Explanation of the Research
Investigators (or IRB approved designees) must use the following steps in order to orient the potential subject to the purpose of the research and why they might wish to participate:
- Step One: The Investigator (or IRB approved designee) must explain the study to the potential subject verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation, etc.), and must allow the potential subject ample opportunity to ask questions.
- Step Two: Following this verbal explanation, the potential subject should be provided with a written consent form and afforded sufficient time to consider whether or not to participate in the research. "Sufficient time" can range from hours to days, depending on how long it reasonably takes to evaluate the procedures, risks, potential benefits, and alternative treatments.
- Step Three: After allowing the potential subject time to read the consent form, an Investigator listed on the consent form should meet with the potential subject and answer any additional questions s/he may have.
Subject Comprehension Assessment
The responsibility of ensuring that a potential subject understands the research and the risks and benefits involved falls upon the Investigator and not upon the potential subject.
- It is critical to the consent process that the Investigator not only field questions but also asks questions.
- Asking questions can further the discussion, elicit questions from the potential subject, prompt the potential subject to think more carefully about the study, and help the Investigator decide whether the person has adequately understood the study.
- Useful questions will be open-ended and non-directive. Rather than asking for yes or no answers, they ask for explanation because these questions often can be answered in a variety of ways, and do not already contain the correct answer.
- Open-ended questions are often introduced with "what," "where," "how often," "when," and "please describe."
Examples of open-ended questions are:
- "Just so that I'm sure you understand what is expected of you, would you please explain to me what you think we're asking you to do?"
- "Describe in your own words the purpose of the study."
- "What more would you like to know?"
- "What is the possible benefit to you of participating in this study? What are the possible risks?"
- "Can you describe what the alternatives to participation in this study are?”
Important Informed Consent Process Reminders:
- Do not use an unapproved consent form.
- Do not use an expired consent form. Confirm the approval and expiration date is within the IRB approval period.
- Changes will be made to the informed consent document during the course of the study. It is the Researcher's responsibility to ensure that the individual signs the latest version of the consent document.
- Do not verbally interpret the English version of the consent form into other languages. Investigators must use an IRB-approved, translated consent form. Subjects cannot waive their right to receive a translated informed consent document.
- Make sure to provide the subject with the Subject’s Bill of Rights (required for studies involving medical experimentation as defined by State law; all clinical investigations).