Microsoft Word search phase 3 Title Page Amendment

8.
 
Human Subjects 
8.1.
 
GOALS 
In this section, we will outline the study’s plans to: 
a.
 
to obtain the highest level of informed, voluntary participation from eligible persons 
with diabetes and their parents/guardians (if they are <18 years of age); 
b.
 
to follow all local and national human subjects regulations; 
c.
 
to respects the wishes of the person with diabetes and their parent/guardian, 
regarding participation, continuation in study, and receipt of clinically relevant test 
results; 
d.
 
to protect confidentiality; 
e.
 
to ensure safety of participants relative to completion of the study measures; and, 
f.
 
to ensure fair and equal treatment of all participants and their parents/guardians 
when applicable. 
8.2.
 
OVERVIEW:  BACKGROUND INFORMATION 
SEARCH Phase 3 will be conducted in two components, a Registry Study and a Cohort 
Study.  Both components will be completed at all five SEARCH clinical centers, and the 
Coordinating Center and Central Laboratory will be the same for both components.  No 
individual will be excluded on the basis of gender or race/ethnicity.  Since the focus of this 
study is to learn more about the impact of diabetes on people who are less than 20 years of 
age at the time of diagnosis, this study includes children, adolescents, and young adults.  This 
study does not involve fetuses, neonates, prisoners, or institutionalized individuals.  Young 
women, who are pregnant and eligible for the study, will not be scheduled to participate in an 
in-person visit (IPV) until at least six weeks after the completion of the pregnancy. 
The SEARCH Cohort study will involve follow-up in-person visits for all participants 
diagnosed in incident years 2002-2005, 2006, and 2008 in SEARCH Phases 1 and 2 and who 
completed a baseline visit as part of the previous SEARCH protocol that have had diabetes 
for at least 5 years.  Youth who were eligible for a baseline visit under the previous SEARCH 
protocol, but who declined to participate in this in-person visit or who explicitly refused 
further contact or are known to be deceased; will not be asked to participate in follow up 
visits for this study.  The IPV will involve the collection of data from medical record review 
(in a subset of participants), a physical examination, self-reported data on health behaviors, 
health care, and psychosocial factors, and the assessment of diabetic retinopathy, neuropathy, 
nephropathy and markers of cardiovascular disease. 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
Section 8B - Page 2 
 Cohort 
Study
 
 
A total of 3,699 youth with diabetes who were diagnosed in incident years 2002-2005, 2006, 
and 2008 have completed a baseline visit thus far as part of the previous SEARCH protocol.  
Therefore, approximately 3,700 individuals will be eligible for a follow-up in-person visit.  
8.3.
 
PROTOCOL DEVEOPMENT AND MAINTENANCE 
The study protocol will be standardized across five centers.  Information will be obtained 
from multiple sources: Medical Records, IPS, IPV (including physical exam, questionnaires, 
and laboratory studies of blood and urine).  Forms used for data collection will be distributed 
to the Study Centers by the Coordinating Center.  Data will be transmitted electronically to 
the Coordinating Center for data analysis.  To maintain confidentiality, materials will be sent 
to the central location with a study number but no personal (such as name, social security 
number, medical record number, contact information, etc).  Subject identifiers will be 
maintained in a separate file, which is maintained and protected locally. 
Methods of recruitment and data collection may vary between centers.  Centers will obtain 
local IRB approval, and follow local IRB regulations.  
Model consent, assent forms and subject recruitment material will be prepared by the human 
SEARCH human subjects committees, translated into Spanish by a certified translator before 
sending to the centers so that they can be further customized and submitted for approval by 
the local IRB committees. 
The Coordinating Center will be responsible for obtaining approval for the Federal Office of 
Management and Budgets for the conduct of the study. 
8.4.
 
CENTER SPECIFIC GUIDELINES 
Each of the five centers and the Coordinating Center in SEARCH work with one or more 
local IRBs, and it is expected that each IRB will have separate requirements.  Content of the 
materials is standardized, while also abiding by local IRB regulations.  For example, 
inclusion of a participant’s bill of rights is required by some states.  This will be added in 
accord with local regulations.  When necessary, all study materials will be provided in 
English and Spanish.  All Spanish translations will be done by certified translators.  Materials 
will be provided in additional languages as determined by the local study population 
demographics.  No potentially eligible subject will be excluded based on language. 
8.5.
 
RECRUITMENT AND METHODS TO ENTER STUDY 
The goals of recruitment are to maximize enrollment while respecting the voluntary nature of 
clinical research.  Recruitment will take place at a number of levels: person with diabetes and 
their family, community (e.g., diabetes support groups, school nurses, and 
television/newspaper) and health care providers.  Methods of recruitment will vary by center. 
All recruitment materials will be developed in collaboration with the CoC and may be 
customized by local centers.  Recruitment materials will require local IRB approval.  Also, 
centers may be advertised on web sites, such as the American Diabetes Association or 

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Section 8B - Human Subjects (Phase 3 - 12/2010) 
Section 8B - Page 3 
 Cohort 
Study
 
 
Juvenile Diabetes Research Foundation.  Again, such advertisements will be posted or aired 
in adherence with local IRB guidelines. 
Local health care providers will be informed of the study objectives, eligibility criteria, and 
local study personnel contact information.  They will be assured that the SEARCH study will 
not interfere with their relationship with their participants.  Each center will have a provider 
network that will be specific to that center.  Centers will use existing methods (with 
enhancements over time when applicable) to conduct efficient, timely surveillance of 
incident cases of diabetes.  Identifiers will be maintained by the local SEARCH personnel 
and not submitted outside the local center.   
8.6.
 
HIPAA PRIVACY ACT 
The Office of Civil Rights has established a Privacy Rule for research, OCR Health 
Insurance Portability and Accountability Act (HIPAA) Privacy TA.5121.001.  The Privacy 
Rules establishes conditions under which protected health information may be used or 
disclosed for research purposes.  The Privacy Rule protects individual’s identifiable health 
information while allowing for the conduct of vital research, with researchers accessing 
necessary medical information.  The means of informing individuals of use or disclosure of 
medical information are also defined in the Privacy Rule.  SEARCH centers will follow 
HIPAA guidelines as needed by each institution.   
8.7.
 
RESEARCH MATERIALS 
All eligible individuals (incident years 2002-2005, 2006, and 2008 who completed a baseline 
visit as part of the previous SEARCH protocol) will be invited to participate in a follow-up 
in-person visit (F-IPV) after.  The person has had diabetes for at least five years.  The F-IPV 
will include the following research material: 
•
 
blood specimens:  diabetes autoantibodies (GAD65, IA2, ZnT8); HbA
1c
; C-peptide, 
and lipid levels; creatinine; fasting serum/plasma for storage; DNA for storage; and 
urine for albumin/creatinine; 
•