Microsoft Word search phase 3 Title Page Amendment

Potential Benefits of the Proposed Research to the Participants and Others 
There are no direct benefits to study participants.  In some cases, however, test results 
may help to more clearly define the type of diabetes an individual may have.  Test results 
may also identify the presence or increased risk for some of the complications associated 
with diabetes.  If the participant gives their consent, test results will be shared with their 
healthcare provider.  In some cases, based on SEARCH test results, the healthcare 
provider may choose to make changes to the treatment plan. 
Participation in this study may also result in potential benefits to society.  This is a large, 
multi-center study that will be well-represented by young people from a variety of 
racial/ethnic backgrounds.  The information obtained in this study will help clinicians to 
better understand the prevalence and incidence of childhood diabetes, the characteristics 
of various types of diabetes, the frequency of the occurrence of complications associated 
with diabetes, and the impact diabetes has on the lives of these young people.  This 
information will also be important in the planning of the distribution of medical and 
financial resources for the care of young people with diabetes in the future. 
Potential risks to study participants are minimal and reasonable in relation to the 
anticipated benefits to society from the knowledge that will be gained from this study. 
8.14.3.
 
Importance of the Knowledge to be Gained 
Diabetes is the third most common chronic disease of childhood and adolescence.  In the 
past, childhood diabetes was thought to consist almost exclusively of Type 1 diabetes.  
Over the past two decades, however, an increasing number of cases of Type 2 diabetes 
have been reported within this population.  Overall, the total number of diabetes cases 
affecting people less than 20 years of age that are developing diabetes seems to be 
increasing over time. 
This is a large, multi-center study that will be well-represented by youth from a variety of 
racial/ethnic backgrounds.  The information obtained in this study will help clinicians and 
researchers better understand the prevalence and incidence of childhood diabetes, the 
characteristics of persons with various types of diabetes, the frequency of the occurrence 
of complications associated with diabetes, the impact diabetes has on the lives of these 
young people, and the factors that relate to high quality diabetes care for children/youth.  
This information will also be important in the planning of the distribution of medical and 
financial resources for the care of young people with diabetes in the future. 
Potential risks to study participants are minimal and reasonable in relation to the 
importance of the knowledge that is expected to be gained from this study. 

---

Section 8A - Human Subjects (Phase 3 - 12/2010) 
Section 8A - Page 12 
 Registry 
Study
 
 
8.14.4.
 
Data and Safety Monitoring Plan 
Even though this study is not a clinical trial, an internal Protocol Oversight Committee 
(POC) has been established for SEARCH to:  1) oversee personnel training and 
certification procedures to assure consistency of measurements among all SEARCH 
centers; 2) review the quality of the data collected, as well as the laboratory results; and 
3) review any adverse events that might occur.  In addition, an external monitor reviews 
the activities of the studies, based on reports from the POC.  The external monitor will 
provide interim and annual safety reports to the Director of the Coordinating Center and 
the POC.  The interim reports will be quarterly and will clarify issues of interest for the 
monitor.  They will be interactive in nature.  Issues raised by the monitor will be queried 
by the POC to the relevant clinics; and clinic responses will clarify handling of issues, 
with copies of event reports signed by the Principal Investigator sent to the POC, the 
Coordinating Center, and to the monitor. 
The annual report will summarize the findings of the monitor over the year period, will 
be on academic letterhead, and will be dated and signed by the monitor.  It will include 
comments about event rates, types of events and relatedness to the study, and other issues 
which the monitor thinks transmit the safety profile of the study to the Principal 
Investigators, and to local IRB's. 
8.15.
 
REPOSITORY 
Testing related to diabetes is limited to basic testing as mentioned in Section 6A and 6B.  
These tests enable medical personnel to evaluate the diabetes status of participants.  
SEARCH investigators recognize that new information may become available during or 
following the collection of data that may make it desirable to perform additional biochemical 
tests on participants who are no longer available for further data collection. 
Since new genetic markers continue to be identified, markers currently available will be 
enhanced by those developed in the future.  These markers will add to the basic knowledge 
of diabetes.  Genetic analyses not currently funded in the SEARCH study, may be more 
efficiently performed on select, well-characterized group(s) of participants.  Thus, genetic 
material will be available to answer specific questions. 
8.15.1.
 
Sample Types 
Two types of samples to be collected and stored are: 
a)
 
Biochemical: serum, plasma, and/or urine 
b)
 
Samples for DNA extraction (buffy coat)  
Genetic analyses may be done on the SEARCH population to identify specific markers 
related to certain types of diabetes.  Genetic markers may add to the understanding of 
diabetes. 

---

Section 8A - Human Subjects (Phase 3 - 12/2010) 
Section 8A - Page 13 
 Registry 
Study
 
 
8.15.2.
 
Consent for Sample Storage 
The consent process will allow study participants to consent or refuse to have samples 
stored in the repository laboratory.  Consent will be structured in such a way that