Research participants may be compensated for their time or travel or be offered in-kind compensation for their participation in research. Participants should be able to make informed decisions to participate based on the real risks and benefits of participation, not on compensation. Direct payments or other forms of remuneration offered as an incentive or reward for participation should not be considered a “benefit” to be gained from research.
Review of participant compensation in the protocol application
The IRB will review proposed study compensation as to whether paid participants are recruited fairly, informed adequately, and paid appropriately as well as determine whether the rewards offered for participation constitute potential undue inducement, coercion or other ethical considerations. To assist the IRB with their review, clearly stated in the protocol application who the subjects are, what incentives are being offered, the schedule of payment, and the conditions under which the offer will be made. The IRB recommends investigators incorporate the below concepts in the proposed study procedures*:
- Compensation is generally allowable with appropriate informed consent and should be appropriate for the time and effort participants devote to participation, for their time and inconvenience as well as an incentive a person to participate. Compensation may include monetary remuneration (cash, vouchers, etc.), non- monetary (gifts/promotional items, course credit, extra credit, etc.) or online compensation using Mechanical Turk or a prepaid online code. Investigators using non-monetary forms of payment should ensure that the method of payment can be readily used by participants (e.g., the store or outlet is easily accessible) and is appropriate to the population.
- Many researchers generally base a payment amount on the average wage in the location where the research is conducted or for the specific study population. This is often an acceptable level of payment that does not exert undue influence. When hourly payments are not suitable or feasible, compensation may be task-or procedure-specific. Overall, subjects completing the same tasks in a single research project should be compensated at equivalent rates.
- Compensation should not be so large to unduly influence or persuade participants to accept risks that they would not otherwise accept or participate in activities to which they would otherwise strongly object based on personal values or beliefs or volunteer against their better judgment. Safeguards must be outlined in a study to protect the rights and welfare of all vulnerable populations (see 45 CFR 46.111(b)).
- Investigators planning to involve minors as participants will need to consider the ways children of different ages view the value of payment and ensure that the amount and method is age-appropriate and does not present undue influence. For younger children, a small gift/toy may be suitable, but for older adolescents/teens, a gift card or other form of payment may be more appropriate. Payment to parents may be provided to defray expenses/inconvenience associated with their child’s participation in the research. However, because parents have the authority to permit a child’s participation in research, excessive payments could cloud the parent’s judgment or cause the parent to exert pressure on the child’s decision to participate, negatively impacting the rights and welfare of these minors as participants.
- Compensation for research is not coercive in and of itself, since it does not involve a threat of harm. However, compensation can create potentially coercive situations. Examples include telling prospective subjects in a class that they will lose grade points if they do not participate in the research or excessively high payments to a parent for a child’s participation Payments or rewards that undermine a person’s capacity to exercise free choice invalidates consent.
- Excessive incentives may also be of concern since they could induce participants to lie or conceal information that would disqualify them from the study in order to receive payment.
* abstracted with permission from Compensation of research subjects, Committee for Protection of Human Subjects, University of California, Berkeley, https://cphs.berkeley.edu/compensation.pdf
Tracking of participant costs
UMBC investigators are required to account for monies disbursed during the course of a project. This is a necessary component of financial auditing. However, this accounting must be done in a way that participant confidentiality is not compromised. Using any type of identifier will void confidentiality protection mechanisms and possibly contradict what the participant was informed about in the consent document.
For this purpose, investigators should maintain a log of expenses, tracking each expense by subject ID, the amount paid and when payment occurred. The log of subject ID and payments may be linked to financial accounting records, but they must be kept separate to protect confidentiality. The log of subject IDs must be stored in the protocol file as a password protected document, accessible only by persons identified in the approved IRB application.