Clinical trials are the fastest, safest way to find treatments that work in people. Research studies require time and travel expenses; some also pay for blood tests and other procedures.
Subjects who enroll in pay-to-participate trials may be more likely to expect direct benefits or to view study participation as a means of gaining early access to a potential new treatment. Therefore, these trials must be carefully described in the informed consent process.
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Study Subjects
In general, research studies involving humans are funded by federal agencies and private drug and device companies. As such, subjects are typically reimbursed for study-related expenses and offered compensation for time and burden. Subjects who participate in paid trials often do so as volunteers for anticipated direct clinical benefit.
Thus, pay-to-participate trials pose a particular ethical challenge for researchers and potential subjects. They may be prone to foster therapeutic misconception, either intentionally or unintentionally, by offering subjects an incentive that equates their participation with medical treatment. Additionally, the unusual requirement to pay subjects may attract a select group of individuals more likely to be financially able to bear participation costs. This may lead to selective enrollment of vulnerable populations, potentially concentrating research risks and burdens in certain groups.
It is essential to provide clear information to potential subjects regarding the nature of the investigational therapy being tested, including scientific uncertainty about whether a positive effect is likely. This information should be conveyed throughout the recruitment process, especially in advertisements and on websites used for recruitment. In addition, knowledgeable research staff should review the written consent form with each potential subject to ensure that they understand key points, such as the difference between research and clinical care, the likelihood of direct benefits, and the availability of alternative treatments.
Study Procedures
Many paid clinical trials are sponsored by drug companies who want to test their new treatments in the hopes that the FDA will approve them. The researchers must follow strict guidelines for conducting the study to ensure that it has no risks or side effects that would affect the participants’ health. The research must be reviewed by an ethics committee or Institutional Review Board (IRB) before it can be started.
These experts ensure that the amount of risk for the volunteers is acceptable compared to the potential benefits. The IRB also looks at whether the research could be used to help other people with the same condition. The research can be dangerous for some patients. That is why all participants must sign a consent form before participating in the study. The consent form tells them the trial details, including the risks and how much time they will have to spend.
In the United States, most studies do not ask participants to pay for their participation. Government agencies, such as the National Institutes of Health, or private drug and device companies usually fund the research. In some cases, however, researchers may ask participants to pay for the study’s cost. These are known as pay-to-participate trials. The amount that participants are charged varies from study to study.
Study Staff
Depending on the kind of participants needed for the trial, the sponsor or contract research organization may help recruit subjects by searching out local sites with access to patients who are likely to be interested in participating in the study. They may also hire marketing companies to promote the trial using various strategies, including patient databases, newspaper and radio ads, doctor’s offices or hospital posters, and investigators’ recruitment of potential candidates.
At each site, one or more research assistants (often nurses) conduct most of the day-to-day tasks in conducting a clinical trial. They are responsible for providing the local institutional review board (IRB) with the necessary documentation, identifying and screening potential subjects, obtaining their consent to participate in the trial and administering the test drug or device, collecting and statistically analyzing data, preparing regulatory binders and maintaining accurate files of all documents and communications.
Regardless of their role in a clinical trial, all researchers must comply with FDA regulations for human subject research. Any person who violates these rules is guilty of a severe offense that can result in a public warning from the FDA, fines, or imprisonment. The most common violations include failure to adequately monitor the safety of participants, improper handling or administration of drugs or devices, and falsification or concealment of data.
Study Results
A clinical trial tests whether a new treatment is safe and effective. Participants are paid for their time, and the sponsor may also reimburse participants for expenses such as meals and travel to and from the clinic. Payment amounts vary from study to study, and they are usually listed on the study’s recruitment page or can be obtained by contacting the research team directly. The IRS requires all payments over $600 to be reported on tax returns. However, reimbursements based on receipts that cover pre-approved expenses up to the maximum allowed amount are excluded from this requirement.
Sponsors use recruitment strategies to find eligible people for their trials, including patient databases, newspapers and radio ads, posters where patients might go (such as doctor’s offices), and personal recruiting of potential subjects by investigators. Sponsors and their contract research organizations also try to recruit subjects from the general population, and they are often required to obtain institutional review board (IRB) approval for the trial before it begins.
As in all research, prospective subjects must be informed that they cannot expect any direct benefit from their participation and must be aware of the possibility of a severe side effect or harm. However, suppose potential subjects are being asked to pay for their participation. In that case, they must understand scientific uncertainty, the nature, magnitude, and likelihood of direct benefit, and the risks and benefits of the study’s design.
