Human Research Protections Office (HRPO)

What is Informed Consent?

As a patient, you deserve the best possible medical care available. You deserve to have healthcare workers treat you with respect, see you as an individual, give you opportunities to talk about treatment options, respect your ability to make decisions about your medical care, realize your right to refuse medical recommendations for your medical care, and give you the same quality of services they give to other patients.

Simply put, informed consent means that a person is given enough information and enough time to make a knowledgeable and clear decision.

Before a person can make an informed decision to become a research study participant they must be:

  1. given clear, relevant, and honest information about the nature of the study
  2. told that the study involves research and the purposes for the research
  3. told about the possible risks, benefits, and alternatives to study participation
  4. told whether any treatments or compensation are available if complications occur during the study
  5. aware of the amount of time and level of involvement or commitment required for study participation
  6. given details about the possible side effects or discomforts involved in the study activities
  7. told what patient health information is used in the study and how this is kept private and confidential
  8. invited to ask questions before giving consent and at any time during the course of the study
  9. allowed enough time, without pressure, to reach a decision about study participation
  10. given a written copy of the consent agreement
  11. told that they have the right to withdraw their consent and to stop participation in the study at any time
  12. given IRB contact information for questions, concerns, or complaints about the research study
  13. advised of the expiration date for the signed consent form and the reasons for this
  14. told of changes to the consent form & provided the opportunity to sign or not sign the revised form

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