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Yours is a common plight faced by U.S. clinical researchers. You’ve completed a study and have leftover de-identified biological samples that look promising for use in future research; Research that wasn’t anticipated on the original consent form. This situation raises a question that Quorum Review’s Legal Department hears often, “Does my proposed project need an IRB review?” Below you will find information to help you get an idea of when your project using de-identified biological samples might not require an IRB review.
We’ve Got De-Identified Samples: Is This Human Subjects Research?
In the scenario described above, an IRB review is generally trigged by the existence of a human subject as defined in the Health and Human Services regulations at 45 CFR 46.102(f).
According to the regulations, research only involves human subjects if the investigator obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information.
Researchers planning to conduct research on leftover de-identified samples can look to the Office of Human Research Protection’s (OHRP) guidance for help clarifying when research on human biological specimens is not considered human subjects research.
This clarification is important to researchers and ethics review boards alike, because research projects that do not involve human subjects does not require an IRB review.
Following the OHRP guidance, researchers can determine whether an IRB review is needed for research involving de-identified biological samples. First, researchers must determine whether the de-identified samples are associated with identifiable private information. If so, any research involving the samples and access to this information is considered human subjects research. However, if the samples are “coded” it may not constitute human subjects research. OHRP’s guidance clarifies when a specimen can be considered “coded” as follows:
- 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.
If the leftover sample meets OHRP’s definition of coded then additional conditions are evaluated to determine if the specimens can be linked, either directly or indirectly, to specific individuals. These additional conditions include:
- “the private information or specimens [should not have been] collected specifically for the currently proposed research project through an interaction or intervention with living individuals.
- the investigator(s) should not be able to “readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain.”
If the linkage between the private information and the individual is not present, then OHRP will not consider the research to involve human subjects. As mentioned above, this generally means an IRB Review is not required1.
Who Determines Whether an IRB Review is Required for De-Identified Samples?
The guidance recommends that organizations have policies in place to authorize only person(s) that are knowledgeable about human subject protection regulations to make a determination as to whether research involving coded specimens constitutes human subjects research. That is to say, OHRP leaves the determination up to the research organization, so long as they have the appropriate level of in-house expertise.
However, in practice, many organizations engage an IRB to evaluate research proposals and make a determination as to whether an IRB review is required. This practice recognizes that seemingly simple determinations may contain hidden complexity, which increases exposure to future compliance issues. In addition, these organizations typically rely on their IRB to make determinations more efficiently than can be achieved in-house.
Does Your Research Project Require an IRB Review?
If you are planning a research project and need expert help determining whether an IRB review is required, Quorum Review offers an efficient low-cost service to support you. This service includes an evaluation of your research proposal and formal opinion as to whether your project constitutes human subjects research.
Consult with us today!
 This assumes the research is not a clinical investigation as defined under FDA regulations, in which case it would require IRB review but may not require consent as described in the FDA guidance, Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006, available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm, accessed February 14, 2014.