Study Recruitment and Advertising Materials
The FDA regards advertising directed at potential study participants to be the beginning of the subject selection and informed consent processes. As such, all advertisement and recruitment materials which are intended to be presented to (physically or verbally) potential participants must be submitted, reviewed, and approved by E&I prior to implementation.
Materials submitted with initial or continuing review or as a part of a modification request will be reviewed with that application. Materials submitted with the initial review will be included in the initial or continuing review fee (up to two materials.)
Materials submitted separately will be presumed to be a minor modification to an already approved protocol and thus may be eligible for expedited review. When materials are submit separately from the study submission packet they will be subject to an additional review fee.
What materials should /must do:
- All recruitment materials must have tracking information such as an item number, version number or, at a minimum, a date.
- It should state the purpose of the study.
- It should be written in simple language, comparable in reading level to the consent document.
- It must be quite clear that it is for research or for an investigation.
- It should give the name of a primary contact and a method of making contact.
- It may give some brief eligibility criteria such as disease, condition, or age limits.
- It may give brief procedural information such as the location of the research, duration of participation, mode of administration and name of the test article
What materials should/must not do:
- It cannot be misleading. It must not make promises of safety or efficacy. Any benefits or financial rewards must be reasonably stated. (Outsized fonts emphasizing money should not be used.)
- No part of the material (language, images, photos, etc.), or it's mode of communication. should create an emotional response that may intentionally or unintentionally be coercive to the intended recipient or imply a certainty of favorable outcome?
As advertising will attract various subsets of the desired population depending on placement, the IRB will also consider placement of any advertising. For each advertisement, the IRB wishes to know:
- the name or type of the media (e.g., the San Francisco Times)
- the targeted audience of the selected media.
- whether the medium selected is available to primarily a specific group. (e.g., Hispanic population, coal miners, or the super wealthy)
Each investigator needs approval for his or her recruitment materials. Many call centers will not refer to an investigator without IRB approval for the 1-800 ad. We have several rules of thumb.
- The scripts used should give information first, should ask questions second and obtain identifying information last
- Callers must be told whether the information will be retained for future recruitment and, if so, their verbal agreement is required.