What is the FDA?
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.
What is Health Canada?
Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, in part by supporting research and, among other things, overseeing the development of investigational drugs and medical devices.
What is a clinical trial?
A clinical trial is a research study involving human subjects. There are different types of clinical trials, for example those designed to answer questions about prevention of disease, new investigational drugs, devices or treatments, and screening and diagnostic techniques.
A clinical trial is conducted according to a written study plan called a protocol. The protocol describes, among other elements, the eligibility criteria for subjects to enter the study, schedules and descriptions of study-related tests and procedures, the investigational drugs/devices, dosages and administration instructions for the investigational drugs/devices, the length of the study, as well as the outcomes that will be measured. Doctors and other health professionals conduct clinical trials according to federal, state/provincial, and local laws designed to help protect human subjects involved in research.
What is a research subject?
A research subject is a person who is taking part in a research study. A research subject may be either a healthy individual or an individual with a specific disease or condition.
What is an investigator?
An investigator is the person responsible for the conduct of the research study. The investigator is the individual who conducts the research study or oversees/leads a team who is conducting the research study.
What is informed consent?
Federal law requires that an individual interested in taking part in research studies be given sufficient information with which to make an informed decision as to whether or not to participate in the study. This is known as the informed consent process. If the individual agrees to participate, he or she must read and sign an informed consent document, which provides the following information:
- 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 investigational;
- Possible risks and/or discomforts;
- Possible benefits;
- Alternative to participation in the study;
- That the study records will be kept confidential to the extent required by law;
- What will happen in the event of a study-related illness or injury, including whether any compensation and/or medical treatments are available;
- Who to contact: in case of an emergency, with any complaints about the study, with questions about research subjects’ rights, and with questions about injuries related to the research; and
- That being in the study is voluntary and subjects may quit at any time.
Who should I talk to about the study before I decide whether or not to participate?
Before signing the informed consent document, you should discuss the study in detail with the investigator or a study staff member. This discussion must take place in private, and you must be given enough time to make an informed decision. In most studies, you should be allowed to take the consent document home for further discussion with others, such as family and primary care physicians. In addition, the investigator and/or study staff must answer all questions to your satisfaction.
You must also be told about any new information learned during the study that may affect your willingness to continue to take part in the study. You may ask questions at any time throughout the study and may decide to stop taking part for any reason.
What questions should I ask about the study?
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, device, or product?
- What are the costs to me and/or my insurance company?
- Will I be paid for being in the study? And, if so, how and when will I be paid?
- What side effects might occur with the study drug, device, or product?
- If I am injured during the study, who will 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, device, or product when the study is over?
- Who should I contact if I have a study-related illness or injury?
- What alternatives are there to being in the study?
When should I contact the IRB?
If you have questions, concerns or complaints about the study, your rights as a research participant, or suggestions regarding Schulman’s role in the protection of rights of human research subjects, you should contact the IRB at the number listed in the informed consent document. If you have questions about a study-related injury or illness or about study compensation, you should contact the study investigator.
Where can I find out more about clinical research studies?
More information about clinical research studies is available from your study investigator.