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I am/I care for a patient with cancer

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. The following is a breakdown of the document elements:

Title and Purpose

Description of Procedures

Duration

Risks

Benefits

Alternatives to Participation

Confidentiality

Costs/Additional Expenses

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

Supplemental Information

Signature