To help you understand informed consent and how to make an informed consent form, the following information is found here:
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:
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:
Regulations further provide that the following additional information be provided to subjects, where appropriate:
Additional Liberty University Requirements
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.