Printer-friendly version
Recruitment strategies in any form must be reviewed by the IRB PRIOR to their implementation. There are some recruitment strategies that are either not allowed or allowed in very limited circumstances at the UI. They include the use of finder’s fees or recruitment incentives and the use of “cold calling” potential research subjects.
Only the currently approved recruitment materials and methods should be used to recruit subjects. No changes can be made to the approved materials without IRB approval via a Modification application.
All recruitment strategies, which include but are not limited to; the mode, method, means, and content of all such recruitment strategies must be reviewed and approved by the IRB prior to their use. Recruitment letters, posters and brochures reviewed by the IRB must contain all information, text, and graphic design elements for the final product. IRB approval is required prior to implementation of any changes in content or graphic design of recruitment materials. Color and graphic design may make the document more attractive and appealing to potential subjects. However, design of recruitment materials must not include graphics, text, fonts, or design effects that emphasize compensation or could be coercive to potential subjects. Certain recruitment strategies (such as Noon News, press releases, mass e-mail) have guidelines for format, content and documentation of IRB approval. For example, an IRB approval stamp is required on 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.
Any material aimed at recruiting potential subjects into a study (including the final copy of the printed advertisement, audio or video tapes or websites) must be reviewed and approved by the IRB prior to being used. Recruitment messages in any form should not be coercive or perceived as “marketing” of the study.
Advertisements or recruitment letters should:
1) Include the purpose of the project and/or briefly state what is expected of the subject
2) Include the time commitment required of the subject.
3) Include the investigator's University department affiliation and where the research will take place
4) List a contact name and phone number.
5) Include in summary form, the criteria that will be used to determine eligibility for the study.
6) Include a brief list of benefits, if any
Advertisements or recruitment letters should not:
1) Emphasize (for example, in large or bold type) 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 or include exculpatory language (language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence).
6) Make exaggerated marketing claims or sales pitches
7) Make claims that the drug, biologic or device is safe or effective for the purposes under investigation.
8) Make claims, that are inconsistent with FDA labeling, that either explicitly or implicitly that the drug, biologic or device is known to be equal or superior to any other drug, biologic, or device
9) Use terms such as “new treatment,” “new medication,” or “new drug” without explaining that it is investigational.
10) Promise “free medical treatment,” when the intent is only to say subjects will not be charged for taking part in the investigation.
11) 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.
The following are suggestions for creating effective recruitment messages for IRB review and approval:
1) Invite subjects to participate
2) The title or invitation to participate should be brief and informative for potential subjects. The title should state that this is a research study. Avoid phrases such as “help needed” or “research subjects wanted.” The recommended wording is “you are invited” or “participants invited.”
3) Identify who is conducting study
4) State that the research study is a University of Iowa study and give the name of the department or college in which the study is conducted.
5) State the purpose of the study:
a. Use lay terms to address briefly why the study is being done.
6) Describe what subjects will be asked to do:
a. Provide a brief description of the study procedures subjects will be asked to do for participation in the study.
7) Describe the primary inclusion / exclusion criteria:
a. Potential subjects need to know whether or not they would be eligible to participate. Only include the criteria that subjects would know about themselves. Limit the exclusion criteria to the most common reasons a person would be ineligible to participate. If there are a lot of inclusion/exclusion criteria, it is not necessary to list all of them.
8) Include the time commitment:
a. Provide a general statement about the overall time commitment for the subject.
9) Describe the primary study procedures:
10) Provide a brief overview of the main study procedures. If the study protocol includes many study activities for the subject, it is not necessary to list them all in the recruitment poster or brochure.
11) State whether subjects will be paid for participation:
a. Do not emphasize (large font or bold type) that payment is offered.
12) Provide contact information:
Provide the name and/or contact information for a member of the research team that the potential subject can call to find out more information about the study or to volunteer to participate. The contact information does not have to be the name and contact information for the Principal Investigator.