Informed Consent and the Principle of Autonomy
Obtaining and documenting informed consent is an important process for protection of human subjects in research. The purpose of obtaining informed consent is to recognize and affirm the ethical principle of individual autonomy of human subjects in research. The informed consent process must be designed to ensure that individuals voluntarily agree to participate in research, understand the procedures and risks of research, and can voluntarily withdraw. On this page we provide several templates and guidance documents for designing consent materials for research projects that require IRB review and those which are exempt from IRB review.
Exempt Research Consent, Parental Permission and Assent Templates
Although the Office of Research Protections does not review consent, assent, or parental permission materials as part of making the determination that research is exempt from the requirement of IRB review, the principal of autonomy—and thus the importance of obtaining consent—applies to exempt research. In our Consent Guidance section below, the “Procedure and Risk Language” document provides language for several procedures that are frequently part of exempt research, such the use of SONA and mTurk for recruitment, interviews, focus groups, and so on.
If your research is exempt, there is the expectation that you will provide the following information to participants: 1) the purpose of the research; 2) an explanation of the procedures of the study; 3) details of any foreseeable risks, benefits, and compensation; 4) an explanation that participant is voluntary and there is no penalty or loss of benefits if a subject refuses to participate or decides to discontinue participation, and 5) contact information for the Principal Investigator (PI), and Faculty Advisor (FA), if the PI is a student.
Researchers conducting exempt research may consider using the Exempt Consent Template below, which incorporates the above elements. If your exempt research involves children, this form can be edited to be used as a parental permission form by replacing “you” with “your child” throughout this form. In addition, although the Consent Template for Exempt Research may be appropriate to use as assent for some children, we have also provided an Assent Form Template. These forms are for guidance only; the Office of Research Protections does not review consent and assent forms as part of an exempt determination.
|Consent Template for Exempt Research||This template can be used for all exempt research procedures involving adults, parental permission, and for assent with some children.||12/18/2013|
|Assent Template for Minors||This template can be used to design assent materials to be used with children for whom the consent template may be difficult to understand, but who are still be capable of understanding the study when explained more simple terms.||09/14/2015|
Non-Exempt Consent, Parental Permission and Assent Templates
Consent forms, parental permission forms, and/or assent forms—as appropriate based on the population of the subjects—are required for all research that is not exempt from IRB review unless some or all of these requirements are waived by the IRB. In this section we provide the templates for consent, parental permission, and assent (which may be more appropriate depending on the population of child subjects in your research). Consent forms that are more than 5 pages require a concise summary at the beginning of the form (this is incorporated in the template below). Researchers conducting non-exempt human subjects research are highly encouraged to use these templates, and the Office of Research Protections or the IRB may require that researchers use these templates as part of stipulations.
|Standard Consent Template for Non-Exempt Research||This template is appropriate for use with all research that is not exempt from IRB review.||11/18/2020|
|Assent Template for Minors||This template can be used for children who may be too young to use the above templates, but may still be capable of understanding the study when explained in more simple terms.||09/14/2015|
The Office of Research Protections has developed several guidance documents to help in designing consent materials for both exempt and non-exempt research. They include guidance on the elements of consent, examples of previously approved language on specific procedures and risks, and suggestions for improving the readability of consent materials.
|Consent Element Checklist and Example Language||This is a tool to be used to ensure that your consent document contains all required elements of consent, and to provide you with examples of language that fulfills the requirements of each element.|
|Procedures and Risk Language||This document suggests language for how to describe common research procedures and associated risks during your informed consent process.|
|Concise Summary Examples||This document provides examples of concise summaries, which is a requirement for consent forms in excess of 5 pages.|
|Consent Readability Guidance||This is a tool for improving the readability of your consent document. It is best applied to a drafted consent document but you can also use it to get started on writing your consent form.|
|Plain Language References||This is a list of free online resources for writing in plain language, including links.|