White Paper

Ten Tips For Writing Compliant Clinical Trial Participant Materials

Source: Quorum Review IRB

By Lizbeth Adams, PhD, Executive IRB Vice Chair; Lisa Chartier, IRB Member and Expedited Reviewer

TenTips

This whitepaper discusses how materials presented to a potential participant or enrolled participant can strengthen or threaten this principle of respect for persons. The paper focuses specifically on materials other than the informed consent document; we refer to these non-consent materials collectively as participant materials (PMs). After providing some regulatory background, this paper will provide examples of practices that do not protect vulnerable populations; that present undue influence; or that are overly reassuring. The thesis of this paper is that recruitment materials are a potential participant’s first introduction to the study and the information the materials contain establishes—if not finalizes—comprehension of and expectations for a study. Further, post-consent materials also can influence an individual’s decision about continued participation. It is therefore important to adhere to the principles of subject protection—that is, allowing subjects to make informed decisions about what is in their own best interest— with the materials that appear at the earliest stages of recruitment as well as through the life of the study.