All research requires informed consent.
Obtaining informed consent from research participants is a basic ethical obligation and a legal requirement for researchers. How that consent is obtained and documented varies based on the research design and the level of risk.
Remember: Informed consent is a process, not just a form.
Information required to make an informed decision must be provided to the participants in a manner that they will understand. Informed consent should be seen as an educational interaction between the researcher and the people who participate in the research activity from the recruitment stage throughout the study.
The IRB will review each study to ensure that the following general requirements of informed consent are satisfied:
Informed consent must be obtained from the participants or their legally authorized representatives before the research begins;
Information must be conveyed in a manner that is understandable to the participants;
Participants must be given sufficient opportunity to consider whether they want to participate;
Vulnerable subjects must be protected with special safeguards;
Consent must be given without coercion or undue influence; and
Subjects must not be made to give up legal rights or be given the impression that they are being asked to do so.
For most studies, informed consent should be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. This document should include all of the elements of informed consent mandated by the Department of Health & Human Services (HHS) regulations at 45 CFR part 46. See the Informed Consent Checklist for a description of these elements.
A copy should be given to the person signing the form.
Sample Informed Consent forms can be found in the sidebar on the right of this page.
Sometimes signed consent is not required or appropriate for the research project.
The IRB may waive the requirement for the investigator to obtain signed consent for some or all of the subjects if it finds that:
- the only record linking the subject and the research would be the consent document
and the principal risk would be potential harm resulting from a breach of confidentiality,
- the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
For most anonymous surveys and other exempt applications, no informed consent form is required.
In fact, an application that requires a signed consent form in this situation may be rejected since it compromises the anonymity of the research subjects. In this case, however, researchers still have an ethical responsibility to ensure that informed consent occurs.
In instances where signed (documented) consent is not required, use a cover letter that includes the required elements of consent but doesn't ask for a signature. See sample cover letters in the right sidebar of this page.
There also are a few other instances where the IRB may grant a waiver of signed consent. These are outlined in the IRB Policy.
If you plan to recruit minors (individuals under age 18) into your study, you will need to obtain signed consent from a parent or legal guardian. If the participant is school age or above, you will also need to document that the individual understands what the research project is and voluntarily agrees to participate, which is called assent.
If you will be recording research participants, specific language is required in the informed consent document. Please refer to this handout regarding audio and video recording.
When reviewing your informed consent form, the IRB will utilize this Informed Consent Checklist. You may find it helpful to reference it when preparing your documents.