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Ensuring Fairness and Compliance
Research Study Coordinators (RSC) and Principal Investigators (PI) play an important, hands-on role in designing research participant compensation plans that are both ethical and practical. Planning fair compensation for research participants is fundamental to making sure that participants are treated well and ethically.
The U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) provide some broad guidelines, but it’s actually up to Institutional Review Boards (IRBs) to make final decisions on compensation.
Let’s look at the various aspects of participant compensation as important reminders of guidance and for keeping transparency throughout the process.
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More about Flexible Research Compensation
Retention is becoming increasingly difficult
Adding flexibility to participant compensation
Diverse populations over time
The benefits of subject participation
Payments should be prorated if a participant withdraws early. For example, if the total compensation for completing the study is $100, but a participant only completes half of the required study visits, they should receive $50. Proration ensures fairness and prevents penalizing participants for early withdrawal, aligning with ethical guidelines that discourage creating a “penalty” for withdrawing (Office for Human Research Protections [OHRP], 2023).
The compensation structure should be evaluated to avoid any appearance of potential coercion. Research participant compensation should acknowledge the time and effort of participants but shouldn’t be so large as to overshadow the study’s risks, or obscure informed consent. A $500 payment might be seen as coercive in a simple low-risk study, while a payment of $50 might not be sufficient to encourage participation in a more time-consuming, higher-risk study.
It’s important to note in any study that compensation is not a “benefit” of participation but rather a reimbursement for time, effort, and expenses such as travel and lost wages. Compensation amounts, methods, and schedules should be clearly described in the informed consent documents. A clear breakdown of payments for each visit or activity should be provided. As an example, participants might receive $50 as a travel reimbursement and $100 for attending a study visit.
When submitting a research protocol, ensure that the IRB application includes detailed descriptions of all research participant compensation methods, whether monetary or non-monetary (gift cards, raffles, etc.). The IRB will assess whether these compensation methods are appropriate for the study population and whether the payment structure might unduly influence participant behavior. It is important to consider factors such as socioeconomic status, as higher payments can disproportionately affect low-income participants’ decisions.
Add a clause in the participant consent form stating that fraudulent participation will result in the forfeiture of compensation. This prevents participants from signing up multiple times or providing false data to collect compensation without fulfilling the study requirements.
Be aware of institutional policies regarding tax reporting and compliance. If participants receive compensation of more than $600, the IRS mandates that these payments be reported, and proper documentation must be collected. Additionally, institutions may have specific requirements for reporting payments under $600, so consult with the IRB office and financial departments to ensure compliance.
Consult with your IRB, legal counsel, and financial office when designing compensation procedures. They can help ensure that all compensation methods align with both ethical standards and regulatory requirements, preventing potential legal issues down the line.
Studies show that by using carefully selected compensation options, participants are easier to more easily recruited and are more likely to stay engaged throughout the duration of a study. According to the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP), the number of clinical trials has grown from just under 3,000 in 2019 to over 670,000 in 2021. As the number of clinical trials grows, the demand for participants has intensified, making it more difficult to attract participants to any single trial.
U.S. Department of Health and Human Services (DHHS). Human Subject Regulations. https://www.hhs.gov
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