Informed consent is the process of obtaining a participant’s voluntary agreement to take part in a research study. It explains the study’s purpose, procedures, potential benefits and risks, as well as the participant’s rights.
If you plan to obtain online or verbal consent, which does not require a signature, then utilize this consent.
Use this form when obtaining written consent, which requires adult participants to provide a signature.
Use this form when obtaining consent for adult participants who are unable to read and/or comprehend the consent due to cognitive impairment.
Use this form when obtaining consent for a child participant.
Use this form when obtaining parent's consent for child participant.
Use this form when obtaining consent for both child and parent participants.
The type and extent of the consent process depend on the nature of the research and the level of risk involved. An effective consent process ensures that prospective participants, or their legally authorized representatives/legal guardians, have the information needed to decide whether to participate. The goal is to promote understanding and respect each individual’s right to determine whether participation is appropriate for them.
Please note, informed consent forms should be written at no higher than an eighth-grade reading level. Additionally, the IRB must have a clear and detailed understanding of how participants will be recruited, how consent information will be presented, and how consent will be documented.
Online or verbal consent, can take place over the phone, online surveys (Qualtrics or Prolific), a teleconference platform (Zoom or Teams), or in person.
Will participants be deceived as part of your study? Researchers may use deception, or incomplete disclosure, as a necessary tool for their study. Deception occurs when the initial informed consent process involves one or more of the following:
In these cases, the deception must be justified by the value of the research. Participants must be debriefed and given a Debriefing Form to document they are fully informed about the study. Participants must choose voluntarily to either remain in, or withdraw from the study and not allow the use of their collected data. Debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants, and the reason(s) why deception was necessary.
Do any participants have limited ability to give informed consent (e.g., minors or adults with cognitive impairment)? Are any in situations where consent may not be fully voluntary or could increase risk (e.g., incarcerated individuals)?
If so, please use the provided consent templates and incorporate additional safeguards, as appropriate, when developing the informed consent process and documentation.
Consider the following:
Avoid Exculpatory Language
Consent forms must not include language that asks participants to give up their legal
rights or releases researchers, sponsors, or the institution from responsibility from
negligence. For example, a consent form cannot state that participants waive their
right to seek compensation for injuries related to the research study.
Link for consent language: NW Suggested Consent Language
Investigator Responsibilities
During the informed consent process, investigators must:
Key Elements of Informed Consent
The informed consent process and document should clearly explain:
Do you need to consider your relationship to the participant?
Relationships with potential participants can lead to coercion. Could your role or position make them feel pressured to take part in the study? Examples include:
If potential coercion exists, consider whether changes to the consent process are needed to ensure participation is completely voluntary.
What is the anticipated reading level of your participants? Consent forms should be written in clear, simple language at no higher than an eighth-grade reading level. Use short sentences and avoid technical jargon whenever possible. For instance, say “You will be asked to do…” instead of "participation in the study will entail…”
Will you use the participant's data in areas beyond the research project? If so, your consent form needs to notify participants that their materials will be used elsewhere.
The answers to these questions will help determine what approach you need to take in developing an instructive consent procedure.