Clinical trials play a crucial role in medical advances — from getting vaccines on the market to testing new cancer treatments. Some people participate to get access to potentially life-saving treatments not yet available. Others just want to earn a little extra money and do some good.
There can be multiple unknowns and potential risks to the procedures and medications being used. Participants (known as research subjects) sign documents that help protect those involved in the trial liability.
So if you suffer harm in a clinical trial, do you have any grounds for a medical malpractice suit? You might.
What is required to give “informed consent?”
Subjects must give their informed consent to the trial. Just what does that mean?
According to the U.S. Food and Drug Administration (FDA), informed consent includes giving potential participants “adequate information to allow for an informed decision about participation in the clinical investigation.” Those running the trial must provide the information in language that can further help laypersons understand the information they’ve provided. They must also allow potential subjects to get all their questions answered and give them time to consider (possibly with the input of their doctor and family members) whether they still want to participate.
Informed consent requires telling subjects that all potential risks can’t be determined. However, they also need to be informed about specifically what procedures and/or treatments they will undergo and what the known potential risks and side effects entail.
Informed consent needs to continue throughout the trial
Informed consent doesn’t end once a participant signs the documents and begins the trial. It requires continued updates “as the clinical investigation progresses or as the subject or situation requires,” according to the FDA. Subjects also need to know that their participation is completely voluntary and that they can end it at any time if they choose.
Failure to provide informed consent is just one potential basis for a medical malpractice suit if someone suffers harm during a clinical trial. Doctors, clinical research organizations and sponsors of clinical trials often have insurance to help cover them in legal actions stemming from a trial.
Don’t assume that you’ve signed all your rights away if you participated in a clinical trial and suffered harm as a result. It’s best to seek legal guidance so that you can determine what legal options you have.