Principal Investigators are responsible for ensuring that all potential research participants are given enough information to make an informed decision on whether or not to participate in a study. PIs must also guard against coercing participation, or even the appearance of coercion. The informed consent process helps address these issues. This should be considered as an on-going process, and questions from research participants must be answered at any time during the research study. Also, PIs must immediately inform participants of any new information that may affect the research risks or requirements.
A main component of the informed consent process is the informed consent document. This document is required for all research studies involving human subjects. In any research where a participant's identity or identifying information will be recorded (including on "coded" lists accessible only to the PI), the signature of the participants verifying that they have read the informed consent document and agree to participate in the study must be obtained by the Principal Investigator. In addition, participants must be given copies of the informed consent documents to keep.
In research where the PI assures participants’ anonymity, in which a signed informed consent document would be the only object linking a participant to the research study, written informed consent should not be collected. Instead, the document should be either read (in the case of telephone interviews) or provided to the participant to read before data are collected. In the case of web-based studies, the informed consent document should be on the initial screen that the participant sees. The participant should be able to indicate by clicking one of two buttons:
- They have read the document and agree to participate in the study. In this case clicking the button will bring them to the research instrument; or
- They do not wish to participate in the study. In this case clicking the button will bring them to an exit page.
Principal Investigators of research studies involving children or individuals with impaired decision-making capabilities must receive written informed consent from parents or legally authorized representatives.
See the following documents for guidance in preparing your Informed Consent document: