ETHICS AND MEDICAL LEGISLATION IN RETROSPECTIVE EXPERIMENTAL STUDIES. THE ROLE AND IMPORTANCE OF THE LEGISLATIVE ASPECT

Abstract

Aim of the study Ethical problems most often arise in research. One of the most important ethical rules governing research on humans is that participants must give their informed consent before taking part in a study. Informed consent is therefore a vital part of the research process, and as such entails more than obtaining a signature on a form. Most researchers however, do not have the requisite knowledge of the importance of informed consent in research. This paper attempts a synopsis of the place of informed consent in research study. Materials and methods A review of literature on informed consent in research. Literature search was done using Google search engine as well as international and local journals. Results Informed consent as an aspect of medical ethics, balances autonomy and beneficence, and provides adequate assurance of voluntary and autonomous participation without negative repercussions on access to study benefits. The search showed that this if adhered to in research, will surely maintain the dignity of man and the integrity of research as a field of human endeavour. Conclusions Researchers must therefore ensure that potential research participants be given sufficient information about a study, in a format they understand, to enable them to exercise their right to make an informed decision whether to participate in a given research.

Keywords

• ethics
• medical legislation
• informed consent