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One common area of noncompliance in human subjects research involves advertising and recruitment materials.
Investigators might begin to market their study to potential participants even before they have received IRB approval, or make changes to their advertising and recruitment materials after an original version and format were approved.
In both cases, the investigators are noncompliant.
“The informed consent process begins with recruitment,” says Joseph Crossno, MS, CPIA, assistant director in the office of research compliance at Central Michigan University in Mt. Pleasant. “If you mislead participants in recruitment and they go into a study thinking they’re going to be doing one thing, then there’s a problem.”
“Not all participants thoroughly read the consent document, so there is a problem of the recruitment material not matching what’s in the consent form,” he adds. “When you explain that to researchers, they understand that advertising has to match what’s said in the consent form or there is the possibility of participants not understanding.”
Researcher education includes a two-page paper titled “Why does the IRB care about advertising?” It explains how the IRB views advertising of an approved protocol to be the beginning of the informed consent process, shared with IRB Advisor by Crossno and Central Michigan University.
According to the CMU educational sheet, the following is the information that recruitment advertisements should include:
• investigator’s and/or research facility’s name and address;
• research purpose and study condition;
• summary of eligibility criteria;
• brief list of benefits;
• subjects’ time and other commitments;
• research location and contact information.
The investigator education also asks that researchers do not use coercive or misleading language or graphics, imply a guarantee of benefits, claim the study product is safe or effective, or emphasize free treatment.
Researchers that tweak their marketing materials in hopes of drawing more attention to their study do not understand that by changing it, they might be dropping something that is required in the regulations, Crossno says.
“Sometimes, it’s as simple as, ‘I can’t fit it on the page,’” he explains. “So they cut things out that they think are unimportant, and it turns out those things are important.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.