The principal investigator must explain to subjects, before they participate in any research activities, the objectives of the research, the procedures that will be followed, any associated risks, and any potential benefits. Investigators must not use individuals as subjects unless they are satisfied that the subjects, or others legally responsible for the subjects' well-being, freely consent to participate and understand the consequences fully.
To signal that they agree to participate, subjects must either sign a written consent form or provide oral consent. A researcher who plans to obtain oral consent must make the case for using oral instead of written consent. The requirement for written consent may be waived if:
- the research involves no or only minimal risk
- the consent form will be the only evidence linking the subject and the research, and the primary risk of harm is to the subject's privacy
Anonymous surveys do not require a written consent form, but the survey form must start with the same explanation of the research protocol that would be used for a written consent form. The subject's decision to complete and return the survey implies consent to participate.
Research that involves deception compromises subjects' ability to give truly informed consent. If your research involves intentional deception, the Institutional Review Board will consider requests to waive some of the requirements for informed consent, but only if the study design meets all of the following criteria:
- the research cannot be done without the deception
- the potential value of the research outweighs any potential risks to the subject
- the subjects are informed of the true nature of the research as soon as possible
- the research involves no more than minimal risk (federal requirement)