Notice Number: NOT-HL-18-634

Key Dates
Release Date: June 1, 2018

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

This Notice is to inform applicants that information regarding the plans for participation of Women, Minorities and Children (Section 2.4) is not required for submission to RFA-HL-19-009 "Cardiothoracic Surgical Trials Network (CTSN) Linked Clinical Research Centers (UM1 Clinical Trial Not Allowed)". Since applicants will indicate that studies completed in response to the FOA are "delayed onset" they will not have access to the application form that instructs them to provide information regarding participation of Women, Minorities and Children.

The following section of RFA-HL-19-009 have been modified (shown in bold-italics).

Section IV. Application and Submission Information

CURRENT LANGUAGE

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Section 2 Study Population Characteristics

2.4 Inclusion of Women, Minorities, and Children
Describe plans to include both genders, and racial and ethnic minorities as appropriate for the scientific goals of the research within the CTSN. 
Delayed Onset Study

REVISED LANGUAGE
NOTE: Because applicants will indicate that studies completed in response to the FOA are "delayed onset" they will not have access to the application form that instructs them to provide information regarding participation of Women, Minorities and Children (Section 2.4).

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Megan Mitchell, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7950
Email: megan.mitchell@nih.gov