ATSU, AZ IRB: Getting Research Consent

Informed Consent of the research participant is the most fundamental value of research with human participants of the modern era, and, consequently, one of the most highly regulated.  Most federal agencies adhere to the "Common Rule." The Common Rule (45 CFR 46) consolidated and unified the regulations for obtaining informed consent across most federal agencies.  Research at ATSU-AZ, usually falls under the Common Rule, unless involving a FDA investigational product (drug, biologic or device).

The Elements of Consent, at the top of the links in the right column, outlines the requirements of an Informed Consent Document.  A recommendation to the Investigator, is to print the Elements of Consent and use it as a checklist to review your consent document, prior to IRB submission. 

The ATSU-AZ IRB has adopted a two-part informed consent form (ICF).  The first part conveys information about the study. The second part includes the confidentiality and privacy information required by government regulations.  The investigator will probably find that the first part requires extensive modifications to fit the study.  The second part should also be modified to include confidentiality and privacy protection procedures incorporated in the study.

The Informed Consent of research participants is a process that should begin with a conversation between the potential participant and the investigator.  The process involves three elements: provision of information, asserting comprehension and voluntary agreement to participate.  The information should be conveyed in language that is easily understandable by the potential research participant.  In most cases, this means written at an 8^th-grade reading level.  The printed consent form can be used to both guide the discussion and document the information conveyed.

Examples of lower reading level wording:

• “see if” instead of determine or measure
• “new” instead of preliminary
• “more” or “new” instead of additional
• “done” instead of performed
• “do” instead of conduct/complete
• “so” instead of therefore
• “side effects” instead of consequences
• “have” or “get” instead of undergo, obtain or receive
• “known” instead of tolerated or documented
• “helps” instead of alleviates
• “lab” instead of laboratory
• “test” instead of analysis
• “after” instead of following administration
• “about” instead of approximately
• “during” instead of throughout
• “happen” instead of occur
• “before” instead of previously
• “exams” instead of examinations

Occasionally, when the potential participant is a non-English speaker, a translated consent or the presence of a certified translator may be an option.  Both of these situations can involve a substantial financial charge to the research.  Before committing to a translation or translator, consultation with the IRB Chair or faculty research advisor can assist with evaluation of the cost-benefit of incurring research translation charges.