What is a Clinical Trial?
Before a new treatment is approved and put on the market, it must undergo rigorous testing to ensure it is safe and effective. This testing is conducted as part of a clinical trial, during which volunteers are given the prospective treatment under strict regulations and guidelines. Clinical trials are research studies that assess ways to prevent, detect, or treat diseases and conditions.
What is Informed Consent?
Before you decide whether to participate in research, you must be fully “informed.” It is important for you to understand:
- Your participation is voluntary
- Why the research is being done
- What the researchers want to accomplish
- What will be done and for how long
- What risks are involved
- What possible benefits can be expected
- What other treatments are available
- You have the right to leave the study at any time without interfering with your regular care
- You have the right to ask questions and have them answered to your satisfaction
Why should I participate in a clinical trial?
People volunteer for clinical trials for many reasons. Some people join clinical trials to help doctors and researchers learn more about a disease and improve health care. Other people, such as those with health conditions, join to try treatments that are not widely available.
Participating in a clinical trial is entirely up to you. If you volunteer for a clinical trial and later decide it’s not right for you, you can withdraw anytime.
What is it like to participate in a clinical trial?
During a clinical trial, you will see a team of researchers who will monitor your health closely.
You may have more tests and medical exams than you would if you were getting standard health care.
Clinical trials occur in doctors’ offices, medical centers, and community-based organizations nationwide. You may need to travel or stay in a hospital to participate in a clinical trial.
Are clinical trials safe?
Clinical trials are generally safe. Though there are risks to participating in clinical research, clinical trials are designed to minimize risks and keep you safe.
Before a clinical trial can start, it must be reviewed and approved by an institutional review board. This review ensures that it is safe and that the potential benefits of the trial are worth the potential risks. The study team will also make sure you meet certain requirements and that it is safe for you to participate. The IRB is an independent committee established to help protect the rights of research participants.
Where can I sign up to participate in a Clinical Trial?
Clinical Trials are conducted locally and nationally. You can find a list of clinical trials at ClinicalTrials.gov. For more information regarding clinical trials at TriHealth, please call 513-862-4012.
What are my rights if I participate in a Clinical Trial?
Research Participant Bill of Rights
As a participant in a clinical trial, you have the right to:
- Be told why the study is being done and who is funding the study.
- Be given an explanation of what will happen during the study, what is expected of you, and what will be different from non-research medical treatment.
- Be given an explanation of any risks or discomforts that may be experienced from participating in the study.
- Be given an explanation of any benefits that may be expected from participating in the study.
- Be told, if treatment is part of the study, of other non-research treatment choices that are available and how they compare to participating in the study.
- Be given the opportunity to ask questions about the study or about participating in the study, before agreeing to participate and during the course of the study.
- Be told of your right to refuse to begin the study, or to change your mind and stop participating in the study after it has started. Your participation is completely voluntary. If treatment is part of the study, this decision will not affect your ability to receive non research treatment.
- Have enough time to decide whether to participate or not and to make that decision without any pressure from the people who are doing the research.
- Be told, if treatment is part of the study, whether there are any costs to you associated with being in the study and whether you will receive any reimbursement for participating in the study.
- Be told who will have access to information collected about you, how the information will be used, and how the confidentiality of your information will be protected.
- Be told who to contact directly with questions about the research, about research related injury, and about your rights as a research participant.
- Be told, if the research is greater than minimal risk, whether any compensation and medical treatments are available should you have a research related injury, what the treatments are, and where further information may be obtained.
- Be told about new information learned during the study that might affect your safety or your willingness to continue to take part in the study.
- Receive a copy of the consent form if one is part of the study.