What is an informed consent form?

The informed consent form is the document that participants must sign before participating in a clinical research study. The informed consent document should give specific information about the study that you are considering and should contain the following information:

  • The name of the clinical research study and its purpose
  • A statement that the study involves research
  • An idea of how long the study will last
  • A description of procedures that will be performed, and whether any of the procedures are investigational
  • A description of possible risks or discomforts associated with the study
  • A description of any benefits to you or to others, if any, that are reasonably expected
  • A description of possible alternatives, if any, to participation in the study that you should consider
  • A description of the level of confidentiality that will be applied to your private health information and who may have access to your records
  • A description of responsibility for costs or expenses associated with participation in the study, including study-related injuries
  • Contact information for questions concerning the study or a research-related injury (usually the clinical investigator), and questions concerning research participant rights (usually the IRB/REB)
  • A statement that participation in the study is voluntary and that a choice not to participate, or to discontinue participation, will not result in any loss of benefits or penalty to you

Other information may be included in a study’s informed consent form if the clinical investigator, the sponsor, and/or the IRB/REB believes that the information is needed to better inform you and assist you in the decision-making process.

The informed consent form will also have a signature line. When you or your legally authorized representative sign the informed consent form you have legally consented to participate in the study. You will be provided with a copy of the signed informed consent form for your personal records and as a reference tool throughout the study.