DEPARTMENT OF HEALTH & HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse & Alcoholism
CONFIDENTIALITY CERTIFICATE
issued to
Individuals
Responsible for the Research Entitled
"A
Prospective Study of College Students"
AA07231
Conducted
by
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 Kenneth J. Sher, Ph.D., Principal Investigator, to protect the privacy of
research subjects by withholding their identities from all persons not
connected with the research. Dr. Sher is primarily responsible for the conduct
of this research.
The purpose of this study is to characterize
the effects of the transition to college on alcohol use and alcohol related
problems and dependence symptoms, characterize individual differences in the
trajectories of alcohol involvement during the college years, identify the
determinants of these trajectories, and understand the role of alcohol and
other determinants in a range of negative outcomes. All entering Fall 2002 freshman at the university will be surveyed at
baseline. Student samples will then be surveyed twice a year for a range of
variables, until they are adults.
Under authority vested in the
Secretary of Health and Human Services by Section 301(d) of the Public Health
Service Act (42 U.S.C.), all persons who
1. are employed by
2. have, during the course of that employment, access to
information that would identify individuals who are the subjects of the
research on alcohol and drug abuse in the study entitled "A Prospective
Study of College Students"
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.
As provided in section 301(d) of
the Public Health Service Act (42 U.S.C. sec. 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
University of Missouri-Columbia, or its contractors and
cooperating agencies, to refuse to reveal information concerning research
subjects if any of the
following conditions exist:
(a) The subject (or, if he 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
(c) Release of such information is required by
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations
promulgated there under (title 21, C.F.R)
(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 and will be given a copy of
this Certificate, except when to do so would put them at risk.
(6) The Certificate is effective upon issuance
and will expire
(7) This research project may also be subject to
special rules for confidentiality of alcohol and drug
abuse patient records, under sections
544 and 548 of the Public Health Service Act (42 U.S.C. §§ 290dd-3 and
290ee-3), and implementing regulations at 42 CFR Part 2, which restrict
voluntary disclosures of information from covered patient records.
Mary C. Dufour, M Deputy
Director
National Institute on Alcohol Abuse and Alcoholism
FEB _ 4 2002
Date