Subject FAQs

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The Food and Drug Administration or "FDA" is an agency of the United States government charged with, among other things, the oversight of the development of investigational drugs and medical devices.

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A clinical trial is a research study involving human subjects designed to answer specific questions. There are different types of clinical trials including those to study, for example, prevention of disease, new investigational drugs, devices or treatments, and screening and diagnostic techniques.

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of subjects may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Doctors and other health professionals conduct the studies according to federal, state, and local laws designed to protect people involved in research.

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A research subject may be either a healthy individual or a patient who is taking part in a research study.

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An investigator, sometimes called the study doctor, is the person responsible for the conduct of the research study.

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Federal law requires that people interested in taking part in research studies be given sufficient information about the study before they agree to participate. This is known as the informed consent process. If the individual agrees to participate, he/she must sign an informed consent document, which states:

• That the study involves research;
• The purpose of the research;
• How long the study is expected to last;
• What the study involves and which parts are experimental;
• Possible risks and/or discomforts;
• Possible benefits;
• Alternative treatments available for your condition;
• That the study records will be kept confidential to the extent required by law;
• What will happen in the event of an injury/side-effect, including whether any compensation and/or medical treatments are available;
• Whom to contact with any complaints about the study, questions about research subjects' rights, and questions about injuries related to the research; and
• That being in the study is completely voluntary and subjects may quit at any time.

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Before signing the informed consent document, the subject should discuss the study in detail with the investigator or a study staff member. This discussion must take place in private, and the subject must be given enough time to make a decision. In most studies the subject should be allowed to take the consent document home for further discussion with others such as family and primary care physicians. In addition, the study doctor and/or staff must answer all questions to the subject's satisfaction.

A subject must be told about any new information learned during the study that may affect his or her willingness to continue to take part in the study. A subject may ask questions at any time throughout the study and may decide to stop taking part for any reason.

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Examples of questions you may want to ask include:

• Why is the study being done?
• How much of my time will be required?
• Has anyone in this study been injured by the study drug or device?
• What are the costs to me and/or my insurance company?
• Will I be paid for being in the study?
• What side effects might occur with the study drug or device?
• If I am injured during the study is compensation available to pay for my treatment?
• Will there be any follow-up treatment after the study is over?
• Will I be able to continue receiving the study drug or device when the study is over?
• Who should I contact if I have a side effect?
• What alternatives are there to being in the study?

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If you have questions about the conduct of the study or your rights as a research participant, you should contact the IRB at the number listed in the informed consent document. If you have questions about a research related injury, contact the study doctor.

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More information about clinical research studies is available form your doctor. Schulman has also provided some Useful Links.