Informed Consent Process in the New Millennium

Informed Consent Process in the New Millennium
Short Communication
Ranabir Pal, Swapan K Paul
Bengal Physician Journal, May-August 2018; 5(2) pp 22-24
Open Access
Abstract
In this new millennium, the clinical trial is inseparably linked with an upgrade of health care by generating invaluable data in preventive, promotive and curative health. Globally research experts have concerns regarding ensuring financial and other compensations along with optimum health benefits for research participants in clinical trials in the emerging market economy. A significant number of human healthy volunteers (participants) take part in researches in both developed and developing countries. Participants are frequently unaware that the informed consent process is mandatory for investigators, funders and participants and their free will must be documented. There are sparse published medical works of literature that attempted to assess the extent to which all the norms of the informed consent process are followed in Indian settings in this area to the best of our knowledge. We need to conduct researches on the preparedness of the clinical trials participants towards their awareness of the criticality of the informed consent process and their motives for participation. This narrative review enlightened the facts that very patient, extensive and careful transparent narration and dissemination of the information can only ensure truly informed and autonomous decision improving the validity of the study.

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