NOTE: for any words or phrases that have a link with a magnifying glass icon, hovering over the term will pop up a more detailed definition.
Secondary uses are analyses to investigate new research question(s), whether conducted by the investigator who initially acquired the data/biospecimens or by any other investigator. An investigator can propose research analysis of retrospective (already existing) and/or prospective (yet to be generated) materials, including those obtained through clinical care.
Primary uses are those specific uses for which data/biospecimens were initially acquired. For the Electronic Medical Record (EMR), the primary use is clinical care. Research analysis of data/biospecimens is “primary use” if it is part of the research project for which the data/biospecimens were collected.
Coded dataset: Per OHRP guidance, means that:
- identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain, has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
- a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. This is regardless of who holds the key to decipher the code.
Engagement in research (for purposes of secondary use research): A performance site is deemed to be engaged in human research when it receives a direct grant or other award to support the research or obtains individually identifiable private information for purposes of the research.
Examples of non-engagement in UM human subjects research: Primary analysis of de-identified or coded information obtained for research purposes at other institutions or releasing identifiable private information or biological specimens (such as from a repository).