The principles guiding the protection of participants in medical research

Abstract

Bioethics relates to ethics in biomedical research. Several unethical practices have been perpetuated in the past in the course of medical research using human subjects as participants without adequate guidelines for the conduct of such researches. Research should address the three main principles of ethics which are autonomy, beneficence and justice, and studies should be designed to protect the physical and psychological well being of participants. The issues of Conflict of Interest and Informed Consent occupy central positions in researches involving the human subject, hence, their ever increasing relevance and continuously changing definitions are given prominence and due emphasis in this review. This review highlights the definition, historical background, the different International Regulations and Codes for research ethics, the requirements for carrying out research on human subjects, and the role of Institutional Review Board in the approval and monitoring of researches. The Helsinki declaration of the World Medical Assembly which has been amended over time, emphasize the need to obtain informed consent in writing from participants. It also emphasize the well being and interest of research participants over and above the interest of science and society. It recommends that the use of placebo should be discontinued and the benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. Relevant recommendations are made in ensuring that the human subjects in developing countries are adequately protected when they participate in biomedical experimentation and researches.

Keywords: bioethics, research participants, autonomy, beneficence, justice

The Tropical Journal of Health Sciences Vol. 12(1) 2005: 5-10