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