Certificate of Confidentiality

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DEPARTMBNT OF HEALTH A RUMAN SERVICES

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Public Health ServIce

Nlltlonel Institutes of Health
National Institute of Mental Health
6001 Executive Boulevard
Bethesda, Mary'land 20892

6/25/2010

Westat, Inc.

Dr. Doreen De Leonardis

1600 Research Blvd.

Rockville, MD 20850

Dear Dr. Leonardis,

Enclosed is the Confidentiality Certificate protecting the identity of research subjects in your project entitled, 'Investigates

the Use and Feasibility of Speed Warning Systems'. Please note that the Certificate expires on 12/3112011.

Please be sure that the consent form given to research participants accurately states the intended uses of personally

identifiable information (including matters subject to reporting) and the confidentiality protections, including the

protection provided by the Certificate of Confidentiality with its limits and exceptions.

If you determine that the research project will not be completed by the expiration date, 12/3112011, you must submit a

written request for an extension of the Certificate three months prior to the expiration date. If you make any changes to the

protocol for this study, you should contact me 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 advise me of any situation in which the Certificate is employed to resist disclosure of information in legal

proceedings. Should attorneys for the project wish to discuss the use of the Certificate, they may contact the Office of the

NIH Legal Advisor, National Institutes of Health, at (301) 496-6043.

Correspondence should be sent to:
Olga Boikess
Certificate of Confidentiality Coordinator
National Institute of Mental Health
6001 Executive Boulevard
Room. 8222, (MSC 9653)
Bethesda, MD 20892
Telephone: 301-443-3877
Fax: 301-443-7264
Sincerely,

0IgaB~~k-

CERTIFICATE OF CONFIDENTIALITY

CC-MH-IO-113

issued to

Westat, Inc.

conducting research known as

Investigates the Use and Feasibility of Speed Warning Systems

In accordance with the provisions of section 30l(d) of the Public Health Service Act 42 U.S.C. 24l(d), this Certificate is
issued in response to the request of the Principal Investigator, Dr. Doreen De Leonardis, to protect the privacy of research
subjects by withholding their identities from all persons not connected with this research. Dr. Leonardis is primarily
responsible for the conduct of this research, which is supported by the National Highway Traffic Safety Association.
Under the authority vested in the Secretary of Health and Human Services by section 30l(d), all persons who:
1. are enrolled in, employed by, or associated with the Westat, Inc. and their contractors or cooperating agencies and
2. have in the course of their employment or association access to information that would identify individuals who are the
subjects of the research pertaining to the project known as Investigates the Use and Feasibility of Speed Warning Systems
are hereby authorized to protect the privacy of the individuals who are the subjects of that research by withholding their
names and other identifying characteristics from all persons not connected with the conduct of that research.
The behavioral research project investigates the feasibility of using an in-vehicle speed monitoring system on a voluntary
population of drivers, with particular emphasis on at-risk drivers with a history of speeding.
A Certificate of Confidentiality is needed because sensitive information will be collected during the course of the study.
The certificate will help researchers avoid involuntary disclosure that could expose subjects or their families to adverse
economic, legal, psychological and social consequences.
All subjects will be assigned a code number and identifying information and records will be kept in locked files at the
Institution.
This research is currently underway and is expected to end on 12/31/2011.
As provided in section 301 (d) of the Public Health Service Act 42 U.S.C. 24l(d):
'Persons so authorized to protect the privacy of such iridividuals may not be compelled in any Federal, State, or local civil,
criminal, administrative, legislative, or other proceedings to identify such individuals.'
This Certificate does not protect you from being compelled to make disclosures that: (1) have been consented to in writing
by the research subject or the subject's legally authorized representative; (2) are required by the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) or regulations issued under that Act; or (3) have been requested from a research
project funded by the National Institutes of Health (NIH) or the Department of Health and Human Services (DHHS) by
authorized representatives of those agencies for the purpose of audit or program review.

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CERTIFICATE OF CONFIDENTIALITY

CC-MH-IO-113

issued to

Westat, Inc.

conducting research known as

Investigates the Use and Feasibility of Speed Warning Systems

This Certificate does not represent an endorsement of the research project by the DHHS. This Certificate is now in effect
and will expire on 12/31/2011. The protection afforded by this Confidentiality Certificate is permanent with respect to
Certific e is in effect.
subjects who participate in the research during t '
Date: 6/25/2010
Associate Director for Management
National Institute of Mental Health

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