By participating in clinical research you may provide important scientific information for developing new disease treatments and further medical knowledge.
Frequently Asked Questions
There may be risks with any clinical study. The risks and benefits are reviewed in detail in the informed consent process. You are encouraged to ask questions throughout the consenting process and while you are in the study. There are no guarantees that the drug or device being studied will be effective. The principal investigator or study coordinator will explain the potential risks and the potential benefits before you sign the consent form and join the study.
A human subject is a volunteer participant who is or becomes involved in a research study. A subject can be either someone who is healthy or someone with a particular medical condition.
A clinical trial is a research study designed to test the safety and/or effectiveness of drugs, devices, treatments or preventive measures in humans.
A blinded study is done so that neither the researchers' nor the participants' expectations about the experimental treatment can influence the study results.
In a single-blinded study participants do not know whether they are in an experimental group or a control group. In a double-blinded study, neither the participants nor the researchers know which participants are in a group.
In a controlled study, participants are assigned either to an experimental group or to a control group. Participants in the control group are used as a standard for comparison. For example, a study may have two groups, an "experimental group" and a "control group." The experimental group is given the experimental treatment under study, while the control group may be given either the standard treatment for the illness or a placebo. At the end of the study, the results of the two groups are compared.
Research subjects are randomized in clinical trials so that bias does not weaken the study results. Bias refers to human choices, beliefs or any other factor besides those being studied that can affect a clinical trial's results. If physicians or participants themselves choose the group, assignments might be personally influenced and therefore unevenly slanted toward one side or the other.
Study participants in the experimental group receive the drug, device, treatment or intervention under study.
A treatment trial tests new treatments (new drug, approaches to surgery or radiation therapy, new combinations of treatments or methods may also be tested). A prevention trial tests new approaches-such as medicines, vitamins, minerals or other supplements-that doctors believe may lower the risk of a condition.
A placebo is an inactive agent used for testing against the active drug. The results of the active compound are compared with the placebo to better understand the actions of the active drug.
The FDA has not approved investigational drugs, or they are drugs approved by the FDA for a different purpose. In most cases, the FDA evaluates new drugs in three separate phases before being approved by the FDA.
Informed consent is required for participation in all research studies involving human subjects. Individuals are given information about what is involved in the study, including possible benefits and risks. Prospective study participants are encouraged to ask as many questions as they like. Below are some examples of the type of questions to consider before signing a consent form.
- What is the purpose of the study?
- What type of tests and treatments are involved?
- Are there any costs involved?
- What are potential side effects?
- How could this affect my daily life?
- What is involved and for how long?
- What other choices do I have? What are their advantages and disadvantages?
Yes. Participation in a research study is voluntary. You may leave at any time for any reason. The principal investigator can withdraw you from the study if new potential risks are reported and if you are no longer benefiting from the treatment
All research participants receive a copy of their signed consent form for their own records and contact information is in the form. If you have additional questions, contact:
Office of Human Research