Below is a list of Frequently Asked Questions. To find out our answer to a certain question simply click on the question to expand the answer.
Each study is trying to answer a different question but there are some elements of a study that are the same. Each study requires a volunteer to take the study medication. Studies require collection of different samples. For example, a study might involve the collection of urine, blood or stool. The details of each study are discussed in the informed consent form given to you at your volunteer screening appointment.
Before enrollment can take place, the Institutional Review Board (IRB) must approve the study. The IRB examines the study to make certain that volunteers who meet enrollment criteria are required to sign an informed consent form. This form discusses the nature of the specific study, the study medication or medical device, and any risks that might be involved.
An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the IRB's responsibility to ensure that the study adheres to the FDA's regulatioins.
- The Common Rule was created by the Department of Health and Human Services as a Federal Policy to protect the confidentiality and rights of human trial subjects (45 CFR part 46).
- Good Clinical Practices (GCP) is the standard that has been created for the design, conduct, monitoring, auditing, recording, analysis of results, and reporting of clinical trials. GCP guidelines are to be compiled with in order to provide assurance that the final results that are reported are accurate and credible and that the confidentiality and rights of trial participants are protected (ICH guideline 1.24).
No. The standard is for all study related physical exams and tests to be done at no cost. Some examples of the tests that may be performed at no cost are EKG, x-rays, and blood testing.
Yes. You will be informed of the name of the medication involved in the study. This information can be found in the informed consent form.
Each study is designed differently. Most of the studies do involve a pre-study physical exam appointment, study involvement time, and follow-up visits. The informed consent will tell you the length of time involved. You always reserve the right to drop out of any study, at any time, for any reason.
To become qualified for a study, certain study requirements must be met. Each study requires a screening physical that may include collecting blood and urine samples. You will be asked questions concerning your health history. You will be asked to read and sign the informed consent. This is also a good opportunity for you to ask additional questions about the study and the informed consent.
The blood taken is studied to determine how much of the medication is absorbed in your body or how effective the medical device is working. Only a small amount of blood is taken from the vein in your arm and only takes moments to perform. The frequency of the blood tests varies from study to study. The amount of blood tests done during the study will be outlined in the informed consent.
An adverse event is an occurrence that is not expected or is out of the ordinary. Every drug has a potential side effect and there is no way of knowing in whom or how the side effects may develop. During a study the investigator will want you to tell them of any side effects you think you might be experiencing. Adverse events are an important part of the information that is being collected.
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information. This is explained more specifically in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.
