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Biorepository Regulatory Frameworks: Building Parallel Resources That Both Promote Scientific Investigation and Protect Human Subjects

Marko-Varga, György LU ; Baker, Mark S.; Boja, Emily S.; Rodriguez, Henry and Fehniger, Thomas LU (2014) In Journal of Proteome Research 13(12). p.5319-5324
Abstract
Clinical samples contained in biorepositories represent an important resource for investigating the many factors that drive human biology. The biological and chemical markers contained in clinical samples provide important measures of health and disease that when combined with such medical evaluation data can aid in decision making by physicians. Nearly all disciplines in medicine and every omic depend upon the readouts obtained from such samples, whether the measured analyte is a gene, a protein, a lipid, or a metabolite. There are many steps in sample processing, storage, and management that need to understood by the researchers who utilize biorepositories in their own work. These include not only the preservation of the desired analytes... (More)
Clinical samples contained in biorepositories represent an important resource for investigating the many factors that drive human biology. The biological and chemical markers contained in clinical samples provide important measures of health and disease that when combined with such medical evaluation data can aid in decision making by physicians. Nearly all disciplines in medicine and every omic depend upon the readouts obtained from such samples, whether the measured analyte is a gene, a protein, a lipid, or a metabolite. There are many steps in sample processing, storage, and management that need to understood by the researchers who utilize biorepositories in their own work. These include not only the preservation of the desired analytes in the sample but also good understanding of the moral and legal framework required for subject protection irrespective of where the samples have been collected. Today there is a great deal of effort in the community to align and standardize both the methodology of sample collection and storage performed in different locations and the necessary frameworks of subject protection including informed consent and institutional review of the studies being performed. There is a growing trend in developing biorepositories around the focus of large population-based studies that address both active and silent nonsymptomatic disease. Logistically these studies generate large numbers of clinical samples and practically place increasing demand upon health care systems to provide uniform sample handling, processing, storage, and documentation of both the sample and the subject as well to ensure that safeguards exist to protect the rights of the study subjects for deciding upon the fates of their samples. Currently the authority to regulate the entire scope of biorepository usage exists as national practice in law in only a few countries. Such legal protection is a necessary component within the framework of biorepositories, both now and in the future. In this brief overview, we provide practical information to the potential users of biorepositories about some of the current developments in both the methodology of sample acquisition and in the regulatory environment governing their use. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
biobank, regulatory, ethics, LIMS
in
Journal of Proteome Research
volume
13
issue
12
pages
5319 - 5324
publisher
The American Chemical Society
external identifiers
  • wos:000346039400004
  • scopus:84915803480
ISSN
1535-3893
DOI
10.1021/pr500475q
language
English
LU publication?
yes
id
c61305d8-1802-44eb-ae63-81339c3c7166 (old id 4957566)
date added to LUP
2015-01-28 15:54:09
date last changed
2017-05-21 03:10:33
@misc{c61305d8-1802-44eb-ae63-81339c3c7166,
  abstract     = {Clinical samples contained in biorepositories represent an important resource for investigating the many factors that drive human biology. The biological and chemical markers contained in clinical samples provide important measures of health and disease that when combined with such medical evaluation data can aid in decision making by physicians. Nearly all disciplines in medicine and every omic depend upon the readouts obtained from such samples, whether the measured analyte is a gene, a protein, a lipid, or a metabolite. There are many steps in sample processing, storage, and management that need to understood by the researchers who utilize biorepositories in their own work. These include not only the preservation of the desired analytes in the sample but also good understanding of the moral and legal framework required for subject protection irrespective of where the samples have been collected. Today there is a great deal of effort in the community to align and standardize both the methodology of sample collection and storage performed in different locations and the necessary frameworks of subject protection including informed consent and institutional review of the studies being performed. There is a growing trend in developing biorepositories around the focus of large population-based studies that address both active and silent nonsymptomatic disease. Logistically these studies generate large numbers of clinical samples and practically place increasing demand upon health care systems to provide uniform sample handling, processing, storage, and documentation of both the sample and the subject as well to ensure that safeguards exist to protect the rights of the study subjects for deciding upon the fates of their samples. Currently the authority to regulate the entire scope of biorepository usage exists as national practice in law in only a few countries. Such legal protection is a necessary component within the framework of biorepositories, both now and in the future. In this brief overview, we provide practical information to the potential users of biorepositories about some of the current developments in both the methodology of sample acquisition and in the regulatory environment governing their use.},
  author       = {Marko-Varga, György and Baker, Mark S. and Boja, Emily S. and Rodriguez, Henry and Fehniger, Thomas},
  issn         = {1535-3893},
  keyword      = {biobank,regulatory,ethics,LIMS},
  language     = {eng},
  number       = {12},
  pages        = {5319--5324},
  publisher    = {The American Chemical Society},
  series       = {Journal of Proteome Research},
  title        = {Biorepository Regulatory Frameworks: Building Parallel Resources That Both Promote Scientific Investigation and Protect Human Subjects},
  url          = {http://dx.doi.org/10.1021/pr500475q},
  volume       = {13},
  year         = {2014},
}