Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
What are the possible benefits and risks of being in a clinical research study?
Possible benefits of being in a clinical research study:
- Participants play an active role in their own health care.
- Participants may gain access to treatments before they are widely available.
- Participants help others by contributing to medical research knowledge.
Possible risks of being in a clinical trial:
What should someone consider before entering a clinical trial?
- It is not known if the new treatment will be more or less effective than the standard treatment for the particular illness or health problem.
- New treatments may have side effects that doctors do not expect or that are worse than standard treatment.
- Health insurance and managed care providers do not always cover all patient care costs in a clinical trial.
You will want to understand all aspects of a research study before you agree to participate. You may wish to ask questions such as:
What is the study about?
What about costs?
- What is the purpose of this study?
- Who is sponsoring the research?
- How long will the study last?
- What happens at each visit?
- How does the study differ from normal health care for the condition?
- Can I take my regular medication while I'm participating?
- Can I see my own doctor?
- How will the information gained by this research be shared?
How are the rights and safety of research participants protected?
- Are extra charges involved?
- How much will my insurance cover?
- Who is available to discuss insurance issues with me?
There are ethical and legal standards that apply to clinical research, just as there are in other aspects of health care. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. Groups of experts at the national and local levels approve research studies before they begin. One of the most important groups is the Institutional Review Board (IRB). Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, ensure that an IRB initially approves and periodically reviews the research.
To help protect confidentiality, individual participants' names will be disclosed only to those involved in the study and will not be mentioned in publications or other reports. Wheaton Franciscan Healthcare Institutional Review Board
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. Details in this consent process include the purpose of the study, its duration, the required procedures, all safety monitoring and potential risks and potential benefits. A member of the research team reviews an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and names of key contact personnel. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
for an example of an informed consent form.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
Does health insurance cover the cost of being part of a research project?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
This varies by insurance plan and by study. Normal health care visits and procedures are usually covered. Potential participants should ask a member of the research team about costs before considering study participation.