INTRODUCTION
Clinical Research Process
Role of the IRB/REB
Research Participant Resources
FAQ
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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, 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.
Therefore, 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 and to make sure that other treatments or medications you are
taking do not interfere with your ability to participate in the study.
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.
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