Special Guidance for Domestic and Foreign Applicants

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If you're proposing a new clinical research study, you must provide information about the participants you plan to include in a Targeted/Planned Enrollment Table, and submit that table with your application.

• For electronic applications, use the Targeted/Planned Enrollment Table in your Grant Application Package.
• For paper applications, use the Targeted/Planned Enrollment Table in the PHS 398.

Later, when you're required to submit a progress report, you'll need to provide updated information about your data in an Inclusion Enrollment Report Table. For more information, read Send the Inclusion Enrollment Form With Your Progress Report in this tutorial.

To learn more about enrollment tables and special instructions for renewal (competing continuation) and revision (competing supplement) applications, look at the following:

• Electronic applications. Read section 4.3, Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research, under Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, in the Grant Application Guide for your Grant Application Package.
• Paper applications. Read section 4.3, Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research, under Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, in the PHS 398.

For additional information, see Investigating Foreign Populations and Develop Your Human Subjects Research Plan in this tutorial.

For human subjects research, you must include justification for inclusion or exclusion of children. Find more information in OHRP's guidance on Special Protections for Children as Research Subjects.

You may need to file an incident report with OHRP if an incident occurs during your research; for example, you're not in compliance with human subjects regulations or IRB or IEC requirements, or you've discovered unanticipated risks to human subjects.

Read the Guidance on Reporting Incidents to OHRP for details on whether to report an incident, information to include, timelines, and other important items.

Take a look at the OHRP Web site for additional guidance on human subjects.

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