Choosing to participate in a clinical research study is an important personal decision. Learn about participating in research studies in Tampa Bay. The next step is to contact the study research staff and ask questions about specific studies.
Scientific progress depends on the successful recruitment and retention of participants in health research studies. Often the most challenging aspect of conducting research studies can be the efficient and effective recruitment and retention of the study participants.
By becoming research study participants in Tampa Bay, you are contributing to the development of scientific knowledge and helping make progress toward the cures of tomorrow. Your participation is pivotal to the success of reaching the key research objectives and helps accelerate research.
Santos Research Center's recruitment process is streamlined to clarify things and keep you informed. We want you to enroll in the most appropriate study according to your needs so you can have the best possible results.
Initial phone conversation to determine study qualifications.
You review forms explaining your rights and obligations as a study participant.
Medical team will determine if you meet the basic study requirements.
You’re entered into the study and assigned a treatment schedule.
The clinical team will guide you and evaluate how you are doing.
Study completion visit to return your diary and medication.
A research study is a systematized activity to find out more about a problem or answer questions. Scientists conduct several different kinds of studies. For example, a clinical research study may examine if a treatment is safe and effective.
A clinical research study may be performed to find out what health care practices work best, to determine the best method to prevent an illness, or to understand the feelings people have about their health.
One type of clinical research study is clinical trials. A clinical trial is a health research study to determine whether brand new treatment options are safe and effective. Treatments are often compared with placebos to determine the effectiveness of new treatments.
A placebo is an inactive substance that may resemble an active substance. However, a placebo typically has no value in treating or preventing an illness.
There are many benefits of clinical trials for volunteers in Tampa, including free treatments, financial compensation, and the satisfaction of helping others.
Often, clinical research trial teams include top-notch medical professionals. By volunteering in a clinical research trial, you could have leading physicians and researchers working on your case. These professionals specialize in the area of your condition or disease.
Clinical research trials provide information about health concerns, diagnoses, and interventions. This information can be invaluable, especially with health conditions or diseases for which few effective treatments exist. If you participate in a clinical research trial, the information learned can help your case or help people with similar diseases or conditions in the future.
A clinical research trial may provide you with specialized care. There is the potential to get health examinations and to test interventions that may prevent or provide early detection of health diseases or conditions.
Aside from being able to experience new treatment approaches, volunteering in a clinical research trial also means that you will receive the best medication and treatment throughout the study.
While the compensation of being a clinical research trial volunteer typically won't replace the need for a job, you will be paid for your time and travel expenses.
A clinical study is conducted based on a research plan known as the protocol. The study protocol answers specific research questions and safeguards participants' health. It contains the following information:
After extensive laboratory research, clinical trials are usually conducted over 4 phases of testing.
To evaluate the safety and monitor the side effects of an experimental treatment, it is tested on a small research participant group (approximately 20-80 participants).
To study the safety and effectiveness of the treatment further, it is tested on a larger research participant group (approximately 100-300 participants).
To confirm the treatment's effectiveness, compare its performance with that of other treatments, and gather data on safe dosage/usage, the treatment is administered to an even larger research participant group (more than 1,000 participants).
After the treatment receives FDA approval and is made available to the public, its benefits and risks are continually tracked.
Generally, clinical studies are designed to add to medical knowledge related to treating, diagnosing, and preventing diseases or conditions.
Some common reasons for conducting clinical studies are the following:
A research subject is an individual that takes part in a health research study. Data is gathered from or about the individual to help answer the question under study. Research subjects are also referred to as human subjects, research participants, or study volunteers.
Each study has its own set of criteria that determine who can participate. This depends on the research questions being asked and may include restrictions according to age, behaviors, health status, or other traits.
Before you are enrolled in a study, the researchers may ask questions to determine if you are eligible to participate. In some cases, you may need to undergo specific testing, like a blood test or physical examination, to determine whether you can participate.
Research is performed to benefit society. It helps us gain knowledge, which might include learning how to live healthier lives, how to treat medical conditions or diseases better, why we do the things we do, or how we learn and develop. And while there are several reasons people choose to participate in research, most people participate in research based on the possibility of helping themselves and others.
It is important to know that you may not directly benefit from taking part in clinical trials. In fact, with lots of research, you will not receive any direct benefit. Additional information on benefits is provided below.
Participating in clinical trials may or may not benefit you directly. With several types of research, you will not receive any benefit. With some types of clinical trials, there may be a possibility that you could receive benefits, but there is no guarantee.
Participating in a clinical trial involving drugs, medical devices, or medical procedures may help specific health conditions get better, stay the same, or even get worse due to your participation. No one can completely predict the result of a clinical trial or its effects on you.
It is also important to understand that research and routine medical care are different. Research is done to answer the question under study or determine whether the drugs, medical devices, or procedures involved work.
Regular medical care is made to improve health, and the drugs, medical appliances, and procedures have already been proven to work.
The ethical and legal codes that govern medical practice are also applicable to clinical research studies. Also, most clinical research programs are federally regulated with built-in safeguards to protect the participants. The trial follows a controlled protocol, a study plan detailing what researchers will do in the study.
As a clinical study progresses, researchers report the trial's results at scientific meetings, in medical journals, and to various government agencies. Individual participants' names will remain secret and not be mentioned in these reports.
