HOW TO PRINT To print this page, use your browser's print button. To print the entire document, download the PDF or click here and use your browser's print button. TOOLS & BACKGROUND MATERIALS Simplification Guide to Medical Terms Dartmouth Informed Consent Evaluation Tool Telephone Evaluation Plan FDA Guidance on Non-English Speaking Subjects
MAIN POINTS Investigators should be attentive to using language easily read and understood by potential participants. Various methods and tools exist to improve and assess comprehension of information. All verbal and written communication about the research study should be provided in language understood by the potential participant.

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?"

DISCUSSION
Gene transfer research concepts are often difficult for potential participants to understand. Thus, particular care should be given to convey these concepts in the consent form in a readable and understandable manner. Readability and understandability are not synonymous; it is possible to make use of computerized readability scales and still have a consent form that is difficult to understand. Sometimes, reducing reading level without providing additional explanatory aids can lead to vagueness and oversimplification of scientific information, which is undesirable.

Improving Comprehensibility of the Consent Form: Comprehensibility of the consent form is promoted by:

• A short summary paragraph or list at the beginning of the form introducing key concepts to potential participants, including that:
• They are being asked to participate in research;
• The principal goal of all research is to develop knowledge that could help others in the future;
• They should ask questions and consult with others before deciding;
• They do not need to enroll in research in order to obtain treatment for their condition;
• They can refuse to participate without repercussions.

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.

• Uncluttered documents, broken into sections with headings
• Use of second-person instead of first-person voice
• Short sentences written at no more than an eighth-grade educational level
• Attention to definitions
• Avoidance of technical jargon
• Consistent use of terms

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:

• Readability software programs, such as the Flesch Reading Ease score and Flesch-Kincaid Grade Level score (can be found in most versions of Microsoft Word), the Smog Readability Formula, and the Fog Index. Because these readability measures use syllable count to calculate the score, you should be aware when using these programs that the score may be somewhat inflated because of unavoidable scientific language.
• Asking colleagues and/or lay readers to comment on the readability, understandability, and internal consistency of the consent form as a whole.

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:

• A communication monitor assigned to the study, or advocate chosen by the potential participant, may be present during discussions, review the consent form, and provide assistance to the investigator and potential participant to ensure comprehension.
• An evaluation tool (such as a short true-false questionnaire) may be used as part of the consent process so that the person obtaining consent can determine whether any parts of the study require further explanation. See Dartmouth Informed Consent Evaluation Tool as an example.
• A telephone follow-up plan may be devised in which a monitor assigned to the study asks potential participants scripted questions about key information after the consent process has occurred. The monitor can request a follow-up meeting with the investigator and potential participant to address any areas of concern. See Telephone Evaluation Plan for an example.

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.