However, researchers also are aware that there are circumstances in which obtaining and documenting consent in social and behavioral research may be a complex, and often challenging process. For instance, potential subjects may be fluent in a language but not literate. Researchers may need to deceive research subjects in order obtain scientifically valid data. Asking subjects to sign consent …show more content…
Informed consent is a process that begins with the recruitment and screening of a subject and continues throughout the subject's involvement in the research. It includes:
• Providing specific information about the study to subjects in a way that is understandable to them.
• Answering questions to ensure that subjects understand the research and their role in it.
• Giving subjects sufficient time to consider their decisions.
• Obtaining the voluntary agreement of subjects to take part in the study. The agreement is only to enter the study, as subjects may withdraw at any time, decline to answer specific questions, or complete specific tasks at any time during the research.
Documentation of consent provides a record that the consent process took place. It generally consists of a consent form signed by the subject or the subject's LAR. In practice, this document often is used as a tool for engaging in the consent process. Informed consent may be documented by other means, such as audio or video recording, as approved by an IRB.
Information That Must Be Provided to Subjects
Federal regulations at 45 CFR 46 (Protection of Human Subjects 2009) about informed consent list specific elements of information that must be provided to subjects. The elements are divided into two categories. The first includes basic elements to be