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Kelly Edwards, PhD is Associate Professor, Department of Bioethics and Humanities at the University of Washington School of Medicine. Edwards is core faculty for the Institute for Public Health Genetics and the Critical Medical Humanities Research Cluster. For more, see her bio in the Department of Bioethics and Humanities.

Edwards describes the questions she helps others consider in her work as a bioethics consultant, often regarding biorepositories. Questions are sometimes  about recruitment and communications to potential recruits, such as “How should we handle consent?” Other questions surround data access, i.e. who has or should have access to data from the repository?

Shannon Sewards is Assistant Director for Operations, Human Subjects Division at the University of Washington. “What is ‘the human subjects division’ all about?” muses Sorensen, noting the intriguing name, before answering simply that it’s “anything that involves research on a person.” For further clarification we offer the following, from the division’s home page:

“Research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB). At the UW, several IRB committees serve this function. The Human Subjects Division (HSD) provides administrative support and facilitates IRB review; assisting researchers throughout the process.”

Sewards describes that the role of IRBs is to be protective for the general public, while they can be a hindrance, relatively speaking for researchers.

Donna Russell, MHA is Director of Research Development and GAPPS at Seattle Children’s. GAPPS is the Global Alliance to Prevent Prematurity and Stillbirth, whose expanded mission includes maternal, newborn, and child health with a global scope.

Russell notes that GAPPS began because of the magnitude of the problem of pre-term birth, here in the U.S. and globally. 13 million pre-term births happen annually around the world, and 1 million of those are fatal. There are also 3 million still births.

That means there are more than ten times the number of still births as there are “SIDS” deaths. SIDS is relatively well publicized while still birth is not.

We still, fundamentally do not know what causes many of these deaths. The best strategy for solving the mystery is to link high quality specimens to descriptive data.

Therefore a cornerstone of GAPPS is their biorepository. They just started collecting data in the last year, after two years of preparation and addressing many of the issues we will discuss today.

A fundamental ethical question for GAPPS is that pregnant woman are a vulnerable population.

Edwards, Russell, and Sewards are introduced by Sorensen

The revolution is a shift from reactive to proactive in health and biomedical research. We are looking at genetics, the environment, and interactions between them and changing medicine for the future. Medicine is becoming more personal with increased understanding and accessibility of genomics. Patients and consumers are playing a key role, participating more in determining their own medical future.

“Biobanks are more than libraries of flesh,” Sorensen declared, in response to some popular media descriptions of repositories. (CityClub blogger Sara Neppl clarified that Sorensen was quoting this Wired magazine article from June 2010 that referred to biobanks as “libraries of flesh.”)

Biobanks combine biological specimens of organs, blood, and so on with data about health and lifestyle. Combining all of this is very powerful but also requires that we proactively and comprehensively address issues of public trust and ethics in research. Today’s panel discussion is one more step in that effort.

Moderator Gretchen Sorensen introduces our topic: