Recruitment Materials

Flyers, posters and brochures are often used to solicit potential research subjects. These types of advertisements are usually placed in strategic locations to be viewed by targeted populations, such as bulletin boards, clinical offices, public transportation or public areas.

Before research recruitment materials can be posted or distributed, it must be IRB-approved. It may also be necessary for the investigator to obtain approval from the sites where the flyer, poster and/or brochure will be placed.

Study-specific recruitment materials should be submitted to the IRB under the related study either during initial submission or via an amendment.

Recruitment material that is more general in nature does not have to be submitted under a study. General research advertisements must still adhere to recruitment do’s and don’ts.

The consenting process really begins at the recruitment stage. Since these types of advertisements are visible tools of recruitment, they must present sufficient information that is accurate and balanced so that potential subjects can make an informed decision about potentially participating.

Generally, recruitment materials should include the following:

• The name and address of the clinical investigator and/or research facility.
• The condition being studied and/or the purpose of the research.
• The time or other commitment(s) required of the subjects.
• The location of the research and the person or office to contact for further information.
• A clear statement that this is research and not treatment.
• A clear statement that participation is voluntary.

Generally, any advertisement should be limited to the information that a prospective subject needs to be able to determine their eligibility and interest in learning more.

Advertisements should NOT:

• State or imply a certainty of favorable outcomes or other benefits beyond what is outlined in the consent document and the protocol
• Overemphasize the benefits and minimize the risks
• Promise “free treatment,” when the intent is only to say subjects will not be charged for taking part in the research
• Include exculpatory language
• Emphasize the payment or the amount to be paid, by such means as highlighted, larger or bold type.

For FDA-regulated research, the advertisement CAN NOT:

• Make claims, either explicitly or implicitly, that a drug, biologic or device is safe or effective for the purposes under investigation
• Make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic, or device
• Use terms, such as “new treatment,” “new medication” or “new drug” without explaining that the test article is investigational
• Include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.

See 800.01 Checklist, Recruitment Materials

Including the amount of compensation in the recruitment material is generally discouraged. This will be considered by the IRB on a case-by-case basis. Although compensation or reimbursement may influence one’s decision to participate in research, the advertisement must be carefully worded so that it does not coerce a subject to participate.

While the IRB will have to review a final version of the materials created, the IRB will be happy to review a draft version if provided enough lead time. Getting IRB feedback on a draft version of your advertising materials can reduce your costs by avoiding the need to redo (re-film or re-record) productions that do not meet approval criteria.