Version
2.3
Date Updated
Monday, April 2, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
Date:  4/2/2012

  1. Introduction
    The IRB must review, approve, and stamp all recruitment procedures and materials prior
    to their use by an investigator, since recruitment materials (e.g., advertisements, flyers,
    phone scripts, newspaper ads, radio and television announcements, bulletin board tearoffs,
    Internet postings, and posters) are part of the informed consent process.
    1. When to Submit Recruiting Materials to the IRB
      • Direct advertising for research subjects is considered the start of the informed
        consent process. Recruitment materials must be submitted with the research
        protocol for initial review.
      • If the investigator decides at a later date to use recruitment materials in addition
        to the approved materials or to change the currently approved materials, the
        materials must be submitted as an amendment to the research protocol and must
        receive IRB approval before they are implemented.
    2. Generally acceptable recruitment approaches
        • advertisements, flyers, phone scripts, newspaper ads, radio and television announcements, bulletin board tear-offs, Internet postings, and posters
        • introduction letters sent to colleagues to distribute to eligible individuals- interested individuals contact research team
        • individuals who are known by or familiar with them (e.g., clinic staff) serve as initial contact with possible subjects to ascertain interest
    3. Generally unacceptable recruitment approaches
        • cold calling, e.g., identification of potential subject through search of medical records or other databases, then have researcher with no previous interaction with them make contact
        • recruit immediately prior to or after a sensitive or invasive procedure
        • retain identifiable information obtained at screening without the consent of those who either failed to qualify or refused to participate for possible recruitment for other studies in the future
    4. Appropriate Content and Format for Recruiting Materials
      • Recruitment materials are evaluated for the relative size of the type used and
        other visual effects. Therefore, materials should be submitted in their final format
        for review and approval.
      • A description should be provided regarding the manner in which the materials will
        distributed/utilized and by whom (i.e., clinic staff will hand flyer to patients or email
        announcement distributed through UIC Massmail).
      • Recruiting materials may state that subjects may be compensated or reimbursed,
        but specific dollar amounts should not be a major feature of the advertisement.
      • For recruiting materials that are to be taped for broadcast, transcripts must be
        submitted for review and approval. The final taped message may be approved via
        expedited procedures.
      • The recruiting material must not be unduly influential in its approach and/or
        should not promise a certainty of cure or other benefits beyond what is outlined in
        the informed consent document and the research protocol.
      • If investigational agents are involved in the research, no claims may be made
        (explicitly or implicitly) that the drug, biologic or device is safe or effective for the
        purposes under investigation, or that the test article is known to be equivalent or
        superior to any other drug, biologic or device.
      • Recruiting materials may not use the terms "new treatment," "new medication," or
        "new drug" without explaining that the test article is investigational, i.e., not
        approved by the FDA. A phrase such as "receive new treatments" leads subjects
        to believe they will be receiving newly improved products of proven worth.
      • Do not promise "free medical treatment" when the intent is only to say that
        subjects will not be charged for taking part in the research investigation.
    5. Items that Must Be Included in Recruiting Materials
      • Research project title or identifier (i.e., “Smoking Cessation”).
      • A description of the type of research and purpose of the research.
      • The word "research" must be included in the description. It is not enough to imply
        that the subject is being recruited for research by just using the word "study".
      • A name of the person or office to contact and the number to call for further
        information.
      • The UIC research protocol number, when available (this number will not be
        available at the first initial review submission), and the fact that the research is
        being performed at UIC.
      • The Principal Investigator's name, department, and address.
      • The specific location of the research.
      • Footer with version # and date.
      • Space for the UIC IRB approval stamp (approximately 2.5 x 1.5 inches).
    6. Information that May be Included in Recruiting Materials
      • In summary form, the criteria that will be used to determine eligibility for
        participation in the research.
      • A description of the time commitment and duration of the subjects' participation
        and number of visits required for the research.
      • A brief description of the benefits of the research, if any (e.g., smoking
        cessation).
    7. What Does Not Require IRB Review
      • Medical society newsletters.
      • News stories (i.e. public service announcements) and
      • Publicity intended for other audiences, such as financial page advertisements
        directed towards prospective investors.
      • Dear colleague/doctor letters - only those announcing the existence of the
        research. Note that if the the letter asks the colleague/ doctor to help with
        recruitment, then IRB approval is required