When planning for recruitment of research participants, the principal investigator (PI) and the research team need to consider how they will communicate with their intended participant population. The IRB, regardless of whether it is a local UI IRB or an external IRB, must review and approve all recruitment methods and materials prior to their use.  

Guidance and Best Practices 

The UI Standard Operating Procedures and Researcher Guide provides information in section II. 11.A.ii Recruitment materials & methods.  

The recruitment message is an invitation for people to consider participating in the research and is the beginning of the consent process. Messages should be brief and informative and written in plain language. A research study may need different recruitment messages for different subject populations. 

It is good practice to plan more than one recruitment method at the beginning of the study and to describe each of them in the HawkIRB application and/or the external IRB application. The research team does not need to use all of the IRB-approved recruitment methods but including them is helpful in case the primary method is not as effective as expected.  

Note: the application for commercial/external IRBs only has two options for recruitment methods. Otherwise, the applications and processes are the same. 

A Recruitment Letter Template,  available on the HSO website, includes standard language and prompts to include study-specific information to assist researchers with preparing recruitment letters and email messages. The HSO strongly encourages the use of this template as it has been endorsed by the IRB, UI Health Care Joint Office for Compliance, and Human Research Protection leadership. 

Recruitment messages should: 

Researchers may state the compensation amount in recruitment materials. However, the language or graphical elements for recruitment materials should not emphasize compensation or present study information in a way that could be considered coercive to potential subjects. Additionally, the language and graphics used should not be perceived as “marketing” the study. 

Recruitment messages should not:  

1) Emphasize the payment amount. 

2) Include the name of commercial sponsors or products. 

3) Use phrases such as "help needed" or "subjects wanted.” Instead use "you are invited"  

or "participants invited." 

4) State or imply a certainty of a favorable outcome or other benefits beyond what is  

outlined in the consent document and protocol. 

5) Emphasize how “important” the study is. Nor should it include any exculpatory language. 

6) Make exaggerated marketing claims or sales pitches 

7) Make claims about the safety or efficacy of the study drug or device or include statements that are inconsistent with Food and Drug Administration (FDA) labeling 

8) Use terms such as “new treatment,” “new medication,” or “new drug,” without stating that the medication is investigational. 

9) Promise free medical treatment when it is just that participants will not be charged for taking part in the study 

The Researcher Guide includes guidance about certain recruitment methods that are not allowed, including cold-calling and the use of finders' fees. 

The Guide also provides information about: 

Additional Considerations 

IRB approval stamp - Some recruitment outlets may have their own specific guidelines for format and content and may require documentation of IRB approval. For example, while the IRB does not require an approval stamp on recruitment messaging, an IRB approval stamp is required for Noon News announcements, Cambus posters and press releases distributed through UI channels. It is important to consult the guidelines for each office or department prior to the IRB-submission of the advertisement, poster or message. 

Positions of power or authority - When the investigator or a member of the research team is in a position of authority over potential subjects (such as an instructor recruiting students in their class or a health care provider recruiting their own patients), to minimize the possibility of coercion or undue influence it may be best for someone else on the research team to conduct the recruitment and consent process and to be the contact person on the research team.  

Use of educational records - Under the Family Educational Rights and Privacy Act (FERPA), recruitment activities can only be conducted by the instructor and others who are authorized to have access to educational records (including who is enrolled in the course). For additional information, see the educational tool  Research Involving University of Iowa Student Records. 

IRB Approval 

All aspects of the recruitment plan and content must be reviewed and approved by the IRB before participant recruitment can begin. Recruitment materials (including posters, emails, videos, letters, etc.) reviewed by the IRB will be reviewed as the final product. Therefore, it is important that they contain all information, text, and graphic design elements. If videos are used as a subject recruitment tool, provide either the URL if the video is posted online or upload it to HawkIRB.  If the video file is too large, the PI can create a OneDrive file.  Add the location of the file in the IRB application and share it with the HSO staff and IRB Chairs involved in the review.  

Once the recruitment plan and materials have been approved by the IRB, no changes to the methods or materials may be made without having the changes approved by the IRB by submitting a modification form in HawkIRB. There may be an exception to this requirement for research that qualifies for exempt status. See the UI IRB Standard Operating Procedures and Researcher Guide, Section I, Part 13 (Exempt Human Subjects Research – Modifications to an Exempt Application). 

For more information about recruitment planning and materials, there are two recorded lectures in the IRB ICON Course for Researchers, under Additional Topics: 

For more information about submitting recruitment plans and materials for approval, see the Herky Hint for HawkIRB in this month’s newsletter.