Informed Consent

Overview

Informed consent is one of the most important documents involved in the research process. This document tells your participants what they can expect by taking part in your research study. The IRB provides the following instructions and templates:


What to Include

The informed consent document must, at a minimum, include the following information:

  • A statement that the study involves research, explaining:
    • Purpose
    • Duration of participation
    • Procedures
    • Experimental conditions
  • Any expected risks or discomforts
  • Benefits
  • Alternative procedures or treatments
  • Confidentiality
  • Compensation
  • Medical treatments available
  • Researcher and IRB contact information
  • A statement that participation is voluntary:
    • Refusal to participate will involve no penalty or decrease in benefits
    • Subjects may discontinue participation at any time without penalty or loss of benefits

If applicable, the informed consent form must also include:

  • A statement that the treatment or procedure may involve risks to the subject which are currently unforeseeable
  • Circumstances under which participation may be terminated without regard to the subject's consent
  • Any additional costs to the subject
  • The consequences of a subject's decision to withdraw from the research
    • Including procedures for orderly termination of participation by the subject
  • A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject
  • The approximate number of subjects involved in the study

Waiving Informed Consent

An IRB may waive the requirement to obtain a signed informed consent document provided the IRB finds and documents that:

  • Research involves no more than minimal risk to the subjects
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects
  • Research could not effectively and practicably be carried out without the waiver or alteration
  • Subjects will be provided with additional pertinent information after participation.

Anonymous Questionnaires and Surveys

Anonymous questionnaires and surveys, where the only link to the subject would be the signed consent form, allow for written consent to be waived because the subject is better protected without the existence of a signed document. More information can be found on the survey research page:

Signed informed consent is required, however, when:

  • Coding of collected data (demographic or otherwise) will be insufficient to insure specific participant anonymity
  • Collected information could be damaging to the subject

Secondary (Archival) Data Research

If an investigator receives secondary data about human subjects or biological samples from human subjects where no possible personal identifiers are transferred to the researcher, written consent may be waived. The source of the data, however, must be disclosed in the application. More information can be found on the archival data research page:

Deception Research

The ability to waive certain elements of the informed consent document may be important for certain studies. However, this involves the use of deception, and requires that certain criteria be met. More information can be found on the deception research page:


Obtaining Consent of a Minor

For noneducational research, studies involving minors (under 18 years old) typically require parental consent as well as the child’s assent. For more information, review the minors in research policy:

Two informed consent forms may be required depending on the age of the child(ren). The assent for children must be explained in a manner that is understandable for their age and developmental level.

The IRB provides the following templates:


Stamped Consent Documents

Once your study has been approved, your consent document will be stamped, saved as a PDF, and returned to you by email along with your approval letter.

Using a stamped consent document assures potential participants that your study has been reviewed and approved by the IRB.