Human Subjects Involvement Codes

See also: Human Subjects Inclusion Codes.

Scientific review group concerns of unacceptable risk or inadequate protection can result in a bar or restriction to award—see the Bars and Restrictions to Grant Awards—Human Subjects SOP. If you see a code on your summary statement, read Know What a Summary Statement Means.

These codes reflect the status of human subjects involvement on summary statements of grant applications and on the grants management and program officer worksheets in IMPAC II:

  • Code 10—Award can be processed, no human subjects involved.
  • Codes X1-X8—Award can be processed, human subjects involved, designates an exemption.
    • Code X1—Exemption category 1—research is conducted in an educational setting using normal educational practices.*
    • Code X2—Exemption category 2—research uses educational tests, surveys, interviews, or observations of public behavior, unless subjects are identifiable and disclosure could place them at risk.
    • Code X3—Exemption category 3—research uses benign behavioral interventions.
    • Code X4—Exemption category 4—research involves the collection or study of existing data, or specimens, if the sources are publicly available or the information is recorded so subjects cannot be identified.
    • Code X5—Exemption category 5—research involves public service program or demonstration project.
    • Code X6—Exemption category 6—research evaluates taste and food quality.
    • Code X7—Exemption category 7—research involves storage of identifiable information or biospecimens for secondary research use. Broad consent and limited institutional review board (IRB) are required.
    • Code X8—Exemption category 8—secondary research uses identifiable information or biospecimens. Broad consent and limited IRB are required.
  • Code 20—Award cannot be processed, human subjects involved and no appropriate exemption designated.
  • Code 30—Award can be processed, human subjects involved, no scientific review group (SRG) human subjects concerns.
  • Code 35—For institutional training grant trainees working on mentored projects that involve human subjects, Federalwide Assurance required just-in-time.
  • Code 48—At time of award, restrictions will apply.

*Cannot include any other procedures, such as collecting clinical data or biospecimens.

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