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physical examination:  height, weight, waist circumference, blood pressure, and 
presence of acanthosis; 
•
 
measure of microvascular complications of the eye:  retinal photographs, using a non-
midriatic camera; 
•
 
measures of peripheral neuropathy:  Michigan Neuropathy Screening Instrument 
(MNSI) physical assessment:  foot inspection (visual and tactile), vibration sensation 
(tuning fork), ankle reflex, and monofilament testing of the great toe; 
•
 
measure of autonomic neuropathy:  using SphygmoCor; 
•
 
measures of vascular function:  arterial stiffness by pulse wave velocity and 
augmentation index by non-invasive arterial tonometry, both using SphygmoCor; 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
Section 8B - Page 4 
 Cohort 
Study
 
 
•
 
surveys and questionnaires to obtain data related to co-morbidities and complications, 
medical and family history, medication inventory, diabetes education, diabetes home 
care, quality of care, quality of life, insurance, parental education, and composition of 
household and income additional data will be obtained from individuals who are 10 
years of age or older:  tanner stage, physical activity, diet, , tobacco use, and 
depression; 
•
 
contact information:  name of the person and her/his parents or guardians and 
alternate contacts, addresses, phone numbers, and e-mail addresses. 
8.8.
 
STUDY DATA 
Each newly diagnosed case will be assigned a unique SEARCH identification number and 
this SEARCH identification number will be used for the Cohort Study in order to link data 
across multiple visits.  Each of the five SEARCH centers will maintain person’s names and 
contact information on a local basis, accessible only to the local research team.  The 
Protected Health Information (PHI) that is transmitted to the SEARCH Coordinating Center 
(CoC) for registered cases is the minimum necessary to conduct this research.  It consists of 
date of birth, county, zip code, date of diagnosis for diabetes, and dates of inpatient and 
outpatient visits.  Data transmitted to the CoC qualifies as a HIPAA Limited Dataset.  Each 
of the centers will enter into a Limited Data Use Agreement with the CoC in compliance with 
the Standards of Privacy of Individually Identifiable Health Information as outlined by the 
HIPAA privacy rules.  Local access to person’s identifiers will be governed by the 
requirements of the local IRB.  Laboratory specimens will be associated with the SEARCH 
identification number and the date of specimen collection.  Data transmitted to the laboratory 
qualifies as de-identified to the HIPAA standard.  Laboratory personnel are not able to 
identify individuals based on the information sent to them.  
8.9.
 
CONSENT FORMS 
The model consent and assent forms developed by the SEARCH Study staff can be adapted 
to meet local IRB guidelines and criteria.  Consent of at least one parent or legal guardian 
will be required of all participants under the age of 18 years of age at the time of the survey 
or study visit.  Participants 18 years of age and older will sign as the participant and will not 
require additional signature of parent or legal guardian or when an emancipated minors. 
Consent forms will contain the following information: 
a)
 
Introductory information, explaining the objectives of the study 
b)
 
Procedures 
c)
 
Risks, Discomforts, Precautions 
d)
 
Incentives/compensation 
e)
 
Benefits 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
Section 8B - Page 5 
 Cohort 
Study
 
 
f)
 
Alternatives of Care 
g)
 
Confidentiality of records 
h)
 
Optional consent to release test results to health care provider(s) 
i)
 
Availability of information 
j)
 
Right to withdraw 
k)
 
Additional elements of consent 
l)
 
Any additional text required by the Center 
m)
 
Witnessing and signatures 
8.10.
 
ASSENT 
The age of assent and the method of obtaining assent will be defined and conducted in 
accordance with the guidelines of the local IRB. 
8.11.