Informed Consent

Informed consent is the exchange of information between the researcher and a human subject to educate them so the person can make an informed decision whether or not to volunteer for the study.

It is considered best practice to provide potential subjects with written information explaining the purpose of the study and that it is considered research, or is part of a larger project. Providing a verbal description, or another format, is acceptable when prior approval from the IRB has been received. Below is a list of additional points to include, as applicable to your study, to assist subjects with their decision to participate:

  • Risks, side effects, or discomforts that might be reasonably expected
  • Benefits that might be reasonably expected
  • Duration of the study and a description of what the subject can expect
  • The procedures, drugs, or devices to be used and if, or how, they will be different that standard medical treatment.
  • Appropriate alternative treatments that might be advantageous
  • Available treatments or compensation, if complications occur during the study
  • Risks to privacy and confidentiality
  • Contact information for the IRB

Be sure to allow for ample time for the potential subjects to ask questions before giving consent, and reassure them that questions are allowed at any time throughout the course of the study. This will help them with their decision whether or not to participate in your study.