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DHHS Final rule and NIH policy affecting clinical trials

DHHS regulation and NIH policy affecting registration and results reporting for clinical trials became effective on January 18, 2017. The DHHS regulation, known as the Final Rule, describes requirements for registering and submitting summary results information for certain Applicable Clinical Trials to A complementary NIH policy applies to all clinical trials funded by NIH, regardless of whether they are subject to the Final Rule.

UNC Policy Statement

For clinical trials subject to the DHHS Final Rule and/or NIH Policy, UNC requires that the Principal Investigator ensure proper registration and results reporting consistent with the requirements of these authorities.

The requirements include both initial registration of the study protocol and results reporting. Generally, the Principal Investigator must register the protocol within 21 days of enrollment of the first participant — note that ICMJE requires completion of registration before the start of enrollment — and complete results reporting within the registry no later than 12 months after the trial completion date. Results must include participant flow, baseline characteristics, all primary and secondary outcomes, adverse events, and a copy of the study protocol and statistical analysis plan when it exists as a separate document.

The text above may be used in NIH applications requiring a statement of UNC policy on registration and results reporting.

Investigators may choose to register a study that is not an applicable clinical trial (ACT) as a condition for International Committee of Medical Journal Editors (ICMJE) publication eligibility requirements.

In addition, allows voluntary reporting of other studies that:

  • Are in conformance with any applicable human subject or ethics review regulations (or equivalent), and
  • Are in conformance with any applicable regulations of the national (or regional) health authority (or equivalent).

Some items that might affect your ongoing or new trials are:

  • The Final Rule applies to most interventional studies of drug, biological and device products that are regulated by the FDA irrespective of product approval status. See policy for exceptions.
    • Trials must be registered within 21 days of the first participant signing the consent form. As a reminder, ICMJE publication eligibility is dependent upon registry prior to enrollment of the first subject (other funding agencies have similar requirements).
    • Results information for an “Applicable Clinical Trial” (ACT) must be completed in no later than one year after the “Actual” Primary Completion date.
  • NIH’s policy expands the requirement to all  NIH-defined clinical trials funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether they are subject to the Final Rule.
    • Applies to grants submitted on or after January 18, 2017 that request support for a clinical trial initiated on or after that date.
    • Applicants for NIH funding are required to submit a plan outlining how they will comply with the clinical trial information dissemination expectations of the policy.
    • Clinical trials that use NIH-supported infrastructure, but receive no other NIH funds for the conduct of that specific clinical trial are not subject to the NIH Policy.
  • Possible non-compliance consequences include the following if required registration and results reporting cannot be verified:
    • Suspension, termination, or retraction of grant (or contract) funding;
    • Consideration of the non-compliance in future funding decisions;
    • Civil monetary penalties to the “Responsible Party” (i.e., Principal Investigator) of up to $14,262/day.