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ISBER Working Groups
Rights to & Control of Human Tissue Samples
Organizers:
Ty Hoover
and
Rajiv Dhir
As human tissue samples become increasingly valued for research, in both
academia and industry, the question of who has the right(s) to control the use
of that tissue becomes increasingly important. Most would agree that specimens
should be used to create the most value. However, there may be disagreements
about what the best value or use of specimens may be. When there is conflict
regarding use, at any point in the life cycle of a human tissue sample, how is
that conflict best resolved? There is little guidance or precedent to look to.
Presently, as with many aspects of biorepositories and biospecimen resources,
the landscape regarding oversight of use, or non-use, of specimens is at best
fragmented. The issues become even more acute when considering the use of scarce
resources such as “rare” tumor samples. And, while it may well be the case that
there is no one-size-fits-all solution, there may be value in thoughtfully
considering if the time is right to consider developing specific recommendations
regarding rights to and control of “donated” human tissue, and if so, what are
the necessary next steps toward that end. Fundamental to developing such working
recommendations, it will likely be necessary to consider some of the following
basic issues:
Issues
The need for guidance |
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1. 2. Existing
guidance (what, where, how specific, what authority)
“Case examples”: Instances where practical guidance would be helpful in
determining most equitable, ethical, and legal means of using a sample?
3. Besides aiding in conflict resolution, is there other value to having
specific guidance? |
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Who “owns” donated
tissue samples? And what does it mean to “own” a sample?
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1. Nomenclature
(science v. legal)
2. Participants v. clinicians v. researchers v. hospital v. institution
v. other
3. Role of informed consent documents, common law (recent reported
cases), policies, other existing agreements vis-à-vis foreseeable
expectations re ownership and use
4. What “rights” exist to human tissue samples in the first place?
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Role of and
composition of tissue oversight committees |
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1. When should
oversight committees exist?
2. Who should be part of these?
3. What is their scope?
4. What would be costs of implementing?
5. What should they consider in making decisions? Can there be a
meaningful algorithm for committees to look to? If so, what are the
elements to consider and what weight to give them? |
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Next steps to moving
forward in development of recommendations |
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International Society for Biological and Environmental
Repositories
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Tel: 301-634-7949, Fax: 301-634-7990,
Email:
isber@asip.org
Web: www.isber.org
All contents ©2009 International Society for Biological and Environmental
Repositories.
All rights reserved. |
