Participating in a clinical trial
Who can participate in clinical research?
All clinical research has guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable
results. 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
These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. These criteria are used to
identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What are the possible benefits and risk 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
- It is not known for sure if the new treatment will help a study participant more than the standard treatment for the particular illness or health problem
- There may be unpleasant, serious or even life-threatening side effects to treatment.
- Being in a clinical trial may require more trips to the study site, more tests or treatments, more complex medication schedules, more recording of information, or possible
What should someone consider before entering a clinical research study?
You will want to understand all aspects of a research study before you agree to participate. You may wish to ask questions such as:
1. What is the study about?
- What is the purpose of this study?
- Who is sponsoring the research?
- How long wills 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?
2. What about costs?
- Are extra charges involved?
- How much will my insurance cover?
- Who is available to discuss insurance issues with me?
3. How are the rights and safety of research participants protected?
There are ethical and legal standards that apply to clinical research, just as there are in other aspects of healthcare. 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 research study 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
4. What is informed consent?
Informed consent is the process of learning the key facts about a clinical research study 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 study at any time.
5. Can a participant leave a clinical research study 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
6. What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
- 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.
7. Does health insurance cover the cost of being part of a research project?
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.
For more information on clinical research studies, call Annette at 920-288-3127.