Recruitment
Keys to Consider
Potential subjects must be recruited in a fair and equitable manner. You must avoid recruitment practices that place potential subjects at risk of coercion or undue influence.
The IRB will evaluate the setting and purpose of your research proposal to confirm that the selection of participants is equitable and will pay special attention whether participants are vulnerable to coercion or undue influence due to their status, condition or situational vulnerability. Do not use exculpatory language in any advertisement.
The IRB may ask you to revise your advertisements for recruitment. Changes may include revisions of font, visual affects as well as text revisions for better subject understanding. You are required to submit a final copy of all advertisements as well as printed advertisements.
How It Will Be Evaluated
The IRB will review direct advertising for research participants which is defined as advertising that is intended to be seen or heard by prospective participants to solicit their participation a study. All advertisements should reflect what is described in the consent form. The IRB will review the information contained in the advertisement and the mode of communication to assure that the procedure for recruitment is not coercive.
Describing Payment
When the IRB evaluates the selection of participants, it considers the influence of payments to participants. While the Federal Regulations do not specifically state how much researchers should pay subjects or what that payment should look like, the IRB will apply the principle of reasonable compensation as it reviews participant payment for their time and effort. The IRB will also take into account information from the community and culture as it evaluates the appropriateness of participant payment.
Your advertisement may state that participants will be paid, but should not emphasize the payment or the amount to be paid, by such means as large or bold type.
Audio/Video Recruiting Submission
If your advertisements will be taped for broadcast you should submit a draft or final copy of the audio/video tape for review. The IRB will review the draft or final copy to confirm that the wording is appropriate and clearly reflects the intent of the research.
Other Criteria
Outcomes and benefits are stated simply and truthfully when compared to the consent document and protocol
- It does not make claims, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation
- It does not make claims, either explicitly or implicitly, that the test article is know to be equivalent or superior to any other drug, biologic or device
- It does not use terms such as “new treatment”, “new medication” or “new drug” without explaining that the test article is investigational
- Does not promise “free treatment”, when the intent is only to say participants will not be charged for taking part in the investigation
Information That May Be Included
Your advertisement to recruit participants should be limited to the information the potential participants need to determine their eligibility and interest. For research conducted through the University of Minnesota advertisements to recruit participant for research must include the words “research” and “University of Minnesota” to further insure potential subjects know it is research. If appropriately worded, the following items may be included in advertisements.
- The name and address of the clinical investigator or research facility
- The condition under study or the purpose of the research
- In summary form, the criteria to determine eligibility for participation
- A brief list of participation benefits, if any (e.g., a no-cost health exam)
- The time or other commitment required of the participants
- Location of research and person or office to contact for further information
References
The Belmont Report on Justice
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