Consent Form Guidelines
The consent form is an essential element of the informed consent process. Thus, it is vital that the consent form be clear and understandable. These guidelines are intended to assist principal investigators in the development of their consent form documents and to address issues that commonly arise.
- All research that involves human participants must use an approved consent form. Approval is granted through the IRB review process and is indicated by an approval stamp on the consent form. The IRB Committee chair will stamp an original consent form as the approved final version. The stamp will indicate the IRB approval and expiration date. The stamped consent form will be sent to the principal investigator with their approval form. The stamped consent form is to be copied and distributed to all potential participants. No consent form may be distributed to participants without an approved stamp clearly visible.
- If a consent form is longer than one page, the principal investigator needs to include spaces for participants to initial and date at the bottom of all non-signature pages.
- Consent forms must be written in language that is accessible to the participants. Technical or scientific language should be used with discretion. Principal investigators need to make every effort to use language appropriate for the participants’ age group and educational background.
- If a research project will use different participant groups (e.g., students, teachers, parents), the principal investigator should develop a different consent form for each target group.
- When an application uses consent forms for different subject groups (e.g., students, teachers, parents, control groups), the principal investigator needs to identify the appropriate subject group in the title of the consent form. For example, stating “Research Participant Consent Form – Students” or “Parent Consent Form” at the top of the form will further the review of an application.
- If a consent form mentions measurement scales (i.e., metrics), the principal investigator needs to include the common measurement scale with which the population of participants would be familiar.
- The principal investigator should describe all procedures that will protect confidentiality. The principal investigator needs to describe where data will be stored and how and when it will be destroyed. If the research includes focus groups, the principal investigator must disclose that confidentiality cannot be maintained, as members of the focus group are not required to uphold confidentiality.
- A principal investigator may not list compensation as a benefit of the study. Federal regulations specifically prohibit a researcher from reporting that compensation, no matter its form, is a benefit to the participant.
- When recruiting participants who do not speak English, the principal investigator must include a copy of a consent form in the primary language that is spoken by the individuals solicited to participate in the study (e.g. a consent form written in Spanish would be included if Spanish-speaking individuals are being recruited, but a consent form written in English is not necessary).
- If the principal investigator is conducting non-curricular research in primary or secondary schools, state and federal law require that a guardian be allowed to review any research instruments used in the research. The principal investigator must specifically indicate in the parental consent form that parents can review any of the research materials. Additionally, the principal investigator is required to gain the signature of both guardians (if there are two) to complete any research involving children and the consent form should include a line for both guardians to sign.
- When a study uses deception, participants must be fully debriefed on the nature of this deception and the reason that it was employed. Federal regulations require that a second consent form be signed during the debriefing period for studies that use deception. This second form should include a full explanation of the deception and a box where the participant can indicate that they do or do not want their data to be used. Participants must be made aware of their right to withdraw their data from use.
- All consent forms must contain information regarding both the risks and the benefits of participation in the study. All research entails risks, even if the risks are considered minimal. Minimal risks are no greater than everyday experiences. If there are no direct benefits of participation, the principal investigator must state this in the consent form.
- All consent forms should include a specific statement of consent. For example, the consent might read: “I have read the above form and have had an opportunity to ask questions. I consent to participate in this experiment.”