Legal and ethical issues in uses of stored tissue in human subjects research

Published on August 31, 2015   51 min
0:00
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.
0:22
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 contribute human 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.
1:41
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.
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Legal and ethical issues in uses of stored tissue in human subjects research

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