Researchers must provide prospective research subjects with enough information to make an informed decision about whether to participate in a research study. If participants cannot give informed consent, it must be obtained from their legal representatives (see below).
Types of Informed Consent
There are three methods to obtain informed consent:
- Through a signed consent form: This is the norm for most research conducted in the United States. See a sample consent form.
- Through implied consent: When the researcher employs a survey, they may include at the beginning of the survey a full explanation of the nature of the research. If the subject proceeds to answer the survey questions, consent is implied. The implied consent text must specifically ask RSs to print or download a copy of the consent text that they can keep for their records.
- Through verbal consent: This may be used when . . .
- The researcher conducts low-risk research in which RSs are members of a distinct cultural group or community in which signing forms is not the norm.
- The principal risks to a research subject would result from a breach of confidentiality about their participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior), and the consent document is the only record linking the subject to the research.
In obtaining verbal consent, the researcher must:
--Put in place a procedure for ensuring and documenting that informed consent was obtained from each research subject even in the absence of a signature.
--Provide a printed copy of the verbal consent script, or an information sheet about the research, 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 researcher or the IRB. If this is declined, provide a business card or written contact information.
Components of Consent Forms, Texts, and Scripts
Consent forms/texts/scripts must be clearly written in plain language (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. If research is to be conducted in a language other than English, copies of the forms/texts/scripts should be provided in that language and English.
All consent forms, text, and scripts (for consent forms, implied consent, and verbal consent) must include the following, federally mandated, information:
- The names, titles, and departmental and institutional affiliations of all researchers, along with contact information
- If the researcher is a student, the faculty mentor’s name, title, and departmental and institutional affiliation should also be given, along with contact information
- A statement that participation is voluntary and that the research subject can refuse to answer a question or do anything asked of him/her. (S)he can also end participation and withdraw from the study at any time without penalty.
- A statement that the study involves research with a prospective written end product [such as a book, article, report, senior thesis, etc.]
- An easy to understand explanation of the purpose of the study
- A clear overview of how the research will be scheduled and how long it will take to participate
- If applicable: a request for consent to video or audio recording of the interview
- A simple description of the procedures to be followed
- Identification of any procedures that are experimental
- If deception is involved: 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 compensation to the subject, if any, and the terms under which such compensation may be withheld.
- Contact information for those who can answer questions about research ethics and the research subject's rights (normally the IRB email). In addition, if applicable, whom to contact in the event of a research-related injury or emotional trauma to the subject.
- A description of the extent, if any, to which anonymity or confidentiality of records will be guaranteed.
- Information about what organization is funding the study
- Information about access to the results of the research.
- The participant's signature, as well as their printed name and the date. The signature can be withheld, provided the researcher has a way to ensure and document that consent has been obtained from all research participants. Electronic signatures are permitted.
Consent for Projects Involving Children (under the age of 18) and Mentally Incapacitate Individuals
Children and mentally incapacitated individuals cannot legally provide informed consent, so assent should be obtained from the research subject, while consent should be obtained from their legal guardian.
Assent from research subject: The individual should be told about the research, including an explanation of the procedures to be used, the risk of discomfort and inconvenience, and the purpose of the research, in language appropriate to their age, maturity, experience, and condition. They should then asked if they wish to participate. They must say "yes." An individual’s failure to say "no" does not constitute assent. It must be made clear to the prospective research subject that no one will be upset with them if they decline to participate. If the child is old enough, an assent form may also be used.
In the protocol, the investigator should indicate the following:
Consent from the research subject’s legal guardian: Even if the research subject ASSENTS, his or her legal guardian(s) must still CONSENT in order for the child to participate. The mechanism for obtaining consent must be the same as that described above, except that forms/texts/scripts are modified as appropriate (e.g., use "you/your child" phrases and change the signature line to include the research subject’s name and the legal guardian’s relationship to him/her).
Consent in Research that Involves Deception
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, debriefing is an essential part of the informed consent process. 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
- A 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
Consent for Photographs and Videotapes to Be Published or Disseminated Publicly
Sample Photo or Video Release Form (download and edit to fit your research project)
Subjects must sign a photo or video release form if the goal of one’s research is to create a film, video art, or webpage, or if published work (book, articles, or reports) will contain research subjects’ images. The photo or video release form is separate from the consent form or script. To be clear, the researcher must obtain consent from the research subject to be video-taped or photographed in the general consent form/script before research begins. A specific photo or video image release form, on the other hand, should be signed by the participant directly before photographing or video recording begins or, if the researcher prefers, and if general consent to be photographed/videotaped was obtained at the beginning of research, at the time that they are organizing the visual images/footage for presentation.