NIH Expands ClinicalTrials.gov Registration Requirements

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Office for Research Protections     |     Institutional Review Board (IRB) 


Effective January 18 of this year, the NIH requires that NIH-funded studies meeting its definition of a clinical trial are registered on clinicaltrials.gov.  This expands the kinds of human subjects research that must be registered, and the expansion can cover research not typically thought of as “clinical trials.”

Clinicaltrials.gov is a registry and results database meant to improve the quality and transparency of research.  The database helps individuals more easily find studies they might want to participate in because enrolling could benefit them.  Clinicaltrials.gov also improves transparency among the research community.  For example, the results of failed studies must also be recorded; such results might otherwise not become public.

Reporting is mandatory for all studies funded by the NIH that meet its unique definition of a clinical trial.  For NIH-purposes, a clinical trial is any human subjects study that prospectively assigns participants to an intervention and measures a positive or negative health-related biomedical or behavioral outcomes, including “changes to quality of life.”  An “intervention” is “manipulation of the subject or subject’s environment.”  Some examples the NIH definition provides for health-related biomedical and behavior outcomes are improvement of mood, reading comprehension, information retention, lung capacity, and gene expression. The NIH definition does NOT specify that clinical trials are only those studies designed to develop or test a treatment.  Many kinds of studies not traditionally called “clinical trials” may be required to be registered in clinicaltrials.gov.

Previously, database registration was only required for certain FDA-regulated studies and by journals which made it a requirement for publication, regardless of study type.  Historically, the NIH only encouraged its awardees to report in the database. This new NIH policy coincides with new training requirements for personnel on NIH-funded clinical trials and changes in FDA regulations.  New regulations have expanded the kinds of FDA-regulated studies that must register in clinicaltrials.gov, and they have clarified the potential legal consequences of non-compliance.  Neither changes regarding clinicaltrials.gov, in NIH policy or regulations, are retroactive.

If you need help determining whether your NIH-funded study needs to be registered, please contact your NIH Program Officer or your Penn State IRB Analyst.  If you need help registering a study on clinicaltrials.gov, please email orp-qm@psu.edu. More information on registering your study on clinicaltrials.gov can be found at https://www.research.psu.edu/qm/clinicaltrials.