Clinical trials are an essential step of the medical development process. Thanks to these studies, researchers can better understand the impact of a treatment on patients, identify side effects and other safety concerns, and receive FDA approval to legally sell and market treatments for patients who need them. Without clinical trials, we’d have thousands of potentially dangerous treatments available – or possibly no treatments at all for severe conditions that impact patient’s lives.
Yet as essential as these clinical trials are to advancing medical care, they aren’t without their risks. An unexplored treatment may work well on some patients but introduce risky side effects on others. A drug may react negatively with a common medication, because no one understood its risk because there hadn’t been tests yet. Patients who participate in stage one clinical trials are at high levels of risk, because they’re the first humans to experience a treatment.
For many, these risks can seem worth it. For patients with chronic or fatal conditions, participating in a clinical trial that can potentially improve their health or create a successful treatment for those who have the same condition in the future is compelling. But then what happens when a patient in a clinical trial becomes injured due to a treatment? Who pays for those damages?
Liability in Research-Related Injuries
In the legal world, liability refers to the party who is financially responsible for any expenses associated with injuries. Usually, liability relates to fault: Whoever caused the damages then pays the appropriate compensation. For example, in a case of medical malpractice where a doctor administered a wrong dose of medication, which caused a patient’s condition to worsen, the doctor (and potentially the medical facility that employed him or her) would be liable.
As clinical trials generally operate in the realm of medicine, it might seem like the same legal rules apply when it comes to liability. Unfortunately, that’s not always the case. In fact, most clinical trials operate under the grounds that a research team is not liable for any damages caused by the study. The scope of this can vary: Some trials will pay the bare minimum for damages only directly related to the experimental product, while others will pay for a bit more. Some trials may not assume any liability at all.
The exact level of liability a research team will take on is in the paperwork clinical trial participants fill out before the study begins. In most situations, the outline of liability is in two places:
- An informed consent form, which outlines the handling of subject injury costs in straightforward language that’s easy for most patients to understand.
- A clinical trial agreement, which discusses both details for compensation and contingencies for any clinical trial injury payments in legal terminology.
When planning to participate in a clinical study, patients should review the terms of liability carefully before signing any documents. If you agree to the terms of an informed consent form and clinical trial agreement, you may legally waive your right to compensation for certain injuries sustained during clinical research.
The Future of Research Liability
While most participants in clinical trials understand there is some sort of risk to research, the lack of financial compensation for injuries and damages can prevent subjects from enlisting in a trial. This can have an adverse impact on studies, because it takes longer to recruit participants before starting a study, which delays the entire process of completing a treatment and receiving FDA approval. The main reasons so many clinical trials still don’t provide compensation for injuries is that a research team may not have the resources to assume the long-term financial risks.
Unfortunately, this lack of compensation in clinical trials has existed for a long time, and it may take extreme action to change the norm. The best thing research participants can do is fully understand the terms of a study’s informed consent form and clinical trial agreement – and, if they suffer injury in a study, they should consult knowledgable personal injury attorneys to learn about their legal options.