Informed Consent is a process in which researchers provide information to participants regarding the details of a research study prior to their enrollment in the study. Topics covered during this process include: the purpose of the study, the procedures involved, how their privacy will be protected, as well as information about any risks, benefits, or compensation. Consent forms document that the informed consent process took place. A signed consent form is certification that the participant agrees to participate in the study.
Unless the IRB has determined that a study meets federal and ethical requirements for a waiver of informed consent, no investigator may involve a human being as a subject in research without obtaining consent of the subject.
The following basic elements are required (per federal regulations) for all informed consent forms:
- 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 procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research. If none, so state.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- For research involving more than minimal risk, statement as to whether there is any compensation and whether medical treatments are available if injury occurs. If so, specify the extent and nature of the compensation and treatment.
- 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.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of 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.
To assist investigators in creating consent forms, the IRB has prepared an Informed Consent Template that addresses the elements discussed above.
Additional Informed Consent Template Information
The template is divided up into distinct sections. Each section contains information about what is required for that section, as well as suggested and/or required wording. Instructions are italicized and presented in brackets. Instructions should be deleted after they have been read and followed.
It is the responsibility of the PI to submit complete and well-written informed consents, not the responsibility of the IRB to correct grammar. Therefore, poorly written informed consents will be returned to the PI for revision and the study deferred.
Information presented in the informed consent form must be in a language understandable to the subject. The IRB has set a reading level standard equivalent to that of a layperson with no college degree for all consent forms. Medical terminology and academic jargon should be avoided or explained parenthetically.
- Leave a 1.5 inch space on the bottom of each page to accommodate the IRB approval stamp.
- The font size used for the consent form should be at least 12 point. For some populations (e.g. elderly or individuals with visual deficits) it may be appropriate to user a larger font size.
- The date the consent form has been written (or revised) must be indicated in the footer of the consent form to allow both the investigator and the IRB to easily identify the current consent form.
- Longer more complex Informed Consents should have a footer for subjects to initial (see template).
Consent forms contain standardized language to ensure mandatory elements of the consent process are included. For research studies that involve certain methods and practices, additional standardized language is required. It is the responsibility of the researcher to determine if their research study involves any of the methods or practices that require additional language on the consent form and to include it.
You may find practices and methods that require additional standardized language in the consent form (please see additional consent templates in the forms section). Please be sure to include such language as you develop the informed consent form for your particular research project. Please contact us if you have questions regarding the consent process or any other aspect of research with human subjects.