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Informed Consent

To help you understand informed consent and how to make an informed consent form, the following information is found here:

  • When informed consent can be waived
  • Federal Requirements for informed consent
  • Additional Liberty University requirements
  • IRB preferences in informed consent design
  • Informed Consent Template

Can Informed Consent Be Waived?

Requests to waive some or all of the informed consent elements must address each of the criteria below. Anonymous questionnaires/surveys and research using secondary data sometimes qualify for this waiver (See below). Research designs involving deception may involve partial informed consent and debriefing (See Consent Instructions for further information on informed consent aspects for those designs).

Federal regulations require that no investigator may involve a human being as a subject in research unless legally effective informed consent has been obtained (45 CFR 46.116). An IRB may waive the requirement to obtain a signed informed consent document provided the IRB finds and documents that:

  • the 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;
  • the research could not effectively and practicably be carried out without the waiver or alteration; and
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Thus, minimal risk, safeguarding the rights/welfare of the participants, practicality, and the presence of debriefing or supplying of relevant information following participation improve the likelihood that informed consent can be waived. Anonymous questionnaires/surveys and studies using secondary data sometimes meet these waiver guidelines.

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. Signed informed consent is required, however, when (1) coding of collected data (demographic or otherwise) will be insufficient to insure specific participant anonymity, and (2) the collected information could be damaging to the subject.

Secondary Data: 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 to the Committee in the application.

Deception-related Research Designs: See Deception Research for further information on informed consent aspects for those designs.

Minors: For noneducational research, studies involving minors (under 18 years old) typically require parental consent as well as the child’s assent. Thus, two informed consent forms may need to be created 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.

Federal Requirements for Informed Consent

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 Liberty University Requirements

  1. The statement "This study is being conducted by researchers from “Liberty University” 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 "Liberty University” 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 in Informed Consent Design Standard Language: Standard language and style guidelines are important for consent forms. The consent template includes 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 font 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 checks 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 a sixth-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.

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 Studies Using Video, Digital Media or Web Material: Projects that involve the use of video, digital media, or web material in their design should provide the IRB with copies (or URLs) for review and approval along with their application materials. Examples: 1) A researcher wants to show subjects a video and analyze their responses to the video through completion of a survey. The video should be included in IRB materials for review by the committee. 2) A researcher has developed a survey on a website for participants. The URL must be supplied to the IRB committee for review. 3) A researcher wants to show photographs to subjects and measure their physiological responses to these. The photographs must be supplied to the IRB along with other submitted IRB materials.