GAIL JAVITT: 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.
And 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 opinion, public scrutiny.
And 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
specimens for research,
as well as of the researchers
and the institutions
that are involved in such research.
While there are myriad legal and
ethical issues that have been
raised, a number of them also have
remained unresolved in the sense
that there 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.
Just to give you a sense of where
I will be going in this talk,
we will spend a few minutes talking
about why biospecimens are so
important for the conduct
of human research,
look at the legal framework for
overseeing human subjects research
in the US generally, not
just biospecimens research,
but how that framework
maps on, to the extent
it does map on, to the
use of biospecimens.
We'll delve into some of
the cases and controversies
that I have alluded to, and leave
with some issues to consider,
the issues that are raised by
these cases and controversy.
And as you'll see, this is an
area that continues to be debated,
and where more policy
work is needed.