Informed consent includes both the process of sharing information and documenting that the process took place. To ensure that potential subjects can truly make informed decisions about whether to take part in research, issues of comprehension, language, and culture need to be considered in addition to the elements of information provided in the regulations. The regulations provide criteria for waiving any or all of the elements of information and the documentation of consent.
Researchers are required to provide information in a manner understandable to the subjects. This requires preparing material in the subjects’ language at the appropriate reading level.
Consent is an ongoing process. Subjects’ initial decisions to take part in research are not binding. They may choose to stop participation for any reason or without cause.
Lorna Hicks, MS, CIP (Duke University) “Informed Consent” module. https://www.citiprogram.org. Accessed 20 March 2016.