Sample Informed Consent Form (download and edit to fit your research project)
Research participants must have enough information to make an informed decision whether to participate in a research study. If participants cannot give informed consent, it must be obtained from their legal representatives. For example, when subjects are minors (under 18) or when they are mentally incapacitated, consent from a legal representative (such as a parent or legal guardian) is required.
Consent documents and scripts must be clearly written in plain English (typically at an 8th-grade reading level) so participants can fully understand the implications of participating. Scientific, medical, and technical terms should be avoided if possible or, if they must be included, clearly defined in simple language.
Components of Consent Forms
Federal guidelines require that a consent form must include:
- A statement that the study involves research
- An easy to understand explanation of the purpose of the study
- How long it takes to participate
- A simple description of the procedures to be followed
- Identification of any procedures which are experimental
- If deception is involved, there should be an indication that the research cannot be fully described at this time, but that at the end of the subject's participation an explanation will be provided
- A description of any reasonably foreseeable risks or discomforts to the subject.
- These include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience.
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- If there is no direct benefit, this should be stated. Please note that payment is not considered a benefit.
- A statement concerning costs or compensation to the subject, if any.
- Contact information for those who can answer questions about the research and the subject's rights, and (if applicable) for whom to contact in the event of a research-related injury to the subject. For senior projects, normally participants should be invited to contact the principal investigator or faculty advisor if they have any questions about the research, and to contact the chair of the IRB if they have questions about their own rights as research participants.
- Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained
- A statement that participation is voluntary, that neither refusal to participate nor participation discontinued at any time will invoke penalty or loss of benefits to which the subject is otherwise entitled
- Information about access to the results of the research.
- The participant's signature, as well as their printed name and date should appear on the consent form.
Projects Involving Children (under the age of 18)
Children cannot legally provide informed consent, if you wish to have children (those under 18) participate in your research, they should be given an explanation of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the purpose of the research. These explanations should, of course, be given at a level appropriate to the child's age, maturity, experience, and condition. In addition, the informed consent must also include the following:
- Children should be asked if they wish to participate in the research or not. A child must say "yes." A child's failure to say "no" does not constitute assent. It must also be made clear to the child that no one will be upset with them if they decline to participate.
- In the protocol, the investigator should indicate the following:
- How assent will be obtained (what the investigator will say to the child and whether or not the child's parent(s) or guardian(s) will be present);
- How assent will be documented. The child may either sign a very brief assent form or verbally indicate a willingness to participate.
- Even if the child ASSENTS, his or her legal guardian(s) must still CONSENT in order for the child to participate.
- Legal guardians must provide written consent. In most cases, consent forms do not need to differ from the standard informed consent form. Investigators are encouraged, however, to modify the text of the form so it is audience-appropriate (e.g., use "you/your child" phrases) and to use the following signature lines:
Your child's name: ________________________________________________
Your signature: ___________________________________________________ Date _____________
Your printed name: ________________________________________________ Date _____________
The employment of deception by an investigator(s) for the purpose of securing subject participation and/or to prevent potentially biased reporting of data/information by the subject is permissible provided all of the following conditions exist:
- Deception is necessary due to the lack of alternative procedures for data collection not involving deception;
- The deceptive procedures will not place subjects at significant financial, physical, legal, psychological, or social risk;
- The data collection/experiment will be followed by careful debriefing sessions whereby the subjects are fully informed of the nature and purpose of the deception; and
- The procedures for deception must meet the guidelines established by the discipline of the investigator through its professional code of ethics.
Sample Debriefing Script (download and edit to fit your research project)
If you anticipate using deception in your research, all subjects must be fully debriefed at the end of their participation. The debriefing is an essential part of the informed consent process and is mandatory when the research study involves use of deception. It provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants and the reason(s) why it was necessary to deceive them. It should also include other relevant background information pertaining to the study. When debriefing is required, researchers must submit a Debriefing Script to the IRB along with their application that includes the following:
- The study title.
- The PI name and contact information.
- A statement thanking participants for completing the study.
- An full explanation of what was being studied (i.e., the purposes, hypotheses, aims, etc.). Use lay terms and avoid jargon.
- An explanation of how participants were deceived.
- An explanation of why deception was necessary.
- An explanation of how the results of the deception will be evaluated.
Sample Verbal Consent Script (download and edit to fit your research project)
There are some situations where a written consent form may not be required:
- The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior);
- The consent document is the only record linking the subject with the research; or
- The research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting.
In those cases, researchers can request a written consent waiver and must submit a complete verbal consent script along with their main IRB Application. Also, a printed copy of this verbal consent script must be given to subjects who agree to participate in the study, so that they can refer to it later if they have any questions or would like to contact the investigator or the IRB. If the participants decline a copy of the verbal consent script for their own records, you should provide as an alternative a printed slip of paper that has contact information for you, your advisor (if student P.I.), and the IRB.
Photographing or Videotaping Subjects
Sample Video Release Form (download and edit to fit your research project)
Subjects must sign a video release form if and only if the goal of your research is to create a film, photographic stills, or video art in which participants' images will be publicly displayed. Such purposes include photographic and video installations or web pages viewed by individuals other than the project investigators (some types of documentary film may be exempt). The video image release form is separate from the consent form. The consent form must be presented first. A video image release form should be signed by the participant before video recording begins. It may also be advisable to present the same form again at the end of the recording period so that the participant may change his or her mind about the image release authorization.
Prisoners as Participants
Research using prisoners is strictly regulated by federal guidelines. All researchers that intend to use prisoners as participants must submit a Prisoner Participant Checklist with their main IRB Application.