IRBs view advertising as the beginning of the informed consent process, as the advertisements can begin to shape a prospective participant’s perceptions of the study—its scope, aim, benefits, etc. Whatever the mode, be it traditional print or television advertising, email or warm calls, or a social media campaign, the guidance generally remains the same.
While the therapeutic misconception is diminished in healthy individuals, as a healthy volunteer is obviously less likely to attribute a curative intent to the intervention, the term “treatment” should generally be avoided in participant materials, to the extent it connotes that the intervention is nonetheless safe and effective rather than investigational. Payment should not be set apart, for example with bolded or larger text. Also, any general testimonials should not be overly reassuring.
The FDA recommends that advertisements contain enough information for prospective participants to be able to assess their likely eligibility and interest. While “free medical treatment” should not be advertised when the intent is only to convey that subjects will not be charged for taking part in the investigation, advertisements may call out a “no-cost health examination” as a benefit for recruiting purposes. Advertising free health exams should be done with caution, however, in the Phase I Healthy context, as it is likely only acceptable when the intent includes the return of useful health information to the participant. FDA guidance encourages the following content for advertisements:
- Name and address of PI and facility
- Condition studied/purpose of the research
- Summary of inclusion/exclusion criteria
- Brief list of benefits
- Time commitment
- Contact information
As for enumerating benefits, care should be taken to not emphasize a prospective participant’s assistance in improving future healthcare. This is because, from phase 1, it is more likely than not that the test product will not result in an approved treatment. Any such representations to the contrary are potentially misleading or overly optimistic about the impact of participation.
Due to the need to recruit healthy volunteers quickly, some Phase I Healthy facilities utilize a “generic” or “general” screening process and consent, to build a database of potential participants. It is important to remember that OHRP considers construction of a database for this purpose to constitute research. Also, the FDA considers any research-specific intervention, including screening, to require IRB oversight and informed consent. If a site is in this situation and looking to speed recruitment, an IRB may consider a waiver of documentation of informed consent and a phone script to verbally consent individuals before they arrive at the clinic for screening procedures, in order to facilitate fasting in preparation of a blood draw or wash out from any other medications.
 Screening Tests Prior to Study Enrollment – Information Sheet, U.S. FOOD & DRUG ADMIN., (last updated June 25, 2014).