Chain of Reporting
The HSCL Coordinator
reports to the Human Subjects Committee board, the HSCL Chair,
and reports decisions of the HSCL to
the Director of Research Integrity.
Responsibility and Charge of the HSCL
HSCL is
responsible for ensuring constructive communication among the
research administrators, department heads, research investigators,
clinical care staff, human subjects, and institutional officials
as a means of maintaining a high level of awareness regarding
the safeguarding of the rights and welfare of the subjects.
HSCL will
review all research (whether exempt or not) and decide whether
the institution will permit the research. If approved by the HSCL,
but not permitted by the institution, the institution will promptly
convey notice to the investigator and the HSCL Chair.
Neither the institution nor any other office of the institution
may approve a research activity that involves human participants.
Communication with Institutional Staff
Institutional officials within the KU Office of Research and Graduate Studies (
RGS) have read-only access to
HSCL's database of human subjects research projects. Also, institutional officials occasionally contact the Coordinator to ask if a specific project has approval or if an investigator has applied to the Human Subjects Committee for approval.
Education of Investigators
Training includes class presentations, an informational video
(PROTECTING HUMAN SUBJECTS (produced by OHRP and
made freely available to the research community by HSCL),
and faculty staff meetings and presentations. HSCL also
has received permission to obtain and distribute a CD titled "Research
101," which serves to educate researchers, administrators,
and other interested parties about various aspects of human subjects
research and how they are affected by the federal regulations
under 45 CFR 46 Protection of Human Subjects. HSCL activities
that are not training but serve the research community include
policy interpretation and providing assistance to researchers
with application preparation. The Coordinator also speaks to
various classes on the Lawrence campus and the Edwards campus
(south Kansas City).
Effective October 1, 2000, HSCL implemented
an online
tutorial which may be accessed at (http://www.research.ku.edu/tutor/hsp/index.shtml)
in order to comply with the National Institutes of Health (NIH)
training requirement for all investigators conducting research
that involves human participants who are submitting applications
for NIH funding
of their projects. In order to be consistent with its requirements
for approving projects involving human subjects and in order
to maximize research participants' safety, rights, and privacy, HSCL requires
that all persons conducting research involving human research
participants take an online tutorial derived from the NIH tutorial
developed for its staff. NIH kindly
allowed other institutions to use its tutorial and modify it
for appropriateness.
Communication with researchers
HSCL decisions
and requirements for modifications will be promptly conveyed
to investigators. Written notification of decisions will be accompanied
by reasons for the decision with provision of an opportunity
for reply by the investigator, in person or in writing.
Communication with other institutions
Researchers at this institution do collaborate with researchers
at other institutions. In such cases HSCL does
require the researchers at this institution to submit an application
for review by HSCL. HSCL may
accept use of another institution's approved protocol and/or
consent form if they meet HSCL's
requirements for approval.
Institutions that are not direct signatories to this Assurance
are not authorized to cite this Assurance. This institution will
ensure that such other institutions and investigators not bound
by the provisions of this Assurance for DHHS-sponsored research
will satisfactorily assure compliance with 45 CFR 46, as required,
as a prior condition for involvement in human subject research
which is under the auspices of this institution.
Institutions that have entered into an Inter-Institutional
Amendment (IIA) to this Assurance must submit a Federalwide Assurance
(FWA) to the Office for Human Research Protections (OHRP)
of DHHS for DHHS-sponsored research, on request, when that research
is not conducted under the auspices of a signatory institution
to this Assurance.
HSCL does
agree to be the IRB of
record for organizations separate from KU when those organizations
have an approved Federalwide Assurance (FWA) from the Office
of Human Research Protection (OHRP)
and have entered into a contractual agreement with HSCL.
Communication with Regulatory agencies
Certification of HSCL review
and approval for all federally-sponsored research involving human
subjects is kept on file and submitted to the Office of Contract
Negotiation, and Research Compliance for forwarding to the appropriate
federal department or agency as needed. Compliance will occur
within the time and in the manner prescribed for forwarding certifications
of HSCL review
to DHHS or other federal departments or agencies to which this
Assurance applies.
As required under Section 119, the HSCL will
review and recommend approval for involvement of human subjects
in federal research activities for which there was no prior intent
for such involvement, but will not permit such involvement until
certification of the HSCL's
review and approval is received by the appropriate federal department
or agency.
HSCL has
developed a form to document the certification process, a sample
of which appears in Appendix I, HSCL DOCUMENTS.
Questions? Please contact:
Mary Denning
785-864-7429 | mdenning@ku.edu
Coordinator |Human Subjects Committee of
Lawrence (HSCL)
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