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
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
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
It depends on whether the FOAs are Program Announcements (PA, PAR, PAS or Parent) or Requests for Applications (RFA). Continue reading
Are you submitting a K application? Check out some new frequently asked questions (FAQs). Continue reading
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
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
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
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
Like all NIH application forms, the new PHS Human Subjects and Clinical trials Information form is accessed through the submission method you are using. ASSIST, Workspace and all system-to-system solutions provide a way to access and complete the forms. …. Continue reading