Frequently Asked Questions about Clinical Research
What is clinical research?
A clinical research study is a way to find answers to difficult scientific or health questions. For example, a clinical study might be conducted to identify what causes people to get a disease (observational study) or test whether a new treatment, surgical procedure or lifestyle change can cure or prevent a disease from occurring. Clinical research enables researchers and doctors to find new and better ways to understand, detect, control and treat human diseases.
Who can participate in a clinical research study?
All clinical research studies have guidelines called inclusion/exclusion criteria that determine who can participate. These guidelines are based on such factors as type of disease, medical history and age. These criteria are used to identify appropriate participants.
What are the benefits to me if I participate?
The benefits to you depend on the particular study you participate in. The largest benefit by far is that you are helping others with similar conditions by contributing to health research.
Other benefits may include:
· obtaining medical care
· taking an active role in your own health care
· gaining access to new treatments that are not available to the general public
What are the risks of participating in a clinical research study?
There is very little risk associated with participating in an observational clinical research study but there are some risks associated with participating in a clinical trial.
Risks may include:
· side effects or adverse reactions to medications or treatments
· the treatment may not be effective for you
· your time and extra trips to the study site
What is an informed consent?
Informed consent is the process of learning the key facts about a clinical research study before you decide whether or not to participate.
The facts include: why the research is being done, what the researchers want to accomplish, what will be done during the study and for how long, what risks are involved in the trial, what benefits can be expected from the study, and what other treatments are available. You will receive an informed consent document, given an opportunity to read it and ask any questions, and then asked to sign it. A copy of the form will then be given to you.
What protections are there for participants in a clinical research study?
The government has strict guidelines and safe guards to protect people who choose to participate in clinical research studies. All clinical studies in the US must be approved and monitored by an Institutional Review Board (IRB) to make sure risks are as low as possible and are worth any potential benefits.
Will it cost me to participate?
There will be no cost to you by participating in a clinical research study. This will be clearly outlined in the informed consent.
Can I withdraw my consent from a clinical study after it has begun?
Yes. You can leave a clinical research study at any time.
Should you volunteer for clinical research studies?
Clinical studies are vital for determining what causes human disease and for finding new cures and treatments. They are also necessary for developing new diagnostic and screening tests for a condition or identifying people who are at a higher risk. By volunteering for a clinical study, you are participating in research that may result in a new treatment for a deadly or debilitating disease. You may be helping scientists prevent future generations from developing the disease.
Where can I find out more about clinical research and studies for specific conditions?
Here are some links that will provide you with some general information about clinical research studies:
www.ciscrp.org -- The Center for Information and Study on Clinical Research Participation (CISCRP)