Attach3 Certificate of Confidentiality

PATH Study Generic Clearance for Methodological Studies (NIDA)

Attachment 3
PATH Study
Certificate of Confidentiality

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
National Institutes of Health
National Institute on Drug Abuse
Bethesda, Maryland 20892

CONFIDENTIALITY CERTIFICATE NO. DA-12-131
issued to
BEHAVIORAL HEALTH GROUP
WESTAT
conducting research known as
“POPULATION ASSESSMENT OF TOBACCO AND HEALTH
OR PATH STUDY”
In accordance with the provisions of section 30l(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, Andrew Hyland, Ph.D.,
Behavioral Health Group, Westat, 1600 Research Boulevard, RB 4121, Rockville, MD 20850-3129, to
protect the privacy ofresearch subjects by withholding their identities from all persons not connected with
this research. Dr. Hyland is primarily responsible for the conduct of this research, which is funded by NIDA
contract# HHSN271201100027C.
Under the authority vested in the Secretary of Health and Human Services by section 301(d),
all persons who:
1. are employed by or associated with Behavioral Health Group, Westat and its research sites,
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 project known as “Population
Assessment of Tobacco and Health or PATH Study,”
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 research began on September 19, 2011 and is expected to end on September 30, 2017.
The purpose of this national, longitudinal cohort study is to examine the epidemiological and health
consequences of tobacco-product use among the U.S. civilian, non-institutionalized population ages 12
years and older.
Study subjects’ identities are protected by linking unique study ID numbers assigned to sampled households
and individuals with personal identifiers. Survey data with study IDs are separated from materials with
personally identifiable information (PII) through data collection, transmission, storage, processing, analysis,
and reporting. Data are collected on encrypted laptop computers. Study data are identified and retrieved by
study ID numbers only. Hard copy consent forms with participant names and all PII are maintained in secure

areas separate from the research data. They are identified only by study ID number and are stored in locked
files. Biospecimens are coded and shipped for analysis by qualified laboratories. No reports or analysis files
will contain PU. Individuals will not be identified in any publication or presentation, and analytic findings
will be reported as aggregate statistics only.
A Certificate of Confidentiality is needed because biologic samples and sensitive information concerning
study subjects’ drug and alcohol use, and sexual orientation/attraction is 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.
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 at the end of September 2017. 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 any time the Certificate is in effect.

Date:
Nora D. Volkow, M.D.
Director

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

AMENDMENT NO. 1

National Institutes of Health
National Institute on Drug Abuse
Bethesda, Maryland 20892

CONFIDENTIALITY CERTIFICATE NO. DA-12-131
issued to
BEHAVIORAL HEALTH GROUP
WESTAT
conducting research known as
“POPULATION ASSESSMENT OF TOBACCO AND HEALTH
OR PATH STUDY”
In accordance with the provisions of section 30l(d) of the Public Health Service Act (42 U.S.C. § 241(d)),
this Amendment to the original Certificate is issued in response to the request of the Principal Investigator,
Andrew Hyland, Ph.D., Behavioral Health Group, Westat, 1600 Research Boulevard, RB 4121, Rockville,
MD 20850-3129, to protect the privacy ofresearch subjects by withholding their identities from all persons
not connected with the research. Dr. Hyland is primarily responsible for the conduct of this research, which
is supported by NIDA contract# HHSN271201100027C.
Under the authority vested in the Secretary of Health and Human Services by section 301 ( d),
all persons who:
1. are employed by, or associated with Behavioral Health Group, Westat and its research sites,
contractors, and cooperating agencies and
2. have in the course of that employment or association access to information that would
identify individuals who are the subjects of the research project known as, “Population
Assessment of Tobacco and Health or PATH Study,”
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 purpose of this Amendment is to amend the protocol to include changes in the recruitment and informed
consent processes, incentives to study subjects, and the survey instruments. The Certificate will expire
September 30, 2017. All other aspects of this research project remain unchanged.

Date:
Nora D. Volkow, M.D.
Director