What is informed consent?

Informed consent is a process of learning and understanding key facts about a clinical trial before you decide to participate. Participation in a clinical trial is voluntary––it is up to you to decide if you want to take part. Informed consent is documented by means of a written, signed and dated consent form.

The consent form answers the following questions:

  • Who is conducting the study?
  • Who is sponsoring or paying for the study?
  • Why is the research study being done?
  • What is the usual treatment?
  • What will happen during the study?
  • How many other people will take part?
  • How long is the study?
  • What is the time commitment of participants?
  • What types of therapies, procedures or tests are involved?
  • What are the risks or benefits to you?
  • Can participation in the study end early?
  • Will it cost you anything? Will you get reimbursed for out-of-pocket expenses?
  • What other treatments are available? What other choices do you have?
  • What are the rights of research participants?

Read the consent form carefully and ask any questions you may have. You may take as much time as you wish to decide whether to participate. It is also a good idea to take the consent form home and discuss it with family, friends or your family doctor.

Ask the research team to clarify anything that you do not understand or would like to know more about. Make sure that all of your questions are answered to your satisfaction before deciding whether to participate in a research study.

If English is not your first language, then you may ask if the consent form is available in languages other than English, or if there is a translator available to help you.

You will receive a copy of the signed informed consent form for your records. Remember that signing the consent form is not the end of the informed consent process. Informed consent is an ongoing process that continues for as long as you are in the study. You have the right to be told about any new information that might affect your willingness to continue to participate in the study as soon as the information becomes available to the research team. You also have the right to ask questions and receive answers throughout the study.

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