Informed Consent, Part 4

by National Cancer Institute

(Page 4 of 5)

What Will I Find in the Informed Consent Document?

In 1998 the National Cancer Institute Working Group on Informed Consent issued recommendations designed to help research institutions and clinical centers write comprehensive, user-friendly informed consent documents. The group also developed a template and sample forms that provide models for covering all of the information that federal regulations require for informed consent documents.

You may wish to print out the template 13 or a sample form 14 and use it as a model of what to look for in the document that you receive.

While informed consent documents do vary from place to place, they should communicate all of the information described below in language that you can understand, with some help from the research team (if needed). Even if your trial is not federally funded and therefore not governed by these regulations, you should know that any scientifically valid trial will provide an informed consent document that supplies such information

The information covered should include:

• TITLE
• PURPOSE [Why is this clinical trial being done?]

In this section, researchers explain why they are conducting the trial. Their reasons will depend on the type of cancer and the trial type (i.e., whether they are investigating new prevention, screening, supportive care, or treatment methods). Researchers conduct treatment trials either because they have not found an effective treatment for a certain type of cancer, or they are not sure which treatment method works best.

In these trials, Phase I tests the safety and effectiveness of a new treatment, or aims to find out what dosage of a new drug can be given safely. Phase II treatment trials evaluate the effects (good and bad) that a treatment may have on people with a certain type of cancer. Phase III treatment trials compare the effectiveness of a new treatment or treatment combination with that of standard treatment. Researchers use prevention, screening, and supportive care trials to evaluate new strategies for preventing cancer, detecting it more accurately and effectively, and alleviating treatment side effects.

• DESCRIPTION OF PROCEDURES [What is involved in the trial?]

This section describes the procedures that you will undergo, how frequently you will have them, and where they will take place (at home, in the hospital or clinical center, or in an outpatient setting). For treatment trials, this section should include:

• procedures that are part of regular cancer care and may be done even if you do not join the trial;
• standard procedures being done because you are in the trial; and
• procedures that are being tested or evaluated by the trial.

If this is a "randomized" trial, then you will be assigned at random (by computer) into one of two or more study groups. People in the different groups will receive different treatments or treatment combinations, so that researchers can evaluate which is most effective. If this is the case, the document should make clear what procedures each group will undergo. It should also indicate what your chances are of being placed in any one group.

• DURATION [How long will I be in the trial?]

This section indicates how long the trial will last and whether it involves followup, and if so, for how long. It also includes information about any circumstances under which the researcher might remove you from the trial (for example, if your condition worsens or new information indicates you shouldn't continue). The document should make clear that you have the right to stop participating at any time, and it should describe any possible medical consequences of sudden withdrawal.

• RISKS [What are the risks of the trial?]

This section includes the foreseeable physical and nonphysical risks of participating in the trial. A nonphysical risk might be time away from work, while physical risks might include side effects such as nausea, vomiting, pain, or susceptibility to infection, among others. The document should indicate the likelihood of these risks occurring, how serious they may be, and whether they are more likely to be short-term (last only during the trial or shortly afterward) or long-term (last weeks, months, or even years after the trial is over). The document should make clear which risks are related to the investigational aspects of the trial. It also should include specific information about reproductive risks (Could participating make you infertile? Should you not get pregnant or father a child while on the trial? Can you nurse a child during the trial?).

• BENEFITS [Are there benefits to taking part?]

The document describes any benefits to you or to others which may reasonably be expected. A trial may or may not involve direct medical benefits to you, but it might lead to new knowledge that can help others in the future.

• ALTERNATIVES TO PARTICIPATION [What are my options if I don't participate?]

For treatment trials, this section describes what care options you have besides participating in the trial, such as other commonly-used therapies or no treatment at all.

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