Basic Exempt Criteria 45 CFR 46.101(b)(4)
Research includes studies of biological specimens that have been banked for research purposes. Although health information about the individuals who provided these specimens can be linked to them, researchers cannot have direct access to their names, or other information that would allow them to be identified. It may be appropriate to use an Honest Broker.
- Specimens may include tissue, blood, or bodily fluid
- Specimens were obtained independent of this research study
- Specimens are archived in a recognized tissue bank
- All specimens and corresponding data are recorded anonymously, OR
- Data are recorded in such a way that researchers cannot identify subjects.
Two acceptable strategies for this de-identification exist:
- Identifiable data are de-identified by an appropriate software program OR
- The de-identification of data is carried out by a person who is independent of the research (i.e., an independent "honest broker") and who has been identified by name in the protocol, and has completed the "honest broker" certification form. Information linking the assigned code numbers to the subjects’ identity (if applicable) is maintained solely by the independent "honest broker"
- All specimens are currently in existence
Additional Requirements or Considerations
- Tissue bank or repository must be identified by name, and the IRB number or a copy of the consent form completed by subjects must be included
- If specimens were collected as part of another research project, a copy of the initial consent form must be attached to ensure that subjects participating in the initial project did not restrict the use of their sample to that initial project or to certain types of analyses
- If specimens are still being collected, the investigators of the proposed study cannot personally participate in the collection of those specimens. Under these circumstances, the study must be approved by the IRB as "not human subjects research" (45CFR46.102(f)). This issue needs to be addressed explicitly in the protocol
Exempt Form: Research with Biological Specimens