Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens
Abstract
Access to human biospecimens is widely regarded as essential to the progress of medical research, and in particular, to the success of “personalized medicine.” Understanding the influence of genetic variation on human health and disease requires that researchers conduct genetic and other studies on thousands of human specimens. Over the past decade, human “biobanks” — vast collections of human biospecimens — have proliferated both in the United States and internationally. These biobanks are subject to a heterogeneous mix of standards that govern the collection and use of biospecimens.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
As illustrated by current US regulations, the result of non-specific and non-harmonized regulations has sometimes been ambiguity, inadvertent constraints on research access, and research proceeding without consent.
“As illustrated by current US regulations, the result has sometimes been ambiguity, inadvertent constraints on research access, and research proceeding without consent (40, 47, 69).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [69]
Understanding public perspectives on these issues is vital, and failure to take public opinion into account can have harsh consequences, as illustrated by the destruction of millions of newborn bloodspots.
“There is no doubt that understanding public perspectives on these issues is vital, and as illustrated by the destruction of millions of newborn bloodspots, failure to take it into account can have harsh consequences (69).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [69]
Cited by
Sorted by citations
Lessons from HeLa Cells: The Ethics and Policy of Biospecimens
Beskow, L. M. (2016) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-083115-022536 · Cited by 146 · see citing works
“More generally, a modernized framework for research ethics could, for example, help develop a coherent view of whether people who are the sources of biospecimens are research participants or donors, and whether their specimens are a gift or a contribution—distinctions that lead to different conceptualizations of relat…”
Background
- Authors
- Javitt, G. H.
- Affiliations
- Sidley Austin (US)
- Corresponding author
- Javitt, Gail H.
- Venue
- Journal of Law, Medicine & Ethics
- Publisher
- Cambridge University Press (CUP)
- Published
- 2013
- Volume
- 41
- Issue
- 2
- Pages
- 424-439
- ISSN
- 1073-1105 (ISSN-L)
- 1748-720X
- OpenAlex
- W1944315701
- Cited by
- 13
- References
- 0
- Citations by year
- 2023: 1 · 2019: 1 · 2018: 2 · 2017: 2 · 2016: 4 · 2015: 3
- FWCI
- 2.38
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- The Journal of Law Medicine & Ethics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- University of California, Los Angeles
- National Center for Research Resources (RC1RR028876)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- human biospecimens, Common Rule, research ethics, research regulation, court cases, public attitudes
- MeSH terms
- Humans, Human Experimentation, Informed Consent, Ownership, Public Opinion, United States, Biological Specimen Banks, Government Regulation
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
