As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.
This paper examines the characteristics of infectious diseases that raise special medical and social ethical issues, and explores ways of integrating both current bioethical and classical public health ethics concerns. Many of the ethical issues raised by infectious diseases are related to these diseases' powerful ability to engender fear in individuals and panic in populations. We address the association of some infectious diseases with high morbidity and mortality rates, the sense that infectious diseases are caused by invasion or attack on (...) humans by foreign micro-organisms, the acute onset and rapid course of many infectious diseases, and, in particular, the communicability of infectious diseases. The individual fear and community panic associated with infectious diseases often leads to rapid, emotionally driven decision making about public health policies needed to protect the community that may be in conflict with current bioethical principles regarding the care of individual patients. The discussion includes recent examples where dialogue between public health practitioners and medical-ethicists has helped resolve ethical issues that require us to consider the infected patient as both a victim with individual needs and rights and as a potential vector of disease that is of concern to the community. (shrink)
In the 1960s, newborn screening programs tested for a single very rare but serious disorder. In recent years, thanks to the development of new screening technology, they have expanded into panels of tests; a federally sponsored expert group has recommended that states test for twenty-nine core disorders and twenty-five secondary disorders. By the standards used to decide whether to introduce new preventive health services into clinical use, the decision-making in newborn screening policy has been lax.
Imagine a genetic counselor working with a young couple pregnant with their first child. The explosion of genetic knowledge and technology in recent years is complicating this professional relationship as a host of new choices brings a few clients with atypical needs. This couple is deaf. They seek not to avoid a child with their disability but rather to assure that the child too will be deaf—a child to share their culture and perspectives on the world. If prenatal diagnosis indicates (...) that the prospective child would be hearing, they intend to terminate the pregnancy and try again. So, how should the counselor respond to this request for services? Does a traditional deference to parental autonomy in reproductive matters require that we respect such decisions by informed couples? More broadly, what are the concepts by which society will guide policy in this new and sensitive domain? (shrink)
The Common Rule governs research on human subjects and attempts to balance respect for individual decision-making with efficiency when research risks are low. The regulations allow research to be conducted without consent if the data or biospecimens collected in a study are deidentified, and consent can be waived for identifiable data and biospecimens if the risks of the research are minimal and consent is deemed impracticable. These approaches have been widely used for research using clinical databases and residual clinical and (...) research biospecimens, and they have proven remarkably successful over the past twenty-five years, if success is measured by a lack of adverse events.But the landscape is changing. (shrink)