Winter Edition | December 2012
Development of an effective recruitment plan is an essential part of any clinical trial. Failing to recruit effectively causes delays, and studies can even be ended due to failure to meet enrollment goals. In addition to considerations of effectiveness, sponsors and researchers need to think through the requirement of IRB review of recruitment and advertising when developing a recruitment plan for a given study.
The IRB review of recruitment and advertising and important considerations are discussed further below.
The FDA does not consider direct advertising to a research subject an objectionable practice; however, the FDA does consider such advertising to be the beginning of the informed consent and subject selection process, bringing it under the purview of the IRB as part of the review of a research study. The IRB is expected to review both the content of advertisements as well as the mode of communication. The FDA Guidance requires the IRB to find that the procedure for recruiting is not coercive and that the information provided “does not imply a favorable outcome beyond what is outlined in the consent document and the protocol.” The advertisements for studies involving investigational products should not include claims that a study product is safe or effective or that it is known to be equivalent or superior to other products.
The FDA advises further that, generally, advertisements should be limited to the information the prospective subjects need to determine their eligibility and interest. See Table 1 for general information guidelines.
The IRB is also expected to review the final copy of printed advertisement to evaluate size of type used and other visual effects. Any audio or video must also be approved by the IRB in final format before it is used.
With respect to payment, FDA allows advertisements to indicate payment will be made, but warns that they should not over-emphasize payment.
When reviewing advertisements the IRB will be asking several questions as outlined below. It is important for sponsors and researchers to consider these questions as well when developing plans for recruiting subjects, in an effort to identify any aspects of plans that could be problematic from the IRB perspective.
- Is this direct advertising or a clinical trial listing that allows additional descriptive information about the trial?
- Is the procedure (information and mode of advertisement) coercive? Does the information provided imply a favorable outcome beyond what is outlined in the consent document/protocol. If the study involves investigational products, does the advertisement claim that a study product is safe, effective, equivalent or superior to other products? Does the advertisement provide more information than is necessary?
- Name/address of investigator study site
- Purpose of research/Name of condition being studied
- Summary of eligibility criteria
- Brief list of benefits
- Time (or other) commitment
- Research site location/contact information
- If payment is mentioned, is the payment or the amount of payment over-emphasized?
- Does the advertisement use phrases like “free medical treatment” when intending to describe study procedures or receiving the study product?
Resources for more information:
“IRB Review of the Use of Social Media in Research.” Cami Gearhart, JD. The Monitor. December 2012, vol.26.iss.5.
“Recruitment Materials Info Sheet.” © 2013 Quorum Review IRB, all rights reserved.
“Recruiting Study Subjects – Information Sheet: FDA Guidance for Institutional Review Boards and Clinical Investigators.” Food and Drug Administration Guidance. October 2010.