Elements of Informed Consent
General Requirements:
Informed consent documents should be written using language at the reading level and technical level of the participant. The general rule is to write consent documents at the 8th grade reading level. To view examples of informed consent documents written at various grade levels, please see the following: Readability Standards for Informed Consent Documents: (see attached from New England Journal of Medicine) http://content.nejm.org/cgi/content/full/348/8/721/T1
No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. (46.116)
Correct all grammatical and typographical errors.
NOTE: add one inch of space for insertion of the stamped expiration date of the research protocol (provided by the IRB when the project is approved), near the participant signature line. (UIUC Policy)
Who, What, Why, Where, When
Consent forms must be presented on letterhead or must state in the first paragraph that the project is being conducted by faculty of the University of Illinois. (UIUC Policy)
Specify who is conducting the research and their affiliation with UIUC. *NOTE: For research conducted by students, the RPI must be a UIUC faculty member. (UIUC Policy)
A statement that the study involves research [46.116(a)(1)]
An explanation of the purposes of the research [46.116(a)(1)]
A description of the procedures to be followed including duration, location, and number of sessions. [46.116(a)(1)]
Identification of any procedures that are experimental. [46.11 (a)(1)]
When appropriate, any additional costs to the subject that may result from participation in the research; [46.116(b)(3)]
When appropriate, the approximate number of subjects involved in the study. (particularly if the numbers are low and there are confidentiality concerns) [46.116(b)(6)]
Voluntariness
A statement that participation is voluntary [46.116(a)(8)]
A statement indicating that the subject may refuse to participate or may discontinue participation at any time during the project without penalty or loss of benefits to which the subject is otherwise entitled. [46.116(a)(8)]
Include a statement that "the decision to participate, decline, or withdraw from participation will have no effect on the subject's grades at, status at, or future relations with the University of Illinois." (UIUC Policy)
When appropriate, anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; [46.116(b)(2)]
When appropriate, the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; [46.116(b)(4)]
Risks and Benefits
A description of any reasonably foreseeable risks or discomforts [46.116(a)(2)]
A description of possible benefits to the subject, which may reasonably be expected from the research, or a statement that individual subjects may not benefit from participation, but that there may be benefits to general knowledge or to society [46.116(a)(3)]
If research involves treatment, disclose any appropriate alternative procedures or courses of treatment that might be advantageous. [46.116(a)(4)]
An explanation of any compensation and, if appropriate, procedures to prorate compensation for subjects who withdraw prior to completion of the study (UIUC Policy)
The UIUC liability statement: "The University of Illinois does not provide medical or hospitalization insurance coverage for participants in this research study nor will the University of Illinois provide compensation for any injury sustained as a result of participation in this research study, except as required by law." (UIUC Policy)
When appropriate, a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable [46.116(b)(1)]
When appropriate, 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 [46.116(b)(6)]
Confidentiality
Describe the extent, if any, to which confidentiality of records will be maintained. If you cannot assure privacy or confidentiality, state that in this document. [46.116(a)(5)]
State where, how, and to whom, results will be disseminated. (UIUC Policy)
Whom to Contact
The name(s), title(s), and contact information (phone and e-mail) of the person(s) to contact for answers to questions about the research or to voice a concern or complaint, and the name, title, and contact information of the responsible project investigator, if different. [46.116(a)(7)]
Add the following IRB contact statement, "If you have any questions about your rights as a participant in this study, please contact the University of Illinois" Institutional Review Board at 217-333-2670 (collect calls accepted if you identify yourself as a research participant) or via email at irb@illinois.edu. [46.116(a)(7)]
The name, title, and telephone number of the person to contact in the event of a research-related injury. [46.116(a)(7)]
Near the Signature Line
A statement that subjects will be given a copy of the consent form (UIUC Policy)
Include a statement such as "I have read and understand the above consent form and voluntarily agree to participate in this study" (UIUC Policy)
When appropriate, include a statement that "I am 18 years of age or older." (UIUC Policy)
An area to mark 'yes' or 'no' to being audio-taped, videotaped, or photographed (if such recording is optional and hasn't already been specified as a requirement for participation). (UIUC Policy)
For Research Involving More than Minimal Risk:
An explanation as to whether any compensation is available if injury occurs. [46.116(a)(6)]
An explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. [46.116(a)(6)]
Statement that "The University does not provide compensation for any injury sustained as a result of participation in a research study, except as required by law." (UIUC Policy)