Welcome to the Clinical Research Department at Colon and Rectal Surgery Associates
We conduct cutting edge pharmaceutical trials within the guidelines and regulations of the U.S. Food and Drug Administration and good clinical practices (GCPs).
The team oriented and well-trained staff is committed to provide safe, honest and compassionate care to study participants in the course of collecting data and to assess the safety and efficacy of investigational drugs and treatments as directed by pharmaceutical sponsors. The Clinical Research Department promotes patient service, teamwork, education and continued growth.
Dedicated to providing premier care and innovative therapies to our patients
One way we meet this goal is by participating in clinical research studies. A clinical research study or clinical trial is designed to evaluate how a new drug, biologic, or device works in treating a specific illness, disorder or condition. A study may evaluate a product that has not yet been approved by the Federal Food and Drug Administration (FDA) or it may compare two approved treatments to see if one is more effective than the other. Our physicians are involved in studies that are designed to allow us to learn as much about a treatment as possible, while maximizing the benefit to our patients.
The safety of all our study participants is of utmost importance to us
Any clinical study that is conducted here is approved by an independent Institutional Review Board (IRB) whose job it is to ensure that patients’ rights are protected and that a study does not present undue risk. Strict federal mandates are followed to ensure that all studies are conducted safely and ethically. Any patient who is considering participating in a clinical trial is required to sign an informed consent form. This document details the purpose of a study, the risks involved, any potential benefits as well as alternative treatments available if they chose not to participate. Potential participants must pass a screening period to ensure they meet all eligibility requirements.
Our Research Staff
We have a dedicated research department whose team members are required to receive additional training on the safe and ethical conduct of clinical research and certification in the protection of human subjects’ safety. Our research coordinators work very closely with our study participants and surgeons to ensure each study is conducted in compliance with the study protocol and all local and federal mandates.
Participation in a clinical research study is always voluntary
Typically our patients do not receive payment for their involvement. If you think you may be interested in a research study, please discuss your interest with your CRSAL physician or call our research department at 651-225-7800 and ask to speak to one of our coordinators. Research at CRSAL is focused on specific disease and disorders of the colon and rectum. We do not conduct studies on healthy volunteers.
What you should know about research studies
Medical research helps improve the quality of life for people around the world. Research studies test new medicines, treatments, devices and equipment.
The following are questions and answers about research studies.
Research studies are also called
- clinical experiments
- clinical research trials
- clinical studies
- clinical tests
- clinical trials
- experimental studies
- experimental tests
- experimental trials
- research experiments
- research tests
- test studies
Will your doctor be doing the research study?
The study may be done by your doctor, another doctor, or a researcher.
Will your health insurance pay for the cost of the research study?
Not always. Ask the doctor or researcher and your insurance company if you will need to pay for any of the research study costs.
What happens during research studies of new medicines?
First, a few volunteers test the safety of the medicine and how much should be taken. Then, larger groups of people test the long-term safety of the medicine and how well it works. Find out which group you will be in.
Are you guaranteed to get the new medicine or treatment?
You could get a placebo in some studies. A placebo is a medicine or treatment that won't affect your health. Or, you could get a substitute medicine or treatment. The substitute is comparable to the new medicine or treatment.
Will the study help you if you get a placebo or substitute?
Probably not, but your participation can result in information that will help others.
Can the research study make your condition worse?
Ask the doctor or researcher what could happen to you during the study. Ask for a copy of the study “protocol” or plan. Ask about side effects of the medicine, treatment, device or equipment. Look for side effects while you are in the study.
What is “informed consent"?
This means that the doctor or researcher told you about the research study and its risks. It also means that you understand what you were told. You will be asked to sign an informed consent form. Take the form home and read it with your family before you decide if you want to sign it.
What should you do if you don't understand the informed consent form or study protocol?
Ask your doctor or the researcher to explain them to you. You can also ask your doctor or the researcher to recommend a patient “advocate.” This person helps patients understand their treatment and their choices in treatment.
Who can you call if you have concerns about the research study?
Many research studies are reviewed by an Institutional Review Board. This board makes sure that the study is safe. It can also stop a study if there is a concern about safety. If the study is paid for by the federal government it must be registered with the Office of Human Research Protections.
Questions to ask the doctor or researcher
- Why is the research study being done?
- Who is doing the study?
- How long will the study last?
- Will you be able to continue seeing your own doctor?
- Is there any cost to you? Will you be paid to participate in the study?
- Does anyone receive money for your participation in the study?
- What tests or treatments will be used in the study?
- What are your other choices if you decide not to take part in the study?
- Will the new treatment help you more than the regular treatment?
- Could you get a placebo or a substitute?
- What could happen to you if you take part in the study? Has anyone reported any bad effects?
- How serious were they?
- Could your condition get worse during the study? What happens if it does? If your condition worsens, will you be told? How?
- Who pays for your care if you're injured during the study?
- Can you stop participating in the study if you change your mind? Is there any danger to you if you stop participating?
- What will happen to you after the study?
- Will you be told the results of the study?
- Who do you contact for information about the study?
- Are there any patient advocates you can talk to? The advocate should not be employed by the clinic or laboratory that is doing the research study.
- Who could benefit financially from the results of the study?
- Does the doctor or researcher personally benefit if you participate?