Appendix_W6_Certificate_Confidentiality_MD_JHU

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

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Centers for Disease Control
and Prevention

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M. Daniele Fallin, PhD, Principal Investigator
Associate Professor
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street, Suite E6035
Baltimore, MD 21205
Dear Dr. Fallin:
I am happy to send you the certificate of confidentiality for the "Study to Explore Early
Development (SEED)."
Please be sure that the informational statement given to participants accurately states the
intended uses of personally-identifiable information and the confidentiality protections,
including the protection provided by the certificate of confidentiality, with its limitations and
exceptions.
May I ask that you advise me of any situation in which the certificate is employed to resist
disclosure of information in legal proceedings. I am at the Centers for Disease Control and
Prevention, (CDC), Mailstop D-74, Atlanta, Georgia 30333. My telephone number is (404)
639-4642, fax (404) 639-3060. Internet: [email protected].
If attorneys for the Johns Hopkins Bloomberg School of Public Health wish to discuss the
use of the certificate, they may contact the Deputy Associate General Counsel to CDC, Ms.
Paula L. Kocher, at (404) 639-7200.
If you have any questions, or if we can otherwise help, please call.
Sincerely yours,

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Betsey Dunaway, M.S., Ed.S.
CDC Confidentiality Officer
Office of the Chief Science Officer

cc: Certificate of Confidentiality

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Centers for Disease Control
and Prevention

CONFIDENTIALITY CERTIFICATE
Issued to
Employees of
Johns Hopkins Bloomberg School of Public Health
and Other Participants
conducting research known as
STUDY TO EXPLORE EARLY DEVELOPMENT (SEED)
Cooperative Agreement # UIO DDOOOI83-01

In accordance with the provisions of Section 30I(d) of the Public Health Service Act (42
U.S.C. § 24I(d)) this certificate is issued to protect the privacy of research subjects by
withholding their identities from all persons not connected with the research.
Under authority vested in the Secretary of Health and Human Services under that section,
all persons who
(1)
are employed by the Johns Hopkins Bloomberg School of Public Health, and their
contractors and cooperating agencies; and
(2)
have, in the course of that employment, access to the information which would
identify individuals who are the subjects of a research project entitled "Study to Explore
Early Development (SEED)" 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, with the exceptions and limitations set forth below.
The Study to Explore Early Development (SEED) was developed to address the gaps in
research related to studying the etiology of autism spectrum disorders (ASDs) in a large,
population-based sample. The overall purpose of SEED is to investigate risk factors for
ASDs and phenotypic subgroups of ASDs, using a population-based, case-cohort study
design. Cohort children identified with ASDs will be compared to a sample of children
identified with other developmental problems, as well as a random sample of all cohort
children.

As provided in Section 301(d) of the Public Health Service Act (42 U.S.c. § 241(d)),
"Persons so authorized to protect the privacy of such individuals may not be compelled in
any Federal, State, or local civil, criminal, administrative, legislative, or other
proceedings to identify such individuals."
The following conditions apply to the protection provided under this certificate:
(1)

This certificate does not authorize the Johns Hopkins Bloomberg School of Public
Health, or their contractors or cooperating agencies to refuse to reveal identifying
information concerning research subjects if any of the following conditions exist:
(a)

The subject (or, ifhe or she is legally incompetent, his or her guardian)
consents in writing to disclosure of identifying information.

(b)

Authorized personnel of the United States Department of Health and
Human Services request such information for audit or program evaluation
of the research project, or for investigation of the Johns Hopkins
Bloomberg School of Public Health, or their contractors or cooperating
agencies in carrying out the research project.

(c)

Release is required by the Federal Food, Drug, and Cosmetic Act (21
U.S.C. §§ 301 et seq.) or regulations promulgated thereunder (Title 21,
Code of Federal Regulations).

(2)

This certificate requires that there be no disclosures of identifying characteristics
of research subjects in any Federal, State, or local civil, criminal, administrative,
legislative, or other proceedings to compel disclosure of the identifying
characteristics of research subjects, except as provided for in paragraph (1) above.

(3)

The confidentiality certificate does not govern the voluntary disclosure of
identifying characteristics of research subjects.

(4)

This certificate does not represent an endorsement of the research project by the
Department of Health and Human Services.

(5)

All research subjects in the project will be given a fair, clear explanation of the
protection this certificate affords, and of the limitations and exceptions to the
protection.

.

(6)

Date:

This certificate is effective upon issuance and will expire at the end of July
2012, or sooner if the holder is notified of cancellation in accordance with the
procedures set out in 42 C.F.R. § 2a.8. The protection afforded by this certificate
of confidentiality is permanent (including after death) for persons who
participated as subjects in the research during any time the certificate was in
effect.

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James W. Stephens, Ph.D.
Associate Director for Science, CDC