Clinical trials, or medical trials, are held by public health agencies or pharmaceutical companies to test new drugs or treatments on human patients. They're designed to find new and better ways to prevent, diagnose and treat a particular disease or disorder. Anyone considering entering a clinical trial should know the legal issues involved.
Before starting a program, here are some things you need to know about your rights as a test subject.
Informed consent must be given to participate in a clinical trial. This requires telling you the trial's details, such as how long it will last and the risks and benefits of taking part in it. You also have the right to ask any questions you may have about the trial. If you're uncertain about anything, ask about it. And you have to be given time to decide whether or not to enter a trial once you get details about it. It's illegal for anyone to pressure or force you to enter a clinical trial.
Each state has laws covering informed consent. The level of information a health care provider must give varies. Some laws require providers give "reasonable information," while others require they give full information. Check the laws in your state or check with your department of health to learn the level of information you need to receive.
In most instances, informed consent is given in writing. When it's given verbally, there must be a witness present. Also, there has to be something in writing stating you were informed of the trial's details and verbally agreed to participate in it.
Clinical trials sometimes have several stages. If you're in one like this, you generally need to consent to each stage.
You have certain rights when enter a clinical trial.
You Can Leave
Informed consent is not a contract, so you can't be forced to continue or complete the trial if you don't want to. Rather, you can leave the clinical trial any time you wish. Keep in mind, though, by leaving early you may not be eligible for payment or free or discounted prescription medication offered to patients who complete the study.
It illegal to include language in an informed consent document requiring you to waive your legal rights. For instance, you can't be asked to agree not to sue the company running the clinical trial if you're injured during the trial because of the company's negligence.
Confidentiality of Records
Federal law requires confidentiality of records for anyone in a clinical trial. Your personal information can't be released. Instead, the provider typically publishes a report giving statistics regarding the study, showing things like the percentage of people whose health improved because of the study.
Cost of Medical Trials
Most clinical trials don't cost anything. In fact, you may get paid for participating in one. However, that's not always the case. When there is a cost to be in a clinical trial, check to see if all or part of the cost is covered by:
- Your insurance company
- Medicare, the federally funded health insurance program for the elderly and disabled
- Medicaid, the health insurance program funded by the federal and state governments to help elderly people with low-incomes, those who are blind or disabled, and families with dependent children
For many, clinical trials offer access to new and potentially life saving drugs and cures. It also gives them a chance to help others. But no one should ignore the risks. If you're considering a clinical trial, think about it carefully. Ask questions and get answers you can understand. And don't hesitate to contact an attorney if you don't fully understand any paperwork you're asked to sign. It's your body and your life, and it's up to you to protect them.
Questions for Your Attorney
- What portion of the costs will our state Medicaid pay for?
- My doctor thinks I'm suffering a side-effect from medicine I'm taking during a clinical trial, but the company running the test disagrees. What should I do?
- Should I write down what I'm doing in the trial so I have a record of it?