Does my research with coded information or specimens require IRB review?

Last updated: April 2020

Research with previously collected coded data and/or specimens

Previously collected coded data or specimens may include left-over clinical samples, medical data, research data or research samples.

If the research is FDA regulated, IRB review and approval IS required.

For research NOT regulated by the FDA, IRB review is not required if BOTH of the following conditions are true:

  1. The data or specimens to be studied were not collected specifically for the current research;

    AND

  2. Investigator(s) cannot readily ascertain the identity of the source(s) of the coded data or specimens because one or more of the following is true:

    1. The investigator(s) and the holder of the key enter into an agreement prohibiting the release of the key to the investigator(s) under any circumstances
    2. IRB-approved written policies and procedures for the repository or data coordinating center prohibit the release of the key to the investigator(s) under any circumstances.

Investigators that want to use research data or leftover research samples must also consult the original informed consent document signed by participants to ensure that subsequent use was specifically permitted.

When UW personnel receive coded data or specimens for the current research

If the research is FDA regulated, IRB review and approval IS required.

For research NOT regulated by the FDA, IRB review is not required because UW is not engaged the in human subjects research if BOTH of the following conditions are met:

  1. UW personnel obtain coded private information or human biological specimens from another institution involved in the research that retains a link to individually identifying information (such as name or social security number); and
  2. UW personnel are unable to readily ascertain the identity of the subjects to whom the coded information or specimens pertain because, for example:

    • the institution’s employees or agents and the holder of the key enter into an agreement prohibiting the release of the key to the those employees or agents under any circumstances;
    • the releasing institution has IRB-approved written policies and operating procedures applicable to the research project that prohibit the release of the key to the institution’s employees or agents under any circumstances; or
    • there are other legal requirements prohibiting the release of the key to the institution’s employees or agents.

NOTE: In some circumstances, IRB review may be required by the sponsor or contract. Please consult with irbreliance@wisc.edu.

See Also:




Keywords:FAQ, private information, biological specimens, biospecimen, coded sample   Doc ID:22226
Owner:Monica E.Group:Health Sciences IRBs
Created:2012-01-12 16:01 CDTUpdated:2020-04-16 14:33 CDT
Sites:Health Sciences IRBs
Feedback:  1   2