DEPARTMENT OF HEALTH & HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse & Alcoholism
Individuals Responsible for the Research Entitled
"A Prospective Study of College Students"
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