Understanding Your Rights
While there is much to be gained by participating in a study,
there are some potential risks as well. Side effects from
the medication may occur, and there are no guarantees that
treatment will work or be as effective as the standard treatment.
To read more about the pros and cons of clinical trials, visit
Luckily, there are safeguards in place to protect your rights
and ensure your safety. Your treatments will be carefully
monitored by healthcare professionals who specialize in cancer
care. Clinical trials are also monitored by a health care
team, as well as by government health authorities and a medical
ethics group. All clinical trials are evaluated by review
boards, which includes medical professionals, ethicists, members
of the community, and patient advocates. Review boards protect
the rights of clinical trial participants. An Institutional
Review Board (IRB) or Institutional Ethics Committee (IEC)
approves all clinical trials, makes sure they are scientifically
sound and that each participant has an understanding of what
There are safeguards in place to protect
your rights and ensure your safety. Your well-being
is the most important consideration.
There are a few key points to keep in mind throughout the
trial. First and foremost, your participation is voluntary.
You do not have to participate and you may withdraw from
the study at any time.
Second, if you have a bad reaction to a treatment that threatens
your safety or health, you will be removed from the trial.
Your well-being is the most important consideration. The medical
team will closely monitor your response to treatment from
start to finish.
Finally, you have the right to an informed
consent. By law, you must be given all of the facts about
a study, including details about the treatments and tests
you may receive and their risks and benefits26.
You will be asked to sign a consent form at the beginning
of your participation and, if new findings develop during
the trial, you will be asked to sign a new or revised consent
form. Informed consent is an ongoing process throughout the
study. The consent form may be intimidating because it tends
to list the risks more than the proposed benefits. Take the
form home and show your loved ones. This is an important decision
and you want to make sure you understand what is happening
from beginning to end. Do not hesitate to ask your treatment
team questions about the trial. Remember that signing a consent
form does not bind you to the study. Even after signing the
form, you may change your mind and withdraw at any time.
Informed consent is the process of learning key facts about
a clinical trial and the purpose of it before you decide to
These facts include:
Why the research is being done
What the researchers want to accomplish
Who sponsors the trial
What will be done during the trial and for how long
What risks are involved in the trial
What benefits can be expected from the trial
What other treatments are available27
For more information about your rights and how you are protected,
Participants in Clinical Trials, on the National Cancer
Institute's Web site which features a guide to understanding
informed consent and the ways participants are protected before
and during a study.