HRP Spring Update: Tips on Informed Consent

HRP Spring Update: Tips on Informed Consent

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Keep in mind the following when considering the research informed consent process at UCI:

  1. Use the latest UCI Institutional Review Board (IRB) and Single IRB (sIRB) Consent templates.
    • Effective April 1, 2022: Use of the most recent consent templates will be required for all new studies submitted on or after April 1, 2022.
    • Templates are regularly updated to accommodate changes in Federal, State, or Institutional policy.
    • Templates are housed on the HRP Forms page.
  2. Ensure that the attachments are part of a complete Consent packet.
    • Find your UCI IRB approved documents in the attachments section of Kuali Research Protocols (KRP).
    • As a courtesy, the UCI IRB will attach the requisite California Bill of Rights and Research HIPAA Form to the UCI IRB approved Consent Form.
    • For sIRB, the California Bill of Rights and HIPAA Form are released as one combined stamped approved document by the IRB of Record.
    • Tip: Double check each time a Consent packet is prepared for a prospective subject. Are all documents attached?
    • California Bill of Rights: California State Statutes are referenced on the HRP page.
    • Research HIPAA: Learn more about research HIPAA here.
  3. Plan for the Consent Process.
    • Consent requirements are specified on both the UCI IRB and sIRB approval letter/s.
    • for the Consent Process. Use these resources as a guide:
      • Review the HRP page on this topic.
      • See what the Feds have to say.
      • If prospective participants include, for example, persons whose primary language is not English, those with low literacy levels, or participants unable to speak, read or write due to physical limitations, researchers should take special care to ensure that both oral presentations and consent forms are comprehensible to all subjects. (Remember, the inclusion of non-English speakers must be prospectively approved by the IRB with the necessary consent determinations made.)
      • You can learn more about consenting these populations on the HRP pages here.

Any questions or comments on the research consent process for either the UCI IRB or sIRB? Please feel free to reach out to HRP Staff.

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