The establishment of ethical guidelines for biomedical research in Libya

O ver recent decades, there has been an upsurge in professional and public interest in how biomedical research and clinical trials are conducted. This has coincided with a growing awareness of the importance of ethical considerations in research. The key ethical principles are to safeguard the rights, well-being, and dignity of research participants, and the obligation to reflect on moral aspects of improvements in health care, science, and technology (1, 2). In this regard, several ethical codes and guidelines have been developed by a number of countries and international organizations (3). The Nuremberg Code (issued in 1947) is considered the foremost contemporary memorandum as it delineated the principles of voluntary consent in medical research (4). Further international guidelines were laid down in the which underlined the commitment of the medical profession to the sovereignty of internationally adopted ethical guidelines (6). The Declaration of Helsinki on Ethical Principles for Medical Ethics and Human Rights (adopted 1964; latest amendment 2013) was developed by the World Medical Association (7). However, this declaration was designed in accordance with Western perspectives. The International Ethical Guidelines for Biomedical Research Involving Human Subjects were proposed by the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization (8). The two latter sets of guidelines proposed a framework of basic values for medical ethics that are considered to be universally shared by other similar bodies (9). However, concerns have been raised that, by emphasizing their universality, these guidelines neutralize factual and legitimate cross-cultural and religious variations in ethical codes (2, 10). Recently, a review of research ethics in Arab countries of the Middle East noted that only a limited number of such countries had already developed their own national guidelines (11). Furthermore, the same review concluded that most of these guidelines frequently contained inadequacies ; therefore, it urged for more efforts of improvement and refinement. To the best of our knowledge from anecdotal evidence, currently there are no clear ethical guidelines for biome-dical research in Libya. There was, nonetheless, a decree issued by the previous Libyan Council of Ministry (12) whereby a concept, rather than a set of guidelines, was instigated and its privilege transferred to the Ministry of Higher Education. However, we wonder if this decree, which was stated ambiguously, i.e. only the phrase biological ethics was mentioned, implemented any guidelines. Based on that, the authors aimed to create a real set of guidelines …