Department of Health
and Human Services (HHS)
and Human Services (HHS)
July 8, 2020
PAR-19-313 - Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 Clinical Trial Optional)
National Institute of General Medical Sciences (NIGMS)
The purpose of this Notice is to revise the instructions in the Human Subjects and Clinical Trial Information sections regarding the establishment of a Human Subjects Core in PAR-19-313 "Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 Clinical Trial Optional)". The creation of a Human Subject Core is no longer recommended. Instead, human subjects Study Record(s) must be included in the component where the work is being proposed, unless the same study spans multiple components. In the latter case, complete only one study record with sufficient information for all involved components and include it in the Overall component. In all components using the same study record, please use the “Other Requested Information” attachment indicating that the study details are included in the Overall component. For more information, see the question X.E.1. “Where do I enter my human subjects study information in my multi-project application?” on the Applying Electronically FAQ page.
Part 2. Section IV.2 Content and Form of Application Submission
Overall Component
PHS Human Subjects and Clinical Trials Information (Overall)
The FOA currently reads:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. If a human subjects protocol(s) is used in a single Research Project or Core of the Center, the study record(s) must be included in the component where the human subjects research is being performed. If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores. A study record(s) with sufficient information for all involved components and projects must be included in the Human Subjects Core.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
This section of the FOA is modified to read:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
Part 2. Section IV.2 Content and Form of Application Submission
Research Core
The FOA currently reads:
When preparing your application, use Component Type ‘Core.’
If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores.
In COBRE applications focusing on rural health, a Community Engagement and Outreach (CEO) Core is required.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
This section of the FOA is modified to read:
When preparing your application, use Component Type ‘Core.’
In COBRE applications focusing on rural health, a Community Engagement and Outreach (CEO) Core is required.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Part 2. Section IV.2 Content and Form of Application Submission
Research Core
PHS Human Subjects and Clinical Trials Information (Research Core)
The FOA currently reads:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. If a human subjects protocol(s) is used in a single Research Project or Core of the Center, the study record(s) must be included in the component where the human subjects research is being performed. If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores. A study record(s) with sufficient information for all involved components and projects must be included in the Human Subjects Core.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
This section of the FOA is modified to read:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
Part 2. Section IV.2 Content and Form of Application Submission
Research Project
PHS Human Subjects and Clinical Trials Information (Research Project)
The FOA currently reads:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. If a human subjects protocol(s) is used in a single Research Project or Core of the Center, the study record(s) must be included in the component where the human subjects research is being performed. If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores. A study record(s) with sufficient information for all involved components and projects must be included in the Human Subjects Core.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
This section of the FOA is modified to read:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
All other aspects of the FOAs remain the same.
Michele McGuirl, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email:[email protected]