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. | |
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. |
Content last reviewed on February 20, 2012