MSU HRPP Manual Section 12-3

12-3, Advertisements

The primary obligation of the MSU IRBs is to protect the rights and welfare of human subjects of research. The MSU IRBs are also concerned with the timely review of research projects.  To facilitate the review of advertisements for research involving human subjects, please consider the following requirements.

If advertisements are proposed to be used, the IRB reviews the following:

  • Information contained in the advertisement

  • Mode of its communication

  • Final copy of printed advertisement

  • Final audio/video taped advertisement

  • Final form for advertisements posted on websites

If investigators would like to use advertisements in their recruitment practices, the advertisements must meet certain requirements. The advertisement should be limited to information prospective participants need to determine their eligibility and interest, such as:

  1. The name and contact information of the investigator or research facility

  2. The study involves research, purpose of the research or condition under study and, in summary form, the eligibility criteria that will be used to admit subjects into the study

  3. Straightforward and truthful description of the risks and/or benefits to the subject from participation in the study

  4. The location of the research or research facility and the person to contact for further information

  5. Time or other commitment required of participants

Advertisements may not:

  1. Include IRB endorsement of research projects either in recruitment materials or consent forms

  2. Include exculpatory language

  3. Emphasize the payment or amount to be paid, by such means as larger or bolder type

  4. State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol

  5. Promise “free treatment” when intent is only to say participants will not be charged for taking part in the investigation

FDA regulated research must follow additional criteria regarding advertisements:

In addition to the above criteria, the following recommendations from guidance provided by the “U.S. Food and Drug Administration Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators – 1998 Update” (http://www.fda.gov/oc/ohrt/irbs/toc4.html#payment) are followed for research to which FDA regulations and policies apply:

  1. “No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. Such representation would not only be misleading to subjects but would also be a violation of the agency's regulations concerning the promotion of investigational drugs [21 CFR 312.7(a)] and of investigational devices [21 CFR 812.7(d)].

  2. Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational. A phrase such as "receive new treatments" leads study subjects to believe they will be receiving newly improved products of proven worth.

  3. Advertisements must not make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.

  4. Advertisements must not allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.”

This guidance document supersedes those previously drafted.

Version Date: 12-11-2015

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