Human Subjects Inclusion Codes

See also: Human Subjects Involvement Codes.

Before you apply, learn about Inclusion of Special Populations: Women, Minorities, and All Ages. After review, if you see a code on your summary statement, read Know What a Summary Statement Means.

Unacceptable inclusion may result in a bar to award—see the Bars and Restrictions to Grant Awards—Human Subjects SOP.

These codes reflect the status of human subjects inclusion categories on summary statements of grant applications and on the grants management and program officer worksheets in IMPAC.

Code Types and Definitions

• Clinical Trial
  • Code (X) — Clinical trial, sex, and minority codes not assigned (for non-clinical research or not discussed applications).
  • Code (Y) — NIH-defined phase III clinical trial.
  • Code (N) — Clinical research, not an NIH-defined phase III clinical trial.
  • Note: X, Y, and N codes do not appear in the header on summary statements.
• Sex
  • Code G1A — Includes both sexes, scientifically acceptable.
  • Code G2A — Includes only women, scientifically acceptable.
  • Code G3A — Includes only men, scientifically acceptable.
  • Code G4A — Sex representation unknown, scientifically acceptable.
  • Code G1U — Includes both sexes, scientifically unacceptable.
  • Code G2U — Includes only women, scientifically unacceptable.
  • Code G3U — Includes only men, scientifically unacceptable.
  • Code G4U — Sex representation unknown, scientifically unacceptable.
• Minority
  • Code M1A — Includes minorities and non-minorities, scientifically acceptable.
  • Code M2A — Includes only minorities, scientifically acceptable.
  • Code M3A — Includes only non-minorities, scientifically acceptable.
  • Code M4A — Minority representation unknown, scientifically acceptable.
  • Code M5A — Includes only foreign (non-U.S.) subjects in study, scientifically acceptable.
  • Code M1U — Includes minorities and non-minorities, scientifically unacceptable.
  • Code M2U — Includes only minorities, scientifically unacceptable.
  • Code M3U — Includes only non-minorities, scientifically unacceptable.
  • Code M4U — Minority representation unknown, scientifically unacceptable.
  • Code M5U — Includes only foreign (non-U.S.) subjects in study, scientifically unacceptable.
• Age
  • Code C1A — Includes children, adults, and older adults, scientifically acceptable.
  • Code C2A — Includes only children (no adults and older adults), scientifically acceptable.
  • Code C3A — Includes no children (only adults and older adults), scientifically acceptable.
  • Code C4A — Age representation unknown, scientifically acceptable.
  • Code C5A — Original review occurred prior to child coding policy (historical inactive value), scientifically acceptable.
  • Code C6A — Includes children and adults (no older adults), scientifically acceptable.
  • Code C7A — Includes only adults (no children and older adults), scientifically acceptable.
  • Code C8A — Includes only older adults (no children and adults), scientifically acceptable.
  • Code C9A — Includes only children and older adults (no adults), scientifically acceptable.
  • Code C1U — Includes children, adults, and older adults, scientifically unacceptable.
  • Code C2U — Includes only children (no adults and older adults), scientifically unacceptable.
  • Code C3U — Includes no children (only adults and older adults), scientifically unacceptable.
  • Code C4U — Age representation unknown, scientifically unacceptable.
  • Code C5U — Original review occurred prior to child coding policy (historical inactive value), scientifically unacceptable.
  • Code C6U — Includes children and adults (no older adults), scientifically unacceptable.
  • Code C7U — Includes only adults (no children and older adults), scientifically unacceptable.
  • Code C8U — Includes only older adults (no children and adults), scientifically unacceptable.
  • Code C9U — Includes only children and older adults (no adults), scientifically unacceptable.