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PARTICIPANT RISKS AND BENEFITS 
For all centers, potentially-eligible participants will be identified by a network of reporting 
health care providers.  Some centers may also identify potential cases by linkage of 
confidential clinical and administrative data systems such as those generated based on 
information in the electronic medical record.  Participant identification and registration will 
be conducted in a manner that is HIPAA-compliant and according to the requirements of the 
local IRB and minimizes the risk of loss of privacy.   
Potentially-eligible participants will be mailed an introductory letter that gives a brief 
description of the research study.  For participants who are less than 18 years of age, the 
introductory letter will be mailed to the participant’s parent or guardian.  Letters sent to 
participants who are 18 years of age or older will be addressed to the participant.  Some 
centers may also mail survey or linkage to the survey on-line as a part of this introductory 
letter.  After mailing this introductory letter, a designated member of the local research team 
or a survey research company working in collaboration with the study center may call the 
parent/participant to complete the IPS.  Consent requirements for completion of this survey 
will be governed by the local IRB. 
Participants who are eligible to participate in the IPV will be contacted and given an 
explanation of the study and will be asked if they would like to participate.  If interested, the 
participant will be scheduled for an appointment and a team member will explain the pre-
appointment instructions to the participant or parent.  When the participant arrives for the 
IPV, a research team member will review the study requirements with the participant and/or 
parent and address any questions or concerns they might have.  Since the IPV includes 
optional serum/plasma and DNA blood samples for storage, the consent form includes two 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
Section 8B - Page 7 
 Cohort 
Study
 
 
special sections which explain the purpose of these extra samples for serum/plasma and DNA 
storage.  Participants or their parent must indicate in writing whether or not they are giving 
their consent for these additional samples.  They may choose to have both samples stored, 
only one sample, or no stored samples.  If the participant is less than 18 years of age, the 
parent or guardian must give written informed consent prior to the initiation of any study 
procedures or data collection, according to the requirements of the local IRB.  Written 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 written 
informed consent.  Copies of completed consent forms will be maintained in the participant’s 
research record, according to local protocol. 
8.14.1.
 
Protection Against Risk 
To minimize the possibility of risks associated phlebotomy experienced medical staff will 
obtain the blood samples in accordance with local or state guidelines.  A numbing 
medicine may be placed on the skin before the blood is drawn to decrease any pain.  
Participants who have a history of fainting or who develop symptoms of light-headedness 
may be placed in the supine position. 
Study personnel will be trained to identify the signs and symptoms of a blood glucose 
level that is low or high.  They will also be trained to check the blood glucose level, using 
a glucometer.  If a low blood glucose occurs (< 70 mg./dl.), study personnel will be 
trained to administer 15 grams of an oral carbohydrate, and to repeat as needed every 10 
minutes until the blood glucose level is > 70 mg./dl.  If the blood glucose level is above 
300 mg./dl., study personnel will be trained to check urinary ketones.   
After the blood sample is obtained, their blood glucose level will be measured using their 
meter or one provided by the local staff and participants will be instructed to take their 
usual dose of insulin or other diabetes medication as prescribed; and the participant will 
then be given breakfast.  In cases of low or high glucose levels (with or without the 
presence of urinary ketones), additional medical interventions may be needed.  Local 
policies dictate these procedures, which may include a one-time adjustment in the dose of 
insulin taken and/or the administration of glucose gel, glucagon, or intravenous glucose.   
The CES-D scale is administered to identify participants who may be at increased risk for 
depression.  If the participant has a high score (> 22 for males or > 24 for females), the