Privacy Impact Assessment

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Privacy Impact Assessment Form
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Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

0920-18CI

2a Name:

07/23/18

Evaluation of TransLife Center (TLC): A Locally-Developed Comb
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Initiation
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

No
Yes
No
Agency
Contractor
POC Title

Project Officer

POC Name

Denson, Damian

POC Organization NCHHSTP/DHPIRS/PRB
POC Email

[email protected]

POC Phone

404.639.6125
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

TBD

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

N/A

11 Describe the purpose of the system.

The purpose of this study is to evaluate a locally developed and
potentially effective intervention, TransLife Center (TLC), which
provides combination (biomedical, behavioral, and social/
structural) HIV prevention services to adult transgender
women at high risk for HIV infection. The information collected
through this study is used to evaluate whether exposure to TLC
prevention services results in improvements in participants'
self-reported sexual health and HIV prevention behaviors,
beliefs and attitudes. The study will use a pre-post design to
compare pre-intervention (baseline) levels of HIV risk to those
at four and eight months post baseline.

The TransLife Center (TLC) study collects: Names, Phone
Numbers, Email, Mailing Address, Date of Birth (DOB),
Facebook ID, and Medical Notes. Data collected through the
study will be used to evaluate a locally developed HIV
Describe the type of information the system will
prevention intervention for transgender women. The Chicago
collect, maintain (store), or share. (Subsequent
House & Social Service (CHSS) Agency, Ann & Robert H. Lurie
12
questions will identify if this information is PII and ask Children’s Hospital of Chicago, and the University of Illinois at
about the specific data elements.)
Chicago collect the information for this study. The PII collected
is not transmitted or stored with any other information nor is it
transmitted CDC. The PII is alway kept separate from study data
and never linked to the CDC data. All collected data is deidentified prior to transmission to CDC.

Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

The TransLife Center (TLC) provides a combination of HIV
prevention services to adult transgender women at high risk
for HIV infection. Participation is voluntary and confidential.
Participants who are eligible and interested in the study will be
enrolled following consent. Written consents are stored in a
locked cabinet away from workstations and only accessed in
the event of a study visit, consent amendment, or an audit.
Data files maintained in de-identified format are not linked to
individual names or identifiers, and are stored in passwordprotected files on secure servers. This database is used to
schedule and track study visits and accessible only to study
staff investigators and data manager who have access to this
data. This data is completely password protected. HIV/STI
testing is completed by clinical staff of Heartland Health
Outreach (HHO) or by non-research staff of Chicago House,
who are under contract from Chicago Dept. of Public Health,
(CDPH). Coded and encrypted electronic data files collected
include, program attendance records, HIV/STI screening
results, and Pre-exposure prophylaxis (PrEP), and, survey,
biomarker results, and medical visit information are
transferred from Chicago House to Lurie Children's Hospital,
from Lurie's Children Hospital to University of Chicago for
analysis in a secure database.
All biological specimens will be labeled with coded identifiers
for processing to maintain privacy All identifying information
will be destroyed at the end of study.

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Yes

14 Does the system collect, maintain, use or share PII?

15

No

Indicate the type of PII that the system will collect or
maintain.

Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number
Name, phone number,
Email, DOB, Medical Notes,
Mailing address, and Social
Media Information collected
are not included in the CDC
data sets.

Taxpayer ID

Other...

Other...

Other...

Other...

Employees
Public Citizens
16

Business Partners/Contacts (Federal, state, local agencies)

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?
18 For what primary purpose is the PII used?
19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

100-499
The primary purpose of the PII is to maintain and track the
participants throughout the study.
Secondary use of PII is for analysis.

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

21

Identify legal authorities governing information use
Public Health Service Act, Title III, Section 301
and disclosure specific to the system and program.

22

Are records on the system retrieved by one or more
PII data elements?

Yes
No

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Published:
Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.

Privacy Act System Notice 09-20-0136: “Epidemio

Published:
Published:
In Progress
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources

23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

New ICR
Yes

24 Is the PII shared with other organizations?

No
Within HHS
Other Federal
Agency/Agencies
State or Local
Agency/Agencies

Identify with whom the PII is shared or disclosed and
24a
for what purpose.

Private Sector
Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Understanding (MOU), or Information Sharing
Agreement (ISA)).
24c

Describe the procedures for accounting for
disclosures

There are no MOUs or ISA s for this information collection
activity, as those accessing the data are joint awardees of the
funding. The HHO is the ongoing medial provider of the TLC
and is not receiving any study data.
None

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Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.

