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The JHM IRB is responsible for ensuring that any payment or remuneration offered to participants in human subject research is fair and not an undue inducement to participate. The following guidelines are provided to help investigators develop payment or remuneration plans.
- Compensation: Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
- Remuneration: Payment for participation in research.
Remuneration for participation in research should be reasonable and the amount paid should be comparable to other research projects involving similar time, effort, and inconvenience. Payment amounts should not be large enough to constitute an undue inducement to participate in a risky or uncomfortable procedure. For studies in which financial remuneration is a major reason for participation, and which represent minimum risk to the participants, remuneration may be sufficient to engage participants.
- Short research studies involving one visit: It is acceptable to provide participant payment contingent upon completion of the study. The plan for remuneration should provide that subjects disqualified through no fault of their own are paid for the time and effort they expended prior to their termination from the study.
- Research studies involving multiple visits or lengthy or repeated participation: Partial payment should be provided to participants who withdraw, are discharged early from the study by the investigator, or otherwise fail to complete the study as agreed. The amount of partial payment should relate to the amount of time, effort, or discomfort involved. Payment schedules may be designed on a per-day, per-visit, or per-procedure rate, or some combination thereof. The terms for partial payment must be described in the application and in the consent form.
- End-loaded incentives, such as completion bonuses: Such remuneration may be acceptable to encourage the completion of a research project. The amount of such incentives should depend on the risk and duration of the study interventions. In general, the range for a completion bonus should not exceed 50% of the total remuneration for the study. However, studies that involve increased risks or discomfort to the participant or which require a long-term commitment by the subject should not include a large bonus.
- Prompt payment: The consent document should describe the remuneration amount and the timing of payment. It is acceptable to withhold some or all of the payment until the end of the study, however, once participation is complete, withdrawn, or discharged, payment must be provided promptly unless the application and consent form provide otherwise.
- Peer or network (“snowball”) recruiting: The IRBs have been asked to consider a recruitment method that is referred to as “snowball recruiting”, “respondent-driven sampling”, or “peer or network recruitment.” The method involves providing remuneration in the form of gift certificates or cash to individuals who participated in a research project if they refer others (friend/associate/partner) for enrollment into a research project. The JHU/JHHS General Counsels have determined that the practice is not illegal in the State of Maryland and that the practice does not meet the definition of a “finder’s fee.” Therefore, an investigator may request approval of this type of recruitment activity. The IRBs will make a case-by-case decision on such requests. They will evaluate the protocol to determine that the proposed amount of compensation is reasonable and reflective of the work involved, that there are proposed limits to the amount that may be provided to those who refer others, and make an assessment of the risk of undue influence or coercion that may be exerted by an individual who refers others for study participation.
What about bonus payments to the research team or the organization designed to enhance recruitment?
The contract for research sponsored by commercial sponsors must include budget terms for conduct of the project. It is the policy of the Organization that a budget for commercially funded research may not include direct payments to personnel who will conduct the project. In addition, a budget may not include a proposed financial bonus or proposed financial penalty specifically targeted at participant recruitment efforts.
Investigators who are approached by sponsors with an offer to provide a payment contingent on a particular rate or timing of enrollment (for example, an extra payment if five participants are recruited in one week, or extra payment to the site with the highest enrollment for the month), should ask the sponsor to renegotiate the per capita rate with the Office of Research Administration (ORA) so that additional resources may be put towards recruitment.