The Compensation of Clinical Trial Participants

In the United States, participating in a clinical trial often means that you will be repaid for your time and effort.

How clinical trial participants are compensated

Clinical trials play a critical role in the development of new drugs, therapies, and medical devices. By involving human volunteers, these trials help researchers determine the safety, efficacy, and potential side effects of treatments, ultimately advancing medicine.

Why compensation is important

Participating in a clinical trial involves more than just showing up for a session or taking a new medication. It often requires individuals to adhere to strict schedules, make frequent visits, complete surveys, and possibly undergo invasive procedures. Additionally, some trials carry physical or psychological risks, making the role of the participant essential to the study success. Compensation acknowledges the commitment, time, and sometimes discomfort participants endure. It’s also an incentive, encouraging diverse groups to contribute to scientific advancements. In many cases, participants value the idea of contributing to medical research, but compensation helps make it a feasible commitment.

Eight approaches to compensation

The specifics of compensation vary based on duration, procedures, and risks. Most clinical trials compensate participants using a few different ways.

Monetary: A widely used form of compensation, the amount of money depends on the time required, procedures involved, and the level of risk or inconvenience posed to the participant. Some trials offer hundreds of dollars for a few hours of participation, while others may offer thousands for longer, more involved studies.

Flat fee or hourly rate: Many trials offer a fixed payment per visit or hourly rate, allowing for a straightforward understanding of compensation based on the time commitment required.

Completion bonus: To encourage participants to remain for the entire study duration, many trials offer a completion bonus at the end; this extra payment incentivizes full participation and helps maintain study consistency.

Escalating payments: With this method, compensation increases for each successive visit or stage of the trial; this is common in longer studies, especially if there is a risk of participants dropping out before completion.

Reimbursement for out-of-pocket expenses: Participation often entails incidental costs, including transportation, meals, or accommodation; many studies cover these expenses to reduce the financial burden on participants.

Medical care and follow-up: Trial participants often receive comprehensive medical assessments (e.g., physical exams, lab tests, imaging studies) at no cost. Such access to medical care can be a valuable component of compensation, especially if it includes follow-up care after the study concludes. Participants may undergo extensive testing like blood work, MRIs, or X-rays, which would otherwise be expensive. These tests can provide valuable health insights and early detection of potential issues. If a trial involves treatments with potential side effects, follow-up care is often provided to monitor and manage any health concerns that may arise due to participation. For individuals without health insurance or with limited coverage, this free medical care is often highly beneficial, offering medical insights and assistance at no personal cost.

Access to experimental treatments: Some participants are drawn to clinical trials due to the opportunity to receive cutting-edge treatments not yet available to the general public. For those with serious or chronic conditions, this can be especially appealing. In trials for potentially life-saving or life-improving treatments, participants may receive early access to drugs or therapies that could enhance their quality of life. Patients with limited treatment options may benefit from access to new treatments that have yet to be widely distributed. It is important to understand that experimental treatments come with risks, and there is no guarantee that they will be safe or effective. Participants should weigh these potential benefits against any possible side effects or unknowns associated with experimental therapies.

Gift cards and vouchers: These and other small tokens of appreciation are particularly common in studies that involve minimal risk or time commitment, such as survey-based trials or studies requiring only a single visit. In cases where financial compensation may be limited, such gestures of appreciation help acknowledge a participant’s contribution.

Factors affecting compensation

Compensation for clinical trial participation is not uniform and can vary significantly. Several factors influence the level of compensation you might receive:

Study phase: Trials in earlier phases, particularly Phase I, often offer higher compensation to account for increased risks and unknowns.

Time commitment: Studies requiring multiple visits, lengthy stays, or extended follow-up periods generally offer higher compensation to reflect the participant’s time investment.

Risk level: Trials involving high-risk procedures, potential side effects, or discomfort typically provide higher compensation than low-risk studies.

Participant population: Some studies target specific demographics or populations with certain health conditions, which may increase compensation levels due to recruitment challenges.

Participants should consider these factors and discuss them with the study coordinators to fully understand the compensation structure before enrolling.

Ethical considerations in compensation

While compensation is intended to fairly acknowledge a participant’s contribution, it must also adhere to ethical and regulatory standards. The U.S. Food and Drug Administration and others oversee trial protocols to ensure that compensation practices are fair and ethical. Regulatory guidelines help prevent undercompensation and ensure participants receive fair value for their contributions. Compensation should align with the level of inconvenience, risk, and time required for participation.

Participants must be informed about study risks, benefits, and compensation before agreeing to participate. The informed consent process provides a thorough outline of what to expect, including details about payment and medical care.