Microsoft Word search phase 3 Title Page Amendment

participant will be contacted for this additional consent.   
Storage of DNA:  Since the study visit includes optional participation in the storage of 
DNA, the consent form includes a special section which explains the purpose of the 
storage of DNA.  Participants or their parent must indicate in writing whether or not they 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
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are giving their consent for the additional sample.  They may choose to have DNA stored 
or not stored.  If the participant is less than 18 years of age, the parent or guardian must 
give informed consent prior to the initiation of any study procedures or data collection, 
according to the requirements of the local IRB.  Assent of participants who are less than 
18 years of age is also governed by the requirements of the local IRB.  If the participant 
is 18 years of age or older, the participant must give informed consent.  Copies of 
completed consent forms will be maintained in the participant’s research record, 
according to local protocol.  No tests will be performed on the DNA obtained and stored 
in this study without first requesting and receiving approval of the IRB.  If the IRB 
decides that consent of each individual is required prior to performing an additional test 
on the stored sample, the investigators will attempt to seek and obtain consent from these 
participants.  Samples will not be tested if consent cannot be obtained or is explicitly 
denied.  All clinically relevant results will be reported to the participant.  Transmission of 
results will be based on the age of the participant at the time that the results become 
available.  If the participant’s parent agreed to have the samples drawn but the participant 
is at least 18 years of age when the results become available, then the participant will be 
notified of the results.   
The data management system for this study will utilize the combination of a local 
tracking application and a web browser-based interface.  The local tracking application 
will be used by local study personnel to manage demographic data, contact information, 
consent, appointments, visits, and communications with the participant.  This database 
will be password-protected and accessible to local study personnel only.  The web 
browser-based interface will be used for recording the majority of the data collected as 
part of this study.  Usernames and passwords will be required to access the SEARCH 
web site.  The Coordinating Center will control web access rights by assigning individual 
usernames and passwords to each staff member, according to the level of access required.  
The web-based data entry system will protect confidentiality and data security by 
utilizing 128-bit encryption and Secure Socket Layer (SSL). 
All PHI will be used or disclosed in compliance with the Health Insurance Portability and 
Accountability Act (HIPAA). A limited amount of PHI will be shared with the SEARCH 
Coordinating Center.  This data includes date of birth, county, zip code, date of diagnosis 
for diabetes, and dates of inpatient and outpatient visits.  Each of the five centers will 
enter into agreements with the Coordinating Center in compliance with the Standards of 
Privacy as specified by HIPAA contingent on the interpretations and processes defined 
by the local IRBs/Privacy Boards.  Local access to participant identifiers will be 
governed by the requirements of the local IRB. 
As an added protection for the privacy of study participants, we plan to request a 
Certificate of Confidentiality from the appropriate federal entity.  We applied for and 
received a Certificate of Confidentiality in SEARCH 1 and 2. 

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8.14.2.