To begin, you will be given information about the study to make an informed decision about whether or not to participate. You will also be given the opportunity to ask questions about the study. This process is called informed consent. Before starting the study, you need to agree to participate (i.e., consent). Study participation is always voluntary.
Once you agree to participate, the specific procedures or activities you will be asked to complete can vary widely and depend on what is under study. The activities you will be asked to accomplish will be described during the consent process.
Clinical trials are directed by a principal investigator, mainly a certified medical doctor. Clinical studies also have a research team composed of nurses, doctors, social workers, and other healthcare professionals. Clinical studies can be funded or sponsored by pharmaceutical companies, academic medical centers, and other organizations.
At Santos Research Center, every study that involves human subjects is reviewed by an Institutional Review Board (IRB) before it is allowed to start.
IRBs consider the risk factors to the participants, the potential benefits to the subjects and/or others, the importance of the medical knowledge that may be gathered, the recruitment procedures, and the consent process that will be used.
An Institutional Review Board (IRB) is a committee of professionals who review projects submitted by researchers of the facility. Each IRB must also have at least one member representing the community who is not affiliated with the research facility.
Protecting the information you provide to the researchers is a high priority, particularly if you provide health-related or sensitive information.
As part of the IRB approval process, all researchers must provide a plan to adequately protect the information they will collect for the study to be approved. This may include assigning a code to the information collected in place of using your name or other identifying information and securely storing the information.
Most clinical studies involve some risks, though the risks can range from very mild to very serious. Some examples of risks include:
Side effects may be temporary or go away with treatment, but in rare cases, they may be permanent, cause disability or be life-threatening. There may also be risks in taking part that we don't know about.
You are always free to withdraw from a clinical research study at any time, for any reason, with no penalty. Your relationship with the facility will not be affected, and you will not lose any benefits to which you are entitled.
Please note that in some cases, the researcher may decide to end your participation in the study even before the study ends. This may happen if the study is no longer in your best interest, you can no longer complete the study activities, or if the study ends early for some other reason.
Each study is different, so the time requirements will vary. Some studies may require very little of your time, sometimes only 5-10 minutes, while others will require several in-person visits over an extended period, sometimes up to several years.
Before you agree to participate in a study, make sure you have a complete understanding of the following:
The voluntary nature of the study
Why it is being done
Who is doing the study
The procedures, activities, tests, or treatments involved in the study
Potential risks, discomforts, or side effects
Potential benefits to participating in a paid clinical trial
How the participants' privacy will be protected
How long the participation will last
What will happen if the volunteer is injured while participating in a research program
The costs to you, if any
What to do in case you change your mind about participating
Whom to contact in case of questions, concerns, or problems
If you are already taking part in a research program, you can communicate with your research team first, most especially if you are experiencing medical issues.
You can contact the Florida Department of Health for help if:
When you have completed everything required by the study, or you have decided to leave the study early, that's usually the end of your participation.
The research team may contact you after the study ends. This will be outlined in the informed consent form. The Principal Investigator (PI) might send you information about the study, which may include any new information that may affect your health.
If you took an experimental drug, you might be able to keep on taking the drug.
Researchers may or may not be able to provide study results at the end of the study. Sometimes, it may take many years to achieve study results. Ask the study investigator about this before you agree to participate.
When the study has been completed, the researchers gather all the information they have collected. They might publish the study results in scientific journals, present the results at conferences, and use the results to conduct more research.
If a drug company sponsors the research study, the company might use the data in order to support an application for approval for the drug by the US Food and Drug Administration.
Thousands of research studies are being conducted every year. These research studies have contributed to health improvements for people from every walk of life.
Very few health care advances would be possible without volunteers in research studies. You may be asked to participate in a research program approved by an IRB. This information aims to help you understand your rights as a research study participant. It will help you decide if you should participate in a research program. It will help you understand some of what is needed for a good research study. We urge you to review this information and discuss it with others you trust.
As a research study participant, you have the right:
1. To have ample time to decide whether or not to be in the research study and to decide without any pressure from the people conducting the research.
2. To refuse to be in the study and stop participating at any time after beginning the study.
3. To be told what the study is aiming to find out, what will happen to you, and what you will be asked to do if you are taking part in a study.
4. To be told about the potential risks of participating in the study.
5. To be told about the benefits of participating in the study.
6. To be told if there are any costs associated with being in the study and whether you will be compensated for participating.
7. To be informed who will gain access to gather data about you and how your confidentiality will be protected.
8. To be told whom to contact with concerns about the research, research-related injury, and your rights as a research subject. If the study involves treatment or therapy:
9. To be informed about the other non-research treatment choices you have.
10. To be told where treatment is available if ever you have a research-related injury and who will pay for research-related treatment.
We will answer your questions and keep you informed. We want you to successfully enroll in the most appropriate study based on your needs so you can have the best possible results.
At Santos Research Center, Corp., we have completed over 400 clinical trials. We utilize efficient and reliable systems to plan and manage quality medical research studies.
For more information about our ongoing clinical research, you may visit us at www.santosresearch.com.
If you are interested in participating in our paid clinical trials, contact us at (813) 249-9100.
Santos Research Center, Corp. is a research facility conducting paid clinical trials, in partnership with major pharmaceutical companies & CROs. We work with patients from across the Tampa Bay area.