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Most people have questions when they are invited to take part in a research trial. Here are some of the more frequently asked questions and the answers to those questions:
Why Can't I Choose which Treatment I Receive?
The purpose of not knowing what group you are in (blinding), and being assigned to a group on the basis of chance (randomization), is to ensure that the results of the study reflect only the treatment and not other factors that may bias the results.
The fact that the medical staff does not know which groups subjects are in ensures that they do not subconsciously, or consciously, make decisions about treatment based on the likelihood of a better result. This method also removes bias on the part of the subject, which could affect the outcome of the study.
When everyone immediately involved in the study are blinded to the treatment groups, the risk of a biased result is minimized.
Is the Study Safe?
All research studies conducted in the Inova Health System are carefully reviewed by an Institutional Review Board. A detailed study plan is examined by the IRB to ensure that the study is designed properly and that the findings are likely to benefit patients. The committee also reviews existing information about the new treatment to ensure that side effects are acceptable and the potential benefits of the study outweigh the potential risks.
Only those studies the IRB has approved will be conducted in the Inova Health System. The risks and benefits of a study are described, in detail, in the consent form.
Who Conducts These Research Trials?
The principal investigator has overall responsibility for the study and plays a major role in conducting and planning the trial. The study coordinator helps the principal investigator in conducting a research trial.
The principal investigator is responsible for conducting research. Screening potential study subjects and obtaining their consent can be delegated to appropriate research personnel. The progress of a participating subject is monitored closely by the coordinator, a physician, and other physicians and nurses as needed.
Does My Physician Need to Approve My Participation in the Research Trial?
A subject’s physician will be made aware of the study. A subject will not be considered for a study if their physician or others do not want the subject enrolled. Research personnel will keep the subject, and their physician’s fully briefed throughout the trial.
What If I Do Not Want To Be Part Of The Study?
Your participation is voluntary. You may decline without any change to your medical care.
What If I Change My Mind?
You may end your participation in a research trial at any time.