Every day, research uncovers new information about medical conditions and possible treatment therapies. Your involvement in clinical research studies could help in the development of a new medication for future use. You and many other people may benefit from your willingness to become involved in clinical research. Your participation in a clinical trial program is entirely voluntary.
Should I Volunteer?
Volunteering to participate in a clinical drug study or trial is one of the best ways you can contribute to the understanding of diseases that affect you and many other people who may have the same illness.
As a volunteer, you are the most critical link in a long chain of research and testing. Without the efforts and willingness of volunteers to participate, medical research could not exist.
Each year, thousands of people volunteer to participate in a clinical research studies. Benefits to you as a volunteer may include:
- Getting expert medical care for your condition, illness or disease
- Learning valuable education about your condition,illness or disease
- Having the satisfaction of knowing that you are helping in the development of medical treatments that may help others
What is a Clinical Research Study?
A clinical research “trial” or “study” is conducted to answer specific questions about investigational medications, medical treatments or devices. All study participants are volunteers. The studies may include a select, very specific group of individuals or may include thousands of individuals in various parts of the world.
How is the Drug Approved for Testing?
Gov ernment agencies typically must authorize a drug company’s proposal to conduct clinical research studies. Drug companies must do years of laboratory research before they can begin testing medicines in people. All research studies have strict guidelines and are overseen by these government agencies to ensure their safety and effectiveness. The Federal Drug Administration (FDA) oversees all clinical trials in the United States.
Who Can Be In a Clinical Research Study?
People with the condition being studied as well as healthy people can volunteer to participate in a study. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with the condition being studied.
Each study has specific requirements such as age, sex or medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate Known risks and discomforts will be explained by the study physician prior to participating in the study. In addition to the known risks, they may be unknown risks, such as medication side effects, involved in participating in a clinical research study. Study procedures, risks and benefits are explained to volunteers during the informed consent process.
What is Informed Consent?
Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical research study. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring that informed consent is obtained from each research volunteer before that person participates in the research study.
Who is the Institutional Review Board (IRB)
The IRB is a group of healthcare professionals and members of the local community that must review and approve a clinical research study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of study participants.
How Can I Become a Study Volunteer?
For more information on clinical research studies and how to become a study volunteer, do either for the following:
- Go to the Enroll Now tab on this site and submit the needed information.
- Contact us at Info@southfloridamedicalresearch.com
- Call 305-931-8080 to speak with a medical professional who can answer your questions about being in a clinical research study and can tell you about the available programs.
We welcome the opportunity to speak with you about current and upcoming studies.
Glossary of Clinical Research Study terms
Clinical Investigator or Study Physician
A medical researcher in charge of carrying out a clinical research study. Researchers are usually doctors, nurses, clinical coordinators or other healthcare professionals.
Clinical Research Study
A process designed to study the effects and/or safety of an investigational medication, medical treatment or device on a group of volunteers.
Food and Drug Administration (FDA)
A government agency that enforces laws on the manufacturing, testing and use of drugs and medical devices. The FDA must approve a drug for marketing before it can become readily available to the medical community and the public.
A discussion of procedures, benefits and risks of a clinical research study between clinical investigators and persons interested in participating in the study. The FDA requires that volunteers sign an informed consent form (approved by the IRB) before entering a study.
Institutional Review Board (IRB)
A group of healthcare professionals as well as members of the local community. The IRB carefully reviews clinical research study activities, as it is responsible for protecting the safety and the rights of the volunteers.