Institutional Review Board

Informed Consent Checklist

The following information must be explained to each potential subject:

  1. Purposes of the research and expected duration of the subject's participation
  2. Procedures to be followed and whether or not they are considered experimental
  3. Any reasonably foreseeable risks or discomforts to the subject
  4. Any reasonably expected benefits to the subject or others as a result of the research
  5. Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
  6. The extent, if any, to which confidentiality of records identifying the subject will be maintained
  7. Terms and nature of compensation, if any (monetary or otherwise)
  8. Medical treatments available, if any, should injury occur as well as how to obtain further information about the treatments and whom to contact in the event of a research-related injury
  9. Where/how overall and/or individual research results will be made available
  10. Suggested additional resources related to the research topic, if any, that may be of interest to the subject
  11. Whom to contact for answers to pertinent questions about the research and subjects' rights and how to contact them (typically, you as the researcher; a student must also include contact information for an advisor)
  12. Participation is voluntary, refusing to participate or discontinuing participation will involve no penalty or loss of benefits to which the subject is otherwise entitled

When appropriate, the following should be explained as well:

  1. A particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable
  2. Circumstances under which the subject's participation may be terminated by the investigator
  3. Any additional costs to the subject that may result from participation in the research
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
  5. Significant new findings developed during the course of the research which may relate to the subjects willingness to continue participation will be provided to the subject
  6. The approximate number of subjects involved in the study