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The initial contact must be initiated by the physician or an employee of the practice or facility. For strategies to minimize undue influence, refer to the IRB policies and procedures regarding Review of Studies Involving Vulnerable Populations.įor studies that involve recruitment of patients from a medical practice or other treatment facility, it is not acceptable for investigators not affiliated with that practice or facility to directly recruit patients. This method raises ethical concerns because individuals may have difficulty saying no to an authority figure.
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The participants/patients provide consent ahead of time to be contacted for future research studies.
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Direct recruitment of participants unknown to the researchers.Examples include flyers posted in public settings, newspaper ads, and radio and television advertisements.
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Use advertisements, notices, and/or media to recruit subjects.All recruitment methods must be described in the protocol application. The following are examples of common recruitment methods for human research studies. The content of recruitment materials and the method for communicating it cannot create undue influence or contain misleading or exculpatory language.
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Materials must also be submitted for review and re-approval at the time of continuing review. The IRB must approve all recruitment methods and material (flyers, letters, brochures, e-mail advertisements, radio announcements, etc.) prior to use. As such, recruitment of participants into a study may not begin prior to IRB approval. Advertisements and recruitment material are considered an extension of the informed consent and participant selection process.
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