Informed Consent

You must always document the process of obtaining informed consent (unless you have a waiver from the IRB). Documenting informed consent usually occurs after explaining the research and assessing participant comprehension. For many studies, it involves obtaining the signature of the participant (or the legally authorized representative, when IRB approved) as well the signature of the person obtaining consent. The signature of the person obtaining consent indicates they have explained the research to the participant, ensured that the participant understands the research and the participant freely consents to participate.

How you will document informed consent is somewhat flexible depending on your research. Your options are written, oral/verbal, electronic, or implied consent. Exempt studies do not require written consent (participant signatures) if it is not appropriate or conducive to the research. For example, if you are collecting data via anonymous/confidential online survey, you will use electronic consent – typically, this just means making your first survey question into a consent question. Adding a document with participant signatures to such a study actually introduces identifiable data into the research, which is often unnecessary for a simple online survey. Other times, it is appropriate and necessary to get participant signatures for your research. For example, if you are meeting participants in person for an interview, collecting identifiable data or taking photos, you should obtain written informed consent. Implied consent can be appropriate in research fields such as SOTL (Scholarship of Teaching and Learning); for example, if a professor would like to have the option of using de-identified coursework for data collection and research, including an informed consent statement in the syllabus with an opt-out choice typically covers the documentation requirements.

Be sure to use the template(s) provided below. Do not create your own.

The participant must sign and date the consent form at the time of the consenting process and only after all questions are answered and s/he agree to participate in the study. Rare exceptions include blind or illiterate participants and participants unable to consent for themselves.

The person who has oriented and obtained consent from the participant must also sign and date the consent form. This signature cannot pre-date the participant's signature.

Important notes

• The participant should always be provided with a copy of the signed and dated consent form to use as continual reference for items such as procedure risks and/or side effects, questions and for emergency contact information.
• If the IRB requires a HIPAA Research Authorization this must also be signed and dated at the time written consent for participation in the study is obtained.

Witness signatures

Witness signatures are required by federal regulations in very limited circumstances and can be required by the IRB to assure an adequate informed consent process for some research studies.

Examples:

• Informed consent is obtained using a short form consent process (when approved by the IRB)
• The participant has decision-making capacity, but cannot read, write, talk or is blind.
• The participant’s guardian/legally-authorized representative (LAR) cannot read, write, talk oris blind.

When required, the witness must be impartial, such as an adult who is not a member of the study team. The witness must sign and date the consent form at the time the consenting process occurs.

A signature of the witness means the requirements for informed consent have been satisfied. Consent is voluntary and freely given by the participant, guardian, or legally-authorized representative.