Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate in the program. Guidelines are based on many factors, such as: age, type of disease, current medical condition, and medical history. Before you can join a clinical trial, you must qualify for the study. Some research studies inquire about volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.
The determining factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. It is important to note that inclusion and exclusion criteria are not used to eliminate people personally. Instead, the criteria are used to identify suitable participants and keep them safe.
How do I decide to participate?
The decision to participate in a clinical trial is made by each person who decides to participate after reviewing, discussing and then signing an informed consent form for a specified clinical trial.
What is an Informed Consent?
Informed consent is the process of learning the key facts about a clinical trial before you make your decision. These facts include:
- Why the research is being done.
- What will be done during the trial and for how long?
- What risks are involved for the patient in the trial?
- What the researchers want to accomplish.
- What benefits can be expected from the trial.
- What other treatments are available.
After signing the informed consent form each participant has the right to stop his or her participation in the trial at any time. If you are considering joining a clinical trial, the research staff will give you informed consent forms that include the details about the study. If English is not your native language, you can ask for the consent forms in your language. We provide our patients with approved translated informed consent forms in five different languages: English, Spanish, Russian, Chinese and Korean. The staff at Queens Medical Associates speaks six different languages to meet the needs of our patients.
Joining a clinical trial is an important decision. You should ask the research team any questions you may have about the study and the consent forms before making a decision.
It is also a good idea to take the consent documents home and discuss them with family members and/or friends. Discussing your options can help you to feel comfortable with your decision. If you decide to join a clinical trial, you will receive a copy of the informed consent forms so you can review them at any time.
Remember, informed consent is more than signing a form. It is a process that continues through the study. You should feel free to ask the research team questions before, during and after the study.
Informed consent continues as long as you are in the study.
What are the benefits to participating in a Clinical Trial?
Being in a clinical trial may offer cutting edge therapy not available elsewhere and you will receive care from our experienced research team. The new treatment may be as good as or better than the standard treatment. If a new treatment is proven to be better, you will be among the first to receive it. You also have the chance to help patients in the future because improvements in medical care result from research.
What are the risks of participating in a Clinical Trial?
Sometimes the new treatment is not found to be better – or even as good – as the standard treatment.
There may be unexpected side effects that are worse than treatment with the standard regimen. Side effects can vary from patient to patient and can be temporary or permanent. All clinical trials we participate in are carefully reviewed and chosen by our research team. Therefore, we can ensure that the potential benefits from participating in our clinical trials will outweigh the potential risks. Weighing the potential benefits against the risks can help to make a decision whether to participate in a clinical trial.
What happens if I agree to participate in a Clinical Trial?
A study team member will thoroughly review an informed consent form approved by an ethics committee with each potential participant. The informed consent form describes all aspects of the clinical trial including an explanation of why the study is being conducted, detailed information of what will happen if you join the study, risks and benefits, other available treatments should you decide not to participate in the trial, information about how to withdraw from the trial at any time, explanation of how your personal information is protected and contact information for study personnel. There must be enough information to allow a potential participant to make an informed choice whether or not to participate in the study.