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participant or parent (if participant is < 18 years of age) will be informed of the test 
result.  If the participant is not already receiving mental health treatment or counseling, 
study personnel may recommend follow-up by a mental health professional.  Specific 
referral procedures are dictated by a written local protocol at each center. 
If any of the test results identify complications of diabetes or an increased risk for 
developing complications, the results may cause some anxiety.  Study personnel may 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
Section 8B - Page 8 
 Cohort 
Study
 
 
recommend follow-up by the participant’s diabetes provider or a mental health 
professional.  Specific referral procedures will be dictated by local protocol. 
Study personnel will be trained to compare blood pressure measurements to a table of 
blood pressure measurements at the 95
th
 percentile, based on the participant’s gender, 
age, and height percentile.  If the participant’s blood pressure (systolic or diastolic) is 
higher than the 95
th
 percentile, the participant or parent (if participant is < 18 years of 
age) will be informed that the blood pressure is higher than expected.  If the participant is 
not already being monitored or treated for high blood pressure, study personnel will 
recommend that they follow-up with their healthcare provider.  Participants who have a 
blood pressure > 180/110 will be referred to their health care provider or the Emergency 
room for immediate attention. 
Whenever a participant has a triglyceride level of > 1000, the Central Laboratory will 
notify the appropriate center Principal Investigator or his/her designee within 24 hours.  
Local personnel are then responsible for referring the participant to their health care 
provider for appropriate follow-up. 
Storage of Serum/Plasma: Since the study visit includes optional participation in the 
storage of serum/plasma, the consent form includes a special section which explains the 
purpose of the stored samples.  Participants or their parent must indicate in writing 
whether or not they are giving their consent for the additional sample.  They may choose 
to have serum/plasma 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 serum/plasma 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.  Any future contact with participants will be based on their age at the 
time of contact.  If the participant’s parent agreed to have the sample stored but the 
participant is at least 18 years of age when additional consent is requested, then the