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pdfAttachment L
Confidentiality and Data
Collection Agreement
CIPSEA Confidentiality Agreement, SAMHSA/CBHSQ
Administered by RTI International
This agreement is intended for review and signature by employees of RTI International and all its subcontractors who have
access to information designated as confidential on a research study sponsored by SAMHSA/CBHSQ covered under CIPSEA.
This agreement must be renewed each year as part of mandated CIPSEA training to maintain access to confidential project
information.
Assurances of Confidentiality under CIPSEA
For any research study sponsored by the Substance Abuse and Mental Health Services Administration’s (SAMHSA)
Center for Behavioral Health Statistics and Quality (CBHSQ) that is covered under the Confidential Information
Protection and Statistical Efficiency Act (CIPSEA) of 2002* and Section 501(n) of the Public Health Service Act, all
data and associated materials collected and/or utilized on that study are subject to protection by CIPSEA. CIPSEA
ensures the confidentiality of all information provided is protected by Federal Law and stipulates that all
information collected shall be used exclusively for statistical purposes. All research subjects contacted on
SAMHSA/CBHSQ’s behalf by RTI International are notified of these protections prior to study participation.
You have been identified as a person who has access to confidential information on a SAMHSA/CBHSQ-sponsored
study covered under CIPSEA (NSDUH and/or DAWN**) and therefore have been designated as an Agent under
CIPSEA. This confidential information includes (but is not limited to) all electronic and hard copy documents
containing respondent information and data, as well as non-data related records containing information that could
identify a location or respondent associated with a particular study.
Protection Agreement under CIPSEA
Per CIPSEA regulations, you agree that any materials that would permit the identification of research subjects are
to be treated as confidential, and that you will never share or use that confidential information with anyone else or
in a manner other than those authorized by CBHSQ. This includes never disclosing confidential information with
law enforcement officials, officers of the court or your supervisor (if not also authorized as an Agent).
To ensure the protection of all confidential information in both physical and electronic form, as an Agent, you also
agree to:
1) keep all confidential information in a space where access is limited only to authorized personnel,
whether on a computer or in hard copy form;
2) keep all confidential information within computer memory controlled by password protection;
3) maintain a secure location (such as file cabinet or locked drawer) for printed materials, diskettes, and
data on hard disks of personal computers when not in use;
4) never remove confidential information from your approved worksite without prior approval from
CBHSQ and/or RTI International;
5) never permit any unauthorized removal of any confidential project information from the limited access
space protected under the provisions of this agreement without first notifying and obtaining written
approval from RTI;
6) notify RTI when you no longer have access to electronic or hard copy files or printed materials
containing confidential project information;
* Public Law 107-347, Title V; for more info: http://www.whitehouse.gov/omb/fedreg/2007/061507_cipsea_guidance.pdf
**National Survey on Drug Use and Health (NSDUH); Drug Abuse Warning Network (DAWN)
v. 12.12
CIPSEA Confidentiality Agreement, SAMHSA/CBHSQ
Administered by RTI International
7) when appropriate, return all confidential project information to RTI;
8) complete annual training on restrictions associated with the use of confidential information;
9) agree that representatives of CBHSQ have the right to make unannounced and unscheduled
inspections of the facilities where you work to evaluate compliance with this agreement;
10) notify RTI International immediately upon receipt of any legal, investigatory, or other demand for
disclosure of confidential project information;
11) notify RTI International immediately upon discovering any breach or suspected breach of security or
any disclosure of confidential project information to unauthorized parties or agencies.
12) and agree that obligations under this agreement will survive the termination of any assignment with
SAMHSA/CBHSQ and/or RTI International.
Penalties under CIPSEA
Any violation of the terms and conditions of this agreement may subject you, the Agent, to immediate termination
of access to confidential information by RTI International or CBHSQ, and will require the immediate return of all
electronic and hard copy files and materials in your possession.
