Faculty Bibliography

Researchers are developing a fertility preservation technique--testicular tissue cryopreservation (TTCP)--for prepubescent boys who may become infertile as a result of their cancer treatment. Although this technique is still in development, some researchers are calling for its widespread use. They argue that if boys do not bank their tissue now, they will be unable to benefit from any therapies that might be developed in the future. There are, however, risks involved with increasing access to an investigational procedure. This article examines four methods of expanding access to TTCP: (1) expansion of institutional review board (IRB)-approved research trials; (2) offering TTCP as an innovative procedure in hospitals; (3) offering TTCP as a standard practice in hospitals; and (4) commercialization of TTCP. The ethical and practical implications of each are evaluated through a comparison with umbilical cord blood banking (UCBB), a technology that has achieved widespread use based on similar claims of future benefit.

Advances in the field of synthetic biology are creating many new practical applications. These new applications raise novel regulatory challenges. Biotechnological innovation was first addressed by the United States (US) National Institutes of Health (NIH) at the advent of recombinant DNA research.1 Today, synthetic biology requires consideration of the ethics and risks involved in the governance of an applied technology that spans national borders and has applications in a wide variety of sectors. Because approaches to governance vary by nation and sector, and can range from precautionary to prudent, it is necessary to consider the context from which different approaches arise if there is to be any successful move towards universal governance

Discovering the genetic variations that create profiles of risk and drive individual responses to drugs and vaccines has proven more difficult than many initially presupposed. Rhetoric about the prospect of personalized medicine has exceeded the ability to deliver on that vision. There also remain significant ethical and policy obstacles that may hinder the arrival of personalized medicine. The emergence of new prenatal genetic tests make the resolution of these ethical challenges imperative.

There may once have been a time when doctors unquestioningly accepted the government's declaration of a drug's effectiveness and when patients unquestioningly accepted the prescriptions of their doctors. That time has passed. Now, information-good and bad-showers from all directions on patients and physicians alike. A filter is needed, and peer review provides the best one. But who or what is this validated information for? Ethically, its primary purpose is to enable patients to make decisions consistent with their values. Providing vetted information in a form that is useful to patients requires an emphasis on comprehensible, comprehensive, trustworthy, verifiable, and transparent communication. The hypothetical comparative effectiveness case study in this month's Health Affairs does not appear to rise to the level that would be helpful to providers or patients.