Human Tissue Ownership and Use in Research: What Laboratorians and Researchers Should Know

Allen, Monica J.; Powers, Michelle; Gronowski, K. Scott; Gronowski, Ann M.

doi:10.1373/clinchem.2010.150672

Cited by 47 publications

(40 citation statements)

References 14 publications

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“…We did not obtain permission from the parents of neonatal patients. Because we do not have access to patients' private information, this research, by definition, would not be human subject research and would not require informed consent from neonates or parents [18].…”

Section: Patientsmentioning

confidence: 99%

Establishing reference values and evaluation of an in-house ferric reducing antioxidant power (FRAP) colorimetric assay in microplates

Üstündağ¹,

Huysal²,

Kahvecioğlu³

et al. 2016

Eur Res J

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Objectives. The total antioxidant capacity (TAC) of a sample can be measured with a ferric reducing antioxidant power (FRAP) assay. There are commercially available kits for FRAP assays, however they are more expensive than in-house kits. We aimed to evaluate a FRAP direct measurement method under our laboratory conditions using a microplate reader and establish reference values to use in future research projects. Methods. An inhouse microplate adaptation of the FRAP method was evaluated. Reference values of FRAP were established for one hundred and twenty subjects aged between 25-55 years. FRAP levels were estimated in 30 serum samples with high glucose concentration, 44 hyperbiluribinemic neonatals and 16 patients receiving renal replacement therapy (RRT). Results. The mean FRAP level was 890±235 µmol/L. The median TAC level was 904 µmol/L. This method was found to be linear up to at least 2000 µmol/L. The intra-and inter-assay coefficients of variation were 2.7-6.7% and 5.3-10.1%, respectively. The mean FRAP level was lower than normal in diabetes and RRT patients and higher in hyperbiluribinemic neonatals (687±209 µmol/L, 609±250 µmol/L and 945±187 µmol/L, respectively). Conclusions. Our reference values give comparable results with the literature. This method is simple, reliable, and inexpensive. It could be used for studies of oxidative stressrelated diseases.Eur Res J 2016;2(2):126-131

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Section: Patientsmentioning

confidence: 99%

Establishing reference values and evaluation of an in-house ferric reducing antioxidant power (FRAP) colorimetric assay in microplates

Üstündağ¹,

Huysal²,

Kahvecioğlu³

et al. 2016

Eur Res J

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show abstract

“…It is worth noting that stewardship is distinct from ownership [4,7]. True ownership of human tissue is a complex topic [1,4,7,12,13,14,15] and may vary internationally depending on how specifically its legal status has been established by different countries. While it is beyond the scope of this article to engage in such debate or to perform a comparative analysis of international approaches to tissue ownership, we will say this: stewards are not owners and that issues of ownership are irrelevant to the practical role of the clinical laboratory as stewards of DT [4].…”

Section: Distinguishing Features Of Dt Relevant To Researchmentioning

confidence: 99%

The Role of Diagnostic Tissue in Research

Cheung

Torlakovic²,

Porwit

2014

Pathobiology

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There are two broad classes (or categories) of excised human tissue: diagnostic tissue (DT) and research tissue (RT). Classification of excised human tissue does not define its ultimate use and ultimate use of excised human tissue does not define its classification. While both DT and RT can be used for research, DT has specific requirements with respect to how it must be handled if and when being accessed for research. We highlight distinguishing features of DT: (1) it is a clinical record, (2) it must be identifiable to a specific individual, (3) it is stewarded by pathology departments/clinical laboratories and (4) it has a mandatory retention period. We discuss how the further sub-classification of DT into archived DT (aDT) and excess DT (eDT) impacts the nature of its role in research. We examine the concept of DT as a clinical record and emphasize the impact of mandatory retention as it applies to how DT may be accessed for research purposes. We explain the role of post-retention eDT as a source of RT as well as procedures for access to in-retention aDT for research. Clarity of such issues will facilitate responsible access to DT for research.

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“…Allen et al 5 provide a summary of the legal decisions in a number of important US cases. The important lessons that come from these cases are that where tissue has been given voluntarily for research and there is no expectation of return, the donors have no rights of ownership in the tissue itself or research conducted on it.…”

Section: Ownership Of Human Samplesmentioning

confidence: 99%

“…The important lessons that come from these cases are that where tissue has been given voluntarily for research and there is no expectation of return, the donors have no rights of ownership in the tissue itself or research conducted on it. Another important case, which involved a dispute between a researcher who wished to transfer to his new employer a substantial collection of samples from patients obtained over a 20 year period and his former employer (Washington University v Catalona, 490F 3d 667 2007: referenced in Allen et al 5 ), supported this viewpoint. In this case, the researcher wrote to his donors and sought their permission to release their samples to him in order to transfer their material to his new employer.…”

Section: Ownership Of Human Samplesmentioning

confidence: 99%

Access to Human Cells and Tissues

Thomas¹

2014

Human-Based Systems for Translational Research

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Improving methods for diagnosis and treatment depend on a better understanding of the biological mechanisms of disease. In the past the tool of choice has been an animal model or a cell line, but increasingly the limited value of this material has been recognised. In the clinic we treat humans, and the ideal model to understand the disease we aim to treat is therefore the human. However, access to human tissue is not always easy or practical, and is complicated by ethics and legislation over both data and tissue samples. The well-being of the donor of the material is paramount, and must never be compromised by the acquisition of samples for research. This chapter will provide an overview of the obstacles that exist to accessing ethically sourced human material for laboratory scientists and suggests models that can be used to facilitate access.

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Human Tissue Ownership and Use in Research: What Laboratorians and Researchers Should Know

Cited by 47 publications

References 14 publications

Establishing reference values and evaluation of an in-house ferric reducing antioxidant power (FRAP) colorimetric assay in microplates

Establishing reference values and evaluation of an in-house ferric reducing antioxidant power (FRAP) colorimetric assay in microplates

The Role of Diagnostic Tissue in Research

Access to Human Cells and Tissues

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