26

Participants will be notified in writing in the consent form
during the consent process that their personal information will
be collected. The consent process which is a discussion
between the participant and the study staff notifies individuals
that their PII will be collected.
Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
27
object to the information collection, provide a
reason.
Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.
Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

Mandatory
Participants may opt out of the information collection during
either the screening or consent processes. Participants who are
eligible and interested in participation will be enrolled and
consent obtained during either the screening or consent
processes.

Participants may be notified in writing by study staff if major
changes occur to the system.

Participants will be provided contact information and
instruction to contact either the grantee principal investigators
as well as the compliance officer for the Lurie Children’s
Hospital Institutional Review Board (IRB).
Data quality will be monitored regularly by the Lurie Children’s
PI and data manager. This will include review of study files and
data for accuracy (Quality Assurance), reconciliation of any file
and data problems as soon as possible, and cleaning of study
data and creation of a codebook prior to analysis. No PII is
transmitted to CDC, all collected data will be
De-Identified prior to transmission. The Chicago House &
Social Service Agency, and Lurie Children's Hospital keep all PII
data and never linked to the CDC data.
Users
Administrators

31

Identify who will have access to the PII in the system
and the reason why they require access.

Developers
Contractors

Chicago House & Social Service
Agency, Lurie Children's, and the
The CDC study team have defined that roles and
responsibilities to access PII is limited to only study
Describe the procedures in place to determine which investigators (Co-PIs, Program Director, and Program Manager)
32 system users (administrators, developers,
will have access to recruitment/retention, survey and interview
contractors, etc.) may access PII.
data.
The study data manager has a defined role that will only have
access to survey and interview data.
Others

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Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

Access to sensitive Personally Identifiable Information (PII) will
be restricted to individuals trained in human subject
protections who are listed on the Institutional Review Board
(IRB) protocol. All PII is collected for a specific and identifiable
purpose with access restricted to specific job tasks and
individuals who perform those tasks. Access to PII in study data
collected for the purposes of analysis is limited to the study
investigators and data manager.

Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

The grantee Co-PIs, Program Director and Program Manager
have completed the web-based course, “Protecting Human
Research Participants” provided by the NIH Office of Extramural
Research. The Program Director and Program Manager have
also completed a 4-hour training session on conducting
consent, protecting confidentiality and privacy, data collection,
and secure storage provided by one of the study Co-PIs.

Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

System users also receive training related to the Health
Insurance Portability and Accountability Act of 1996 (HIPAA).

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Yes
No

Records are retained and disposed of in accordance with the
CDC Records Control Schedule 04-4-22 Family of HIV Surveys,
Division of HIV/AIDS Prevention/Surveillance and
Epidemiology, (N1-442-02-3-4, Item 1). Record copy of study
reports are maintained in agency records from two to three
years in accordance with retention schedules. Source
documents for computer are disposed of when no longer
needed by program officials. Personal identifiers may be
deleted from records when no longer needed in the study as
determined by the system manager, and as provided in the
signed consent form, as appropriate. Disposal methods include
erasing computer disks or tapes, burning or shredding paper
materials or transferring records to the Federal Records Center
when no longer needed for evaluation and analysis. Cut off
closed grant, contract, or cooperative agreement files at the
end of the calendar year in which the project ends or a final
report is written and destroy six years after cut off.
All identifying information will be destroyed as soon as
possible at the end of study and no longer than three years
from the closure of the study protocol with the Lurie Children’s
Hospital IRB.

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Physical
Consents and locator forms will be stored in locked cabinets in
the research offices. Data files (survey and interview)
maintained in De-Identified format, stored in passwordprotected files on secure servers. All biological specimens
labeled with coded identifiers for processing to maintain
confidentiality. Biological specimens (urine, anal swabs, blood)
for HIV/STI testing will be de-identified, coded and transferred
by local courier for processing in external laboratories used
commonly in the testing programs at Lurie Children's and
Chicago House.
Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Technical
Tracking files (i.e., linking database) are maintained in a highly
secure scheduling and monitoring database at Northwestern
University. This database is used to schedule and track study
visits and accessible only to study staff; it is completely
password protected. Survey data employs Transport Layer
Security (TLS) Encryption during transmission.
Administrative
Lurie Children's and Chicago House are responsible for
following their organizations specific security procedures,
which at a minimum include restricting access to the PII to only
authorized users. The grantee Co-PIs, Program Director and
Program Manager have completed the web-based course,
“Protecting Human Research Participants."

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

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Reviewer Questions

Answer

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Reviewer
Notes
10

Is the PII appropriately limited for use internally and with third parties?

Yes
No

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

Reviewer
Notes
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

General Comments

OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2018.07.30
18:10:58 -04'00'

HHS Senior
Agency Official
for Privacy

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