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

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. Continue reading

Still Have Questions on the NIH Early Stage Investigator (ESI) Policy?

Looking for answers to your questions on our Early Stage Investigator (ESI) policy? Check out the following highlighted frequently asked questions (FAQ) for information on how NIH defines and reviews ESI applications to promote the growth and stability of the biomedical research workforce. Continue reading

How Do I Determine if My Institution is Eligible For an R15 Research Enhancement Award?

As of January 24, 2019, NIH will no longer maintain its list of institutions ineligible to apply for R15 grants. Instead, for R15 applications submitted for due dates on or after February 25, 2019, institutions are responsible for determining their own eligibility. Institutions can determine eligibility using the NIH RePORT website. Continue reading

Are Studies Ancillary to Clinical Trials Considered to be Clinical Trials As Well?

It depends. Yes; if the ancillary study adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met. No; if the ancillary study is only adding additional measures to an existing clinical trial. 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?

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 … Continue reading

After My Application is Submitted, Can I Include a Copy or Citation of a Preprint as Post-submission Materials?

No. Pre-prints are not included in the list of allowable post-submission materials, because they do not fall in the category of unanticipated events.

Post-submission materials are not intended to correct oversights or errors discovered after submission of the application, but rather …. Continue reading

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?

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. Continue reading