Perceptions of Pregnant Women with Low Educational Attainment about Informed Consent after Registering into Randomized Controlled Trial in India-A Qualitative Study

Abstract

Background: Informed consent is more than simply getting a patient to sign a written consent form. Aim: The aim of the study was to assess the perceptions of pregnant women with low educational attainment about informed consent after registering into randomized controlled trial in India. Method: A consecutive sample of 120 subjects aged 18 and above, participating in randomized controlled trial was surveyed. The individual interview was carried out using interview schedule. All items regarded basic components of the informed consent such as: study objectives, potential benefits and risks, and participants’ rights and obligations were included. Results: Out of 120 enrolled, 78% had High-school education or less, and only 2% had attended college education. Mean age of the participants were 24±3.5 years. All individuals were participating in a randomized controlled trial for the first time. Majority of the subjects were satisfied with the information given. Most volunteers were able to identify correctly study objectives and potential benefits. Only one third acknowledged there could be no benefit from enrolling in the trials. Conclusion: In general, the understanding about basic components of the informed consent in this population of low educational attainment was good, particularly, in regard to study objectives and participant’s rights.