Deciding whether or not to be a research participant in a clinical study is an important decision. Before making that decision, become informed about what it means to beCOME a participant.
Below are frequently asked questions by those trying to make that decision.
Q. What is an IRB?
A. An Institutional Review Board, also known as an Independent Ethics Committee, Ethical Review Board, or Independent Review Board (IRB), is a type of board that applies research ethics by reviewing methods proposed for research to ensure they are ethical. In its simplest form, the word ethics may be defined as a system of moral principals. This type of review board also ensures that the risks of a study or of a trial, do not outweigh the benefits to the research participants. The ultimate goal and purpose of an Independent Review Board (IRB), is to protect human subjects who enter research trials.
Q. What is a clinical trial?
A. A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Q. Why join a clinical trial?
A. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Many subjects also enter research studies for the monetary compensation they receive. Some trials pay several thousands of dollars for participation in a clinical trial.
Q. What is informed consent?
A. 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. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. 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.
Q. what are the benefits and risks of participating in a clinical trial?
A. Clinical trials that are well-designed and well-executed are the best approach for participants to:
Play an active role in their own health care.
Gain access to new research treatments before they are widely available.
Help others by contributing to medical research.
There are also risks to clinical trials:
There may be unpleasant, serious or even life-threatening side effects to treatment.
The treatment may not be effective for the participant.
The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements
Q. What are side effects and adverse reactions?
A. Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental
treatments must be evaluated for both immediate and long-term side effects.
Q. What should you consider before participating in a clinical trial?
A. People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
What is the purpose of the study?
Who is going to be in the study?
Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
What kinds of tests and treatments are involved?
How do the possible risks, side effects, and benefits in the study compare with my current treatment?
How might this trial affect my daily life?
How long will the trial last?
Will hospitalization be required?
Who will pay for the treatment?
Will I be reimbursed for other expenses?
What type of long-term follow up care is part of this study?
How will I know that the treatment is working? Will results of the trials be provided to me?
Who will be in charge of my care?
Q. what kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
A. Please see the bullet points below:
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.
Bring a tape recorder to record the discussion to replay later.
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, have an IRB that initially approves and periodically reviews the research.
Q. Does a participant continue to work with a primary health care provider while in a trial?
A. Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Q. can a participant leave a trial after it has begun?
A. 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.
Q. where do the ideas for trials come from?
A. Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
Q. Who sponsors clinical trials?
A. Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
Q. what is a protocol?
A. 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.
Q. what is a placebo?
A. 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 treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment. If a research study is dealing with participants who have a serious disease, like cancer or diabetes, for example, they will never be given a placebo in place of the trial drug.
Q. What is a control or a control group?
A. 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. If a research study is dealing with participants who have a serious disease, like cancer or diabetes, for example, they will never be given a placebo in place of the trial drug. These participants will either receive the study drug being tested or the industry standard of care, or treatment that is currently on the market, to be used for the comparison.
Q. What are the different types of clinical trials?
A. Please see the bullet points below:
Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
Q. What are the phases of clinical trials?
A. Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
The above information is provided by clinicaltrials.gov, a service of the National Institute of Health.
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