It is not business as usual at the NIH for competitive applications due Jan 25, 2018 and after. The NIH has a new definition of a clinical trial and with that comes a new Human Subjects and Clinical Trials Info (HS/CT) form and new requirements even for basic science researchers.
Step 1 – BEFORE You Apply, Answer These 4 Questions.
1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
If you say No – ask yourself when I read question 3 above did I read “efficacy” rather than “effect?” NIH is asking about ANY “effect.” This is much broader. Please reconsider.
4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If you say No – ask yourself when I read question 4 above did I read “improve or cure any disease or symptom of a medical or psychological condition or syndrome?” NIH is asking about ANY “health-related biomedical or behavioral outcome.” This is much broader. Please reconsider.
If the answer is Yes to all 4 questions, your study is an NIH clinical trial.
Step 2 – Choose the CORRECT Funding Opportunity Announcement (FOA)
Many of NIH’s updated FOAs include the following information in the title:
– Clinical Trial Not Allowed
– Clinical Trial Required
– Clinical Trial Optional
If you apply to the wrong FOA, your application will be rejected.
Step 3 – Complete the Human Subjects and Clinical Trials Information (HS/CT) Form
Your application will be rejected if completed incorrectly. Please see list below of possible reasons.
- You did not answer the Clinical Trials Questions correctly at the top of this form. See Step 1 for more information.
- You completed sections of the form that are not required for your study.
- And the opposite – you didn’t complete the sections of the form that are required for your study.
- You did not follow the character limitation rule.
Click here to view Research IT’s instructions on the form. These instructions highlight requirements to help you avoid the pitfalls written above.
Contact the Program Officer on the FOA if you have questions. Get in writing whether your study is a clinical trial.
NIH Clinical Trial Resources
- Training Resources – NIH Clinical Trials Policies
- 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
Below are some questions GCO Staff has received regarding NIH’s new HS/CT form and the NIH’s new Clinical Trial Policy in general. We are passing the answers along to you.
FAQs on NIH’s new Human Subject and Clinical Trials Information Form
1. Q: I am not doing human subjects research. Therefore, I don’t need to complete the new form, correct?
A: Incorrect. There are questions that must be answered in the top portion of the form even if you are not doing human subject research. All competitive NIH applications include the new form.
- Q: I am not doing a safety and efficacy study. In fact I am only using healthy volunteers. Therefore, NIH’s new policies on Clinical Trials do not apply to me, correct?
A: Incorrect. You might be doing a study the NIH defines as a clinical trial and therefore be subject to the new requirements. NIH’s definition of clinical trials is very broad and includes research that one intuitively would not think is a clinical trial. Please review NIH’s new definition, case studies/examples plus the training and resource material available to make the determination.
- Q: I am not doing a safety and efficacy study. In fact I am only studying the pharmacokinetics of a drug. Therefore, NIH’s new policies on Clinical Trials do not apply to me, correct?
A: Incorrect. Same response at # 2 above.
- From the NIH Case Studies website
Q: The study involves the recruitment of healthy volunteers who will be randomized to different durations of sleep deprivation (including no sleep deprivation as a control) and who will have stress hormone levels measured. It is designed to determine whether the levels of stress hormones in blood rise in response to different durations of sleep deprivation. Is this a clinical trial?
A: Yes, this is a NIH Clinical Trial. See Case #9 on the NIH site for more complete information.
Questions about Sponsored Projects? Please click here for a listing of Departmental Grants Specialists at the GCO who can help you.