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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 Registry Study will involve ascertainment of cases diagnosed in the calendar 
years 2010 - 2014.  Registered cases in all five incident years will be asked to complete an 
initial participant survey (IPS).  The survey will be used to validate a diagnosis of diabetes, to 
confirm study eligibility, and to obtain essential core data elements.  For the incident years 
2011 and 2013, potentially eligible participants will be invited to participate in a baseline 
(IPV).  Cases of secondary diabetes or any other specific types of diabetes, however, will be 
excluded from the study visit.  Local study personnel will send study newsletters and conduct 
other local activities in order to try to maintain contact with these cases to allow for 
recruitment of these persons for future ancillary studies.  
Based on previous SEARCH incidence data, we anticipate approximately 1,316 new cases of 
diabetes to occur per year in the base populations of these five centers.  Therefore, we 
anticipate a total of approximately 6,000 new cases to be identified and registered for the 

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Section 8A - Human Subjects (Phase 3 - 12/2010) 
Section 8A - Page 2 
 Registry 
Study
 
 
period throughout the grant period.  This includes the 2010 cases that would be identified and 
registered starting September 30, 2010.  We will attempt to have an IPS completion rate of 
90% of all registered participants.  We also anticipate approximately 1,700 participants will 
be involved in the IPV for the 2011 and 2013 incident years. 
8.3.
 
PROTOCOL DEVELOPMENT 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, 
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, 

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Section 8A - Human Subjects (Phase 3 - 12/2010) 
Section 8A - Page 3 
 Registry 
Study
 
 
centers may be advertised on web sites, such as the American Diabetes Association or 
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 incident cases of diabetes in the study clinical center areas age less than 20 years will be invited to 
complete the IPS and, of those who complete an IPS whose diabetes is not known to be secondary to 
other conditions, will be invited to participate in the IPV.   
8.7.1.