Resources

Home › Research Participants › The Clinical Research Process

Clinical Research Process

A clinical research study is a study that seeks to answer a specific scientific or health question. The study may involve the testing of an unproven drug, an investigational medical device, a diagnostic tool, a food or drink, or an existing therapy used in a new but untested way to see if the product is helpful in preventing, diagnosing, or treating a disease or condition. The study may involve an existing product used in a way that was previously found to be safe and effective in order to learn more about the product's safety. Or the study may involve only the collection of health information in order to study a health issue in the general population.

People who volunteer to participate in a study may be called human subjects, research participants, or another term that identifies their role as volunteers in a clinical research study.

The doctor or healthcare professional who conducts the clinical research study may be called:

• a clinical investigator,
• principal investigator,
• or study doctor.

It is important to remember that the role of a clinical investigator is very different from the role of the health care provider. While your health care provider is responsible for making health care decisions for you based upon your medical condition, a clinical investigator is conducting a research study and is responsible for carrying out the study as described in the study protocol or study plan.

This means that while the clinical investigator is responsible for carrying out the study in a way that minimizes research participant risks and maximizes the study benefits, the clinical investigator is limited by the requirements of the study with regard to the treatment options that can be provided to you, the research participant.

If you volunteer to participate in a research study, it is important that you maintain contact with your primary health care provider (your regular doctor) and other specialists before, during, and after your participation in the study to make sure that you have the best information about your health care decisions.

The people who assist the clinical investigator are part of the research team or study staff and generally include other doctors, nurses, study coordinators, and other healthcare professionals.

Finally, studies involving a product are generally paid for and supported by the company that developed the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health, also act as sponsors in funding clinical research.