Frequently Asked Questions
Most people have questions when they are invited to take part in a research trial. Following are some of the more frequently asked 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 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 by 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.
