My name is Gail Javitt.
I am Of Counsel with DLA Piper,
a law firm in Washington DC and also affiliated with
the Berman Institute of Bioethics at Johns Hopkins University.
I am going to be presenting
legal and ethical issues in uses of stored tissue in human subjects research.
Let me outline for you what I'm going to be discussing.
As many of you may already know,
human specimens are increasingly important to the conduct of scientific research.
The topic of the use of biospecimens in research has received
increasing attention in recent years as a result of several legal cases,
as well as highly publicized controversies
that did not necessarily result in a lawsuit,
but nevertheless garnered a lot of public opinions, public scrutiny.
These cases and controversies have raised a number of issues
regarding what should be and what are the rights, expectations,
and obligations of people who contribute human specimens for research,
as well as of the researchers and the institutions that are involved in such research.
While there are myriad of legal and ethical issues that have been raised,
a number of them also have remained unresolved in the sense that they are
not necessarily uniform policies to address the concerns that have been raised.
Different entities, such as IRBs or academic institutions and others,
have adopted different approaches,
and so there continues to be some confusion and uncertainty in this field,
as we will review.