Continuing education of the research community is a very important function of the Institutional Review Board (IRB). Once a month, topics of interest will appear in the UNMC Today. Today’s topic is on subject recruitment.
Do subject recruitment efforts require IRB approval?
Yes. All recruitment strategies and materials, such as print (newspaper and fliers), online (UNMC Today) and radio advertisements, must be reviewed and approved by the IRB before they can be used to recruit potential subjects. Additionally, all recruitment fliers posted at UNMC, The Nebraska Medical Center, and the University of Nebraska at Omaha must include the IRB approval stamp. A copy of the flier will be kept in the IRB study specific file.
What should appear on an advertisement?
Generally all advertisements should be limited to information a potential subject may need to determine if they are interested and eligible to participate in a study. Appropriate items to include are:
- Name and address of the investigator and associated institution
- Purpose of the research
- Eligibility criteria (in shortened, easy to read format)
- Listing of realistic benefits to the subject
- Time or other commitments required from the subject
- Location of the research (if different from the associated institution listed above), contact person, and phone number for further information.
Print advertisements should use appropriate font size and bolding so that the subject is not misled by inappropriate attention paid to a particular point in the advertisement.
What should NOT appear on an advertisement?
- Do not use the word “new” to describe the treatment or drug.
- Do not use statements that may lead the subject to think that the investigational drug, device, or treatment is safe and effective.
- Do not make claims that the investigational drug, device, or treatment is equal to or better than other current available treatments.
- Do not promise “free medical treatment.” Alternately use the more appropriate statement, “participants will not be charged for taking part in this research study.” The promise of free medical treatment may be seen as coercive to lower income or uninsured subjects.
Can I tell potential subjects that they will be paid to participate in the study?
The IRB prefers that advertisements do not discuss financial compensation due to the potential for coercion. With justification, the IRB may permit mention of financial compensation (such as “a stipend may be available”), but will not allow monetary amounts to be stated in the ad (such as “you will be paid $200 for participation in this research study.”)
Does the IRB need a copy of the published newspaper ad?
Yes, so that the IRB can be certain that the layout and font size approved by the IRB is reflected in the final published copy.