Waiver of Documentation of Consent

Investigator’s Name:

Project #

Study Title:

  1. I would like to ask you to participate in a study that involves research.
  2. Participation is voluntary and your decision not to participate will not involve any penalty or loss of benefits [include if medical study: “and will in no way affect the medical care you receive”].
  3. For this study, [provide description of what is involved. This is detailed information on what is involved in the study (procedures, tests, drugs, surveys, interviews, etc.) and the timeline of all study events. If surveys are used, provide description of survey content and length of time needed to complete surveys.]
  4. The purpose of our study is to [provide nature and purpose of why the study in being conducted.]
  5. We are asking approximately [insert number] subjects to participate in this study.
  6. The study staff may withdraw you from the study at any time after explaining to you the reason for withdrawal.
  7. While on the study, you are at risk for [provide list of risks or discomforts from participation]. You should discuss these with the investigator [if medical study, add: “and/or your doctor”].
  8. If you agree to take part in this study, [describe benefit(s) of participation, or state there are no benefits of participation]. You may expect to benefit from taking part in this research to the extent that you are contributing to medical knowledge. [Include if a treatment study: “There is no guarantee that taking part in this research will result in any improvement in your condition.”]
  9. [Provide a description of appropriate alternative procedures and courses of treatment, if any, which might be advantageous to the participant.]
  10. If you choose to participate, [describe procedures on how study data will be kept confidential.]
  11. [Provide a list of costs and/or potential costs to subjects. This can be a statement whether the participant will be charged for any tests, procedures, medications or devices used in the research. ]
  12. There is [List the amount of compensation given, or state “no compensation”] given to you for participation in this study.
  13. It is not the policy of the University of Missouri to compensate clinical research subjects in the event the research results in injury. The University of Missouri, in fulfilling its public responsibility, provides medical, professional, and general liability insurance coverage for any injury in the event such injury is caused by the negligence of the University of Missouri, its faculty or staff. The University of Missouri also will provide facilities and medical attention to subjects who suffer injuries while participating in research projects at the University of Missouri.
  14. If you have any questions regarding your rights as a participant in this research and/or concerns about the study, or if you feel under any pressure to enroll or to continue to participate in this study, you may contact the University of Missouri Health Sciences Institutional Review Board (which is a group of people who review the research studies to protect participants’ rights) at (573) 882-3181.
  15. If you have any problems or questions, you many contact [Provide name of Principal Investigator or Study Contact] at [555-555-5555].
  16. I would be happy to answer any questions that you may have.
  17. A copy of this script will be given to you to keep (if applicable, waiver of documentation of consent is discouraged when written consent may occur)

HS IRB

Waiver of Documentation of Consent