Any violation of this agreement may also be a violation of Federal criminal law under Title V, subtitle A of the EGovernment Act of 2002 (P.L. 107-347); and/or Section 501(n) of the Public Health Services Act. Alleged violations
under the Title V, subtitle A of the E-Government Act of 2002 are subject to prosecution by the United States
Attorney. The penalty for violation of subtitle A of the E-Government Act of 2002 is a fine of not more than
$250,000 and imprisonment for a period of not more than 5 years. In addition to the above, all relevant statutory
and regulatory penalties apply.
Your signature (whether in electronic or written form) below affirms your understanding and acknowledgement of
all the regulations, requirements and penalties associated with CIPSEA as part of your work on this
SAMHSA/CBHSQ project for RTI International.
Name
ID Number (if applicable, RTI employees only)
Signature
Company Name
Date
Job Title
v. 12.12
Project Name:
National Survey on Drug
Project No.:
Use and Health
0212800
.
.
DATA COLLECTION AGREEMENT
I, __________________________________________, an employee of Headway, agree to provide field data collection
services for the benefit of RTI in connection with the RTI Project shown above (“the Project”). Further, I
1)
am aware that the research being conducted by RTI is being performed under contractual arrangement with the
Substance Abuse and Mental Health Services Administration (SAMHSA);
2)
hereby accept all duties and responsibilities of performing specified data collection tasks and will do so
personally, in accordance with the training and guidelines provided to me. At no time will I engage the services
of another person to perform any data collection tasks for me without the prior written approval of both my
employer (Headway) and RTI;
3)
agree to treat as confidential all information secured during interviews or obtained in any Project-related way
during the period I am working on the Project, as required by the Confidential Information Protection and
Statistical Efficiency Act of 2002 (CIPSEA), and understand, under Section 513 of this Act, I am subject to
criminal felony penalties of imprisonment for not more than five years, or fines of not more than $250,000, or
both, for voluntary disclosure of confidential information. Any breach of confidentiality must be reported
immediately to the National Field Director. This information will be shared with the SAMHSA Project Officer
and Headway. I have also completed and fully understand the CIPSEA training provided to me;
4) agree to treat as confidential and proprietary to RTI/SAMHSA any and all information provided by the
public, whether collected or accessed in electronic or printed form during the course of my service on this
Project, including but not limited to all data collection computer software and respondent data, and will protect
such items from unauthorized use or disclosure;
5) am aware that the survey instruments completed form the basis from which all analyses will be drawn, and
therefore, agree that all work for which I submit invoices will be legitimate, of high quality and performed in
compliance with all Project specifications to ensure the scientific integrity of the data;
6) understand that I am fully and legally responsible for taking all reasonable and appropriate steps to ensure that
any computer equipment issued to me for use on this Project is safeguarded against damage, loss, or theft. I also
understand that I have a legal obligation to immediately return all equipment at the conclusion of my
assignment or at the request of my supervisor;
7) fully agree to conduct myself at all times in a manner that will obtain the respect and confidence of all
individuals that I encounter as a representative of the Project and I will not betray this confidence by divulging
information obtained to anyone other than authorized Project representatives of RTI;
8) understand that evidence of falsification, fabrication or distortion of any data collected for this Project will
be reported to RTI's Scientific Integrity Committee, and such acts are grounds for immediately removing me
from the Project and can result in my suspension from any government-funded research. Also, if falsification of
data is substantiated, I understand a formal fraud complaint will be submitted to the U.S. Department of
Health and Human Services’ Office of Inspector General (OIG) and I could be subject to criminal and/or
civil prosecution and thereby face imprisonment, financial penalties or both;
9) understand my obligations under this agreement supersede any prior or existing agreements on the same subject
matter and will survive the termination of any assignment with RTI and/or my employment by Headway.
_________________________________________________________
Employee Signature
Disposition: Original to Headway, Yellow retained by employee.
__________________________
Date
2/12
File Type | application/pdf |
File Title | CIPSEA Confidentiality Agreement |
Subject | Sponsored by Substance Abuse and Mental Health Services Administration (SAMHSA/CBSHQ) |
Author | Administered by RTI International |
File Modified | 2013-04-17 |
File Created | 2013-04-17 |