Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-2

Title 2:

Subject Recruitment and Compensation

Effective Date:

09-24-14

Revision History:

06-20-00;08-29-00; 09-20-01; 06-07-04; 6-21-06; 11-30-09

Objective

To describe the policies and procedures of the VCU IRB pertaining to subject recruitment and compensation.

Description

  1. Subject Recruitment:

    Recruitment materials, including brochures, flyers, advertisements (such as printed-, radio-, television-, email-, and webpage- ads), audio tapes, video tapes, and letters to potential subjects, must not contain coercive language or incentives. The information provided should be an accurate presentation of the research study purpose and/or procedures.

    For example, if the study involves comparing an investigational drug to a placebo,the advertisement should not mention the study drug only. Rather, it should indicate that some subjects in the study will receive a placebo, or describe the purpose of the study as comparing the investigational drug to a placebo.

    Advertisements are limited to the information prospective participants need to determine their eligibility and interest, such as:

    • In summary form, the criteria that will be used to determine eligibility for the study.
    • A brief list of benefits to participants, if any.

    Any material aimed at recruiting potential subjects into a study (including all media described above or any other medium) must be reviewed and approved by the IRB prior to being used.

    1. Guidelines for Developing Recruitment Materials:
      1. Include the purpose of the project and/or briefly state what is expected of the subject. Include the time commitment required of the subject.
      2. Include the investigator's University department affiliation and where the research will take place.
      3. List a contact name and phone number.
      4. Do not include the name of commercial sponsors or products.
      5. Do not include the name of commercial sponsors or products.
      6. Do not include exculpatory language.
      7. Avoid phrases such as "help needed" or "subjects wanted." The recommended wording is "you are invited" or "participants invited.
    2. VCU IRB Procedures:
      1. The IRB will review the information contained in the advertisement and the mode of its communication to determine that the procedure for recruiting participants is not coercive.
      2. The IRB will review the final copy of printed advertisements to evaluate the relative size of the type used and other visual effects.
      3. Video and Audio Advertisements:
        • When advertisements are to be taped for broadcast, the IRB will review the final audio/video tape.
        • The IRB will review and approve the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording.
        • The review of the final taped message prepared from an IRB-approved script/text may be accomplished through the expedited review procedure.
      4. The IRB will review all advertising and recruitment materials to ensure that advertisements do not:
        1. State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and in the protocol.
        2. Include exculpatory language.
        3. Make claims, either explicitly or implicitly, that the instrument, drug, biologic, or device is safe or effective for the purposes under investigation.
        4. Make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other instrument, drug, biologic, or device.
        5. Use terms such as "new treatment," "new medication," or "new drug" without explaining that the test article is investigational.
        6. Promise "free medical treatment," when the intent is only to say participants will not be charged for taking part in the investigation.
        7. Advertisements may state that participants will be paid or compensated for their time, but should not emphasize the payment or the amount to be paid by such means as larger, colored, or bold type.
    3. Compensation for Research Participants:

      Payment for participation in research may not be offered to the subject as a means of coercive persuasion. Rather, it should be a form of recognition for the investment of the subject's time, loss of wages, or other inconvenience incurred. Accordingly, compensation may not be withheld contingent on the subject's completion of the study. In most cases involving continued participation, compensation should be given on a reasonable prorated basis to avoid the impression that the investigator is coercing the subject to continue in a study or is punishing the subject for non-compliance.

      1. VCU IRB Guidelines for Compensation of Research Participants:
        1. If participants will be paid for their time/effort, it is recommended that the wording "Compensation Available" be used, rather than specifying a specific amount.
        2. Compensation should not be excessive to the nature of the project. If the investigator wishes to include a specific amount of compensation in an ad, the Application Form should include the investigator's justification as to why this is needed.
        3. Payment to research participants will not be considered in the analysis of risks and potential benefits, but rather a recruitment incentive.
        4. The amount and schedule of all payments should be presented to the IRB at the time of initial review.
        5. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither is coercive or presents undue influence.
        6. Any credit for payment should accrue as the study progresses and not be contingent upon the participant completing the entire study.
        7. Unless it creates undue inconvenience or coercive practice, payment to participants who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn.  For example, in a study lasting several days, the IRB may find it permissible to allow a single payment date at the end of the study, even to participants who had withdrawn before that date.
        8. While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable, providing that such incentive is not coercive.
        9. The IRB will determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.
        10. All information concerning payment, including the amount and schedule of payment(s), should be provided in the informed consent document.
        11. Compensation for participation in a trial offered by a sponsor may not include a coupon good for a discount on the purchase price of the product once it has been approved for marketing!
        12. NOTE: Important information regarding how to process payment for research subjects is available through VCU Grants and Contracts Accounting and/or your Department. Participants may be asked to sign agreements, including providing Social Security Numbers (SSN) and home address information for the purpose of taxation.
      2. VCU-Wide Compensation Prohibitions:
        1. VCU prohibits payments (including offers for unrestricted grants/gifts) from sponsors to research staff or organization that are tied to the rate or timing of research participant recruitment ("bonus recruitment payments").
        2. VCU prohibits payments in exchange for referrals of research participants ("finders fees").
    4. IRB Processes

      IRB review of advertising that will be presented as audio or video advertising will involve both scripts and copies of the tape prepared according to the script. It is strongly recommended that a proposed WRITTEN script for radio, television, or video first be submitted for review by the IRB.

      1. If the study requires full board review, the SCRIPT will be reviewed, and found “approvable” or “not approvable”. Where found “not approvable”, modifications may be suggested.
      2. If the study can be reviewed via expedited review, the SCRIPT will be reviewed, and may be found “approvable”, “not approvable”. Where found “not approvable”, modifications may be suggested.
      3. An approvable script will be returned to the submitter to use to prepare a tape.
      4. For full or expedited, a single reviewer will review the tape (audio or video) when submitted, according to the approvable script.
      5. Insignificant (MINOR grammatical) deviations (for example: “a” changed to “an”; “the” changed to “those”) from the script are acceptable as long as they do not violate the IRB advertising guidelines. These deviations must not change the meaning of the script in any way and are taken at risk of refusal by the IRB. In other words, deviations that do violate the guidelines will cause rejection of the tape by the VCU IRB.
      6. The reviewer may find the tape “approved” or “unable to approve”.
      7. The IRB Panel or a single reviewer may review a tape (audio or video) submitted without an approvable script. If the tape follows the IRB advertising review guidelines appropriately, it may be approved. However, if there is anything in the tape, which a single reviewer finds unacceptable, the tape will be referred to full Panel. If not approved by Panel, the submitter will be asked to submit a script so that the full panel may indicate in writing the modifications that the IRB requires for approval.
      8. Audio scripts which are for “ON HOLD” communications for phone systems or public service announcements will be reviewed by a single reviewer. These scripts may be found “approved” (to be read verbatim) if acceptable to the reviewer.

Responsibility

It is the responsibility of the principal investigator to follow these guidelines and submit all advertising materials for review and approval by the IRB, prior to use. It is the responsibility of the IRB to review these materials, ensuring that a coercive situation does not exist, and to follow the processes described above.

References

Gift card/cash policy for research subject compensation