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Human Subjects Inclusion 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 unscored 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.

Gender
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.

Minority
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.

Children
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.

Department of Health and Human Services

National Institutes of Health

National Institute of Allergy and Infectious Diseases

October 29, 2008