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Participants (or their parent/guardian if <18 years) will be asked whether or not they wish 
their diabetes and/or primary care provider(s) to receive their clinically relevant test results 
such as: HbA
1c
, lipid profile, C-peptide, DAA, microalbumin, and glucose.  Receipt of these 
results will be viewed as a possible but not definite benefit to the participant; as such 
information may or may not affect subsequent diabetes (or complication) management. In 
view of the laboratory measures obtained, there will be few if any critical values.  If critical 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
Section 8B - Page 6 
 Cohort 
Study
 
 
laboratory values do occur, the central laboratory will contact the local Principal Investigator 
and/or his/her designee, and the information will be shared with the participant or his/her 
parent/guardian if <18 years of age, as well as the provider if permission was given at the 
time of the study visit.   
Information from interviews (general interviews and supplemental interview conducted with 
youth ≥ 10 years) will NOT be shared with parents or guardians with one exception.  If the 
alert value for the Centers for the Epidemiologic Studies of Depression (CES-D) scale is 
reached, the center personnel will offer participants (and their parent/guardian if <18 years of 
age) assistive referrals. 
Participants who are ≥ 10 years at the time of the interview will be administered a 
supplemental survey.  This survey includes questions related to eating disorders.  Parents will 
be allowed to review the survey before it is completed by their child and will be asked to 
waive their right to review their child’s answers.  If they refuse to waive their rights to 
review, the supplemental survey will not be administered.  Youth ≥ 10 years will also be 
asked to complete the CES-D scale as described above. 
8.14.