Human Subjects Sections

Protection of Human Subjects:

This section is required for applicants answering “yes” to the question “Are human subjects involved?” on the R&R Other Project Information form. If the answer is “No” to the question but the proposed research involves human specimens and/or data from subjects applicants must provide a justification in this section for the claim that no human subjects are involved. Do not use the protection of human subjects section to circumvent the page limits of the Research Strategy.

Inclusion of women and Minorities:

This section is required for applicants answering “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.

Targeted/Planned enrollment:

If this application involves the Inclusion of Women and Minorities, applicants must complete the Targeted/Planned Enrollment Table for each protocol; see Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, Section 4.3. For applicants answering “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, complete the Targeted/Planned Enrollment Table for each protocol.

Inclusion of children:

For applicants answering “Yes” to the question “Are human subjects involved” on the R&R Other Project Information Form and the research does not fall under Section 4, this section is required .

Last Modified: October 25th, 2012