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Office of Research Oversight

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Basic Research Requirements

What is a Research Study?

A research study is an organized activity to learn more about a problem or answer a question.  Many different kinds of studies are conducted.  A research study may be done to:

  • Test a product (such as a drug or device) to see if it is safe and effective.
  • Determine the best way to treat an illness, or how to prevent an illness.
  • Find out what health care practices work best.

One specific type of research study is a clinical trial.  A clinical trial is a medical study to determine whether medicines, new therapies or new devices are safe and effective.  In clinical trials, drugs or treatments are often compared with placebos to check the effectiveness of that drug or treatment.  A placebo is an inactive substance which may resemble an active substance, however, it typically has no value to treat or prevent and illness. 

The Informed Consent

Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer.  Your agreement to volunteer should be based upon a clear understanding of what will take place in the study and how it might affect you.  Informed consent begins when the research staff explains the facts to you about the research study.  These facts include details about the study, tests or procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.

The research staff will assist you with the "Informed Consent Form." that goes over these facts so you can decide whether or not you want to take part in the study.  You should take your time when you read the Informed Consent Form.  If you have questions, ask the research staff to explain.  It may be helpful to talk with your family members, friends, or your health care providers before you make a decision.

 

 

 

 

If you decide to take part in the study, you will be asked to sign the informed consent form.  However, the informed consent process is more than just signing a piece of paper.  It is a process that goes on throughout the study.  During the course of the study, you may be told of new findings, benefits or risks.  At that time, you can decide whether or not to continue your participation in the study.  You may change your mind and leave the study before it starts or leave at any time during the study or the follow-up period.

The Institutional Review Board (IRB)

The IRB is a group of people such as doctors, nurses, pharmacists, scientists, ethicists, and people from the local community who ensure that human research is well-planned and ethical.  The IRB serves to protect your rights and welfare before and during the research study.  For example, the IRB makes sure that any risks in the study are as small as possible.  The IRB does not make a decision for you.  The IRB decides, when approving research studies, that it is reasonable to ask people whether they want to be involved in the study.  The IRB also reviews each study while it is going on to make sure volunteers are protected. 

In the VA, there is another committee called the Research and Development (R&D) Committee.  This committee reviews the work and recommendation of the IRB.  This is VA's way of ensuring that any study you are asked to take part in has been thoroughly reviewed.