If the key is not available to anyone on the research team, these specimens are considered nonidentifiable even if the key is held in the biobank. Note: The terms code, link, and key are often used interchangeably.Ī nonidentifiable biospecimen is a biospecimen for which the identity of the donor cannot be ascertained by the investigator. As long as a link exists that is accessible to the study investigators, these biospecimens are considered indirectly identifiable.
KELSEY KULLO CODE
Identifiable information is retained separately such that the code can be used to link the biospecimen back to the donor. Such biospecimens are samples with the individually identifiable information removed and replaced with a unique code. A subset of identifiable biospecimens includes coded biospecimens (indirectly identifiable biospecimens). Biobanks typically exist to support medical and environmental research.Ī human biospecimen is any natural material from the human body, such as tissue, blood, and urine, as well as derived materials, such as cells and cellular analytes, including nucleic acids, proteins, carbohydrates, and lipids.Īn identifiable biospecimen is a biospecimen for which the identity of the donor is or may readily be ascertained by the investigator or is associated with the biospecimen.
The current US system of protection for human research subjects (Common Rule) is heavily influenced by the Belmont Report.Ī biobank is a system (including facilities, personnel, and procedures) for storing and retrieving biological samples, including tissue, blood, and urine derived materials, such as cells, proteins, and nucleic acids and pertinent demographic and clinical data. Was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and outlines the basic ethical principles in research involving human subjects. On the basis of these considerations, this article provides recommendations for investigators to consider when planning and executing human biospecimen research, with the objective of appropriately balancing the interests of research subjects, the need for ensuring integrity of the research process, and compliance with US laws and regulations. This article discusses the rationale for returning individual research results to subjects, the potential risks associated with returning these results, and the legal framework in the United States that governs testing of identifiable human biospecimens. The concept of an individual's interest in knowing the results of testing on their tissue is pitted against individual and systemic risks and an established legal framework regulating the performance of laboratory testing for medical care purposes. The recent movement toward returning individual research results to study subjects/participants generates ethical and legal challenges for laboratories performing research on human biospecimens.
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