Information for Research Participants
Study participants are integral to the success of research conducted by the University of Florida. Deciding whether or not to participate in research is significant and voluntary. You do not have to participate in any research. If you decide to participate, you can stop participating at any time. The University of Florida will not penalize you in any way nor will you lose any benefits that you are entitled to if you do not want to participate in research or chose to stop participating in research. Before deciding to participate in research you should make sure you understand the research including what will be done as part of the research, the risks to you, how you or others might benefit, if it will cost you anything to participate, what information researchers will collect about you, who they will share that information with, and if applicable other issues described in the Informed Consent form for the study. You should also discuss whether or not to participate with your family and friends.
Below is some additional information about participating in research.
Should I take part in a research study?
If anyone asks you to take part in a research study, you have the right to say “no.”
- Your decision will not affect your relationship with the organization conducting the research.
- You need to weigh both the risks of the study and the benefits.
- It may be help to talk with family, friends, or other people you trust.
- If you decide to take part in a research study, you can change your mind and stop or leave the study at any time without anyone holding it against you.
If you have any questions, concerns, or complaints about research, or just want to talk to someone about research in general, please contact:
UF IRB Office
Sheppard Broad Building
1300 Center Street
Gainesville, FL 32610
We are committed to responsible research. Research has significantly contributed to improvements for many people from every walk of life.
Many advances in knowledge would not have been possible without individuals willing to take part in research. You may be asked to volunteer for a research study. This booklet will help you understand your rights as a research volunteer and help you to decide if you should take part. It will also help you understand some of the basic requirements for good research. We urge you to review this information and discuss it with other people you trust.
What is a research study?
A research study is an organized activity to learn more about a problem or answer questions. Many different kinds of studies are conducted. For example, a study may test if a product, such as a drug or equipment, is safe and effective. A study may be done to find out what education practices work best. A study may use a survey or an interview to understand needs, problems, or feelings people have about an important topic. A study may be done to determine the best way to treat or prevent an illness.
What is a clinical trial?
Clinical trials are a type of research study that explores whether a specific medical strategy or treatment (usually a drug or device) is safe and/or effective in humans. For example, clinical trials may show which treatment works best for certain illnesses or groups of people. The purpose of clinical trials is to produce information that helps provide better treatment (such as more effective, fewer side effects, shorter, or less expensive) for patients. Clinical trials may or may not be better than the treatments that already exist.
Click here to learn more about clinical trials.
What is a research participant?
A research participant is someone who decides to participate in a research study. Deciding to participate in research is completely voluntary. Research participants help researchers look at the questions he/she wants to study. Research participants can quit participating in research at any time.
Who can be a research participant?
Anyone can participate in research. Participants include patients in the hospital, students at UF or elsewhere, people in our local community, or possibly even people elsewhere in or outside the United States. Research studies usually have specific requirements for who can and cannot participate in the research. In order to protect research participants, only people who meet the requirements can participate in the study.
Why volunteer for a study?
There are many reasons to take part in research. You may want to:
- help scientists find out more about how the human body and mind work.
- help other people.
- help find a cure for an illness.
If you decide to take part in a research study, you do so as a VOLUNTEER. That means YOU decide whether or not you will take part. If you choose to do so, you have many important rights.
Are there benefits to participating in a research study?
There may or may not be a direct benefit to you if you take part in a research study. You may get better as a result of your taking part in the study, you may stay the same, or you may even get worse. No one can predict the outcome of a research study or how it might affect you. The study may not help you personally, but your taking part may result in information that helps others in the future.
What questions should I ask before I agree to participate in a research study?
Before you decide to volunteer to take part in a research study, you need to know as much as possible about the research study. If there are any issues that concern you, be sure to ask questions. You might want to write your questions down in advance or take this booklet with you. The following is a list of sample questions. Not every question will apply to every study.
Remember, if you do not understand the answer to one of your questions, ask the question again and ask the person to explain the answer in a way you can understand it. If you forget the answers to the questions during the study, just ask them again.
- Who is doing this study and what question might it answer?
- Will this research help in understanding my condition? If so, how?
- What tests or procedures will be done?
- Will I have to make extra trips?
- What could happen to me, good and bad, if I take part in the study?
- How long will this study last?
- What will happen to any specimens that I give?
- Who has reviewed and approved this study?
- Could I get worse during the study? What will happen if I do?
- What other options or choices do I have if I decide not to take part?
