The Department of Health and Human Services (DHHS) published a new policy that outlines requirements for clinical trial registration and results submission. The new NIH policy is in
most ways similar to the Final Rule, except that NIH now requires that
all NIH-funded clinical trials register and submit results, whether or
not the trial is required to register the Final Rule. Thus, the NIH
policy now covers more types of trials than the law, including phase 1
studies, small feasibility studies, and trials that do not involve any
FDA-regulated product, such as trials involving only behavioral
interventions. A table comparing the new NIH policy to the Final Rule is found at this link.
Final Rule Compliance Dates
The
Final Rule became effective on January 18, 2017, and trials that are
required by law to be registered (i.e., “applicable clinical trials”)
must be in compliance with the Final Rule by April 18. The new
registration requirements described in the Final Rule applies to
trials initiated on or after January 18, and the new results submission
requirements apply to trials that reach their
primary completion date on or after January 18. Trials that were initiated
before January 18 will follow the previous registration requirements.
NIH Policy Compliance Dates
The
new NIH policy applies to applications submitted on or after January 18, 2017,
for clinical trials initiated on or after January 18, 2017, as well as to
competing renewal applications that include a new clinical trial (i.e., a
clinical trial initiated on or after the effective date of the policy).
Compliance will be a term and condition of NIH awards.
This policy does
not apply to: 1) NIH-funded clinical trials initiated before the
effective date of January 18, 2) clinical trials that use NIH-supported
infrastructure but do not receive NIH funds to support their conduct, or
3) clinical trials of ongoing, non-competing awards.