IRB Advertising Guidelines

The IRB defines advertising as "any outreach effort designed to encourage potential subjects to contact the investigator's site requesting information."

It views advertisements as an extension of the consent process and subject selection process. Therefore, the IRB must review all means of recruiting subjects to participate in a research study, including advertisements prior to publication.

Advertising Resources

FDA Advertising Guidance

What requires review and approval

The IRB review policy includes, but is not limited to:

• Newspaper ads,
• Radio or television announcements
• bulletin board tear-offs
• posters
• health fair materials about the study
• computer bulletin boards or internet advertising
• 800 number ads
• disease databases (PDQ) - if the researcher has any control over the content
• talk show appearance media kits
• press releases designed to promote a study and encourage participation

What doesn't require review

• Ads in professional journals targeted at referring physicians
• Flyers to referring agencies that are not to be seen by patients

IRB Advertisement Review Considerations

1. It can not be misleading. It can not make promises of safety or efficacy; benefits or financial rewards must be reasonably stated. (Outsized fonts emphasizing money are discouraged.)
2. No claims should be made, explicitly or implicitly that the research is superior to any current practice.
3. It must be quite clear that it is for research or for an investigation.
4. It should give the name of a primary contact and a method of making contact.
5. It may give some brief eligibility criteria such as disease, condition, or age limits.
6. 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.

The IRB will also consider placement of any advertising. For each advertisement, the IRB wishes to know:

1. the name or type of the media (e.g., the San Francisco Times)
2. The targeted audience of the selected media.
3. Whether the medium selected is primarily designed to target a specific group. (e.g., specific ethnic or cultural group, gays, adolescents, etc.)

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