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Informed Consent and Parental Consent

IRB guidelines for Informed Consent

The purpose of informed consent is to inform research participants about the nature of the research, the procedures involved and the risks and benefits associated with participation.  Informed consent is to be documented by the use of a written consent form approved by the IRB and signed by the participant or participant’s legally authorized representative.

Any research involving human subjects requires informed consent.  

  • For studies that involve minors (<18 years old)
    Parental Consent and Assent forms are required
    Click on the pages “Assent” and “Forms” to view information / form
  • For studies that involve adults (>18 years old)
    Informed Consent form is required
    Click on the page “Forms” to view form

All participants or legally authorized representatives must be given adequate time to read the consent form before it is signed.  A copy of the signed consent form must be given to the participant.  The consent form must be written in lay language at the sixth-grade level.

The following elements are required in the consent document:

  • The title of the study
  • A statement that the study involves research
  • An explanation of the purpose of the study
  • The expected duration of the participant’s participation
  • Where the study will take place
  • A description of the procedures
  • A description of any foreseeable risks or discomforts the participant might experience
  • A description of any benefits to the participant or to others
  • A description of how confidentiality will be maintained
  • A statement that participation is voluntary
  • A statement that refusal to participate will involve no penalty or loss of benefits
  • A statement that the participant may discontinue participation at any time without penalty or loss of benefits
  • Name and contact information of the investigator

Please use standard wording that is provided wherever possible; however, you must adapt the forms as appropriate to your study.