HSP Module 2: Informed Consent

Obtaining informed consent from human subjects is essential for the conduct of ethical behavioral, social science, and biomedical research.  The consent process lays the foundation of trust between researcher and subject.  As such, it constitutes a dialogue with the subject that begins in the recruitment process and continues through the course of the study, and often beyond.

For the investigator, the process of informed consent is his or her covenant with the subject with regard to the terms of the research. Breaking any aspect of this agreement or acting in less than a completely ethical manner will erode the level of trust and respect between subjects and investigators, potentially jeopardizing the current study, future studies, and the reputation of research in the wider community.

The process of informed consent has two components: informing and consenting. Informing may be defined as the conveyance of information from the investigator to the prospective subject. The consent of the prospective subject is defined as his or her declaration that, after assimilating the information, he or she is willing to assume the role of subject. These two components generally occur sequentially, and may re-occur in the course of the study, as the subject has new questions, and/or as new information is made available to the researcher that may impact a subject’s willingness to continue participation. Thus the process may be viewed as ongoing.

Prior to obtaining consent from a subject, an investigator must assess both the subject’s comprehension of the material and the subject’s autonomy. Populations of subjects who may be deemed vulnerable because they are unable to comprehend the information or act autonomously (e.g., children, decisionally impaired subjects, seriously ill subjects), and therefore lack the capacity to give informed consent, are provided special protections, which are described in Module 7.

The process of informed consent is an ongoing collaborative dialogue between the investigator and the prospective subject.  It is a give and take of information that includes the following four elements: informing, assessment of comprehension, assessment of autonomy, and consent. The basic elements of informed consent can be found on the United States Department of Health & Human Services (DHHS) website. The consent process and consent document must address each of these elements, and these elements should be considered the minimal amount of information that must be divulged to the subject during the process of informed consent. The consent document and process must reflect the type and nature of the research being conducted as well as the risks and benefits of participating and must be tailored to the subject population.

In certain situations the process of informed consent (or some elements of informed consent) or its documentation (the signing of a consent form) may be waived. Additional information on this topic is available in the Specific Guidance>