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

Which Funding Opportunity Announcement (FOA) Should I Use if My Human Subject Research Study is Delayed Onset?

The type of FOA you will need depends on whether you anticipate that your delayed onset human subject study will meet the definition of a clinical trial.

If it will, you will need to choose a funding opportunity that explicitly allows clinical trials (it will be designated ‘Clinical Trial Optional’ or ‘Clinical Trial Required’). Be sure to check the ‘Anticipated Clinical Trial’ box when completing your Delayed Onset Study record within the application.

If no clinical trial is involved, you will need to choose a funding opportunity designated as ‘Clinical Trial Optional’ or ‘Clinical Trial Not Allowed.’

When completing your application, follow the SF 424’s Delayed Onset Study instructions …. Continue reading

We’re preparing a training grant application but don’t have all the historical data requested in the new data tables…. What should we do?

“We’re preparing a training grant application but don’t have all the historical data requested in the new data tables, such as the length of prior, full-time research experience for trainees entering the program five years ago. What should we do?”

Because reviewers are asked to assess a training program and its record based, in part, on data presented in the tables, applicants should provide as much data…. Continue reading