BY: Matthew Turner | IN: Medical Malpractice, Defective Devices and Dangerous Drugs
Clinical trials are vital to developing and testing lifesaving new drugs and medical devices. They help researchers establish whether a new medical product or treatment approach is helpful, harmful, or no different than current treatments or no intervention at all.
In a clinical trial, participants agree to receive specific medical “interventions” according to a research plan or protocol. These interventions can involve participants using medical products like drugs or medical devices, undergoing a medical procedure, or changing their behavior in specific ways (such as changing diet or exercise regimens). Investigators document many different aspects of the trials and each participant’s responses to the interventions.
Clinical trials may evaluate the efficacy and side effects of a new drug, procedure, or standard of treatment over the short or long term. Some studies compare new treatments to current accepted medical protocols or treatments; others contrast them to the effectiveness of existing treatments. Others analyze the studied intervention against data from people who receive no medical intervention.
Participants in research studies may have a particular illness or condition that is the topic of study, or they may be healthy participants. Others are members of a specific demographic or share certain characteristics relevant to the study. Following World War II, the United States and international allies agreed to the Nuremberg Code, a set of medical ethics rules regulating experiments conducted on humans. Its first principle is that every participant must give voluntary consent to any experimental intervention.
Before testing a product, procedure, device, or treatment protocol on humans, researchers conduct extensive laboratory testing. This can include computer simulations, trials involving animals, and the publication of peer-reviewed results. If preliminary results indicate the intervention may benefit humans, the researchers may solicit approval for human testing. According to the National Institute of Health, these studies are also reviewed, approved, and monitored by an institutional review board (IRB) made up of doctors, researchers, and community members. Some clinical studies are also closely watched by data monitoring committees (also called data safety and monitoring boards) and regulated by other federal agencies.
However, because the safety and effectiveness of drugs, procedures, or treatments studied in clinical trials have not yet been established, there are risks to participating in clinical trials. Although another principle of the Nuremberg Code is that the risks of any experiment may not exceed the benefits, sometimes the adverse effects of an intervention can be significant. Subjects should be free to end their participation in an experiment or clinical trial at any time.
Participants in clinical trials go through a process of informed consent before agreeing to participate in the study to effectively communicate and ensure they understand the study’s risks, potential benefits, and alternatives. This process can involve interviews, question-and-answer sessions, informational literature, and hands-on activities measuring participant understanding. At its conclusion, each participant must sign an informed consent document confirming they were given information and understand the risks, potential benefits, and alternatives to participating in the trial.
Although the participants in a clinical trial consent to certain risks involved with experimental interventions, their consent is not a blanket waiver of their rights to sue for malpractice or negligence. In Michigan and most states, an individual can sue for negligence or medical malpractice if they establish that the medical care they received from the hospital or medical organization conducting the study was below the expected, reasonable standard of care in a similar or normal situation.
If a participant suffered injuries because the medical personnel or organizations involved in a study were negligent, reckless, or committed deliberate wrongdoing, the injured participant might be able to recover compensation. If the informed consent process was flawed, causing the participant to misunderstand or fail to appreciate the risks, their consent might be overturned. A lawsuit may reveal systemic improprieties in a study, unlawful actions by one or more of the study’s administrators, or indicate that a manufacturer of a drug or device withheld information about potential risks and dangers.
If you have been involved in clinical study and have suffered personal injuries, you should consult with an experienced Michigan personal injury and medical malpractice attorney. An investigation that reveals improprieties may not only allow you to recover but protect others from future injury. Don’t wait—contact an attorney today.
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Matthew Turner is a shareholder with Sommers Schwartz, and focuses his practice on medical malpractice, legal malpractice, ERISA, and class action matters.