Informed consent process: a challenging issue of health research in india

Informed consent, a prerequisite for enrolling participants in biomedical research, is becoming a challenge for the researchers in India. The aim of this study was to explore the perception of researchers on challenges of informed consent process.
The study was designed as qualitative type, through semi-structured interviews. Interview guide was prepared to explore researchers’ experiences in informed consent process, behavior and interactions of the patients participating in research studies. The data were analyzed using thematic framework approach.
The challenges perceived by the researchers in informed consent process were multifaceted. In regulated clinical trials, they were related to time and duration of the whole process, especially in audiovisual recording of consent process, legalized in India. Patients’ comprehension on risk and benefit in drug trial was found to be another challenging issue. In questionnaire based studies, issues like decision making, expectations, certain cultural norms were playing significant role resulting in increase in refusals for participation. It was also revealed that there was failure in conveying adequate information by the researchers to patients on the study to be carried out because of apprehension of the researchers towards changing decision or refusal to consent by the participants in the study.
The issue of informed consent in research done in India is a challenge due to various complexities of culture, level of education and demographics resulting in increased nonparticipation or refusal to give consent. The guidelines, prepared in line with western culture, need to be relooked in light of the complexities and sociocultural diversities in India.