Guidelines for Human Biospecimen
1 Guidelines for Human Biospecimen Storage, Tracking, Sharing, and Disposal within the NIH Intramural Research Program September, 2019; Revised May, 2021; Revised September, 2021 This Photo by Unknown Author is licensed under CC BY-ND 2 Contents Preface ........................................ ........................................ ........................................ ............... 3 Introduction ........................................ ........................................ ........................................ ....... 4 Definition of Human Biospecimens ........................................ ........................................ ............. 4 1. Legal and ethical considerations ........................................ ........................................ ............. 6 2. Collection and storage.
number, medical record number, etc.). 3 • “ Identifiable biospecimen” (2018 Common Rule definition) meaning a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. 4 • "Individually Identifiable " (Pre-2018 Common Rule definition) meaning that the
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