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Elements of Informed Consent: Augsburg IRB
Elements of Informed
Consent
Elements of Informed Consent, Requirements and Guidelines for
Consent Forms
Informed consent is a process of
communicating to the subject the purpose, risks, benefits, and
voluntary nature of a specific study.
The consent form documents that
the communication process took place. The consent form must
contain all of the required "elements" of informed consent. The
"sample consent form" should be used as a guide for writing a
consent form. Rules and regulations are subject to change and
revision. Standards for consent documents change over time. The
investigator should be prepared to revise and update consent forms
at the request of the Institutional Review Board (IRB).
The consent form should be written
in lay terms; jargon and technical language should be avoided. If
that language cannot be avoided, the terms should be defined
parenthetically so that subjects can make an informed decision.
The IRB recommends that researchers write the consent forms using
simple declarative sentences, avoid technical language and have
the final draft of the consent form reviewed by a person
unfamiliar with the research to test for comprehension, prior to
submitting it for review. Foreign language versions should be
prepared for research with subjects whose English is
limited.
Elements of Informed consent which
must appear in the consent form: (Federal Policy
46.116-111)
- A statement that this is
research, an explanation of the purpose of the research and the
expected duration of the subject's participation, (including an
estimate of the total amount of the subjects' time involved in
participation ), a description of the procedures to be
followed, and identification of any procedures which are
experimental. The reason for the subjects' selection.
- A description of any
reasonably foreseeable risks or discomforts to the subject
(including psychological risks such as stress, invasion of
privacy etc.).
- A description of any benefits
to the subject or others which may reasonably be expected from
the research. If there is no benefit to participation to the
individual subject, an honest declaration of that fact must be
included in the text of the context form.
- A disclosure of appropriate
alternative procedures or courses of treatment, if any, that
might be advantageous to the subject. If any standard treatment
is withheld as a result of participation, the subject must be
informed.
- An explanation of whom to
contact for answers to pertinent questions about the research
and research subjects' rights. A name and telephone number
should be included. (If the researcher is a student, the
advisor's name and telephone number must be included on the
form.)
- A statement that participation
is voluntary, the subject may refuse to participate, and may
discontinue participation at any time without penalty or loss
of benefits to which he/she is otherwise entitled. The
consequences of a subject's decision to withdraw from the
research, if any, and procedures for an orderly termination of
participation by the subject, should be included. Generally,
use of friends, co-workers or clients makes voluntary
participation impossible.
- A statement describing the
extent to which confidentiality of records identifying the
subject will be maintained. If data obtained will be made
available to any person or organization other than the subject,
the investigator, and the investigator's staff, or become part
of a permanent record maintained in the subject's name, the
purposes of the disclosure, and the nature of the information
to be furnished must be described. If audio or video tape
recording, photographs, or movies will be taken, they should be
described. The duration of time they will be retained before
erasure or destruction should be specified. Use of such data
for other purposes, including educational purposes, must be
disclosed and permission obtained in a special portion of the
consent form. Video or audio recording also requires separate
consent in a special portion of the consent form.
- An offer to the subject of a
copy of the consent form.
- Anticipated circumstances
under which the subject's participation maybe terminated by the
investigator without regard to the subject's consent, i.e.,
when in the investigator's opinion, it would be detrimental to
the subject to continue.
- Space for signature and date.
(If applicable there should be a separate signature for
permission to video-tape or audio-tape interviews.)
- Space provided to document
oral or written consent of minors. Parental consent for minors
is required. However, the minor must also consent in writing if
possible. If the child cannot provide wirtten consent, oral
consent is sufficient but must be documented by a witness whose
signature is obtained. Mere failure to object should not be
construed as consent.
- If a subject will receive
compensation or if there is an inducement or reward for
participation, specific information concerning the terms of
disbursement must be clearly described on the consent form,
including consequences of subjects early withdrawal.
- If there is the possibility of
injury as a result of the research, information as to the
medical treatment and compensation available should be
included. (Note: if the research involves any invasive
procedures, a "Health and Biological Sciences" application for
approval form should be completed in lieu of the "Social
Sciences Form."
Tips for completing consent
form:
- Write the form in second
person "You", e.g., "You are invited to participate in a
research project conducted by " Avoid language like "you have
been told…" or "you understand… ." Numerous language
and coercion pitfalls result when using those phrases;
- define or explain research
terms such as "randomization" (like "the flip of a coin"),
"double-blind" ("neither the researcher or the subject will
know");
- quantities for blood drawing
should be listed in lay term equivalents, not milliliters
(teaspoon equivalents);
- headings for paragraphs are
helpful and make the form easier to read;
- typeface should be a
comfortable-readable size; avoid fine print. The form may not
fit on to one page, additional pages are acceptable as long as
they are essential.
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