Elements of Informed Consent
Consent forms should be written in lay language easily understood by the subject population and should be formatted to separate required elements of the informed consent.
Describe the research, including its purposes and methods.
Describe the nature and duration of the participant’s participation. Identify any experimental procedures.
Describe any benefits to the participants or any others that may be expected from the research.
Suggested text: "Although you may not receive direct benefit from your participation, others may ultimately benefit from the knowledge obtained in this study."
Describe any payments or other incentives that participants will receive.
Describe any foreseeable risks or discomforts to the participant.
Suggested text: "There is no risk or foreseeable discomfort involved with being in this study beyond that associated with daily activities."
Describe the extent to which confidentiality will be maintained, if it will.
Describe the eventual disposition of identifiable information, tapes, questionnaires, etc. Describe any legal duty to report abuse that might supersede confidentiality promises. (Usually only for research involving risky or illegal behavior.)
Suggested text: "You will not be identified in any reports on this study. Records will be kept confidential to the extent provided by federal, state, and local law. However, the Institutional Review Board, the sponsor of the study (i.e. NIH, FDA, etc.), or college and government officials responsible for monitoring this study may inspect these records." or
“I/We will make our best effort to protect your statements and answers, so that no one will be able to connect them with you. These records will remain confidential. Any personal information that could identify you will be removed or changed before files are shared with other researchers or results are made public.” or
"The information in this study will only be used in ways that will not reveal who you are. You will not be identified in any publication from this study or in any data files shared with other researchers. Your participation in this study is confidential." or
If the study involves research on risky or illegal behaviors you should add:
“Federal or state laws may require us to show information to college or government officials [or sponsors], who are responsible for monitoring the safety of this study.”
7) Participant rights:
State that participation is voluntary, that the participant may refuse to participate, or discontinue participation at any time without penalty or loss of benefits. State that a signed copy of this consent form will be provided to the participant.
Suggested text: "Your participation in this project is voluntary. Even after you sign the informed consent document, you may decide to leave the study at any time. (If there is a benefit for completing the study add:) without penalty or loss of benefits to which you may otherwise be entitled."
Suggested text: "One copy of this document will be kept together with the research records of this study. Also, you will be given a copy to keep."
Additional text to include if applicable: Survey Research
"You may skip or refuse to answer any survey question without penalty or loss of benefits."
8) Questions about who to contact about the study or about your rights as a participant:
Explain who to contact for answers to questions about the research study, research participant’s rights, or whom to contact in the case of a research related injury or adverse effect. This should include, in this order, the Principal Investigator’s name, title and contact information; if a student project, the name, title and contact information of the faculty supervisor; AND the IRB chair (include name of current chair), College of Arts and Sciences, Office of the Dean (440-775-8410).
If applicable, an explanation about any compensation or medical treatments that may be available, if injury occurs, what they may be and where to get further information.
If applicable, include a statement that audio and/or video recording devices will be used. You must also state what will be done with the recordings/pictures upon completion of the study (destroyed, erased, archived, kept for future studies, etc.). Provide a separate line on the consent form for the subjects to agree to be recorded/photographed.
Be sure that the terms confidentiality and anonymity are used correctly and consistently. Anonymity means no one, anywhere, ever can identify individual subjects. Confidentiality refers to methods used to ensure that information obtained by researchers about their participants is not improperly divulged.
Any information that could ultimately lead to identification of the subject is NOT anonymous. (A few examples of methods that are confidential but not anonymous: Collecting surveys with OCMR#, collecting surveys by hand, audio taping individuals, group interviews.)
In listing benefits, payment or other “rewards” (candy, gift certificates etc.) are considered incentives to participate, NOT benefits to participation in the research. Providing payment or offering other “rewards” is permissible as long as they are not so large as to induce subjects to participate in the research against their better judgment. Examples of benefits include, but are not limited to, a participant’s increased awareness of healthy living options or the participant learning a new subject.
Adapted, with permission from Jami Peelle, IRB administrator, Kenyon College website
In some circumstances, the IRB may waive the requirement for written consent and allow researchers to obtain verbal consent. However, a waiver of signed consent does not mean a waiver of a consent process altogether.
The verbal script must include the following basic elements:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subjects.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- Disclosures of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and who to contact in case of a research related injury to the subject.
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise