Confidentiality Certificate

Data To Support Social and Behavioral Research as Used by the Food and Drug Administration

Confidentiality Certificate

OMB: 0910-0847

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2/25/2019
Denver Health and Hospital Authority
Dr. Richard Dart
777 Bannock St
MC 1952
Denver, CO 80204
Dear Dr. Dart,
Enclosed is the Confidentiality Certificate, protecting the identity of research subjects in your single-site/single-protocol
project entitled “Survey of Non-Medical Use of Prescription Drugs (NMU-Rx) in the United States”.
Please note that the Certificate expires on 07/01/2026.
NIH expects investigators to inform research participants of the protections and the limits to protections provided by a
Certificate of Confidentiality issued under the NIH Policy. NIH has provided sample language for informed consent
forms that researchers are free to use or adapt as needed and appropriate for their participants.
If you determine that the research project will not be completed by the expiration date, 07/01/2026, you must submit a
written request for an extension of the Certificate three (3) months prior to the expiration date. If you make significant
changes to the protocol for this study (e.g., change of principal investigator or institution), you should contact the COC
Coordinator regarding modification of this Certificate. Any requests for modifications of this Certificate must include the
reason for the request, documentation of the most recent IRB approval, and the expected date for completion of the
research project.
Please contact the NIH CoC Coordinator if you have any questions about the Certificate of Confidentiality at
[email protected].
Correspondence should be sent to:

NIH COC Coordinator
BG RKL1 RM 3524
6705 ROCKLEDGE DR
Bethesda, MD 20817
Sincerely,

Approved Date: 02/25/2019

NIH Certificates of Confidentiality Coordinator
Office of Extramural Research, National Institutes
of Health

CERTIFICATE OF CONFIDENTIALITY
Number:
CC-OD-19-170
Issued to
Denver Health and Hospital Authority
conducting research known as
Survey of Non-Medical Use of Prescription Drugs (NMU-Rx) in the United States
In accordance with the provisions of section 301(d) of the Public Health Service Act, 42 U.S.C. 241(d), this Certificate
is issued to the Principal Investigator, Dr. Richard Dart and Denver Health and Hospital Authority to protect the privacy
of subjects in the above named single-site/single-protocol research study, which is collecting or using identifiable,
sensitive information. If there is a discrepancy between the terms used in this Certificate and section 301(d), the
statutory language will control.
Research data containing identifiable, sensitive information collected during this study initiated on 02/21/2019 (and
concluding on 07/01/2026) is covered by the Certificate. Identifiable, sensitive information protected by the Certificate
and all copies thereof are protected for perpetuity.
The recipient of this Certificate shall comply with all requirements of subsection 301(d) of the Public Health Service
Act.
This Certificate does not represent an endorsement of the research project by the Department of Health and Human
Services. Information collected during the term of the Certificate is protected in perpetuity. However, this Certificate
does not protect information collected from participants enrolled after the term of the Certificate.

2/25/2019
Date

NIH Certificates of Confidentiality Coordinator
Office of Extramural Research
National Institutes of Health


File Typeapplication/pdf
File TitleNIH Letterhead
AuthorJ. Eater
File Modified2021-06-14
File Created2019-02-25

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