Encapsulating the frailty of the human condition in one stark sentence.
One man overwrought by feelings of despair, indecision, and confusion.
Is there any wonder this quote can be applied to NIH’s new definition of a clinical trial (eff w/ competitive apps. w/ due dates 1/25/18 and later)?
Have you asked yourself these other 4 questions… the ones that will provide the answer you need… the ones that will pull you out of any existential NIH clinical trial conundrum, and put you on the path leading to a successful application?
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If you’ve answered Yes to all of these questions, you’ve got yourself an NIH Clinical Trial. Note that no other entity but the NIH (although there are no guarantees in this fast paced world, folks.. we will do our best to keep you informed) uses this definition. So be sure you remember to whom you are speaking or to which funding agency you are applying before stating unequivocally, “To Be or Not to Be!” I mean “Yes, I have a clinical trial!” If you’re still not sure or need additional resources to help navigate you through, please see the list towards the bottom of this email.
Besides this NIH definition, all should be aware of NIH’s new Human Subjects and Clinical Trial (HS/CT) form in which the top portion must be completed even if you are doing research on potato spuds.* This form has a sub-form called the “Study Record” form and embedded in that is the sub-sub form entitled the “Inclusion Enrollment Report,” which should sound familiar to veteran applicants. Recently, Research IT released its instructions for completing this form, which includes what’s required in each section. Click here to view Research IT’s instructions on the form.
If there was ever a time to submit to the Grants and Contracts Office (GCO) EARLY or at least 5 business days prior to your NIH deadline, now is the time.
But before you submit, make that way before you submit, choose the correct funding opportunity announcement (FOA). (Parenthically speaking, the updated FOAs include some pretty important information within the parentheses in the FOA title, namely “(Clinical Trial Not Allowed),” or “(Clinical Trial Required)” or “(Clinical Trial Optional.)”)
And no worries..if you are holding a specimen like this Shakespeare playing Hamlet, you can safely say No to Clinical Trials. If your protocol does contain a resuscitation intervention, answer Yes.
NIH Clinical Trial Resources
- NIH Glossary’s definition of an NIH-defined clinical trial
- NIH’s Definition of a Clinical Trial page
- NIH Definition of Clinical Trials Case Studies page
- FAQs on the NIH Clinical Trial Definition
- NIH’s decision tool will help determine whether your human subjects research study is an NIH-defined clinical trial
- Your study may also be subject to additional regulations. Read NIH’s Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov.
- Instructions – PHS Human Subjects and Clinical Trials Information Form
Videos and Podcasts
- Video (approx. 9 minutes) – A Walk-through of the PHS Human Subjects and Clinical Trials Information Form
It’s recommended you watch this video to orient yourself with the new form.
- Podcast (approx. 12 minutes)- Understanding the Definition of a Clinical Trial and What That Means for You
Video (approx. 15 minutes) – Overview of New NIH Policies on Human Subjects Research and Clinical Trials
* Did you know that according to Wikipedia, “The word (spud) has an unknown origin and was originally (c. 1440) used as a term for a short knife or dagger, probably related to the Latin “spad-” a word root meaning “sword”; cf. Spanish “espada”, English “spade” and “spadroon”?” This was approximately 160 years before Shakespeare wrote Hamlet.