. Their awareness of the elements of the bill of rights was lesser than their counterparts. Conclusions Significant difference in the awareness of bill of rights was observed after the educational intervention. Additional intervention could be given to participants who are females, of older age group (middle age and older), did not complete high school, and the unemployed when they participate in clinical trials to ensure their awareness of the bill of rights of clinical trial participants. Varied learning materials must be given to participants to emphasize the clinical research objectives and activities as well.



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