Privacy Act Review

DATE:

December 27, 2019

TO:

David Sharlip
National Library of Medicine

FROM:

NIH Privacy Act Officer

SUBJECT:

Applicability of the Privacy Act: “Information Program on Clinical Trials:
Maintaining a Registry and Results Databank (NLM)”

I have reviewed the National Library of Medicine (NLM) submission to OMB under the
Paperwork Reduction Act which proposes to renew the existing clearance for the
ClinicalTrials.gov website, which is the largest and most comprehensive clinical trial registry
and results database in the world.
The information collection will enable compliance with statutory requirements of the Section
801 of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) and
satisfy the purposes of the original clinical trial information collection that was established to
comply with the FDA Modernization Act of 1997 (FDAMA). The information collection is
necessary to allow researchers and organizations who are not subject to FDAAA or FDAMA to
voluntarily register trials and other clinical studies. The information collection will provide
patients, family members, clinicians, and researchers with timely access to up-to-date
information about clinical trials, other types of clinical studies and their results. Alone or when
combined with collected results information, the information collection can contribute to betterinformed decisions about medical treatment, and reduce inadvertent and unnecessary duplication
of clinical research studies.
Information is collected via electronic submission to the ClinicalTrials.gov Protocol Registration
System, available at https://clinicaltrials.gov/ct2/manage-recs/register. The expanded clinical
trials registry provides basic information about the studies, their implementation, and how to
enroll. The results portion of the databank summarizes the outcomes of the trial and helps ensure
that scientists have access to the latest scientific information about potential treatments for
disease, as much of this information is not published in the scientific literature. The information
can help scientists to better plan new research projects, and avoid duplication that can expose
human volunteers to unnecessary risks. It can also ensure that treatment decisions are based on a
more complete set of scientific evidence.

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Applicability of the Privacy Act: “Information Program on Clinical Trials: Maintaining a
Registry and Results Databank (NLM)”

I have determined that the Privacy Act will not apply to this information collection. Although
personally identifiable information will be collected, none of the data elements will be retrieved
to identify the individual. If you have any questions, please contact me at (301) 402-6201.

Celeste Dade-Vinson
NIH Privacy Act Officer
cc: David Sharlip, NLM