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.
Section 8B - Human Subjects (Phase 3 - 12/2010)
Section 8B - Page 13
Cohort
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.