Human Subjects Protection Coding: Instructions and Examples
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Human Subjects Protection:
Supplementary Instructions and Examples for Applicants and Investigators

Item 4 (Page 1) and “Section E-Human Subjects” of the PHS 398 must be filled in appropriately in all applications for NIH grants (see: PHS 398 instructions, Part II).

Applications should be designated “No” Humans Subjects Research in Item 4:

  • If the donor was deceased before, or has died subsequent to, collection of coded private information or biological specimens.
  • If the coded private information or biological specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals and they are either (i) anonymized before receipt by the investigator or (ii) coded, and the specimens/data are not individually identifiable to the investigator if, for example:
  • (a) the key to decipher the code is destroyed before the research begins;
    (b) the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;
    (c) there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
    (d) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

    Applications should be designated “Yes” Human Subject Research in Item 4:

    •  If the investigator or a collaborator has access to the identities of individual live donors at any time.
    •  If an investigator, conducting research, obtains data through intervention or interaction with living individuals.
    •  If an investigator, conducting research, obtains identifiable private information about living individuals.
    •  If the research will use coded private information or biological specimens from living individuals collected specifically for the study from living individuals.

    In any of the four situations above, the proposed research involves human subjects even if the investigator or a collaborator codes, re-codes, or anonymizes the coded private information or biological specimens. Exemption 4 will not apply because the most protective, conservative designation takes priority.

    Reviewers will need the following information to assess the involvement of human subjects in your proposed research:

  • the role of the provider of the coded private information or biological specimen,
  • the roles of the recipient investigators,
  • what is being obtained, and
  • whether the coded private information or biological specimens can be linked to living individuals.
  • OEP/OER/NIH, July 26, 2005

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