Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adult All Comers)

18-33-CDER
CERTIFICATE OF CONFIDENTIALITY
issued to
Research Triangle Institute (RTI) International
and other persons engaged in research funded under FDA Contract #HHSF223201510002B.
The purpose of this research is to assess comprehension of the Drug Facts Label in adult
prescription-opioid and heroin users by conducting in-person survey interviews for over-thecounter naloxone use in emergency response.
Under the authority vested in the Secretary of Health and Human Services by section 301(d) of
the Public Health Service Act (42 U.S.C. 241(d)) and delegated to the Commissioner of Food
and Drugs, this Certificate is issued to require Research Triangle Institute (RTI)
International and other persons engaged in the research to protect the privacy of research
subjects by withholding, from all persons not connected with the research, the subjects’ names
or any information, document, or biospecimen that contains identifiable, sensitive information
about such individuals and that was created or compiled for the purpose of the research.
Identifiable, sensitive information means information that is about an individual and that is
gathered or used during the course of the research, and:
(1) through which an individual is identified; or
(2) for which there is at least a very small risk, as determined by current scientific practices
or statistical methods, that some combination of the information, a request for the
information, and other available data sources could be used to deduce the identity of the
an individual.
All persons who:
(1) are employed by or affiliated with Research Triangle Institute (RTI)
International and, if applicable, its contractors, subgrantees, and cooperating
agencies; and
(2) have access to information, documents, or biospecimens that contain identifiable,
sensitive information created or compiled for the purposes of the research
shall not,
(1) disclose or provide, in any Federal, State, or local civil, criminal, administrative,
legislative, or other proceedings, the names of the research subjects or any information,
document or biospecimen that contains identifiable, sensitive information about those
U.S. Food & Drug Administration
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Certificate of Confidentiality – Page 2

individuals and that was created or complied for purposes of the research, except in
circumstances described below; or
(2) disclose or provide to any other person not connected with the research the name of a
research subject 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.
Disclosure is permitted only when:
(1) required by Federal, State, or local laws (e.g. state mandatory reporting laws; as
required by the Federal Food, Drug and Cosmetic Act, or regulations promulgated
thereunder; or in connection with an HHS audit or program evaluation of the research
project), excluding instances of disclosure in any Federal, State, or local civil, criminal,
administrative, legislative, or other proceeding;
(2) necessary for the medical treatment of the individual to whom the information,
document, or biospecimen pertains and made with the consent of such individual;
(3) made with the consent of the individual to whom the information, document, or
biospecimen pertains; or
(4) made for the purpose of other scientific research that is in compliance with applicable
Federal regulations governing the protection of human subjects in research.
This Certificate does not represent an endorsement of the research project by the Department
of Health and Human Services or by the Food and Drug Administration.
For studies in which informed consent is sought, all research subjects will be informed that a
Certificate has been issued, and they will be given a clear explanation of the protection that this
Certificate affords, and of the limitations and exceptions to the protection.
This Certificate is effective upon issuance. The privacy protection afforded to the individual
subjects by this Certificate of Confidentiality is permanent (including after the death of a
subject) and is not subject to termination.

David C. Burrow, PharmD, JD
Acting Director
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration