My resubmission of a competing renewal application (Type 2 A1) was not funded. May I submit a new renewal (Type 2 A0)?

April 25, 2019

No. Only a single resubmission of a competing new, revision, or renewal application (A0) will be accepted. After a resubmission of a competing renewal (Type 2) application that is not funded, a subsequent new renewal (Type 2 A0) application may not be submitted. The next application submitted on this topic should be submitted as a new application (Type 1 A0) on an appropriate due date for new applications (see NOT-OD-18-197 for exceptions).

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?”