Appendix B: Certificate of Confidentiality

6710B ROCKLEDGE DRIVE
Rm 2158
Bethesda, MD 20817

7/2/2018
MDRC
Dr. JoAnn Hsueh
16 East 34th Street
19th Floor
New York, NY 10016
Dear Dr. Hsueh,
Enclosed is the Confidentiality Certificate, protecting the identity of research subjects in your singlesite/single-protocol project entitled “Variations in Implementation of Quality Interventions (VIQI): Examining
the Quality-Child Outcomes Relationship in Child Care and Early Education Project”.
Please note that the Certificate expires on 12/31/2022.
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, 12/31/2022, 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: 07/02/2018

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

CONFIDENTIALITY CERTIFICATE
CC-HD-18-150

issued to
MDRC
conducting research known as
"Variations in Implementation of Quality Interventions (VIQI): Examining the Quality-Child
Outcomes Relationship in Child Care and Early Education Project"
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.
JoAnn Hsueh, to protect the privacy of research subjects by withholding their identities from all
persons not connected with this research. Dr. JoAnn Hsueh is primarily responsible for the
conduct of this research, which is funded by:
1. Other Federal agency:Office of Planning, Research, and Evaluation
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 MDRC 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
“Variations in Implementation of Quality Interventions (VIQI): Examining the Quality-Child
Outcomes Relationship in Child Care and Early Education Project”.
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 early childhood education study examines how different dimensions and thresholds of
quality relate to children’s outcomes to unpack the “black box” of quality and its drivers in early
child care and early education settings. VIQI will test how different levels and features of
classroom quality relate to children’s developmental outcomes. The study will look at the
relationship of initial classroom quality to changes in observed quality and children’s outcomes
through a rigorous experimental design. VIQI will also include an in-depth implementation study
to understand the conditions necessary to plan, install, and implement an evidence-based
intervention that will produce changes in the content of instruction, quality of teacher practice,
instruction and interactions with children, and child outcomes. Classrooms will include those in
community-based child care and Head Start programs and centers that serve 3- and 4-year-old
children.

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 VIQI staff sign agreements requiring data confidentiality & security. Anonymous research
IDs linked to identifiable information are generated for use with analysis files. The
design/configuration of the networked Secure Data Systems & corporate rules for collecting and
managing confidential data are FISMA compliant. Individual level data on study participants are
stored on secure servers with restricted access, protected by strong passwords, screen locking, &
physical protections; they download the latest virus definition daily and receive regular security
updates. Intrusion Detection System & Intrusion Protection System are used to detect and
prevent malicious network attacks & unauthorized computer usage. Secure file transfer methods
are used to send/receive files containing confidential & individually identifiable data via Box,
Huddle, Qualtrics, Salesforce, which areFedRAMP compliant & meet U.S. federal security
requirements for encryption at rest & while being transferred.
This research begins on 10/01/2016 , and is expected to end on 12/31/2022.
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 12/31/2022. 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: 7/2/2018

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