HSCL serves
as the conduit through which human participant research is reviewed
and approved. As such, HSCL maintains
an educational program
and an online tutorial to increase the awareness of human research
participant issues at the University of Kansas, Lawrence campus.
Funded research that incorporates human participants must be
approved by HSCL before
distribution of grant
funds to researchers.
HSCL is
the mechanism through which the University of Kansas abides by
federal regulations pertaining to the protection of human research
participants.
HSCL will
review, and have the authority to approve, require modification
in, or disapprove all research activities, including proposed
changes in previously approved human subject research. For approved
research, HSCL will
determine which activities require continuing review more frequently
than every twelve months or need verification that no changes
have occurred if there was a previous HSCL review
and approval.
Researchers who wish to change an approved protocol may communicate
their request via email, fax, or surface mail. The Coordinator
reviews the request for change and evaluates how the changes
affect the approved procedures. If the requested changes are
minor the Coordinator issues an approval letter for the change,
noting in the approval letter the approval period. Approved changes
do not affect the twelve-month approval period and researchers
are informed in the approval letter that about one month before
the approval anniversary date they will be sent a status report
form. The approval letter states that researchers must complete
the status report form in order to receive HSCL approval
for another twelve month period.
HSCL will
determine which studies need verification from sources other
than the investigators that no material changes have occurred
since previous HSCL review.
When there are indications that approved protocol may not have
been followed, HSCL may
contact research participants, witnesses, and other individuals
and/or institutions as needed to obtain the requisite information.
This procedure applies to all approved research projects regardless
of the level of risk to participants and to research projects
that may have been conducted without HSCL review
and approval. HSCL requires
that subcontracting institutions and investigators submit reports
to HSCL as
required, including annual Project Status Reports, and other
information as requested by HSCL.
Questions? Please contact:
David Hann
785-864-7429 | dhann@ku.edu
Coordinator | Human Subjects Committee of
Lawrence (HSCL)
— or —
Mary Denning
785-864-7385 | mdenning@ku.edu
Associate Coordinator |Human Subjects Committee of
Lawrence (HSCL)
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