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As noted by the U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP), "Informed consent is a process, not just a form. . . . The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand."1 Federal regulations specify the type of information that should be disclosed to potential research participants, as well as procedures for documentation of consent, but other than suggesting that the investigator read the consent form to individuals being recruited for research, or that the individuals be given the opportunity to read the consent form themselves before signing it, there is no regulatory guidance on how consent forms should be integrated into the overall consent process.2
Enhanced consent procedures that go beyond the printed consent form-e.g., using multimedia or PowerPoint® presentations-can be helpful.3 However, because federal regulations mandate the use of printed consent documents as part of the consent process, a key question remains: How can written consent documents be more effectively integrated into the overall consent process so that the intent of the regulations-to ensure participant comprehension-is most faithfully respected?
A number of studies employing postconsent questionnaires and/or comprehensive decisional capacity instruments have demonstrated the feasibility and utility of an iterative process using questions to assess comprehension and providing corrective feedback.4 Yet the purpose of such investigations has typically been to examine decisional capacity (or at least the level of manifest comprehension) after review of the consent form, rather than on identifying an efficient means of presenting the consent form itself. One small study involving patients with schizophrenia included a comparison of postconsent comprehension when the consent form was presented with interspersed queries and corrective feedback (n = 20) versus a "standard administration" procedure in which the consent form was simply read to the individual without the interspersed questions and corrective feedback (n = 12).5 On a postconsent test of understanding, a "medium" (but statistically nonsignificant) effect size was found favoring the group that received corrective feedback during the disclosure process.
Guided by the above findings, we sought to develop and implement a systematic approach to the process of reviewing printed consent forms with potential research participants in a way that: a) provides for checking...