Experimenting on Patients in CA: Know Your Rights!
There is a Patient’s Bill of Rights for human experiemental subjects. That means you are entitled to all kinds of information and rights prior to and during the experiment. There are the obvious rights. For instance, you have the right to know what the experiment is and what it is for before you agree to be a part of it. You also get to know the risks and benefits.
Use Your Rights in the Experiment
There are some rights that you might not have thought of. Legally, you have the right to withdraw consent to being part of the experiment at any time. No one can demand you sign any kind of contract that would prevent you from opting out. You are allowed to leave “without prejudice.” Also, you may ask any question you like that is related to the experiment. Don’t let any doctors or staff poo poo your questions as irrelevant or not worth their time. You have the right to answers, and you deserve them if you are participating in the experiment. What is also good to know is that you have the right to know if there are any alternative drugs or procedures that you should consider besides the experiment. If your experimenters won’t talk to you about alternatives, they are breaking the law. Long story short, you are entitled to full disclosure. So use it!
Vengeance is Yours! (Monetary Damages for the Patient)
If your rights are being violated the good news is that you can collect damages. If you don’t give informed consent prior to being in the experiment, the person responsible for the ethics (we’ll call him Mr. Ethical) of the experiment owes you a minimum of $500 and a max of $10,000. If a court determines Mr. Ethical purposely didn’t get your informed consent, then the number jumps to a minimum of $1,000 and a max of $25,000.
When Experimentation is a Misdeameanor (Patients, Send that Bad Boy to Jail!)
If the above Mr. Ethical did not collect informed consent, willfully, and put you at risk of “substantial” bodily or psychological harm, Mr. Ethical could potentially get up to a year in jail. And he could be fined as high as $50,000.
However, Mr. Ethical is off the hook in certain circumstances. If he is contracted with a pharmaceutical company and informed consent is withheld even from him, then he is not responsible for the risks you may have encountered. For instance, if a pharmaceutical company has an employee or representative responsible for sharing knowledge of the experiment with Mr. Ethical, and that person purposely withholds the information, then it won’t be Mr. Ethical doing time. The Pharma employee will possibly get jail time of one year and a fine of up to $50,000.
Information obtained from California Legistlave Information: http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=HSC&division=20.&title=&part=&chapter=1.3.&article=