IRB Guidance: Informed Consent

Informed Consent is a federal requirement intended to provide clear and concise information that a reasonable person would want in order to decide whether or not to participate in the research. Information should be written in such a way as to be easily understandable to the participant population included in the research.

Unless the IRB approves a waiver of informed consent, no researcher may involve a human subject in research unless he/she has obtained the informed consent of the participant.

The Consent Process and Documentation

The default consent process is for a researcher to have the participant sign a written document called an Informed Consent Form. However, the IRB has the ability to approve any number of other consent processes—but it is the responsibility of the researcher to provide the IRB with an appropriate justification as to why an alternative to the signed consent form is most appropriate for the study that is being reviewed.

Consent forms must be presented to the IRB in the format in which they will be used. Although not all inclusive, the following are examples of common alternatives to the signed consent form:

Waiver of signed consent (no signature is obtained)

Alteration of the required elements of consent
Waiver of informed consent (no consent is obtained)
When determining the most appropriate method of obtaining informed consent, consider the following: literacy level of participants/reading level of documents, cultural norms, and/or confidentiality concerns.

Documentation of Consent for the Participant

Required Elements of Informed Consent 

Regardless of the format of the consent process, consent documents must include the following Required Elements of Informed Consent:
Consent Form Wizard
  • The majority of modifications requested by the IRB are due to consent form errors. The Consent Form Wizard is a tool for those submitting to the ED/SBS IRB to help ensure all federally required elements of consent are included. Access to this tool can be found at:
NOTES:
  • The Wizard aids in creation of a template consent document that researchers must then proofread and edit to an acceptable format for the intended audience.  Also, the elements of consent outlined in the consent document should mirror what is in the IRB application (e.g., the risks outlined in the consent should be the same as the risks outlined in the application).
  • The Wizard is only recommended for those submitting to the ED/SBS IRB as it does not address some issues common to biomedical research.  For those submitting to the HS or MR IRB, please be sure to use the templates provided on their website instead.
Other Considerations

Assent for minors
  • Any research activity that includes minors as participants must also include an Assent process.
  • Recruitment of minor participants must begin with the parent or guardian.
  • Once parent/guardian consent is obtained, minors may be recruited and provide their own assent.
  • Assent forms should be written at an age-appropriate level.
  • Typically written assent would only be obtained from minors age 11 and older. Those under age 11 would likely provide oral assent.
Non-English speaking participants
  • If the consent document will be presented in a language other than English, translated documents are required to be uploaded to the ARROW application prior to final IRB approval.
Mandated Reporting Language
  • Required for research taking place in private homes and/or where the Study Design indicates that information that might require reporting could be obtained.
Appropriate Use, Retention, and Storage of Consents
  • When written consent is approved by the IRB, the approved consent form will have an approval date stamped on it.
    • NOTE:  This does not apply if the project is determined by the IRB as Exempt
  • Only the most current stamped consent forms should be used; outdated consent forms should not be presented to participants.
  • For consent process(es) other than signed consents, the Study Team should have a process in place for how the researcher(s) will document that each person from whom data was collected provided informed consent through the appropriate approved method.
  • Along with other research data, the complete, signed consent forms must be stored and retained on campus for at least 7 years after the completion of the study. These and/or other documentation that consent was appropriately obtained may be requested for review during an audit process.