- Will I be charged anything or paid anything to be in this study?
- If I decide to take part in this study, how will it affect my daily life?
- What will happen to me at the end of the study?
- Will I be told the results of the study?
- Who will find out that I am taking part in this study?
- How do I end my taking part in this study if I change my mind?
- Whom do I contact for questions and information about the study?
What is informed consent?
Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon a clear understanding of what will take place in the study and how it might affect you. Informed consent begins when the research staff explains the facts to you about the research study.
The research staff will assist you with the “informed consent document” that goes over these facts so you can decide whether or not you want to take part in the study. These facts include details about the study, procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.
Who will answer my questions about the informed consent document?
You should take your time when you read the consent document. If you have any questions, ask the research staff. If you don’t understand something, ask them to explain it to you so you do understand. If English isn’t your native tongue, ask for an interpreter to be present when you are discussing the study with the research staff. The written and verbal informed consent information will be given to you in a language that you know. You can take the information home with you and discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the study.
If you decide to take part in the study, you will be asked to sign the informed consent document. However, the informed consent process is more than just signing a piece of paper. It is a process that goes on throughout the study. During the course of the study, you may be told of new findings, benefits or risks. At that time, you can decide whether or not to continue your taking part in the study. You may change your mind and leave the study before it starts or leave at any time during the study or the follow-up period.
Who will see my records?
Like your medical record, the information in your research record will be confidential. Information will be given only to the researchers who carry out the study or to those who make sure that the study is safe and carried out the way it was planned. The groups of individuals who might look at your records are the research staff, The Institutional Review Board (IRB), the company or group funding the study, and various government oversight agencies. It is important for these groups to be able to look at your records so they can ensure that the study is conducted using acceptable research practices.
What is a PI?
PI is an acronym that stands for Principal Investigator. The PI is the researcher who is in charge of conducting the research study. The PI directs any other researchers or research staff who help conduct the research. These researchers might help the PI obtained informed consent from participants, conduct some of the research activities, collect or analyze the research data, or other tasks to conduct the research. The PI is responsible for ensuring the research is done correctly.
Who do I talk to if I have a concern, complaint, problem, or question about my rights as a research participant?
If you have a concern, complaint, problem, or question about your rights as a research participant, you can contact the UF Institutional Review Board (IRB) at:
Phone: (352) 273-9600, or via the IRB Compliance Hotline at (352) 294-5549.
UF IRB Office
Sheppard Broad Building
1300 Center Street
Gainesville, FL 32610
Concerns can also be reported anonymously via UF’s Compliance Hotline:
What is an IRB?
The Institutional Review Board (IRB) is a group of people such as scientists, non-scientists, and people from the local community who ensure that human research is ethical.
The IRB serves to protect your rights and your welfare before and during the research study. For example, the IRB makes sure that any risks in the research study are as small as possible. The IRB does not make a decision for you. The IRB decides, when approving research studies, that it is reasonable to ask people whether they want to be involved in it, The IRB also reviews each study while it is going on to make sure volunteers are protected.
What research studies can I participate in at UF?
The University of Florida, Shands Hospitals, and North Florida/South Georgia Veteran Health Systems (NFSGVHS) have many different types of research available. This includes not only medical clinical trials (such as experimental treatments for specific diseases/conditions), but also research on everything from gene therapy, psychological conditions, dentistry studies, physical therapy, biology/pathology, general population studies, to numerous other studies.
The Institutional Review Board’s (IRB) primary mission is to protect the rights and welfare of the subjects / participants in research studies. The IRB does not inform potential subjects or referring physicians about available research studies.
However, if you are interested in learning more about what research is available at UF, Shands, or the NFSGVHS, you need to contact the appropriate department to learn what studies are currently open and enrolling new subjects. You can call the hospital operators at the numbers below and ask to speak to someone in the deparment you are interested in:
UF&Shands operator = (352) 265-0111
NFSGVHS operator = (352) 376-1611
In addition, information can also be found on the internet at:
- UF Health Research Studies & Clinical Trials
- Research at the UF College of Dentistry
- Research at the UF College of Health and Human Performance
- Research at the UF College of Medicine
- Research at the UF College of Nursing
- Research at the University Of Florida Health Cancer Center
The NFSGVHS has helpful information for veterans considering research at:
Click here for the federal Office for Human Research Protections pamphlet “Becoming a Research Volunteer: It’s Your Decision.”