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Office of Research Oversight

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Are You Considering Participating in a Research Study?

The Department of Veterans Affairs (VA) ranks as one of the nation's leaders in health research. Thousands of studies are conducted at VA medical centers, outpatient clinics, and nursing homes each year.  VA research has resulted in many health advancements.  For example, VA researchers:

 

  • developed artificial limbs that allow amputees more independence and a better quality of life
  • invented the cardiac pacemaker
  • performed the first successful liver transplantation
  • played a major role in the development of the CT (or CAT) scan to view the inside of the body
    tested new drugs and treatments for diseases as AIDS, diabetes, Alzheimer's, and osteoporosis
  • developed the nicotine patch to help people stop smoking

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.

What is 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.

How Does ORO Protect Me?

ORO is responsible for oversight of compliance with VA and other Federal requirements for the conduct of research in VA.  Created by statute in 2003, ORO’s jurisdiction includes the protection of human research subjects, laboratory animal welfare, research safety, research laboratory security, research information protection, research misconduct, and governmentwide debarment for research impropriety.  The ORO Chief Officer has the statutory authority to halt research found to pose imminent risks to participants.  ORO staff are  located in VHA Central Office in Washington and in 5 Regional Offices.   ORO conducts routine and for cause reviews of VHA research programs to assess compliance with policies and procedures.  ORO’s duties also include investigating complaints about VA research studies.