Recruitment of Subjects

Recruitment

Investigators and their research staff are responsible for recruiting participants in a fair and equitable manner, weighing the potential benefits of the research to the participants against their vulnerability and the risks to them.

Recruitment materials, including brochures, flyers, advertisements, audio tapes, video tapes, and letters to potential subjects, must not contain coercive language or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol. 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.

Any material (including audio or video) aimed at recruiting potential subjects into a study must be reviewed and approved by the IRB prior to being used. Advertisements used to recruit research participants should generally be limited to the information the potential research participants need to determine their eligibility and interest:

• Name and address of the PI and research facility (if applicable)
• Condition under study and/or the purpose of the research
• In summary form, the criteria that will be used to determine eligibility for the study
• Brief list of participation benefits, if appropriate (e.g., a no-cost health examination)
• Time or other commitment required of the research participant
• Location of the research and the person to contact for additional information
• Do not include the name of commercial sponsors or products.
• Avoid phrases such as "help needed" or "participants wanted." The recommended wording is "you are invited" or "participants invited."
• Advertisements may state that research participants will be paid but should not emphasize the payment amount by such means as larger or bold type. 

 

Materials That Do Not Require IRB Review

• Doctor to Doctor Letters - communications intended to be seen or heard by health professionals, such as "dear doctor" letters and doctor-to-doctor letters (even when soliciting for study subjects) do not require IRB approval
• News stories
• Publicity intended for other audiences, such as financial page advertisements directed toward prospective investors

 

Research Participant Compensation

Monetary compensation is allowed as a form of recognition for the investment of the research participant’s time, loss of wages, or other inconvenience. Monetary compensation should be relevant to the cultural context in which the research participant resides. It should be appropriate to the time and procedures involved.

Compensation plans must be evaluated and approved by the IRB. The IRB will evaluate the compensation method on a study-by-study basis to assure the amount of payment and the proposed method and timing of disbursement is not coercive and does not present undue influence.

The IRB will consider the following when reviewing the proposed compensation plan:

• Payment should accrue as the study progresses and not be contingent upon the participant completing the entire study.
• 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, provided the incentive is not coercive.
• Any amount paid as a bonus for completion must be reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.

If compensation is involved, the consent form should state the value of such compensation, method of payment and payment schedule (such as mailed to participants, given to participant in person, etc.). If payment is prorated, the consent should describe the prorated scale if the participant decides to withdraw or is withdrawn by the researcher.

Information regarding how to process payment for research subjects is posted on the Accounting Services webpage.

 

Reimbursement for Study-Related Expenses

Reimbursement for actual expenses, such as travel to and from the clinical trial site and associated costs such as airfare, parking, and lodging does not raise issues regarding undue influence. Reimbursement requires participants to provide copies of receipts for their actual expenses.