IRB Terminology Related to Tissue or Data Collection

Submissions to the IRB are often returned to the investigator for clarification of the nature of data collection. The IRB must be able to determine whether the data are:

a) Anonymous – the identity of the respondent cannot be determined; no links exist between the data and the individual about whom the data are recorded;

b) De-identified – identifiers have been removed from the dataset under consideration; links between the data and the individual about whom the data are recorded exist but are not readily accessible to the researcher at CU;

c) Coded – identifiers have been removed from the dataset under consideration but can readily be replaced through the use of a master list that is accessible to the investigator;

d) Identifiable or non-coded – the identity of the subject is documented, linked or associated with the data.

The manner in which data are recorded and maintained influence the decisions of the IRB, particularly determination of risk level and type of review required. To avoid delay in the review process, investigators should clearly state whether data are anonymous, de-identified, coded, or identifiable. A description of the data to be recorded is particularly helpful.

All protocols involving identifiable or coded data should include mechanisms to ensure confidentiality is maintained.

March 9, 2004