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  as age, medical history, current medications, health conditions, and other characteristics. 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 healthcare
• 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 informed consent process includes information about:

• Why the study is being conducted
  
• What researchers hope to learn
  
• What participation involves
  
• How long the study may last
  
• Potential risks and benefits
  
• Available alternatives, when applicable
  
• Your rights as a research participant
  

You will have an opportunity to review the informed consent document, ask questions, and discuss the study with the research team. You should only sign the informed consent document if you understand the study and choose to participate. You will receive a copy of the signed informed consent document for your records.

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 U.S. 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 for participating in a clinical research study. Some studies may also provide compensation for time and travel. 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 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)

www.ClinicalTrials.gov

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