FREQUENTLY ASKED QUESTIONS

Medical research is the systematic investigation of health and disease to develop better ways to prevent, diagnose, and treat illnesses. It is the scientific foundation that allows medical professionals to understand how the human body works and how it responds to new therapies.

A clinical trial is a specific type of research study involving human participants that evaluates the safety and effectiveness of new medical treatments, drugs, or devices. These studies are essential for gaining FDA approval and bringing innovative care to the general public.

Medical care focuses on treating an individual’s current condition using established, proven methods. Medical research, however, focuses on gathering scientific data to help future patients by testing new, innovative approaches that are not yet part of standard care.

Randomization is a process used in some trials where participants are assigned by chance to different groups - usually one receiving the new treatment and one receiving a standard treatment or placebo. This ensures that the results are scientifically objective and not influenced by the researchers or participants.

Participating in a trial allows you to access innovative medical treatments before they are widely available and play an active role in your own healthcare. Additionally, your involvement helps advance science for future generations. Many trials also offer compensation for time and travel. 

Participant safety is the highest priority. Every trial is overseen by the FDA and an independent Institutional Review Board (IRB) to ensure ethical standards are met. Furthermore, the Informed Consent process ensures you are fully aware of all procedures, risks, and benefits before you begin.

Before joining a study, you will undergo a screening process to ensure the trial is safe and appropriate for you. These assessments may include physical exams, blood tests, or a review of your medical history to determine if you meet the specific eligibility criteria for the research. 

No. All study-related care, including exams, laboratory tests, and the investigational treatment, is provided at no cost to the participant. Health insurance is not required to qualify for or join a study.

Yes. Clinical trials are a supplement to your regular healthcare, not a replacement. We encourage you to stay in contact with your primary care physician, and our team can even share relevant study data with them at your request.

Your privacy is strictly protected under HIPAA and federal regulations. Personal identifying information is kept confidential, and your data is typically coded with a unique ID number so that your identity is never revealed in research publications or to third parties.

Yes. Participation in clinical research is entirely voluntary. You have the right to withdraw from a study at any time and for any reason without it affecting your future medical care or relationship with your doctor.

Yes, most clinical trials offer reimbursement to compensate participants for the time and effort required to attend study visits. This payment is intended to cover travel expenses, meals, and other costs associated with your involvement in the research.

We understand that getting to appointments can be a challenge, which is why we are happy to organize transportation for our participants. If you need assistance with a ride, please contact our research coordinator in Miami to arrange the details and ensure your visit is as easy as possible.

The duration of a clinical trial varies significantly depending on the study’s objectives. Some trials may last a few months, while others can span several years. Your specific time commitment - including the number of clinic visits and their frequency - will be clearly outlined in the informed consent documents before you begin. Our research coordinator will provide a detailed schedule to help you plan accordingly.

To help you navigate the research process, here are definitions for common terms you may encounter:

• Principal Investigator (PI): The lead doctor at the research site responsible for the conduct of the clinical trial and the safety of all participants.
• Informed Consent: The ongoing process of providing you with all the facts about a study, including potential risks and benefits, so you can make an educated decision about participating.
• Protocol: The detailed scientific plan that outlines exactly how the study will be conducted, what data will be collected, and the rules every researcher must follow.
• Inclusion/Exclusion Criteria: The specific requirements (such as age, health history, or medical condition) that determine whether a person can safely and effectively participate in a study.
• Placebo: An inactive substance or treatment used in a controlled study to compare the effects of the actual investigational drug or therapy.
• Institutional Review Board (IRB): An independent committee of medical and ethical experts that reviews and monitors research to ensure the rights and welfare of participants are protected.
• Sponsor: The organization (such as a pharmaceutical company or government agency) that initiates and funds the clinical trial.
• Adverse Event: Any unexpected or unfavorable medical occurrence that happens during a study, which is closely monitored and reported by the research team.

•  ClinicalTrials.gov: A comprehensive database of privately and publicly funded clinical studies conducted around the world.
  • https://clinicaltrials.gov/
• U.S. Food & Drug Administration (FDA): Information on how the FDA regulates clinical trials and ensures the safety of medical products.
  • https://www.fda.gov/patients/clinical-trials-what-patients-need-know
• Office for Human Research Protections (OHRP): Part of the U.S. Department of Health and Human Services, OHRP provides leadership on protecting the rights and welfare of research volunteers.
  • https://www.hhs.gov/ohrp/
• National Institutes of Health (NIH) – Clinical Research Trials and You: A dedicated resource for patients to learn the basics of clinical trials, find studies, and read personal stories.
  • https://www.nih.gov/health-information/nih-clinical-research-trials-you
• CISCRP (The Center for Information & Study on Clinical Research Participation): A non-profit organization focused on educating and informing the public about the clinical research process.
  • https://www.ciscrp.org/
• Association of Clinical Research Professionals (ACRP): Offers insights into the high standards of professional conduct and ethics that govern the people running clinical trials.
  • https://acrpnet.org/