Research Protections

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

The principal of autonomy—and thus the importance of obtaining consent—applies to exempt research as well as non-exempt research. In our Consent Guidance section at the bottom of the page, the “Procedure and Risk Language” document provides language for several procedures that are frequently part of exempt research. Please review this guidance document as you craft your exemption form, making sure to add in relevant procedure and risk language where appropriate.

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).

Researchers conducting exempt research are encouraged to use 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. Finally, if your research procedures involve accessing FERPA data, you are required to use the appropriate FERPA consent form attached below for obtaining signed permission for the release of student education records to the research team.

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.

Consent for Use of Identifiable Information in Reports of Findings

As part of some research projects, photos/videos, audio recordings, names, and/or other identifiers may be used in reports of research findings. Consent is required in order to use identifiable information about participants in the research findings. If you wish to use photos, videos, audio recordings, names, or other identifiers in reports or presentations of research findings, please use the appropriate form below to obtain consent for these procedures in a manner that complies with 45 CFR 46.116(a)(6) (i.e. “No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”). Please note that this form may only be used following official approval or exemption from the IRB Office for the use of this form.

Consent Guidance

Research Protections staff have 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.