Protocol Application Submission Guidance for Recruitment/Advertising
Protocol application submission should include:
- The advertisement(s) described in the protocol application.
- Uploaded final printed ad, flyer, or audio/videotape with the protocol submission.
Please note: IRB approval must be obtained for any changes to approved advertising materials for Expedited or Full Board protocols.
Required Elements of Research Advertisements:
- Clearly state that the advertisement is for participation in a research project.
- State the purpose of the research.
- Summarize the eligibility criteria.
- Provide the benefits to the participant, if applicable.
- Indicate the time and participation commitment.
- Indicate the location of the research.
- Provide the name, address/email, and department of the Principal Investigator (PI).
- Provide a contact person and phone number.
- Indicate that WVU IRB approval or acknowledgement is on file.
- Do not imply a certainty of a favorable outcome or other benefits beyond the information contained in the consent document and the protocol.
- Do not include exculpatory language.
- Do not emphasize compensation by using a larger, bold, or different color font.
Advertisements for Research Involving Drugs, Devices, or other Test Articles:
- Do not make claims either explicitly or implicitly that the drug, biologic, or device was safe or effective for the purposes under investigation.
- Do not make claims either explicitly or implicitly that the drug, biologic, or device was known to be equivalent or superior to any other drug, biologic, or device.
- Use terms such as "investigational new treatment," "investigational new medication," or "investigational new drug."
- Do not promise "free medical treatment" when the intent is to indicate that participants will not be charged for their participation in the research.
- If a placebo is used, clearly state that some participants may receive a placebo.
Planning to recruit via MyChart?
Please use the COE MyChart Template with Examples under "WVCTSI Resources" on the WV Center of Excellence (COE) website in order to streamline the advertisement approval process.
Please see WVU OHRP SOP 027: Screening, Recruiting, and Advertising for Participant Enrollment, for more information about participant recruitment and advertising.