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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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A one-size-fits-all approach to research compensation fails to account for diverse populations’ varied preferences and needs.Flexible Payment Options in Clinical Trials are no longer a luxury in today’s competitive environment.
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.
Fair and ethical research participant compensation should ensure that payments are proportional to the demands of the study. This includes prorating payments for partial participation. Research shows that participants should be compensated based on the amount of work they have completed, not necessarily conditioned on them actually completing the study (Gelinas et al., 2020).
Compensation levels should be carefully developed to avoid undue influence on participant decision-making. DHHS guidelines emphasize that research participant compensation should not be so high that it coerces participants, especially those in sensitive or high-risk studies (DHHS, 2021). For example, offering excessive payments might create pressure for low-income participants, and might be considered coercive.
According to the Office for Human Research Protections (OHRP), informed consent should clearly outline all compensation information, ensuring participants fully understand the payment structure before they commit to the study. Transparency is important. Knowledge of full compensation details is essential to supporting trust and ethical standards in clinical research.
The institution’s IRB plays a key role in reviewing and approving compensation plans to ensure that payments are fair and that participants are not unduly influenced. IRBs review research proposals to ensure they adhere to ethical guidelines, regulations, and relevant policies. They also monitor ongoing studies to ensure participant safety and well-being.
Preventing fraud and abuse has become more important than ever, especially with the increasing use of online research. The National Institutes of Health (NIH) recommends incorporating fraud prevention clauses into consent documents, particularly for online studies. This helps ensure that only legitimate participants are compensated in the study.
In the United Sates, research participant compensation payments that exceed $600 in a calendar year must be reported to the Internal Revenue Service (IRS). The IRS requires researchers to collect participant information such as Social Security Numbers or tax IDs for those receiving these amounts. Institutions are also responsible for ensuring that these payments are handled in compliance with tax laws.
In designing research participant compensation structures, researchers must adhere to both institutional policies and federal regulations. While the DHHS and FDA provide broad guidelines, specific policies may vary depending on the institution, the type of study, and the populations involved. Institutions such as the OHRP and FDA offer resources for researchers navigating these complex ethical issues (FDA, 2018).
Offering research participants a choice in how they receive their compensation can significantly improve the overall participant experience. Whether it’s through gift cards or other payment methods, when people have a say in their reward, they feel a greater sense of control and involvement in the process. When participants feel that compensation reflects their needs or interests, it contributes to a more satisfying and respectful research experience.
U.S. Department of Health and Human Services (DHHS). Human Subject Regulations. https://www.hhs.gov
Internal Revenue Service (IRS). About Form 1099-MISC. https://www.irs.gov
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