Social Issues & Ethics
Adherence to the simple prescription, "First, do no harm," is no simple matter as the onrushing pace of technology brings new treatments, each of which presents its own balance of benefits and risks. Over the decades the medical and research communities have developed principles and guidelines to protect human subjects in research, to guide the use of human biological materials in research, and to provide thorough and meaningful informed consent for medical treatments, clinical trials, and donation of blood or tissue. At the Asilomar conference in 1975, the scientific community assembled to develop its own regulatory system to guide the use of genetic engineering in developing gene therapies and novel organisms.
Yet, with all the guidelines and best intentions in the world, the medical and research communities and the patients they serve are constantly falling behind the pace of technology. While the basic values of protecting patients do not change, the context in which those values are implicated is constantly changing. For that reason, there is a constant need to define and implement appropriate safeguards as new technologies and treatments emerge, and to do so in a way that both protects patients and promotes the research that is essential to developing cures for diseases.
Medical research never has operated and never will operate in a risk free environment. Therefore, acceptance of risk by well-informed patients is a critical part of the research enterprise. Education and communication regarding those risks within the context of clearly defined ethical values are necessary ingredients to improve the participation of patients in research. Without a relationship of trust between patients and researchers, there can be no progress in accelerating medical solutions.
