This institution is guided by the ethical principles regarding
all research involving humans as subjects, as set forth in the
report of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (entitled: Ethical
Principles and Guidelines for the Protection of Human Subjects
of Research [the "Belmont Report"]), regardless
of whether the research is subject to federal regulation or with
whom conducted or source of support (i.e., sponsorship).
- The University of Kansas and the individual members of its
faculty, staff and student body recognize their responsibility
for protection of the rights and welfare of human subjects.
- Appropriate professional attention and facilities shall be
provided to insure the safety and well-being of human subjects.
No subject in a research activity shall be exposed to unreasonable
risk to health or well-being.
- Research involving minors, that is persons less than 18 years
of age, and/or others for whom the ability to provide informed
consent may be limited may be approved if there is no risk
or suffering for the individual subject. Research involving
children, or others who may be unable to give informed consent
and which involves greater than minimal risk may be approved
by the HSCL,
but each research project must be reviewed and evaluated on
a case-by-case basis.
Research involving children, or others who may be unable
to give informed consent, except for educational research,
described above, requires written parent/guardian permission
and must receive full board review.
- The confidentiality of information received from subjects
in experiments or respondents to questionnaires shall be fully
protected, both during and after the conduct of a research
activity, within the limits of the law.
The application and the consent form must describe what
measures will be taken by researchers to protect the confidentiality
of research participants. That is, who will have access to
the data, how participants' names are shielded from unauthorized
third parties, how data will be stored, and what happens
to the data upon completion of the research project. Research
that incorporates audio or video taping must describe who
will have access to the tapes, how the tapes will be kept
secure, and what are the researcher's plans for the tapes
upon completion of the project. Tapes may be erased or destroyed,
returned to participants, or archived. However, research
participants must be informed about the planned disposition
of the tapes and must agree to those plans.
- Before a subject participates in research involving risk
or substantial stress or discomfort, this shall be carefully
explained; the investigator shall be satisfied that the explanation
has been understood by the subject; and the consent of the
subject shall be obtained. Minimum standards for informed consent
are established by the federal government and may be augmented
by the University according to 45 CFR 46.
The research participant or the research participant's
legal guardian must be legally empowered, by virtue of age
and also be cognitively competent to understand and agree
to the terms of the consent document. The board may require
a researcher to alter the language of a consent form to ensure
that it is written at a language level that the participant
or the participant's guardian can understand. HSCL also
requires that, even if a parent or legal guardian gives permission
for their child/ward to participate, the researcher must
obtain "assent" from the research participant The
assent procedure is a request from the researcher to a prospective
participant to take part in a research project. It includes
a verbal explanation of the proposed research activity and
incorporates elements of a regular consent, such as statements
that participation is voluntary, estimated time commitment,
what is being asked of the participant, and that participants
may withdraw with no adverse consequences or loss of services.
- A request by any subject for withdrawal from a research
activity shall be honored promptly without penalty or without
loss of benefits to which the subject is otherwise entitled.
Consent forms, information statements, and assent procedures
must include a statement that participants may withdraw their
participation at any time with no adverse consequences. The
language level is to be appropriate to the cognitive abilities
of the participants.
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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