The majority of changes in the PHS Forms -E relate to the consolidation of human subjects and inclusion enrollment information in the application. Previously this information was in several different places within the application. The new form also expands clinical trial data collection to allow reviewers the ability to improve oversight. A key focus of the new form set is the revised definition of Clinical Trial and Clinical Research.
The application guide for the Form-E
PIs take note!
While many other sections of the Form set have changed, the most critical changes in the are to the PHs 398 Research Plan Form. Here is a summary of the key changes to that portion of the application:
- Removed Human Subject Section
- Dara safety Monitoring Plan
- Inclusions of Women and Minorities
- Inclusion of Children
- Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed Research but applicants should not duplicate information collected in the new OHS Human Subjects and Clinical Trials Information
- Includes instructions to describe research methods for trials that randomize groups or deliver interventions to groups
- Renumbered the form fields
- made minor text edits
- Includes the updated appendix policy that goes into effect for applications submitted on or after January 25, 2018. Thus policy eliminates clinical trial-related material. See the: NIH Guide Notice of Allowable Appendix Materials
Please contact the OSP Preaward Team if you have any questions!
- Melita Lindsey
- Michelle Lester
- Ginny Geer
- Brenda Murrell
- Sarah White
