NCCIH Research Blog

In the Office of Grants Management (OGM) at the National Center for Complementary and Integrative Health (NCCIH), we want to help applicants and recipients navigate required processes and policies and avoid errors that may impede a researcher’s grant and work. 

In this post, I’ll discuss a few tips related to policies that recipients performing human subjects research and conducting clinical trials must follow. There are many policy requirements that must be met to receive National Institutes of Health (NIH) funding; when policies are not followed, the consequences can include a “bar to award”—a withholding of support to your project until NIH’s concerns are resolved. 

1. Inclusion enrollment reports (IERs) are important. Almost all exempt and nonexempt human subjects research (with the exception of exemption #4) requires submitting an IER. Make sure you include one in your Research Performance Progress Report (RPPR). Your IER needs to include both your planned and actual enrollment numbers based on factors such as sex/gender, race, ethnicity, and age. 
2. For research involving clinical trials, consider all requirements related to adding information to ClinicalTrials.gov. For example:
   • You need to register your trial within 21 days of enrolling your first participant. Once registered, your study will be assigned an NCT number (also called the ClinicalTrials.gov Identifier). Include this number in your RPPR. If there is no NCT number for your study, you will receive a bar to award.
   • Is your trial completed or almost there? You need to submit the summary results of your trial to ClinicalTrials.gov no later than 12 months after the trial’s actual primary completion date. To not do so incurs a bar to funding.
3. One of the mistakes we see most often among investigators is lack of alignment among different sources, primarily:
   • The information they furnish on their trial to the ClinicalTrials.gov website 
   • The Section 1 data that they provide on their trial to the NIH Human Subjects System (HSS) system via their RPPR
     
     I suggest that you check back and forth between these sources to ensure they are in alignment. It’s best to update data from changes in your trial as quickly as you can. 

A few final thoughts to help avoid bars and other restrictions: 

• Take the time to read NIH’s requirements and regulations carefully, including on the period between receiving funding and starting the trial.
• If you receive a communication from NIH on the topic of compliance, please read and respond to it promptly. This is in your interest. 
• Work closely with your institutional officials to complete your human subjects and clinical trials requirements on time. 

I hope these tips are helpful! A few additional resources are listed below. 

For More Information

• NIH Clinical Trials Reporting Compliance: A Shared Commitment – by Michael Lauer, M.D., NIH's Deputy Director for Extramural Research.
• eRA Training for Human Subjects System (HSS)
• Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov
• NIH Grants Policy Statement and Select Policy Topics