Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as research subjects. It is a fundamental mechanism to ensure respect for persons. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. The process of obtaining informed consent must comply with the requirements of federal regulation 45 CFR 46.116.
Additional Topics Related to Informed Consent
- Required Elements of Informed Consent
The regulations at 45 CFR 46.116 details basic elements of consent that should be provided to each subject involved in a research study. Get details.
- Parent Permission and Child Assent
- When a minor child is involved as a subject in a research study, parent permission and then child assent must be obtained. Requirements for parent permission and child assent can be found in the regulations at 45 CFR 46 Subpart D. Sample forms may be found on the forms page. Additional information is available under the “Children and Youth” section of Special Topics.
- Waiver or Alteration of Informed Consent
- According to 45 CFR 46.116, the IRB has the latitude to approve a consent procedure that alters or waives some or all of the elements of consent, provided the IRB finds and documents certain criteria. In addition, according to 45 CFR 46.117, the IRB may waive the signature requirement on an informed consent document if it fits certain criteria outlined. This does not waive the consent process itself, but the requirement for a signature on the document. This is typically used for survey research conducted via the internet or with research involving secondary data.
- Alternative to Informed Consent for Exempt Research
- For research studies deemed exempt, the ORI-HS has developed an “Information Sheet for Exempt Research Study” template to assist researchers while informing participants involved in exempt research. This document includes many of the elements of informed consent required by the regulations for non-exempt research but does not require a signature on the document itself. The researcher would simply review the information sheet with the participant and give them a copy of the document.
- Consent Form Retention Requirements
- Consent forms must be kept for a period of three years beyond the end of the project. They should be kept on campus in a locked file drawer to be readily available during this time. Under no circumstances should a consent form be kept in the investigator’s home.
- Video/Audio Taping
- If a subject is to be video/audio taped, a separate consent signature is needed. Additionally, an additional signature is required to give permission if the tapes will be used for diagnostic purposes, teacher education, and/or presentation to professional meetings.
- Exculpatory Language in Informed Consent
According to 45 CFR 46.116, informed consent, whether oral or written, may not include any exculpatory language through which the subject is asked to waive or appear to waive any of the his or her legal rights, or to release or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
- Examples of Exculpatory Language (which is not acceptable): “I waive any possibility of compensation for injuries that I may receive as a result of participation in this research” or “I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. government and hereby relinquish all right, title, and interest to said items.”
- Examples of Acceptable Language: “Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur” or “By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.”
- Non-English Speaking Subject information
- Federal regulations require that informed consent information be presented “in language understandable to the subject” and that the process be documented by the written signature of the subject. Therefore, informed consent documents must be translated into the subject’s language and submitted for IRB review. Alternatively, the regulations allow for the use of a short form document that is signed by the subject, along with an oral presentation of the informed consent information, and a written summary of what is presented orally. For additional guidance on these procedures, please contact the ORI-Human Subjects at 702-895-2794 or via email at [email protected].