The content of the consent form must be written at a level appropriate to potential participants and use of technical jargon should be avoided. When technical or unfamiliar terms must be used, explain these terms in language understandable to a layperson. If the participants do not read English, the consent form must be translated into the appropriate language. Because TWU has many studies that use a Spanish translation of the consent form, the Spanish translation of the required verbatim statements are included in this Guide. Please note that names of individuals and agencies are used as is and do not get translated. The consent form should be typed using a legible type font (preferably no smaller than 11-point). A parent/guardian must sign the consent form if the subjects are minors. A who is capable of reading and understanding may sign an assent form that indicates the youth’s agreement to participate. An assent form can be used in addition to but not in place of the consent form signed by the parent/guardian. The following elements MUST be included in all consent forms. (A) The heading: TEXAS WOMAN'S UNIVERSITY CONSENT TO PARTICIPATE IN (B) The of your study (C) The degrees, and office phone numbers of the investigator(s) and advisor (if applicable). Do not use the title of in the names of persons with doctoral or medical degrees; just list “Dr.” the degree at the end of the name (Ph.D., Ed.D., M.D., etc.). Inclusion of home phone numbers is not recommended. E-mail addresses may also be listed. (D) A description of the research study, which must include the following: NOTE: The descriptions of these elements in the consent form must match the descriptions provided in the IRB application. An explanation of the purpose of the research. A description of the procedures to be used in the study, including details of the participant’s involvement, and identification of any procedures that are experimental. The total time commitment for the participant. If audio or video taping will be used, an explanation of the purpose of the taping and who will have access to the tapes. A description of potential to the participant and the steps that will be taken to minimize those risks. The risks identified on the consent form and the steps to minimize those risks must match the risk information in the application.
The content of the consent form must be written at a level appropriate to potential participants and use of technical jargon should be avoided. When technical or unfamiliar terms must be used, explain these terms in language understandable to a layperson. If the participants do not read English, the consent form must be translated into the appropriate language. Because TWU has many studies that use a Spanish translation of the consent form, the Spanish translation of the required verbatim statements are included in this Guide. Please note that names of individuals and agencies are used as is and do not get translated. The consent form should be typed using a legible type font (preferably no smaller than 11-point). A parent/guardian must sign the consent form if the subjects are minors. A who is capable of reading and understanding may sign an assent form that indicates the youth’s agreement to participate. An assent form can be used in addition to but not in place of the consent form signed by the parent/guardian. The following elements MUST be included in all consent forms. (A) The heading: TEXAS WOMAN'S UNIVERSITY CONSENT TO PARTICIPATE IN (B) The of your study (C) The degrees, and office phone numbers of the investigator(s) and advisor (if applicable). Do not use the title of “Dr.” in the names of persons with doctoral or medical degrees; just list the degree at the end of the name (Ph.D., Ed.D., M.D., etc.). Inclusion of home phone numbers is not recommended. E-mail addresses may also be listed. (D) A description of the research study, which must include the following: NOTE: The descriptions of these elements in the consent form must match the descriptions provided in the IRB application. An explanation of the purpose of the research. A description of the procedures to be used in the study, including details of the participant’s involvement, and identification of any procedures that are experimental. The total time commitment for the participant. If audio or video taping will be used, an explanation of the purpose of the taping and who will have access to the tapes. A description of potential to the participant and the steps that will be taken to minimize those risks. The risks identified on the consent form and the steps to minimize those risks must match the risk information in the application.
irb-guide-to-writing-a-consent.docx