Assurance Statement

Updated assurance statement 06022023.pdf

Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)

Assurance Statement

OMB: 0925-0689

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Attachment 1
Assurance Statement
Check the box next to the statement below if the statement is true:

 This request is submitted by an institutional official who has signature
or other authority to submit this request.
 This institution agrees to use the Certificate of Confidentiality to
protect against the compelled disclosure of personally identifiable
information. In addition, this institution will ensure any third-party product
or entity utilized for this project (e.g., contractors, online platform vendors)
to collect or store information can and will protect against the compelled
disclosure of the personally identifiable information. The institution agrees to
support and defend the authority of the Certificate
against legal challenges.
 The institution understands that research information protected by a
Certificate of Confidentiality is subject to the protections and the
disclosure requirements noted in 42 U.S.C 241 and 42 CFR Sect. 2a.
Any investigator or institution conducting research protected by a
Certificate of Confidentiality SHALL NOT disclose or provide to any
other person not connected with the research the name of such an
individual or any information, document, or biospecimen that contains
identifiable, sensitive information about such an individual and that
was created or compiled for purposes of the research without the
specific consent of the individual to whom the information pertains or
as otherwise permitted in accordance with 42 U.S.C 241 and 42 CFR
Sect. 2a.
 This Certificate of Confidentiality will not be represented as an
endorsement of the project by the HHS or NIH or used to coerce
individuals to participate in the research project.
 The institution and personnel involved in the conduct of the research
will comply with the informed consent requirements of the applicable
Federal regulations, including 45 CFR Part 46.
 All subjects will be informed that a Certificate has been issued, and
they will be given a description of the protection provided by the
Certificate and disclosures that are outside the scope of coverage of
the Certificate (e.g. public health reporting as required by Federal,
State, or local laws, or requirements for child or elder abuse reporting).
Any research participant entering the project after expiration or
termination of the Certificate will be informed that the protection
afforded by the Certificate does not apply to them.


File Typeapplication/pdf
AuthorLahl, Lyndi (NIH/OD) [E]
File Modified2023-06-02
File Created2023-06-02

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