Required Components of Informed Consent
Informed consent is not a single event or just a form to be signed; it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include:
- full disclosure of the nature of the research and the participant's involvement,
- adequate comprehension on the part of the potential participant, and
- the participant's voluntary choice to participate.
It is the investigator�s responsibility to document that the informed consent process has taken place, and an informed consent form is the standard for documenting the process for research projects involving human participants.
Consent forms must contain all the required components of informed consent as defined in SOP 9: Informed Consent Options, Processes, and Documentation and summarized below. The consent form must be written in language that is easy for a potential participant to understand and assures that individual�s comprehension. Therefore, avoiding technical terms and complex sentences, even for the educated layperson, is very important.
When the participant population is not homogeneous, different consent documents may be required for different groups of people. If the research population will include participants under 18 years of age, then the IRB will expect investigators to use an assent form and a parental permission form instead (see SOP 11: Informed Consent, Enrollment, and Other Considerations for Research Involving Children). Similarly, research with cognitively or decisionally impaired individuals will require documented consent from another party�namely that person�s legally authorized representative (see SOP 9, section 8 and/or SOP 10: xxx).
The IRB also recognizes that there are instances when documenting written informed consent is not appropriate to a research project. Alternatives to using a signed form for documenting informed consent are detailed in SOP 9.
Regardless of the method of documenting informed consent, however, the process of obtaining informed consent should always contain the same required components.
Helpful guidelines for constructing an effective consent form:
- Use common, ordinary language instead of technical, academic terms. Ideally we would like consent forms to be written an 8th grade reading level. A helpful gage is to consider if one�s 13 year-old cousin would be able to understand the research after reading the consent form. Try to keep the sentences as short and simple as possible.
- Write in the second person using you/your pronouns. For example: "You are being asked to participate in a research project�," "If you have questions later, you may contact�," or "You will be given a copy of this form to keep for your records."
- Do not use assumptive statements such as "You understand that ..." or "You have been told that...."
- Use adequate white space so that the form is easy to read, and avoid using small fonts to squeeze all the text onto one page.
- Headings for paragraphs are helpful and make the form easier to read and understand.
Required Elements of Informed Consent Forms:
- A clear, concise explanation of the purposes of the research, including the name of the study and prominent use of the term "research." (Note: the IRB can waive this element if the study requires deception. In such cases, a debriefing statement should also be used to inform participants at an appropriate time after their involvement in the study.)
- An explanation of what will be happening to the participant during the study, and an indication of the participant's time commitment for each component.
Description of the risks, side effects or discomforts of the study procedures. For instance, even though it is not considered a risky procedure, a needle stick to draw blood may cause brief pain or discomfort. For social science and behavioral research, though risks usually do not extend beyond the possible loss of confidentiality and/or mild emotional distress, these should also be made clear to prospective participants.
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." Please see our Sample Consent Form for an example of appropriate wording of a risk statement.
Description of any potential benefits from participating.
For individual participants, these should be limited to direct benefits: information about better coping skills, awareness of available support or resources, or any other personal gain other than financial rewards. (Learning about how experiments are conducted, receiving a gift, or earning extra credit for being a research participant are NOT recognized as benefits. Gifts, extra credit for courses, and reimbursement for expenses are considered compensation.) If there are no direct benefits, simply indicate that there are none.
For indirect benefits to society or scientific knowledge, statements such as "�information from this study may benefit other people now or in the future�" or "�we hope to learn more about ________ �" are appropriate.
- A statement 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 their academic standing, record, or relationship with the university.
- A statement 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.
- A description of how the participant's confidentiality will be protected.
- A description of what will be done with the data once the study is completed.
An indication that recording devices, audio or visual, are being used (when applicable).
Be sure to 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.).
Also, provide a separate signature line on the consent form for the participant to agree to be video/audio taped or photographed, if the recording is optional for participation. 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:
- An indication that the participant shall receive a copy of the signed and dated consent form.
- The name(s) of the investigator(s) and contact information.
- An indication that the participant may contact the Institutional Review Board for Human Participants (IRB) with any concerns or complaints. Include our email address (firstname.lastname@example.org), phone (607-255-5138), and website. Additionally, a statement indicating that participants can report their concerns or complaints anonymously through Ethicspoint (www.hotline.cornell.edu) or by calling toll free at 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.
- A "statement of consent" and the name and signature of the participant.
- The name signature of the person obtaining consent.
- At the bottom of the form the following statement: "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]."