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OSP Informational Session for NIH Researchers on FORMS E
Wednesday, January 10, 2018
4:00 PM – 4:45PM
Auditorium B, DHMC
The presentation will cover the new NIH Human Subjects and Clinical Trials Information Form by showing the additional required questions and how to select the correct FOA.
To attend remotely click on the link below after 3:50PM on January 10th for a live-stream of the presentation:
https://video.dartmouth-hitchcock.org/media/Global+2/1_dkfar49z
During the presentation, remote participants can email questions to
[log in to unmask] which will be monitored during the presentation and questions will be read and answered as they are received.
FORMS E
Important Changes to NIH Forms
NIH will require the use of application packages with a Competition ID of ‘FORMS-E’ for due dates on or after
January 25, 2018.
Applications prepared using the prior ‘FORMS-D’ packages for due dates after
January 24, 2018 will be rejected without review by NIH.
Changes are focused on human subjects questions and clinical trials but other changes apply to all applications:
1.
If your research involves human subjects in any way,
including human specimens and data, please be aware of the new questions below:
2.
If “yes” to Human Subjects you will need to create a Study Record:
*Study Record Screen Shots Appear After the Resource Links Below*
Links to resources:
Is my project a clinical trial?
Decision-making tool:
https://grants.nih.gov/policy/clinical-trials/definition.htm
See example case studies here:
https://grants.nih.gov/policy/clinical-trials/case-studies.htm
FAQ:
https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm
Training Video for the Study Record:
https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm
Instructions the Study Record:
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
Screen Shots of New Form and Study Record:
Data
Collection
for
Delayed
Onset
Study
Study
Record:
PHS
Human
Subjects
and
Clinical
Trials
Information
Full
study
records
are
comprised
of 5
sections.
Inclusion Enrollment
Report
Data
Collection will be in Study Record