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"I want to know more about being in a research study."

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Answers from the Human Subjects Protection Program

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What is a research study?img10

A research study is a way for researchers to find out information about a particular topic or to answer a specific question.

What is a research subject?

A research subject is a living person who takes part in a research study - someone like you!  Most research studies have certain requirements that you must meet in order to take part.  These requirements are designed to protect the safety of the subjects as well as ensure the usefulness of the research.

Who leads research studies?

All research studies are led by a principal investigator (PI).  The PI has overall responsibility for the research study.  If the research study involves human subjects, then the PI is responsible for assuring the safety of the subjects.

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Who else is involved in research studies?

PI's often rely on a research team to assist them in the day-to-day operation of their studies.  The research team can be made up of coordinators, statisticians, social workers, educators, graduate students, doctors and other people with specialized skills needed for the study.

What kind of activities are involved in research studies?

Research studies involve a variety of activities, ranging from filling out surveys and questionnaires to using experimental medicines or devices.  Some studies last only a few minutes, while others last for years.  The research team will tell you the activities involved in the study.

Are there benefits to being in a research study?

Yes, but not everyone who takes part in a research study will benefit personally.  Sometimes your taking part in the research study will only be of benefit by helping researchers to learn more about a certain disease or condition.

The research team will tell you any known benefits of being in the study before you decide whether or not to participate.

Are there any risk to being in a research study?

Research studies may involve some risk.  The research team will tell you any known risks of being in the study before you decide whether or not to be in the study.

What kinds of questions should I ask about any study?

  • Why are you doing this study?
  • Who is sponsoring the study?
  • Who can be in the study?
  • What possible risks or benefits are there to being in this study?
  • If I am upset because of questions asked in the study, how will I get help?
  • What happens at the end of the study?img12
  • Will the results of the study be given to me?
  • Can I stop being a part of the study at any time?
  • What kinds of tests or exams will I have to take while I am in the study?
  • How much time do these take?
  • What is involved in each?

For medical studies:

  • Will I be hospitalized, and if I am, how often and for how long?
  • What are the costs to me?
  • Will my health insurance pay for any of the costs?
  • What are my other treatment choices?
  • How do they compare with the study treatment?
  • What are the possible risks for and benefits to being in the study?
  • What side effects can I expect from the study treatment?
  • How do they compare with side effects of the usual treatment?
  • How long will they last?

Where can I find out more about being in a research study?

Research studies at the University of Louisville are advertised in many ways, such as local newspapers, TV, radio, Web sites and postings on bulletin boards.  If you are interested in research about a specific disease or condition, you also can speak with your doctor or therapist about research studies for which you might qualify.

Who reviews research studies?

Research studies that involve human subjects are reviewed by an institutional review board (IRB) before they are allowed to begin.

University of Louisville Research Partners

Norton Healthcare Inc.

Jewish Hospital & St. Mary's Healthcare

University of Louisville Hospital

Jefferson County Public Schools

This brochure is provided to you by the Human Subjects Protection Program Office at the University of Louisville.

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