Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015

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4.3 Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research

The NIH Policy on the Inclusion of Women and Minorities in Clinical Research is described in Part II, Section 5.6. The NIH Policy on Reporting Race and Ethnicity Data for Subjects in Clinical Research is described and referenced in Section 5.8. For paper PHS398 applications, if your application involves subprojects, attach the Targeted Enrollment Tables to the relevant subproject descriptions. For electronic SF424 (R&R) applications, if your application includes Targeted/Planned Enrollment tables, save all as a single PDF file and attach them using section 8. Targeted/Planned Enrollment of the PHS 398 Research Plan Component (for F applicants, item 11of the PHS Fellowship Supplemental Form - Research Training Plan).

A. New Applications

All new NIH-defined clinical research studies should collect and report information on participants with respect to two categories of ethnicity and five categories of race which are based on the Office of Management and Budget (OMB) reporting standards for data on race and ethnicity. Investigators should review the instructions and Frequently Asked Questions about using the Enrollment Table format at

Instructions for Completing Targeted/Planned Enrollment Tables

( for paper applications, for electronic applications)

Investigators are instructed to provide plans for the total number of subjects proposed for the study and to provide the distribution by sex/gender, racial, and ethnic categories using the Targeted/Planned Enrollment Tables.

For paper PHS398 applications, provide the study or protocol title. For electronic SF424 (R&R) applications, attach the Targeted/Planned Enrollment Table as Item 8. Provide the study or protocol title. If the application involves subprojects, provide Targeted Enrollment Tables for each subproject description. Provide the information as numbers of subjects, not percentages.

The Total Planned Enrollment means the number of subjects that are expected to be enrolled in the study, consistent with the definition in

The Total Planned Enrollment will be reported in two ways in the table: by Ethnic Category and by Racial Categories.

Ethnic Category: Provide the numeric distribution of the Total Planned Enrollment according to ethnicity and sex/gender in the top part of the table.

Racial Categories: Provide the numeric distribution of the Total Planned Enrollment, this time by racial categories and sex/gender, in the bottom part of the table. Note that Hispanic is an ethnic, not a racial, category. Participants are permitted to select more than one race when self-identifying. If the sample is likely to include individuals who identify with more than one race, they should be accounted for in the “More than one race” category on the Targeted/Planned Enrollment Table(s). If including individuals identifying as more than one race is not expected, enter zeroes in that category.

If there is more than one study/protocol, provide a separate table for each. At a minimum, any foreign studies/protocols should be reported separately from domestic studies/protocols. See below for additional guidance under “Research Conducted at Foreign Sites.”

List any proposed racial or ethnic subpopulations below the table.

Submitting Applications or Proposals Using Existing Data in Clinical Research with No Plans for Collecting New/Additional Data:

If the investigators are proposing to use existing data with no plans to collect new/additional data and the data on race and ethnicity of participants were originally collected prior to January 10, 2002, they are not required to re-contact subjects solely to comply with the current OMB categories.

If Data Collection is Ongoing, Such that New Human Subjects Will be Enrolled and/or Additional Data Will be Collected from Human Subjects:

Investigators should submit sex/gender, race, and ethnicity sample composition using the Targeted/Planned Enrollment Table.

Research Conducted at Foreign Sites:

If proposed studies involve a foreign site(s), investigators are encouraged to design culturally sensitive and appropriate data collection instruments that allow research participants to self-identify their racial and/or ethnic affiliation. However, these items should be designed in a way that they can be aggregated into the OMB-required categories. Also, the investigator can report on any racial or ethnic subpopulations by listing this information in an attachment to the required table. This may be particularly useful when distinctive subpopulations are relevant to the scientific hypotheses being studied.

When completing the Targeted/Planned Enrollment Table(s) that describe research at foreign sites, investigators should asterisk and footnote the table indicating that data include research participants from foreign sites. If the aggregated data only includes participants in foreign research sites, the investigator may provide information in one table with an asterisk and footnote or may provide separate tables for each foreign country. However, if the study includes both domestic and foreign sites, the investigator should, at a minimum, complete different tables to separate domestic and foreign participants.

B. Renewal and Revision Applications

( for paper applications, for electronic applications)

For Renewal applications, investigators should provide information on cumulative enrollment from the previous funding period(s). The Inclusion Enrollment Report must be used for reporting accrual data to the NIH.

For Revision applications, any proposed additions to the Targeted/Planned Enrollment Tables should be provided, in addition to providing an Inclusion Enrollment Report of participant recruitment to date.

Instructions for reporting annual total enrollment in funded awards are provided in Section 5.8.

In addition, if a given study/protocol will continue with additional enrollment or if new studies/protocols are proposed, provide a Targeted/Planned Enrollment Report for each.

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