Attachment 9 Certificate of Confidentiality

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Eunice Kennedy Shriver National Institute of Child Health and Human Development
Dr. Ronald Iannotti
6100 Executive Blvd., 7B05
Bethesda, MD 20892
Dear Dr. Iannotti,

Enclosed is the Confidentiality Certificate protecting the identity of research subjects in your project entitled, 'Health
Behavior in School-Age Children: NEXT Longitudinal Study 2009-2013 '. Please note that the Certificate expires on
10/31/2013. If an Institutional Review Board (IRB) has provided conditional approval for this study, then the Certificate
wil only become active following receipt by the National Institutes of Health of documentation of final IRB approval.

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 proj ect wil not be completed by the expiration date, 10/31/2013, 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

Health, at (301) 496-6043.

NIH Legal Advisor, National Institutts of

Correspondence should be sent to:

Steven Hirschfeld, MD PhD
Associate Director for Clinical Research
Eunice Kennedy Shriver National Institute of

31 Center Drive, Room 2A03, MSC 2425
Bethesda, MD 20892-2425
Telephone: (301) 496-0044

Fax: (301) 480-1104

Child Health and Human Development

the

CERTIFICATE OF CONFIDENTIALITY
CC-HD-09-99
issued to
Eunice Kennedy Shriver National Institute of Child Health and Human Development
conducting research known as
Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2013
Generated on: 12/16/2009
In accordance with the provisions of section 301 (d) of the Public Health Service Act 42 U .S.C. 241 (d), this Certificate is
the Principal Investigator, Dr. Ronald Iannotti to protect the privacy of
research
subjects by withholding their identities from all persons not connected with this research. Dr. Iannotti is primarily
responsible for the conduct of this research, which is supported by Eunice Kennedy Shriver National Institute of Child
Health and Human Development, National Heart, Lung and Blood Institute, National Institute of Alcohol Abuse and
Addiction, Health Resources and Services Administration.
issued in response to the request of

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 the Eunice Kennedy Shriver National Institute of Child Health
and Human Development and their contractors or cooperating agencies, and

their employment or association access to information that would identify individuals who
the research pertaining to the project known as Health Behavior in School-Age Children:
NEXT Longitudinal Study 2009-2013
2. have in the course of
are the subjects of

are hereby authorized to protect the privacy ofthe individuals who are the subjects of
names and other identifying characteristics from all persons not connected with the conduct of

that research by withholding their
that research.

This study wil follow 2700 10th-grade students for 4 years: to identify the trajectory of adolescent health status and health
the onset of
key
adolescent risk behaviors and indicators during this period; to identify family, school, and sociaVenvironmental factors
that promote or sustain positive health behaviors; and to identify transition points in health, risk behaviors and changes in
family, school, and social/environmental precursors to these transitions.
behaviors from mid-adolescence through the post high school year; to examine individual predictors of

A Certificate of Confidentiality is needed because sensitive information wil be collected during the course of the study.
The certificate wil help researchers avoid involuntary disclosure that could expose subjects or their families to adverse
economic, legal, psychological and social consequences.

All subjects wil be assigned a code number and identifying information and records wil be kept in locked fies at the
Institution.
This research is currently underway and is expected to end on 10/31/2013.
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.

CERTIFICATE OF CONFIDENTIALITY
CC-HD-09-99
issued to

Eunice Kennedy Shriver National Institute of Child Health and Human Development
conducting research known as
Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2013
Generated on: 12/16/2009
the research project by the Department of
Health and Human
Services. This Certificate is now in effect and wil expire on 10/31/2013. The protection afforded by this Confidentiality
Certificate is permanent with respect to subjects who participate in the research during the time the Certificate is in effect.
This Certificate does not represent an endorsement of

Date: 12/16/2009

Steven Hirschfì d, PhD
Associate Director for Clinical Research
Eunice Kennedy Shriver National Institute of Child Health and Human
Development