|NIH Guidance on Informed Consent
For Gene Transfer Research
NIH GUIDELINES: "How will the major points covered in Appendix M-II, Description of Proposal, be disclosed to potential participants and/or their parents or guardians in a language that is understandable to them?"
Improving Comprehensibility of the Consent Form: Comprehensibility of the consent form is promoted by:
The text of the consent form can then provide detailed information about the particular study, and may repeat some of the summarized issues in the context of the particular study.
Sometimes, "research" and "treatment" terms are used interchangeably in consent forms. Consistent use of terms is preferred, however, to help minimize the potential for confusion. For example, one term should be used to describe the experimental gene transfer intervention, instead of calling it, at various places, study injection, delivery of a modified virus vector, or gene shot. One term should be used to refer to the investigator (instead of using, for example, both "researcher" and "study doctor"), and one term should refer to participants (instead of using, for example, both "patients" and "subjects" to refer to those enrolled in the study).
Furthermore, consent forms should be written in the second person rather than the first person. Telling potential subjects, "This is what will happen to you if you are in this study" conveys information more clearly than "I have been told that if I join this study, this will happen to me" - a construction that can be awkward and confusing.
In addition, the use of emphatic and directive language should be avoided. A common example is "You understand that....". This construction should never be used in consent forms because it conveys a presumption about what the participants comprehend and detracts from the consent form's proper educational focus on providing information and explanations to potential participants.
Various tools exist to gauge the comprehensibility of the consent form before it is used with potential participants. Such tools include:
Improving Comprehensibility of the Consent Process: In some studies that are especially complicated or risky, or that propose to enroll especially vulnerable participants, it may be desirable to develop a communication evaluation plan to ensure that study personnel have clearly and thoroughly explained key information and that potential participants understand key issues. Such evaluation can take many forms, including:
Communicating with Non-English Speakers: Federal regulations require that consent be provided in a language understood by the potential participant. For potential participants who do not understand English, it may be advisable for the consent form and any supplementary materials to be professionally translated and for the translation to be checked for scientific accuracy so that important nuances are properly conveyed. In addition, investigators, institutional review boards, institutional biosafety committees, and institutions should have appropriate plans in place for use of interpreters experienced with the translation of medical information in all verbal communication during the consent process and throughout the study.