Clinical trials of new medicines or treatment protocols must be tested on human subjects prior to being approved by the US Food and Drug Administration (FDA). Participation in clinical trials is voluntary, and participants must agree to assume the risk of some potentially negative consequences if they choose to participate.
However, in giving their consent, clinical trial participants are only legally agreeing to information that was clearly understood and treatment that is properly administered. Clinical trials are monitored for adherence to ethical standards by independent review boards. When a clinical trial participant is injured, the entire process is evaluated to determine if the clinical trial followed the correct procedures.
At Ernst Law Group, our practice includes helping clinical trial participants recover from unexpected injuries resulting from participation in a clinical trial. The following are common questions that our San Luis Obispo personal injury lawyers are often asked by clients injured in clinical trials.
When can you sue for clinical trial injury compensation?
A clinical trial participant who was injured during the course of the research may have the right to bring a clinical trial injury lawsuit if the injury was the result of a misunderstanding about the risks involved in participating in the study or the persons or entities administering the treatment failed to exercise the appropriate care.
Some participants may also experience serious reactions to the treatment that were not anticipated. How these situations are handled by the persons conducting the trial may result in liability for a clinical trial injury.
Can you sue for unresolved adverse effects from a clinical trial?
Adverse effects are any unexpected and unfavorable medical occurrences that can happen to clinical trial participants from the treatment received during the study. They may include abnormal test results, the development of symptoms, and the onset of diseases. In some cases, adverse effects can be life-threatening and even result in death.
When a clinical trial participant experiences an adverse effect, patient safety must be the primary goal. If appropriate protocols are not followed, and a participant experiences unresolved adverse effects, those implementing the clinical trial may be liable for the damage caused.
What does it mean to give ‘informed consent’?
Informed consent is an acknowledgment of the willingness to participate in a clinical trial. In the case of human research subjects, informed consent must be given voluntarily, based on an understanding of all the relevant information, particularly concerning the potential risks, and with the capacity to appreciate the consequences of the decision to participate.
The information provided to a clinical trial participant must include, at a minimum, the reason for the study, the health condition that is to benefit from the research, how the treatment will be administered, and the possible risks and benefits associated with participating in the trial.
Where can I get help for injuries suffered during a clinical trial in California?
Persons and facilities that conduct clinical trials must make sure participants understand fully what can happen if they participate in the study. Participants must be treated ethically, and treatment protocols must be followed. When unanticipated symptoms or reactions occur, the safety of participants must be the primary consideration.
If you participated in a clinical trial and were injured, you may be entitled to compensation. A California personal injury lawyer can help you determine if you have a claim. For a free consultation, contact Ernst Law Group or call (805) 541-0300 to schedule an appointment.