Critical evaluation of research articles in relation to informed consent.

ABSTRACT

The concept of research bioethics arose and developed over the last three decades mainly in response to moral crisis created by rapidly advancing medical science and technology. Accordingly, reinterpretation of some fundamental principles of ethics is needed. At the heart of the ethical principle of respect for person, lies the informed consent process. Nuremberg Code, Helsinki Declaration of World Medical Association (WMA), Council for International Organizations of Medical Sciences (CIOMS) Guidelines etc. demonstrated the importance of informed consent in biomedical research involving human subjects. This article was planned to evaluate the reflection of informed consent in the published research articles. Fifty-two articles published in national and international journals were studied among which informed consent was found to be taken only in 21(40.4%) occasions and the same was not taken in 31(59.6%) occasions. Study showed that out of 38 articles published in national journals, informed consent was taken from only in 12(31.6%) situations, while out of 14 articles published in international journals, informed consent was taken in 9(64.3%) situations. Out of 36 observational studies, informed consent (both written and verbal) was taken from only 27.8% cases, whereas out of 16 interventional experiments, informed consent was taken in 68.8% situations.