Informed Consent Checklist


 Download the Informed Consent Reviewer Checklist here.

 

Basic Elements

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A statement that the study involves research.

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An explanation of the purpose of the research.

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A description of the procedures to be followed.

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The expected time required to participate in the study.

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A description of any foreseeable risks or discomforts.

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A description of the benefits to the subjects or others that may result from the research, if any.

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A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and reported.

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An explanation that participation is voluntary and that the subject may discontinue at any time.

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An explanation about what will be done with information already collected if subjects decide to discontinue participation.

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Terms of incentives and conditions under which subjects will receive partial or no incentives (if applicable).

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An explanation of whom to contact with questions about the research.  Include:

  • Principle Investigator name and contact information
  • UTC IRB contact information
  • Local contact, if applicable.
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A statement that the research project has been approved by the UTC IRB. 

Additional Elements, as Applicable

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A statement that the subject must be 18 or older to participate (if no child assent is obtained.)

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Identification of procedures that are experimental, rather than providing standard treatment.  A description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.

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For research involving more than minimal risk, an explanation about whether any compensation is offered and/or whether medical treatments are available if injury occurs, and where further information may be obtained.

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For research involving more than minimal risk, an explanation of whom to contact in the event of research-related injury.