Appendix D. NIH Certificate of Confidentiality

6710B ROCKLEDGE DRIVE
Rm 2158
Bethesda, MD 20817

12/6/2017
Mathematica Policy Research
Dr. Cheri Vogel
P.O. Box 2393
Princeton, NJ 08543
Dear Dr. Vogel,
Enclosed is the Confidentiality Certificate, protecting the identity of research subjects in your singlesite/single-protocol project entitled “The Early Head Start Family and Child Experiences Survey (Baby
FACES)—2018”.
Please note that the Certificate expires on 09/29/2020.
Please be sure that the consent form given to research 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 limits and exceptions.
If you determine that the research project will not be completed by the expiration date, 09/29/2020, you must
submit a written request for an extension of the Certificate three (3) 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:

Dennis Twombly Ph.D.
6710B ROCKLEDGE DRIVE
Rm 2158
Bethesda, MD 20817

Sincerely,

Approved Date: 12/06/2017

Dennis Twombly Ph.D.
Deputy Director OEP
Eunice Kennedy Shriver National Institute of Child
Health and Human Development

CONFIDENTIALITY CERTIFICATE
CC-HD-17-104

issued to
Mathematica Policy Research
conducting research known as
"The Early Head Start Family and Child Experiences Survey (Baby FACES)—2018"
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 in response to the request of the Principal Investigator, Dr. Cheri
Vogel, to protect the privacy of research subjects by withholding their identities from all persons
not connected with this research. Dr. Cheri Vogel is primarily responsible for the conduct of this
research, which is funded by:
1. Other DHHS agency:Administration for Children and Families
Under the authority vested in the Secretary of Health and Human Services by section 301(d), all
persons who:
1. are enrolled in, employed by, or associated with Mathematica Policy Research and its
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
“The Early Head Start Family and Child Experiences Survey (Baby FACES)—2018”.
3. 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.
This descriptive study focuses on understanding the processes in Early Head Start core services
(classrooms and home visits) that support infant and toddler development; namely, nurturing and
responsive relationships between children and caregivers. The study design involves a nationally
representative sample of EHS programs, centers, classrooms, teachers, home visitors, and
children and families (including pregnant women). The study team will collect rich information
using interviews, self-administered questionnaires, classroom observations, and administrative
data sources.
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.
Electronic data will be collected via secure websites, with unique logins and passwords for each
participant. Electronic data will be encrypted in transit and at rest. Electronic data will be stored
on Mathematica’s systems and network drives, which are protected using FIPS 140-2 compliant
encryption and a firewall. Access to data files is restricted to project staff whose roles require it.

Any data collected via hard-copy is secured in locked storage. We maintain two separate sets of
files: one includes participants’ identifying information and a study-created ID but no survey
data; the other includes survey data and the study-created ID but no identifying information. All
employees must undergo security awareness training and sign a confidentiality pledge when
hired. All study staff with access to confidential study data must review a memo outlining the
procedures used to protect study data. Additional safeguards are described in our Data Security
Plan, which we can submit if needed.
This research begins on 09/30/2015 , and is expected to end on 09/29/2020.
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."
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 NIH or DHHS by authorized representatives of those agencies for the purpose of audit
or program review.
This Certificate does not represent an endorsement of the research project by the Department of
Health and Human Services. This Certificate is now in effect and will expire on 09/29/2020. The
protection afforded by this Confidentiality Certificate is permanent with respect to any individual
who participates as a research subject (i.e., about whom the investigator maintains identifying
information) during the time the Certificate is in effect.

Sincerely,

Signed Date: 12/13/2017

Della Hann Ph.D.
Associate Director for Extramural Research
Eunice Kennedy Shriver National Institute of Child Health
and Human Development