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Oakland City University
Basic Elements of Informed Consent
(Based on: 45 CFR 46.116)
No informed consent, whether oral or written,
may include any exculpatory language through which the subject or
the representative is made to waive or appear to waive any of the
subject’s legal rights, or releases or appears to release
the investigator/researcher, the sponsor, the institution or its
agents. In seeking informed consent, the researcher will provide
the all following information to each subject:
(1) A statement that the study involves research,
and explanation of the purposes of the research and the expected
duration of the subject’s participation, a description of
the procedures to be followed, and identification of any procedures
which are experimental.
(2) A description of any reasonably foreseeable
risks or discomforts to the subject.
(Note: This includes any information about procedures that might
make a subject hesitant to participate.)
(3) A description of any benefits to the subject
or to others which may reasonably be expected from the research.
(4) A disclosure of appropriate alternative procedures
or courses of treatment, if any, that might be advantageous to the
subject.
(5) A statement describing the extent, if any,
to which confidentiality of records identifying the subject will
be maintained.
(6) A statement about research involving more
than minimal risk, an explanation as to whether any compensation
and an explanation as to whether any medical treatments are available
if injury occurs and, if so, what they consist of, or where further
information may be obtained.
(7) An explanation of whom to contact for answers
to pertinent questions about the research and research subjects’
rights, and whom to contact in the event of a research-related injury
to the subject.
(8) A statement that participation is voluntary,
that refusal to participate will involve no penalty or loss of benefits
to which that subject is otherwise entitled, and that the subject
may discontinue participation at any time without penalty or loss
of benefits to which the subject is otherwise entitled.
In addition to the foregoing required information,
under certain circumstances an informed consent may require additional
information be given to the subject. All researchers/students should
read and be familiar with the all the requirements of 45 CFR 46.116.
[hyper link to 45 CFR 46.116]
IRB
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