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.

Continuing updates

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.