Avicenna, an outstanding Persian physician and philosopher (980 AD-1037 AD), established a clinical treaty, or doctrine, without which medical experimentation would not have progressed. This doctrine emphasizes the ultimate divine power of God or a higher being over healing and mandates the patients' well-being as the crucial aspect in all medical care and experiments. The Institutional Review Board, as the ethical body that oversees clinical research, is in line with this doctrine. However, the lack of a homogenous and internationally recognized code of ethics, the decentralized work of ethics oversight committees, the improper implementation of established ethical standards and a shortage of scientific auditing capacities have raised concerns over the possible exploitation of vulnerable populations.
Key words: Avicenna, bioethics, IRB, Belmont report, vulnerable population, international research
Avicenna, a Persian physician scientist and philosopher (980 AD-1 037 AD) and a pioneer of clinical trials, suggested several blueprints for the assessment of safety and the effects of medicine on patients. Avicenna's highly influential Canon of Medicine continues to inspire his modern colleagues. His clear understanding of pilot studies for drug quality, investigations into action time and reproducibility of treatment effects antedates modern clinical trials by one millennium (1).
Avicenna established a philosophy that perceives God as the ultimate healer and patients' well-being as the crucial aspect in all medical care and experiments. Avicenna's clinical treaties recall Hippocratic decorum but emphasize two ideas that are not in the Hippocratic tradition: the ultimate power of God over life, death, and healing and the obligation to care for the needy and preserve their rights. In the Canon of Medicine, his masterpiece, he highlights the facts that care for the sick requires empathy and an understanding of their rights.
Mandating care for those in need and observing the rights of vulnerable populations are aspects of the modern concept of the Institutional Review Board (IRB). Although there is no doubt that clinical trials are the crucial aspect of medicine to combat diseases, incidences of abuse in the name of research require independent oversight by ethical committees.
One of the most horrific of these incidents, which is often cited in medical history, is the Tuskegee, Alabama syphilis study (1 932-1 972). This incident has increased awareness of the need to protect vulnerable populations. The Belmont Report conceptualized the aim of the IRB as ensuring that all experiments follow the ethical principles that govern the protection of all human subjects in research (2).
Fischer et al. describe the IRB as "an independent reviewing body that evaluates investigational protocols prior to their implementation to ensure their validity and ethical integrity by implementing good clinical practices and standards" (3). In the United States, the IRB for biomedical sciences is composed of representatives from different areas of a hospital or medical university, including clinicians, ethicists, clergy, scientists and educators, who review all of the research proposals to safeguard and protect the human subjects involved in research projects.
The IRB ideally follows all of the basic ethical principles that govern the protection of human subjects (4). The research project cannot begin until the investigator addresses potential issues, and the contingent responses should be approved by the IRB.
IRBs place special emphasis on reviewing studies that involve vulnerable population groups, such as members of minority ethnic groups, children, the poor, women, soldiers, prisoners, international populations, and persons with impaired decision-making capacities. Eckenwiler defines vulnerability in terms of "threats to self-development, self-determination, and equality that exist independent of research" (5). …