paperKB
coga / coga-kb
Help
Sign in

Chunk #18 — PART I. DEFINITIONS

Source
Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
Embedded
yes

Text

In part because some biobank research is considered human subjects research under the Common Rule while other research is not, a range of terms is used to refer to the human beings whose data and samples are housed in biobanks. Such an individual may be called a “participant” or “human subject” when the research being conducted qualifies as human subjects research, or the individual may be called a “donor” or “source” of the data or samples. Because we address both human subjects research and “human non-subjects research,” we use a more encompassing term than “subjects” or “participants.” We generally use the term contributors to refer to the individuals whose data and samples are collected in biobanks, whether or not they also qualify as “human subjects” under the Common Rule. We avoid the term “sources,” as this is ambiguous in a biobank research system in which the primary research or collection sites are institutional sources for biobank data and samples, and the biobank in turn is a source for secondary researchers. We also avoid the term “donors,” to avoid implying that