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GENERAL APPLICATION GUIDE FOR NIH AND OTHER PHS AGENCIES
SF424 (R&R) - Forms Version D
Released: March 24, 2017

G.500 - PHS Inclusion Enrollment Report

Who should use the PHS Inclusion Enrollment Report?

The PHS Inclusion Enrollment Report is required for any application that involves NIH-defined clinical research. Refer to the NIH Glossary for the definition of a clinical research.

For more information on how to use the PHS Inclusion Enrollment Report:

Refer to the Supplemental Instructions, Part II, Section 4.3: Instructions for Completing the PHS Inclusion Enrollment Report(s) for additional guidance on how and when to use the PHS Inclusion Enrollment Report. The section has general guidance as well as specific guidance for different application types, applications involving more than one study, and applications with multi-site studies.

Study Title (must be unique):

This field is required.

The Study Title can have a maximum of 250 characters.

Enter a unique title that describes the study the participants will be involved in. If there is more than one study, provide a separate Study Title for each.

Delayed Onset Study (Yes/No)?

This field is required.

Check the appropriate box to indicate whether the study is considered delayed onset. If the study is delayed onset, select "Yes." If the study is not delayed onset, select "No."

"Delayed onset" generally means that a study has not been developed and cannot be described in terms of human subjects' protections and inclusion. This does NOT apply to a study that can be described but will not start immediately.

For additional guidance on whether a study meets the criteria to be considered "delayed onset,", refer to the Supplemental Instructions, Part II, Section 2. Scenario D: Delayed-Onset Human Subjects Research.

If you have answered "Yes" to the "Delayed Onset Study?" question, the rest of that particular PHS Inclusion Enrollment Report will be disabled. Complete additional PHS Inclusion Enrollment Reports, if applicable.

If you have answered "No" to the "Delayed Onset Study?" question, you must answer the following questions and complete the enrollment table:

Enrollment Type (Planned/Cumulative):

This field is required.

Select whether the enrollment table reflects:

Planned Enrollment: Individuals will be recruited into the study (and/or individuals have already been recruited and continue to be part of the study).

Cumulative (Actual) Enrollment: Studies use an existing dataset or resource.

Using an Existing Dataset or Resource (Yes/No):

This field is required.

Select whether this study involves use of an existing dataset or resource.

"Using an existing dataset or resource" generally means that investigators are utilizing data from a previous study or data bank. Do NOT answer "Yes" for individuals previously recruited specifically for this study.

For additional guidance on what is considered an existing dataset, refer to Supplemental Instructions, Part II, Section 4.2: Inclusion of Women and Minorities and these NIH Frequently Asked Questions on Monitoring Inclusion when Working with Existing Datasets and/or Resources.

Enrollment Location (Domestic/Foreign):

This field is required.

Select whether the participants described in the Inclusion Enrollment Report are based at a U.S. or at a non-U.S. site. At a minimum, participants at U.S. and non-U.S. sites must be reported separately (i.e., on separate PHS Inclusion Enrollment Reports), even if it is for the same study.

For additional guidance on how to complete the PHS Inclusion Enrollment Report if you will be working with non-U.S. populations, refer to these Frequently Asked Questions on Monitoring Inclusion in Non-US Research Participants.

Clinical Trial (Yes/No):

This field is required.

Select whether the study these participants are involved in is considered a clinical trial.

Refer to the NIH Glossary for the definition of a clinical trial.

NIH-Defined Phase III Clinical Trial (Yes/No):

This field is required.

Select whether the study is an NIH-defined Phase III clinical trial.

Refer to the NIH Glossary for the definition of a Phase III clinical trial.

Comments:

Your comments can have a maximum of 500 characters.

Enter information you wish to provide about this PHS Inclusion Enrollment Report. This includes, but is not limited to, addressing information about distinctive subpopulations if relevant to the scientific hypotheses being studied and/or a study that will have a delayed onset.

Racial Categories:

American Indian/Alaska Native:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both American Indian/Alaska Native and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both American Indian/Alaska Native and Hispanic or Latino. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative").

Asian:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both Asian and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both Asian and Hispanic or Latino. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative").

Native Hawaiian or Other Pacific Islander:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both Native Hawaiian or Other Pacific Islander and Hispanic or Latino. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative").

Black or African American:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both Black or African American and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both Black or African American and Hispanic or Latino. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative").

White:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both White and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both White and Hispanic or Latino. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative").

More than One Race:

These fields are required.

Enter the expected number of females and males (in the respective fields) who both identify with more than one racial category and are Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who both identify with more than one racial category and are Hispanic or Latino. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative").

Unknown or Not Reported:

These fields are required.

Enter the number of females, males, and individuals of unknown/not reported sex/gender (in the respective fields) whose race is unknown/not reported and who are Not Hispanic or Latino. Enter the number of females, males, and individuals of unknown/not reported sex/gender (in the respective fields) whose race is unknown/not reported and who are Hispanic or Latino. Enter the number of females, males, and individuals of unknown/not reported sex/gender (in the respective fields) who are both of unknown/not reported race and of unknown/not reported ethnicity. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative").

Total:

The total fields at the bottom will be automatically calculated and reflect the totals of all racial categories for females, males, and individuals of unknown/not reported sex/gender who are Not Hispanic or Latino and of all racial categories for females, males, and individuals of unknown/not reported sex/gender who are Hispanic or Latino. Use the "Unknown/Not Reported" fields only when reporting actual enrollment (i.e., your "Enrollment Type" is "Cumulative"). The "Total" fields in the right column will be automatically calculated to total all individuals in a given racial category.