Biomedical Engineering Reference
In-Depth Information
11.3.4 InformedConsent
Common to all the codes drawn up by IRBs is the principle that experimentation
cannot be conducted on human subjects without their informed consent. Research-
ers have an ethical and legal duty to obtain a patient's informed consent before
ordering testing and treatment. The consent document is a written summary of the
information that should be provided to the participant. Many investigators use it as
a guide for the verbal explanation of the study. The entire informed consent process
involves:
1. Giving a participant adequate information about the study;
2. Providing adequate opportunity for the participant to consider all options,
and responding to the participant's questions;
3. Ensuring that the participant has comprehended this information;
4. Obtaining the participant's voluntary agreement to participate;
5. Continuing to provide information as the participant or situation requires.
11.3.4.1 Information
The informed consent process must allow human participants, as much as they are
able, to be given the opportunity to choose what will or will not happen to them.
Most codes of research establish specific items for disclosure intended to assure that
subjects are given sufficient information. The minimum components of an informed
consent form include:
1. A description of the intended research which should include: the purposes
of the research, the expected duration of participation, the procedures to
be followed, and the identifi cation of any procedures that are still in the
experimental stage.
2. A description of any adverse effects (risks) or discomforts to the subject.
3. A description of anticipated benefits to the subject or to others, which may
reasonably be expected from the research.
4. Disclosure of alternative procedures or treatments (where therapy is in-
volved) that might be advantageous to the subject.
5. For research involving more than minimal risk, a description to whether
any compensation and any medical treatments are available if injury oc-
curs and, if so, what they consist of, or where further information may be
obtained.
6. Contact information incase the subject wants to ask questions about the
research and his or her rights. Also, contact information in the event of a
research related injury to the subject is necessary. The consent document
should provide the name of a specific contact person, and information such
as telephone numbers and e-mail addresses. It is important for the subject
to know what events should necessitate contacting the contact individual.
The person named for questions about research subjects' rights should not
be the primary investigator since this may tend to inhibit subjects from
reporting concerns and discovering possible problems. If a student is con-
