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Human Subjects Inclusion Codes

See also: Human Subjects Involvement Codes.

Unacceptable inclusion may result in a bar to award—see the Bars 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 inclusion catetegories on summary statements of grant applications and on the grants management and program officer worksheets in IMPAC.

Code Definition
Clinical Trial
(X)* Clinical trial, gender, and minority codes not assigned (for non-clinical research or not discussed applications).
(Y)* NIH-defined phase III clinical trial.
(N)* Clinical research - not an NIH-defined phase III clinical trial.
  * These codes do not appear in header on summary statements.
G1A Includes both genders, scientifically acceptable.
G2A Includes only women, scientifically acceptable.
G3A Includes only men, scientifically acceptable.
G4A Gender representation unknown, scientifically acceptable.
G1U Includes both genders, scientifically unacceptable.
G2U Includes only women, scientifically unacceptable.
G3U Includes only men, scientifically unacceptable.
G4U Gender representation unknown, scientifically unacceptable.
M1A Includes minorities and non-minorities, scientifically acceptable.
M2A Includes only minorities, scientifically acceptable.
M3A Includes only non-minorities, scientifically acceptable.
M4A Minority representation unknown, scientifically acceptable.
M5A Includes only foreign (non-U.S.) subjects in study, scientifically acceptable.
M1U Includes minorities and non-minorities, scientifically unacceptable.
M2U Includes only minorities, scientifically unacceptable.
M3U Includes only non-minorities, scientifically unacceptable.
M4U Minority representation unknown, scientifically unacceptable.
M5U Includes only foreign (non-U.S.) subjects in study, scientifically unacceptable.
C1A Includes children and adults, scientifically acceptable.
C2A Includes only children, scientifically acceptable.
C3A Includes only adults, scientifically acceptable.
C4A Age representation unknown, scientifically acceptable.
C1U Includes children and adults, scientifically unacceptable.
C2U Includes only children, scientifically unacceptable.
C3U Includes only adults, scientifically unacceptable.
C4U Age representation unknown, scientifically unacceptable.
Content last reviewed on February 20, 2012