IRC Research Toolkit: Obtaining Meaningful Informed Consent

Voluntary informed consent is a legal requirement of human subjects research, but meaningful informed consent entails more than the participant’s signature on a consent form. The Belmont Report, which provides an ethical foundation for human subjects research, requires that “subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them,” and this occurs during the consent process.  The manner in which we obtain this consent is crucial to ensure the protection of research participants, especially among the vulnerable populations with whom we work.