Where Should I Address the Inclusion Across the Lifespan Policy in My Application?

March 25, 2019

Applicants should include a rationale for the age range of study participants and justification for age-based exclusion in the Inclusion of Women, Minorities, and Children section of the PHS Human Subjects and Clinical Trials Information Form (Section 2.4). This section will continue to have the heading “Inclusion of Women, Minorities, and Children” until the next forms update. See the instructions under Inclusion of Children in the application guide for additional information.

In the RPPR, do we need to fill out the Human Subjects and Clinical Trials Information form if we submitted a competing application before January 25, 2018?

July 24, 2018

The Human Subjects and Clinical Trials Information form appears for all recipients with human subjects studies. However, those who submitted competing applications for due dates on or before January 25, 2018 only need to update inclusion data via the Human Subjects link in the RPPR.  The remaining fields (e.g. milestones) are not required to be … Continue reading “In the RPPR, do we need to fill out the Human Subjects and Clinical Trials Information form if we submitted a competing application before January 25, 2018?”

How do you define a “study” for the purposes of providing information on the PHS Human Subject and Clinical Trial form and registering in ClinicalTrials.gov?

February 5, 2018

Our application instructions provide guidance to submit a study record for each protocol. When in doubt, NIH supports lumping several aims or hypotheses into a single study record, to the extent that makes sense for your research.

Have other questions related to the new PHS Human Subject and Clinical Trial form or NIH clinical trial policies? Find more FAQs and their answers at grants.nih.gov.