FAQ on Informed Consent
Do I need to obtain informed consent?
- Informed consent is a dialog between the researcher and participant about the nature of the research, its risks and benefits, and the participant's rights. It is an ongoing process that may occur at several points during the research, and not just at the beginning. Informed consent is a basic right of research participants.
- However, the IRB may waive the requirement for informed consent in special circumstances. A waiver of informed consent may be issued if:
- The research is exempt from IRB review and it is not practically possible to obtain informed consent. Examples include observational research of public behavior, or archival research of publicly-available data;
- The research involves only the assessment of activities that are not voluntary. This is most common in educational research, in which the research activity involves only participation in regular classroom activities. Informed consent is required for those portions of the research that are voluntary. It is also required if the participants could be identifiable in any way in any published report of the research. For example, if samples of student journals were to be included in a Master's thesis, students (and their parents if appropriate) would provide informed consent; or
- It is necessary to withhold some information from participants for scientific reasons. If you are using deception in your research, participants should still consent to as much of the research as is possible, the deception be justified by the benefits of the research, the procedures do not include any greater risk than that to which participants have consented, and the deception is revealed at the earliest possible time.
- When Informed Consent documentation is waived an Information Sheet is recommended. an Information Sheet contains the same information as a signed consent document but does not require signatures.
What needs to be included on the consent form or information sheet?
Below is a checklist that covers the necessary requirements. There are templates and samples available on the Informed Consent page. (Some types of research may require other components of informed consent - see the CSUSM Policy on Research Activities Involving Human Subjects.)
- On CSUSM letterhead
- Is written in language that is easy for your subjects to understand.
- Indicates that the project involves research, and describes the overall purpose of the research.
- Describes the procedures that your subjects are agreeing to.
- Describes any known risks to the participant.
- Describes any direct benefits to the participant as a result of being in the study.
- Describes any compensation that will be received as a result of participation (note compensation is different than a direct benefit of the research).
- Includes a statement that research participation is voluntary, and that participants may withdraw at any time without penalty.
- Includes a statement about the confidentiality of the results, and the way the results will be shared (e.g., will be presented at scientific meetings, shared with an organization etc). Avoid statements like "confidentiality will be maintained to the extent provided by law" unless you know what that extent is, and are prepared to explain it to your subjects if they ask.
- Includes the statement "The researcher has answered any questions I have at this time". Avoid statements like "The researcher has fully explained the procedures to me" (your participant doesn't know if you have fully explained the procedures or not).
- Includes contact information for the researcher and their supervisor (if the researcher is a student), whom participants can contact if they have questions about the research .
- Includes the statement "Questions about your rights as a research participant can be directed to the Institutional Review Board at (760) 750-4029."
- Includes explicit permission to photograph, audiotape, or videotape participants, and explains what will become of those images.
- Is signed and dated by the participant and the researcher.
How do I do an assent form with children?
- Individuals under the age of 18 cannot legally consent to participate in research. Therefore, a parent or legal guardian must supply consent. However, the child should be involved in the consent process to the extent that is appropriate for their age. At a minimum, children should be told that research is voluntary, and their verbal assent to participate should be obtained. With older children, a written assent document may be beneficial, with the understanding that it does not replace parental consent. For more information, see the OHRP FAQ's on child assent .
What if I need to translate a consent form?
- Federal regulations require that informed consent be provided in language that is understandable to the participant. Thus, if a participant (or parent of child participant) does not read in English, a translated consent form is required. Instructions for translated forms can be found at: Consent form Language Requirements