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Informed Consent

Overview and guidelines

  • Informed consent is process of ensuring that subjects understand the research and voluntarily decide to participate. As part of this process, participants learn about study procedures, risks, benefits, and their rights.
  • Individuals sign an informed consent document to authorize their agreement to participate in a study.
  • Researchers should refer to the IRB forms page for examples of consent and assent form templates.
  • Federal regulations require that there are some elements that must be included in consent forms. Researchers whose studies are subject to FDA regulations should also refer to FDA guidance.
  • The information in the consent form should match the application.
  • The form should be written in language that is understandable to the subjects.
  • If the consent form will be administered in a language other than English, the IRB will want to see a copy of the form in English as well as in that language as well as a Translation Certification Form .
  • If the subject is being asked consent to various options (researchers accessing records, future use of tissue samples, being videotaped, audiotaped, etc) there should be one signature for overall consent for the study and separate signatures authorizing permission for each of the options.

Resources

 

A Guide to Understanding Informed Consent (NCI)

A Guide to Informed Consent (FDA)

Informed Consent Checklist (OHRP)

Frequently Asked Questions about informed Consent (OHRP)

Research Involving Individuals with Questionable Capacity to Consent (NIH)

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