Reading an Informed Consent Form
Consent documents vary from institution to institution, however
they should contain all the following elements in easy-to-understand language,
based on NCI recommendations. If any of the sections explained below are not
present in a consent document you are reviewing, don’t hesitate to ask for
them. According to federal regulations, no informed consent document may
include language that asks or appears to ask you to waive your legal rights, or
that releases or appears to release the investigator, sponsor, or institution
from liability for negligence.
You are not required to sign the document immediately. You are
entitled to take as much time as needed to read and understand the material.
You can also change your mind after the document has been signed. The following
is a breakdown of the document elements:
These sections give you
the formal name and code number of the trial and describe the reason for it,
such as investigation of new treatments, screening, or supportive care. It also
outlines the study rationale, based on previous research, and tells you which
phase the trial is in.
Description of Procedures
This section describes what will be involved in the trial—the
procedures you will undergo, how frequently they will take place, and where
they will take place. For treatment trials, this should include procedures that
are part of regular cancer care; standard procedures, such as tests or scans,
being done because you are in the trial; and procedures that the trial is
evaluating. If the trial is randomized this section will outline how that
randomization will be done. In some cases, researchers may also ask permission
to use tissue such as tumor, blood, skin, or urine as part of your study or for
This section indicates
how long the trial will last, including any long-term follow up. It also
outlines any circumstances under which you might have to stop participating in
the trial. This section only describes how long you will participate in the
trial, not how long the entire trial will take. Your treatment might last only
a few weeks or months, but a trial could last for years, depending on factors
such as the total number of patients involved, how quickly patients are
recruited to participate, and how long it takes to analyze the results.
This section outlines
both the nonphysical and physical risks of participating in a trial.
Nonphysical risks might include missing work, and physical risks might include
side effects such as nausea, vomiting, pain, or susceptibility to infection.
This section should indicate the likelihood of risks, how serious they might
be, and whether they are more likely to be short-term or long-term. It should
also include information about reproductive risks, such as pregnancy,
infertility, or the ability to nurse a child during the trial.
This section describes
any benefits which may reasonably be expected from the trial. Remember, doctors
cannot guarantee any individual patient that any treatment will improve or cure
them, whether or not it is part of a trial.
Alternatives to Participation
In treatment trials,
this section describes what options you have for treatment other than the
trial, such as a standard treatment or no treatment.
This describes the
extent to which your information will be kept confidential. It should also
inform you about any groups or organizations that might have access to your
records for quality assurance and data analysis. This could include the
National Cancer Institute, the Food and Drug Administration, or other trial
This area of the
document indicates whether participating in the trial will result in added
costs for you or your health insurer. It also outlines who would pay for
emergency treatment in case of injury or illness, and whether or not you will
receive payment for participating.
An informed consent document should
Your participation is voluntary.
You can choose not to take part or leave the trial at any
time without penalty or loss of benefits.
Any new information that might affect your participation
will be shared with you.
You should have a
contact name and information, usually of a member of the research team, if you
have questions about the study. You should also be given contact information
for the Institutional Review Board or a patient representative, if you have
questions about your rights as a research participant.
This lists additional
resources such as NCI’s Cancer Information Service, informational booklets,
community organizations, and Internet resources.
represents your legal consent to participate in the trial.
When you sign the informed consent document, you
should receive a copy. If not, ask for one. You may also request a copy of the
trial protocol, which is a detailed medical document describing the complete
study plan. Also remember that even though you have signed the informed consent
you are able to drop out of the trial at any time.