Informed Consent

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.

Title

• Formal name
• Code number

Purpose

• Phase of trial
• Reason for trial (new treatment, screening, supportive care)
• Study rationale

Description of Procedures

• Types of procedures involved (tests, scans)
• Frequency of procedures
• Where conducted
• How randomization will be conducted

Title Purpose

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 future research.

Duration

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.

Risks

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.

Benefits

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.

Confidentiality

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 sponsor.

Costs/Additional Expenses

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.

Participants’ Rights

An informed consent document should specify that:

• 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.

Contact Information

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.

Supplemental Information

This lists additional resources such as NCI’s Cancer Information Service, informational booklets, community organizations, and Internet resources.

Signature

Your signature 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.

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