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.
2:26
A biospecimen is biological material collected from human beings. And that biological material can be blood, cells, both healthy cells and tumor cells, blood plasma, urine, as well as really any other kind of sample from the human body that you can think of. Biospecimens contain DNA, which in turn, is the source of genetic information. And this is an important reason why biospecimens are needed, and needed for many, many people in order to conduct many different types of scientific research.
3:01
Now where did these biospecimens come from? They are collected as part of diagnosis. If you have a baby, at least in the US, and I assume in many other countries as well, these babies are screened for a number of metabolic disorders at the time of birth. Newborn screening, such as phenylketonuria and many others, and those residual blood spots are saved. If you go into the hospital to have a biopsy of a lesion or a tumor, or something that you may think may be cancerous, some of that is studied by the pathologist to give you a diagnosis. But again, there is a remnant of that tissue that is stored. Similarly if you then have a tumor removed, or in the case of having a baby, your placenta is removed, that is examined as part of your treatment. But then it's left over, as it were. No further use to you, but potentially useful for research. And then finally as another example, in the context of development of pharmaceuticals, blood and other specimens are taken from patients. They're from the subjects who are participating in that research. And that also can be stored for later use. So there's many different contexts in which we all are giving biospecimens in the context of medical care, even if we are not research participants. But those leftover specimens may have value in research.
4:29
So where do these biospecimens go? They can be stored in a biorepository, or also called sometimes a biobank. Biospecimens can be annotated with information such as the demographic information about the person from whom it was collected, clinical information about the person, what was the outcome of the biopsy, et cetera. And linking that clinical information to the biospecimen, particularly if you study the genetic information about that person, can tell you something about, for example, the genetic determinants of disease. In addition, in order to identify those genetic determinants of disease, it is necessary to have many, many biospecimens from many, many different people to make correlations between a genetic variant and illness. So biospecimens are considered critical to enabling modern molecular based research, including genomics, proteomics, molecular imaging, and to drive the development of targeted diagnostics
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Legal and ethical issues in uses of stored tissue in human subjects research

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