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  • 1. Board Member Updates February-March 2007
  • 2. What has changed about the Consent Templates?
    • Main Campus Consent Templates
      • Clear direction and more sample text appropriate for main campus researchers
      • Currently posted on the web for use
    • Biomedical Consent Templates (HIPAA) including VA
      • Held up due to research-related injury language
      • Currently being reviewed by select board members
  • 3. Informed Consent
    • The information provided must include the elements of informed consent as described in DHHS and FDA regulations.
    • The prospective participant must have sufficient opportunity to ask questions and consider whether to participate.
    • Coercion or undue influence must be minimized.
  • 4. Informed Consent
    • No informed consent may include any exculpatory language through which the participant is made to waive or appear to waive legal rights.
    • Information must be in a language understandable to the subject or representative.
  • 5. General Requirements for Informed Consent
    • 1. Research purpose and procedures
      • A statement that the study involves research
      • An explanation of the purposes of the research
      • The expected duration of participation
      • Description of the procedures
      • Identification of any procedures which are experimental
  • 6. General Requirements for Informed Consent
    • 2. Risks and discomforts
    • 3. Potential benefits
    • 4. Alternative procedures or treatments, if any
    • 5. Provisions for confidentiality
      • If the research is subject to FDA regulation, a statement that notes the possibility that the FDA may inspect the records
  • 7. General Requirements for Informed Consent
    • 6. Research related injury
      • For research involving more than minimal risk , an explanation as to whether:
        • any compensation is available if injury occurs
        • any medical treatments are available if injury occurs
        • and if so, what they consist of, or where further information may be obtained
      • The IRB staff and General Counsel developed a new, flexible liability statement.
  • 8. General Requirements for Informed Consent
    • 7. Contacts for additional information
      • Contact information for the research team
        • Questions about the research, research-related injury (or, if the participant feels harmed by the research), and/or concerns or complaints
      • Contact information for the IRB
        • Questions about the research, about research participants' rights, and/or concerns or complaints when the participant wants to talk to someone other than the research team
      • New language is in the Main Campus consent templates but not yet posted for Biomedical.
  • 9. General Requirements for Informed Consent
    • 8. Voluntary participation and the right to discontinue participation without penalty
      • New language is in the Main Campus consent templates but not yet posted for Biomedical.
  • 10. Additional Elements of Informed Consent
    • When appropriate, the additional elements of informed consent should be provided in the consent.
    • Generally, the additional elements of informed consent will not be required for studies which are no more than minimal risk. The additional elements of informed consent are not included in the Main Campus consent templates with the exception of “additional costs”.
  • 11. Additional Elements of Informed Consent
    • 1. Unforeseeable risks
    • 2. Termination of participation by the investigator
    • 3. Additional Costs
    • 4. Consequences of discontinuing research participation
    • 5. Notification of significant new findings
    • 6. Approximate number of subjects
  • 12. What about other University of Utah or VA requirements?
    • Templates outline specific requirements (e.g. name of PI and title of study on each page).
    • The IRB may approve a consent without template requirements. Any change to the standard template language must be approved by the IRB at the time of review.
  • 13. Guidelines for Reviewing the Consent Document
    • Resist the urge to make unimportant changes to the consent document: When considering a change in the consent document, ask yourself “Is this change likely to have an important impact on the protection of research subjects?” If the answer is no, don’t make the change.
    • “ IRB Board Member Handbook” by Robert Amdur