Effective Use of Consent Forms and Interactive Questions in the Consent Process (Insight‪)‬

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[R] 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?