Your doctor would be happy to answer any questions you have about research.
You can also reach out to our clinical research coordinators with any questions you may have. Their contact information is provided with each clinical trial listing. They would be happy to help!
What is clinical research?
Doctors and scientists study new treatments for illnesses and disease. They also study how to help people stay healthy. This is done by gathering specific information from people and is called clinical research.
Here at Ochsner, we have teams of doctors, scientists, and clinical research coordinators who work together to improve patient care through clinical research.
What is a clinical research study?
A clinical research study is a project to learn more about a specific illness or disease or treatment. There are different types of research studies. Some studies only ask participants to answer questions about their health. Other studies may test a new medicine or medical device. When the study is testing a new medicine or device, it is called a clinical trial.
What is a clinical trial?
A clinical trial is a scientific study that determines how a new medicine or medical device works in people. Clinical trials are done before a new treatment is available by prescription or to be purchased over-the-counter. Any medication or medical device that you use has been studied this way.
Why do we need clinical trials?
We need clinical trials so that we can see how the new medicine or device will work in the real world in people who may need it. Clinical trials test new treatments in a small number of people. Not every clinical trial leads to a successful new treatment, but each can provide another piece of knowledge toward solving the puzzle.
Who are the study staff or the study team?
The people who work together on each research project are known as the study staff or the study team. The team is made up of doctors, scientists, clinical research coordinators, pharmacists, and others.
What if I get asked to participate in a research study?
Participating in a research study or clinical trial is always your choice. Research studies cannot be done without patients who want to help. Your doctor or a member of the study team will explain the study to you in detail. This is part of the informed consent process. They will answer any questions you may have. They will ask if you are interested in participating.
If you are asked to participate – it’s your choice! Your care will not change if you decide not to participate.
Who looks out for me?
Rules and Regulations
There are federal and international regulations that are designed to protect the rights of people who participate in research. You can visit the FDA website to learn more about the rights of research participants.
One important requirement is that people everywhere have the right to choose whether or not they want to participate in research. Another requirement is that all research studies involving people must be reviewed and approved by an independent group of people. This group of people is called an Institutional Review Board.
Institutional Review Board (IRB)
Any research that is being conducted must be approved by an Institutional Review Board (IRB). This is a group of physicians, scientists, nonscientists, clergy, and community activists. They carefully review each study to make sure:
- that it does not put the participants at unnecessary risk
- the research is necessary
- the research is being conducted in an ethical and responsible way
Everyone at Ochsner who is involved in research is trained to follow the regulations and to respect the rights of each person who participates in research. You may even notice that the research team refers to you as a “research subject” instead of a patient. Research professionals do this, so that they never forget that you have special rights and protections. They also do this out of respect and appreciation for your willingness to participate and to help us improve care for all of our patients.
At Ochsner, we value our research subjects!
What is informed consent?
Informed consent is a process where a member of the study team explains the study in detail to someone who is considering whether or not to participate.
The person explaining the study will discuss the purpose of the study and its known risks and benefits. They will provide detailed information on what participating in the study will look like. People considering participation are encouraged to ask questions or talk about their concerns.
What is a consent form?
When a study team member talks to you about participating in a study, usually they will have a document for you to review called a consent form. This is a document that details everything about the study. It tells you what treatments or procedures would be required if you participate and what doctors hope to learn from doing the study. It spells out the known risks and any possible benefits to participating.
This form is used along with the informed consent process to ensure that you have all of the available information. This should allow you to decide whether or not you want to participate. Please be sure to ask your doctor or the study team about anything you do not understand.
If you decide to participate, you will sign this form. A copy of the signed form will be given to you for your records.
Are there benefits to participating in research?
There may be benefits to participating in a research study. Each study is different. Your doctor or a member of the study team can explain any expected benefits of a particular study.
Are there risks to participating in research?
There may be risks if you choose to participate in research. If you are asked to participate in a study, your doctor will explain any risks that may be related to that study. Be sure to ask any questions you have.
What is a blind study?
In a blind study, participants do not know which treatment they are receiving. They are “blind” to which treatment they are getting. Double-blind means that both the participant and the doctor do not know which treatment a person is receiving. If you are participating in a research study that is blind, please ask the study team to explain how it works for your study.
What does randomized mean?
The goal of most clinical trials is to use different treatments for similar patients to learn which treatment works the best. In order to make sure that the groups are the same, or almost the same, people get assigned to each group randomly. It is a lot like flipping a coin. A randomized study means that you and your doctor do not get to pick which treatment group you are assigned to. If you are participating in a study that is randomized, be sure to ask the study team for more information.
What is a placebo?
A placebo is a fake or sham treatment. It is made to look just like the treatment being studied. A placebo is sometimes used in research studies because it helps doctors and scientists know if the treatment is helping people get better or if they would get better anyway without the treatment. A placebo is not used in a research study when it might be unsafe or unethical to not treat the people participating. If a study you are participating in has a placebo, the study team can explain more. Be sure to ask!
What is a Sponsor?
Some medicines and medical devices are developed or manufactured by companies. When a company wants to test their new medicine or medical device through a clinical trial, they need people who are willing to participate. They often partner with hospitals, clinics, and doctors who have patients that may want to participate.
The sponsor usually provides financial support to the hospital to do the study and may provide the medicine or device to the participants for free.
Who approves a new medicine or medical device?
The FDA approves new medicines and medical devices using the information learned from clinical trials. You can learn more at the FDA website, www.fda.gov.