Informed Consent for Cancer Clinical Trials
The Informed Consent Process
Details of the informed consent process vary from institution to
institution, but cancer clinical trial participants should generally expect the following:
An initial meeting with the research team
At this time,
prospective participants receive the informed consent document and
its contents are explained. This meeting could include physicians, nurses,
social workers, patient representatives, and/or a staff psychologist. The
information should be presented to the participant logically and at a
comfortable pace. Remember, the clinical trial research team is there to answer any questions
and address any concerns. Participants may want to bring along a family member
or friend for support and to help take notes. In some cases, the document may
be supplemented with a video, audiotape, or interactive program to aid in
understanding the information.
Time to digest the information
The informed consent
document does not have to be signed right away. If a copy of the document is
not made available, ask for it. Take it home and review it as many times as
needed to completely understand the information before making a decision on
whether to participate.
Assessment of understanding
The clinical trial research team should
take active steps to make sure the potential participant understands the
information. This could be through a written questionnaire, asking questions
verbally, or asking the participant to explain parts of the document in their
own words. If there is anything you do not understand, or if the document is
written in words that are too difficult for you, tell the researchers.
Opportunities to ask questions
Participants always have
the chance to ask questions at every point in the process. Keep asking until
you have all the information you need to make an informed decision.
As the cancer clinical trial continues,
there may be new information that could affect health, welfare, or willingness
to stay in the study. Participants may be asked to sign a new informed consent
document. Remember, participants are always free to leave a study at any time
if new information causes concern about continuing to participate.