Questions on Using Generic Recruitment Flyers at Clinical Trial Sites

Question:

We have a generic flyer for a specific condition that we would like to send out.  The flyer is IRB approved at the sponsor level and we would like to know if it is acceptable for our site to use.
- Regulatory Coordinator, University Medical Center

Response:

For this question, I am assuming that a “generic” recruitment flyer is one that includes protocol specific information and may include information about the sponsor but does not include site-specific information.

Generic flyers approved by the IRB may be used by the site.  Changes to approved generic materials must be reviewed and approved before use.  For example, including site-specific information such as an address or phone number, changing font type or format, or including site-specific dollar amounts that will be paid to subject participation in the research would trigger the requirement for IRB approval of the flyer.

As is often the case, if there is any question, you should contact your IRB for assistance in determining if the material needs to be submitted for review, being mindful that different IRBs may have different policies regarding review and approval of recruitment materials.

About the Author

Yvonne Higgins | Quality Assurance Advisor, Compliance

Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).

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