IRB Informed Consent

Informed consent is one of the most important aspects of conducting ethical research with human participants. Respecting the autonomy of research participants, the investigator must provide complete and true information regarding the study. The "informed" in informed consent means the participant has all the information necessary to make a decision. To help new researchers develop a consent process that works, the IRB staff offers a brief video tutorial on the basics of informed consent.

The principle of informed consent applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies.

Typically, a "consent form" documents that the informed consent process has taken place. It must contain all the required components of informed consent, as defined in 45 CFR 46.116, and described below. The consent form must be written in language that is easy for the participant to understand. Avoid technical terms and complex sentences, regardless of your intended audience. When there are different groups or types of participants who may take part in a study, different consent documents may be required for different study populations.

• Signed informed consent is the gold standard, and what is generally required for research with human participants. This involves presentation of a written document to the prospective participant, including all elements of informed consent. The document is read and signed by the participant and kept as a record by the researcher.

Remember: if you choose a written informed consent process, the research will not be anonymous.  Do not promise anonymity to prospective participants and then ask them to sign a consent form!

• Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. This type of consent process is most common in internet-based research. Participants must still be presented with the consent information - the information a participants needs to know in order to make an educated decision about whether or not to participate. This type of process is be considered a waiver of documentation of informed consent, and must meet certain requirements to be applied to a given study (see IRB SOP #10).
• Oral consent occurs when the researcher reads a consent script, and the subject verbally indicates that they agree to participate. Subjects should be given the opportunity to ask questions and, in most cases, provided with an information sheet containing key information about the study, including contact information for the PI. See IRB SOP #10 for more details on how to implement and document an oral consent procedure.
• In research with children, a parent or guardian must typically give their permission (called "parental consent") to allow the child to participate. Also, if the child is mature enough, they will need to give their "assent" to participate. For detailed information, please read the IRB's guidance document on Research Involving Children.

General advice:

• Start with an IRB-approved consent form template.
• Headings for paragraphs are helpful and make the form easier to read.
• Use adequate white space so that the form is easy to read. Avoid fine print.

1. Provide a clear, concise explanation of the purposes of the research including the name of the study (the IRB can waive under certain specific circumstances if appropriate).

• Replace any technical terms with ordinary language, and use simple, clear phrasing. Avoid unnecessarily long or wordy paragraphs.

2. Explain what will be happening to the participant during the study and indicate participant's time commitment for each component.

• Be clear about what the participant will be asked to do, not vaguely say, "You might be asked to," state "You will be asked."  The participant needs to understand what the experiment involves in order to decide whether they want to participate.
• Write in the second person "You" -- for example: "You are invited to participate in a research project..., " "You will be asked to..."
• Do not make coercive statements such as "you understand that ...," "you have been told that...

3. Describe the frequent and/or important risks, side effects or discomforts of the study procedures (e.g., even though it is not considered a risky procedure, a needle stick to draw blood creates discomfort).

• If it appears that there are no real risks to participation, state, "We do not anticipate any risks to you participating other than those encountered in daily life." See our Sample Consent Form. 

4. Describe any direct or indirect benefit from participating.

• Learning about how experiments are conducted, receiving a gift, or earning extra credit for being a research participant are NOT direct benefits. Gifts and extra credit are considered compensation or incentives.
• Learning about how research is conducted, gaining some knowledge of a particular subject, or enjoying a game played during the research, may be indirect benefits.

5. State that the participant's involvement is voluntary, the participant may refuse to participate before the study begins, discontinue at any time, or skip any questions that may make him/her feel uncomfortable, with no penalty to him/her, and no effect on the compensation earned before withdrawing, or academic standing or record.

• If completing the entire study is required for compensation, make this clear. Likewise, if there are minimum requirements to be met to earn compensation, state this clearly.
• If partial compensation or pro-rated compensation will be given, please make clear how the amount of compensation will be determined.

6. State that the participant is allowed to ask questions concerning the study, both before agreeing to be involved and during the course of the study. See required contact information in #11 below.

7. Describe how participant's confidentiality will be protected.

8. Describe what will be done with the data once the study is completed, including identifiable information.

• Include any plans to share either identifiable or de-identified data with other researchers, or to publish in journals or present at conferences.

9. Indicate that recording devices, audio or visual, are being used (when applicable).

• If identifiable images or videos will be used for any purpose other than analysis of data, please make this clear and make sure the participant indicates permission for these uses (see below).
• Describe what will be done with the any video or audio tapes upon the completion of the study (destroyed, erased, archived, etc.), and when (after transcription,3 years, 5 years, etc.).
• If being audio/video recorded is required to participate in the study, please make this clear on the consent form. Whether this is required is up to the PI, but if so it should be clear for the participant.
• If recording is optional, provide a separate signature line on the consent form for the participant to agree to be video/audio taped or photographed. For example:

^{Please sign below if you are willing to have this interview recorded on tape (specify audio or video).
You may still participate in this study if you are not willing to have the interview recorded.
I am willing to have this interview recorded on tape:
Signed: ______________ Date: __________}

10. Indicate that the participant shall receive a copy of the signed and dated consent form.

11. Provide the name(s) of the investigator(s) and contact information.

12. Indicate that the participant may contact the Institutional Review Board (IRB) with any concerns or complaints.

• Include our email address (irbhp@cornell.edu), phone (607-255- 5138), and website. 
• Concerns may also be reported anonymous through EthicsPoint online at www.hotline.cornell.edu or by calling toll free 1-866-293-3077. Ethicspoint is an independent organization that serves as a liaison between the University and the person bringing the complaint so that anonymity can be ensured.

13. Include at the bottom of the form: "This consent form will be kept by the researcher for at least three years beyond the end of the study and was approved by the IRB on [date]."

Remember, if the participant is under the age of 18, parental/guardian consent is required. This includes college and university students under the age of 18, unless the IRB approves a request for waiver of parental consent (at their discretion). If the participant is 7-17 years old, child assent is also required.

• You will need to explain the deception and the reason for it to the participant as soon as the study is completed. Deception (including incomplete disclosure) is a technique that is sometimes used in social and behavioral research, in order to avoid response bias or for other valid scientific reasons. However, deception conflicts the subject's ability to make a fully informed decision about whether or not to participate in the research. To mitigate this concern, debriefing is an essential part of the consent process whenever a study involves deception.
• Once a participant has been debriefed, it is almost always appropriate to offer them the opportunity to withdraw their consent to participate. A template for creating a debrief can be found here: Sample Debriefing Statement.

Informed Consent Options, Processes, and Documentation

Informed Consent - Research Involving Children

Informed Consent - Research Involving Normal, Healthy Participants

Informed Consent - Research Involving Cornell Students

Informed Consent - Research Involving Prisoners

Parent/Guardian Permission for Studies Involving Children

Guidance for Protocols Involving Oral Consent

Informed Consent 101 Video