This guidance document defines the standards and parameters for utilization of advertisements and other recruitment materials in research studies.  The main purpose of such materials is to inform and invite potential subjects to participate in a research study.  Advertisements and recruitment materials targeting research participants should be thought of as the beginning of the informed consent process.  These materials should be limited to the information prospective subjects need to determine their eligibility and interest.

Advertisements and Recruitment Materials

Prior to posting and/or distribution, the IRB must approve the final content of any and all advertisements and recruitment materials for studies that are conducted under the purview of the IRB.  This includes but is not limited to recruitment via flyers, telephone (verbal guide), SONA, email, social media, and internet*.

This information should be submitted to the IRB with the initial application or project revision.

The IRB reviews the material to assure that it is accurate, not coercive or unduly optimistic, and not creating undue influence on the subject to participate; this includes but is not limited to:

a) Statements implying a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and protocol

b) Claims, either explicit or implicit, that the activity, intervention, drug, biologic or device is safe or effective for the purposes under investigation

c) Claims, either explicit or implicit, that the activity, intervention, or test article is known to be equivalent or superior to any other drug, biologic or device

d) Use of terms like “new test,” “new treatment,” “new method,” or “new drug” without explaining that it is investigational

e) Promises of “free tests,” or “free treatment” when, in actuality, the participants will just not be charged for taking part in the investigation

f) Emphasis on compensation (e.g., bold type, larger font, etc.)

g) Inclusion of exculpatory language

Recruitment materials must include:

a) Title of the study

b) Name of the PI

c) Clear statement that this is research

d) Contact information for interested individuals

When appropriately worded, the following items may be included:

a) Condition being studied and/or the purpose of the research

b) Primary criteria that will be used to determine eligibility for the study

c) Time or other commitment required of the subjects

d) Location of the research

e) Potential direct or societal benefits

Recruitment materials and compensation plans cannot include:

a) coupons or discounts on the purchase price of the study product, if marketed

Once approved by the IRB, recruitment material cannot be altered or manipulated in any way without subsequent IRB approval. 

*Recruitment using social media ads that are size limited (e.g Facebook, Twitter, etc.) must be linked to a page or document that contains all required recruitment elements.

Examples

Recruitment Email

Recruitment Flyer with Pull-tags

Bad Flyer Sample

Good Flyer Sample

 

Guidance Version Date: October 16. 2013