NIH Inclusion of Women and Minorities Template-valid on or after November 25, 2014 with applications that
indicate “ADOBE-FORMS-B1,” “ADOBE-FORMS-B2,” or “ADOBE-FORMS-C” in the “Competition ID” field of
the SF424 (R&R) forms package.
Format: Arial, Helvetica, Palatino Linotype, or Georgia typeface in black font color, at least 11 points or larger.
At least one-half inch margins on all sides. No information should appear in the margins, including the PI’s
name and page numbers. Although no specific page limitation applies to this section, be succinct.
Complete this section if you answered “yes” to the question “Are human subjects involved?” on the R&R Other
Project Information form and the research does not fall under Exemption 4.
See the Supplemental Instructions for PHS 398 and SF424 (R&R) for examples of acceptable justifications for
the exclusion of a sex/gender or racial/ethnic group.
ANY INSTRUCTIONS IN RED TEXT SHOULD BE REMOVED BEFORE UPLOAD.
Inclusion of Women and Minorities
In this section of the Research Plan, address, at a minimum, the following four points:
1. Describe the planned distribution of subjects by sex/gender, race, and ethnicity for each proposed study and
complete the format in the Planned Enrollment Report.
Additional guidance for research utilizing existing datasets:
• If using existing datasets or specimens that meet the NIH definition for clinical research and information about
sex/gender, race, and ethnicity is available, this information should be described as with any other type of
study.
• If using existing datasets or specimens that meet the NIH definition for clinical research but without access to
information on the distribution by sex/gender, race, and/or ethnicity, so state and explain the impact on the
goals of the research as part of the rationale that inclusion cannot be described.
• For an existing dataset or specimens, use the Cumulative Inclusion Enrollment Report rather than the
Planned Enrollment Report.
2. Describe the subject selection criteria and rationale for selection of sex/gender, racial, and ethnic group
members in terms of the scientific objectives and proposed study design. The description may include, but is
not limited to, information on the population characteristics of the disease or condition under study.
3. Provide a compelling rationale for proposed sample specifically addressing exclusion of any sex/gender,
racial, or ethnic group that comprises the population under study (see examples below).
4. Describe proposed outreach programs for recruiting sex/gender, racial, and ethnic group members as
subjects.
Office of Research Support, University of Texas at San Antonio, 2014
Source: SF424 (R&R) Application Guide for NIH and Other PHS agencies, II-12-13.