What must be included on a consent form?

• Federal Requirements
• University Requirements
• IRB Preferences

Federal Requirements

Every consent form must include these essential elements of informed consent as described in federal regulations:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research?related injury to the subject; and
8. A statement that participation is voluntary, refusal to participate will involve no penalty or decrease in benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Regulations further provide that the following additional information be provided to subjects, where appropriate:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to an embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. 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; and
6. The approximate number of subjects involved in the study.

Additional University of Minnesota Requirements

1. The statement "This study is being conducted by researchers from the University of Minnesota" should appear on the front of the consent form, with the name of the campus or clinic included. The department should also be identified.
2. The form should not say that the study is "sponsored" or "endorsed" by the University. The group conducting the study can be identified in the text of the document, but not at the very top of a consent form, and the identification should not advertise the group.
3. If the project is conducted by faculty or staff, the first page of the consent form should be printed on departmental letterhead, and the Principal Investigator should be identified by name on the first page.
4. For student projects, the words "University of Minnesota" should appear in the header on the first page, and advisers' names and phone numbers should be given with the student's name and contact information.

IRB Preferences

Standard Language

The University of Minnesota IRB has established standard language and style guidelines for consent forms. The sample consent forms include the standard language preferred by the IRB.

Typeface Preferences

The IRB prefers that all documents be printed in an appropriate typeface no smaller than 12 point type to assure readability. If the study population is known to have difficulty handling small print, reasonable accommodations should be made in the formatting of the consent documents.

Title Page of Consent Form

The title of the study should appear on the first page of the consent form. The title should be listed as it is in IRB files unless there is a compelling reason to shorten or change the title and the IRB has approved the change.

Page Numbering

Following the title page of the consent form, each subsequent page should be numbered so that pages appear in a logical order and missing pages are readily noted, e.g., "page 2 of 4."

IRB Code Numbers

After a study is approved, the IRB code number pertaining to the study should be added to the bottom of the consent form.

Expiration Dates

After a study is approved, the words, "IRB Expiration Date ____" and the expiration date assigned to a study at initial or continuing review should be added. This could appear at the end of the form below the signature lines. Forms that have expired should not be used. Periodic check on the current status of consent forms may occur as part of continuing review mandates from the federal regulators.

Readability

Researchers are encouraged to use simple declarative sentences in their consent forms. The IRB strives for an eighth-grade reading level in sample forms and encourages researchers to use available software packages to check their "readability" scores and make changes and define terms as necessary to achieve a reasonable readability score. Also, check the Common Language Dictionary for help.

For Complicated Study Designs

In many instances, a study involves numerous visits and complicated tracking based on eligibility at different times during the study period.
A flow chart or calendar-like diagram may be useful to subjects as an attachment to the consent form. The IRB encourages the use of these tools to enhance understanding by research subjects.

For Video, Digital Media or Web material

Provide the IRB with copies of final videos, cd copies of digital media, or URLs for review and approval. See IRB Advertising Guidelines

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