For many of us, the idea of joining a clinical research study may be exciting, yet unfamiliar. Choosing to participate in a clinical research study is an important personal decision. It is often helpful to talk with your physician, family members or friends before deciding to participate in a research study. Questions that can arise in the process of deciding on joining a study may include:
What is a clinical research study?
Before a pharmaceutical company can bring a new drug to market the investigational drug must be tested in several clinical research studies. A clinical research study is carefully designed to test the safety, effectiveness, and side effects of an investigational medication on a group of volunteers.
Clinical research studies are regulated by the Food and Drug Administration (FDA) and closely monitored by an independent review board and sponsoring pharmaceutical company. Clinical research studies are an important step in making new medications available.
Who pays for clinical research?
Funding for clinical research comes from both the federal government through the National Institute of Health (NIH) and private industry, from pharmaceutical and biotech companies. The sponsor of the research hires physicians to conduct the clinical trial.
Who conducts a clinical research study?
A research team that conducts clinical research studies is led by a doctor or other qualified clinician, known as the Principal Investigator . The team may also include nurses and research staff. The research study may occur in our local hospital, medical center, or doctor’s office.
Who makes sure my rights are protected?
An independent ethics committee, known as an Institutional Review Board (IRB), must review clinical research studies before they begin. The IRB is a group of doctors, nurses, and people from the community.
They review all clinical research studies to help protect participants’ rights and safety. In addition, the FDA (Food and Drug Administration) sets requirements for drug testing. The FDA reviews the results from certain clinical research studies to decide if an investigational drug should be made available to the general public.
What is Informed Consent?
Informed consent is the process that takes place before you join a clinical research study. A doctor, nurse, or study coordinator will go over a consent form that helps explain why the study is being done and what you can expect. You can ask any questions you have about the study or any part of the consent form you do not understand. If you decide to participate in the research study, you will be asked to sign the consent form.
Are clinical research studies safe?
The government has put in place strict guidelines and safeguards to protect those who choose to participate in clinical trials. All research studies are overseen by the Institutional Review Board who examines the study’s protocol to ensure that the patient’s rights are protected, and that the study does not present an undue or unnecessary risk to the patient. In addition, anyone participating in a clinical research study in the United States is required to sign an informed consent form which details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
Should I participate in a clinical research study?
Each year, thousands of people volunteer to participate in clinical research studies. By volunteering you might:
- gain access to new research treatments before they are made available to the public,
- play a more active role in your health care,
- learn new information about your medical condition,
- receive study-related medicines and medical exams during the study, and
- help others by contributing to medical research.
Will participation in a clinical study cost me anything?
In exchange for the voluntary participation in our research, we provide professional care and close monitoring for each of our patients at no cost, and there is no need for health insurance.
Will I be compensated?
Compensation for your time and travel may be available and varies from study to study. It is determined by the length of the visits and any additional study requirements placed upon the volunteer subject.
Who can be in a clinical research study?
Each clinical research study has different requirements for participation. Study criteria are based on factors such as age, gender, or medical condition. Our research team will review your medical history and study requirements with you to determine if you are eligible.
What if I enter a study and change my mind?
You may leave a study at any time. You may choose to take part or not, and you can always change your mind later, even after you enter a trial.
What can I expect as a study volunteer?
During the study, our research team will review your medical history, give you instructions for participating, and monitor your health. Studies may involve laboratory tests and doctor visits.
How do I participate in a clinical research study?
To learn more about participating in a clinical study, simply call us at 352-629-5800 or toll-free at 877-629-5800. One of our study specialists will tell you about our enrolling studies and discuss qualification criteria with you.
Renstar Medical Research is currently conducting trials with local area physicians …
Please call (352) 629-5800 and speak with one of our Patient Recruitment Specialists to learn more information and find out if you qualify for participation.