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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 to expect25.
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 participate.

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, visit Protecting 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.