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participants can agree to have either serum or DNA or both or neither kept in the 
repository without affecting their participation in the remainder of the SEARCH protocol. 
8.15.3.
 
Sample Maintenance 
8.15.3.1.
 
Duration of Storage 
Samples will be stored for as long as they last and will be retained in the repository 
laboratory for the duration of SEARCH funding.  The Laboratory Director is 
responsible for maintaining a current list of all samples to provide to Principal 
Investigators for matching.  In the event that SEARCH funding for repository 
maintenance is exhausted, the principal investigators will be responsible for 
determining the disposition of study samples for his or her study center. 
8.15.3.2.
 
Sample Destruction 
Individual participants (or their parents if participants are < 18 years old) when 
sample destruction is desired) may request that their DNA and/or serum samples be 
destroyed at any time.  When this occurs, the principal investigator will notify the 
laboratory, which will assure destruction of the sample(s).  Any analyses done on 
their samples before the data the request is received will remain in the study dataset. 
8.15.3.3.
 
Use of Repository Samples 
Samples will be made available (with Executive Committee approval) to SEARCH 
investigators and their collaborators.  Samples will be used solely for analyses related 
to diabetes or its complications or risk factors.  All studies using repository samples 
will be approved additions to the SEARCH protocol or approved ancillary studies 
which require a review by the Ancillary Studies Committee.  Distribution of samples 
by the laboratory will be only by direction of the executive committee. 
8.16.
 
ANCILLARY STUDIES 
It is expected that there will be a number of ancillary studies.  Submissions for ancillary 
studies will be reviewed and approved by the Ancillary Studies Committee and the Executive 
Committee.  Publications based on Ancillary Studies must be approved by the Publications 
and Presentations Committee.  Involvement in the ancillary studies will vary by study center.  
Each ancillary study will require separate IRB approval, and a separate source of funding. 

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Section 8A - Human Subjects (Phase 3 - 12/2010) 
Section 8A - Page 14 
 Registry 
Study
 
 
8.17.
 
FUTURE STUDIES 
SEARCH is designed to provide population-based information about selected aspects of 
diabetes in youth, with the protocol written by SEARCH investigators to reflect the best 
design given current knowledge.  It is expected that new tests or methods will evolve that 
would provide additional information and/or enhance the study.  Participants are asked at 
each visit if they would like to be contacted for future studies.  Annual contact will be made 
with participants or their parent/guardian (if ≤ 18 years of age) to update information such as 
address and telephone numbers.  Participants who withdraw from the study will not be 
contacted for future studies.   

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SEARCH Phase 3 Protocol - Section 8B 
Cohort Study 
Human Subjects 
Table of Contents