IRB: Ethics & Human Research

Improving the Quality of Informed Consent to Research

In order to facilitate the informed consent process, we suggest recording it. If investigators routinely recorded the consent process—including subsequent testing of participants’ comprehension and reeducation efforts—they could monitor the consent practices of their staff and determine what changes in procedure may be needed. In addition, should the adequacy of consent ever be challenged (say, by a dissatisfied subject), investigators would have an easily accessible record of what had transpired. And finally, a pool of data would be created that could be accessed by researchers who study informed consent issues and are interested in identifying ways of further improving the process.
Key words/concepts: human subjects research, informed consent process, comprehension, reeducation

Victor Schwartz and Paul S. Appelbaum, “Improving the Quality of Informed Consent to Research,” IRB: Ethics and Human Research 30, no. 5 (2008): 19.